KR101904438B1 - Method for Manufacturing Wire-Mesh Stent - Google Patents

Abstract

본 발명은 스텐트 시스템의 주요한 구성 요소인 스텐트(stent)와 전달기구(delivery device)를 분리가 아닌 통합 관점에서, 특히 현실적 필요사항인 전달기구에 적용이 가능한 장착성(loadability)을 확보하기 위해 와이어 엮기 스텐트의 기본 구조 형태를 미시적으로 접근하여 분석 및 정량화 하였으며, 특정한 1가지 스텐트 구조가 아닌 요구되는 특정 성능 구현을 위해 다양한 응용 구조 변경이 가능한 다변형성 구조패턴을 형성하였다.The present invention relates to a wire-mesh stent having a combination of a hook and a cross having an outermost border radius defined by the following formula (1), a method for producing the wire-mesh stent, ≪ / RTI >
Equation 1

The present invention is not limited to a stent and a delivery device, which are the main components of a stent system, but is a wire harness for securing loadability that can be applied to a delivery mechanism, The stent structure was microscopically analyzed and quantified, and a multi-deformable struc- ture pattern was formed to allow various application structures to be modified to achieve the required specific performance rather than a single stent structure.

Description

TECHNICAL FIELD [0001] The present invention relates to a method for manufacturing a wire-mesh stent,

The present invention relates to a method of calculating a stent diameter after compression, a method of manufacturing a wire-wired stent, and a method of patterning a polymodal structure of the wire, and more particularly, ) And a cross, a method for manufacturing a wire-wired stent, and a method for patterning a polymodal structure of a wire-wired stent.

The stent, which is a cylindrical medical device inserted into the body for the purpose of maintaining the lumen of the human body, can be classified according to the human organs to which it is applied (Fig. 1), but the more extensive classification is largely classified into plastic stent, Tube stents, and wire stents (Fig. 2).

In particular, the stent is a medical device applied to the interventional medical operation field based on the concept of minimally invasive medical care. Therefore, the stent is not applicable directly to the stent itself, (FIG. 3), it is very important to form the stent structure considering the mounting performance that can be easily mounted on the delivery mechanism together with the performance of the stent itself.

Particularly, the delivery device is thinner, that is, smaller in diameter, for minimizing the suffering of the patient and for the convenience of the medical staff due to the characteristic of being inserted into the human body and passing through the lumen of the human body It is expected that the development of the stent structure considering the mounting mechanism of the delivery mechanism will become one of the main points in the future stent field, especially in the wire stent field.

Stent Insertion Mechanism The ease with which the stent is inserted can be more easily understood if the stent is attached to the stent. The currently used method is to push the stent into the delivery device (push type) or pull it in the opposite direction (pull type) (Fig. 4).

Therefore, in order to facilitate the installation, the smaller the compressed volume of the stent is, the smaller the diameter of the stent is.

This is a technical performance factor of the stent, which can be defined as the compression rate (ie, how much compression (compression) can be done), so that the higher the compression rate, the smaller .

In order to consider the compressibility associated with the mounting of a small diameter transmission mechanism, it is necessary to microscopically analyze the shape structure of the wire stent when it is woven, so that it is basically necessary to have a sufficiently stable compressed structure.

In addition, a stent structure or structure patterning method having various structural deformations capable of customizing the required performance according to the characteristics of other applied stents is required, and the technique has been devised.

On the other hand, the prior art has the following problems. First, we describe (describe) a specific structure and the method of weaving (manufacturing) the structure. Secondly, we describe the process of weaving (manufacturing method) as a center without technical description of the main elements of the weaving (manufacturing) method. Third, the manufacturing method is very difficult to understand and the applicability to the deformed structure (pattern) is very limited. Fourth, as a review of the loadability and loading accessibility of the delivery device, which is focused on the implementation of a specific function of the stent itself in the macroscopic point of view, The analytical approach to the microscopic point of view was lacking.

On the other hand, the microstructure of the wire-wired stent has a pattern having a multi-layer structure unlike the tubular stent, which forms a single-layer pattern by laser processing or the like.

The core of the tubular stent structure is the strut and the cell shape and arrangement. The strut acts as the frame / frame of the structure and the state of the cell (open or closed) depends on the connection type of the strut. (Fig. 5).

In addition, the structure of the tubular stent composed of the strut and the cell is such that the cross section of the cylindrical tube becomes the base layer (thickness) constituting the stent and all the patterns are formed in the form of various struts and cells on a single cross section And can be seen as a single layer stent (Figure 6).

However, since wire-wired stents intersect or twist wires to form a specific structure (shape or pattern), a simple and basic structure of hook and cross structure is constituted. A cross is a structural form that occurs when wires are crossed and crossed (Figure 7).

Due to the structural form of the wire weaving structure, the wire-woven stent can be seen as a structure having a multi-layer rather than a single layer. In order to smoothly mount the wire- You should look at the structure in.

The basic form of hook and cross is very simple, but the structure of the wire-wrapping stent with various mechanical properties is formed by various arrangements of hooks and crosses.

Woven wire staples can be made by manual labor or machinery work to form a specific structure (shape). In case of mechanical work, it is difficult to work such as torsion, A stent structure is formed. A representative stent of this type is a wall stent (U.S. Pat. No. 4,655,771) (Fig. 8).

There is also a stent structure consisting of only a hook through manual operation. Representative example is as shown in Fig. 9 (Korean Patent No. 267019).

The basic form of hook and cross is very simple, but the structure of the wire-wrapping stent with various mechanical properties is formed by various arrangements of hooks and crosses.

Therefore, the core of the wire weaving stent structure can be said to be a hook and a deployed pattern of hook and cross (hereinafter referred to as a structure pattern) . ≪ / RTI >

In brief, in the case of the two stents, a stent composed of only a cross has good manufacturability and good attachment of the delivery mechanism, but is poor in shortening, axial force, and anti-migration performance .

For reference, shortening is performed by pressing (compressing) a larger-diameter original stent and mounting it on a delivery device with a smaller diameter than the original length of the stent. It is difficult to mount it precisely on the part, so the shorter the length, the more advantageous it is.

In addition, axial force refers to the force that stretches out to the axial direction. When the axial force is large, the stent tends to remain straight. Therefore, when the stent is mounted on the digestive tract, Is forced to extend to the date to cause pain, the lower the axial force, the more advantageous it is.

In addition, anti-migration is more likely to move to a site other than the target site on which the stent is mounted.

A stent consisting solely of a hook is superior to a stent consisting only of a cross in the axisymmetric, axial and migration prevention performance, but the volume increase due to the hook and the twisted line (Fig. 10), there is a significant problem with the delivery device mounting due to the additional volumetric increase resulting in a larger diameter delivery device than a cross-only stent, (Insertion) and difficulty in tilting when moving in the intestines, resulting in difficulties for both the patient and the practicing physician.

In addition, fatigue failure of the stent due to long-term interlocking motion of the intestines such as the esophagus and the large intestine is also weaker than the cross structure.

As can be seen from the above example, a stent composed of only a hook or a cross has an extreme advantage of the wire-wound stent. Therefore, rather than using only a single structure as described above, The proper combination of the hook and the cross is more effective in the wire-wired stent structure.

It is also known that the upper esophagus, the lower esophagus, the duodenum, the biliary, the hephatobiliary, the pancreas, the ascending colon, the transverse colon, Since the organs such as descending colon, sigmoid colon, and rectum have unique intestinal structure, function, and kinetic characteristics, it is necessary to make a suitable stent structure in each organ. We need a structural patterning method of wire weaving stent that can apply various deformability instead of a single structure with limited structural deformity.

Numerous papers and patent documents are referenced and cited throughout this specification. The disclosures of the cited papers and patent documents are incorporated herein by reference in their entirety to better understand the state of the art to which the present invention pertains and the content of the present invention.

The present inventors have sought to develop a method of forming a structure of a stent taking into account the performance of the stent itself and the ease of mounting to a delivery mechanism. As a result, the stent and the delivery device, which are the main components of the stent system, are not separated from each other but from an integrated point of view. In order to ensure loadability that can be applied to a delivery mechanism, A wire-mesh stent, which is defined by the compression ratio (or compression ratio, r _comp ), was manufactured by microscopic analysis and quantification of the basic stent structure. We have developed a method to facilitate the description and structural modification of the stitch structure pattern of wire weaving through symbolic expression, and we have developed a wire weaving method which can diversify the function, performance and implementation method (manufacturing method) of the wire stitching stent. A variety of technical implementations have been developed for hooks and crosses, which are the basic elements of the stent, and one specific stent The present invention has been accomplished by developing a multi-deformable structure pattern forming method capable of changing various application structures in order to realize a specific performance required not a structure.

It is therefore an object of the present invention to provide a wire-mesh stent having an outermost border radius defined by equation (1) and consisting of a combination of hooks and crosses.

Another object of the present invention is to provide a method of manufacturing the wire-weaving stent of the present invention described above.

It is still another object of the present invention to provide a method of patterning a polymodal structure of a wire-wound stent of the present invention.

Other objects and advantages of the present invention will become more apparent from the following detailed description of the invention, claims and drawings.

According to one aspect of the present invention, the present invention provides a wire-binding stent having a compression ratio (or a compression ratio, r _comp ) defined by the following equation (1) and composed of a combination of hooks and crosses wire-mesh stent:

Equation 1

In Equation (1), D _stent represents a diameter of stent before compression, D _ob represents a diameter of stent after compression, D _ob = 2R _ob , R _ob represents the radius of the outmost boundary.

According to an embodiment of the present invention, the outermost border radius (R _ob ) is defined by the following equation:

Equation 2

In Equation (2), R _tb represents an inradius of an outmost boundary and is defined by Equation (3), where N _xo is the number of virtual hook nodes tangent to the outermost boundary tangential on the outmost boundary) and is defined by the following equation (4).

Equation 3

Equation 4

In Equation (4), W _hook denotes a nominal width of a hook node and is defined by Equation (4-1) below.

Equation 4-1

According to another embodiment of the present invention, in the above Equation (4-1),? _W represents a diameter of wire, SF _wh represents a hook scale factor of a hook node 3.3, R _tb in Equation (4) represents an inradius of the outmost boundary and is defined by the following equation (5), and the number of virtual hook nodes (N _xo ) tangent to the outermost boundary line: Is a round to the nearest integer that satisfies the boundary condition of Equation (6): < RTI ID = 0.0 >

Equation 5

Equation 6

및 R_ib < R_tb < R_ob

And R _ib <R _tb <R _ob

In Equation (5), R _ib represents a radius of an inmost boundary, and H _hook represents a nominal height of a hook node.

인 경우에 다음의 수학식 7의 경계 조건을 만족하는 정수(integer)이다:According to still another embodiment of the present invention, in the above Equation (4), the number of virtual hook nodes (N _xo ) tangent to the outermost boundary line is

Is an integer that satisfies the following boundary condition of Equation (7): &quot; (7) &quot;

Equation  7

According to yet another embodiment of the present invention, in Equation (4), the radius R _{ib of} the innermost circumference is defined by the following equation (8), and the hook node nominal height H _{hook is} calculated by the following equation Lt; / RTI &gt;

Equation  8

Equation  9

In Equation (8), N _xi denotes a number of virtual hook nodes tangent to the innermost boundary, and SF _hh denotes a hook node height measure factor height scale factor of the hook node) and has a value of 3.

More preferably, the number of virtual hook nodes (N _{x i} ) tangent to the boundary of the innermost circumference is the largest round to the nearest integer satisfying the boundary condition of Equation (10)

Equation  10

Even more preferably, W _avg represents the average nominal width of the node per section of stent and is defined by the following equation (11), where N _t is the total number of nodes per stent section (12) where N _h represents the number of hook nodes per section, and N _h represents the total number of nodes per section of stent.

Equation  11

Equation  12

In Equation (12), N _c represents the number of cross nodes per stent section.

Even more preferably, W _total represents the total sum of nominal widths of all nodes per section of the stent section and is defined by: &lt; RTI ID = 0.0 &gt;

Equation  13

(수학식 14)로 정의되며, 상기 SF_wc는 크로스 노드 폭 측도인자(width scale factor of cross node)를 나타내고 2의 값을 갖는다.In Equation (13), W _cross represents a nominal width of a cross node

SF _wc is a width scale factor of a cross node and has a value of 2.

According to another embodiment of the present invention, the number of hooks satisfying the compressibility defined by Equation (1) is an integer of 3 to 8 per radial section of the stent.

According to another embodiment of the present invention, the stent is made of a material selected from the group consisting of metal, synthetic polymer, and natural polymer.

According to another embodiment of the present invention, the metal may be a Ni-Ti shape memory alloy, a martensitic Ni-Ti shape memory alloy, a stainless steel tantalum, tungsten, gold, platinum, silver, nickel, titanium, titanium, and the like, Chromium (Cr), cobalt chrome alloy, platinum-chrome alloy, platinum-iridium alloy (Pt-Ir) And a magnesium alloy.

According to yet another embodiment of the present invention, the synthetic polymer is a degradable, non-degradable polymer or a combination thereof.

More preferably, the degradable polymer is selected from the group consisting of poly (lactic acid) and copolymers thereof, poly (glycolic acid) and copolymers thereof, polyhydroxy butyrate (poly poly (hydroxy butyrate), poly (e-caprolactone) and copolymers thereof, poly (alkylene succinates), polyanhydrides and polyorthoesters poly (ortho esters)).

More preferably, the non-degradable polymer is selected from the group consisting of polyamides (nylons), poly (cyano acrylates), polyphosphazenes, thermoplastic polyurethanes, and low density polyethylene low density polyethylene, poly (vinyl alcohol), poly (ethylene oxide), poly (hydroxyethyl methacrylate), poly (methyl methacrylate) ), Polytetrafluoroethylene (PTFE), polydimethylsiloxane, polyethylene oxide-propylene oxide (poly-ethylene oxide), polyvinyl methyl ether methyl ether), poly (N-alkyl acrylamide), polyethylene terephthalate and polypropylene e).

According to another embodiment of the present invention, the natural polymer may be selected from the group consisting of collagen, albumin, silk protein, poly (L-lysine), poly (L-glutamic acid) acid, or poly (aspartic acid), polysaccharides and derivatives thereof, carboxymethyl cellulose, cellulose sulphate, agarose, alginate, from the group consisting of alginate, carrageenan, hyaluronic acid, heparin, glycosaminoglycan, dextran and its derivatives, and chitosan and derivatives thereof, from the group consisting of alginate, carrageenan, hyaluronic acid, heparin, glycosaminoglycan, Is selected.

According to another aspect of the present invention, there is provided a method of manufacturing a wire weaving stent comprising the steps of: (a) forming a plurality of nodes crossed with a horizontal node line and a vertical node line, j) and identifying a planar matrix as shown in Fig. 35; (b) selecting a wire-weaving movement mode among the hourglass-type moving and radial-movement modes shown in FIG. 44; (c) selecting a start node position S # (i, j) by checking the number of horizontal node lines, the number of vertical node lines, the node position information, the node shape information, and the advance information; (d) selecting a basic direction of movement (D.mv) from the starting node position S # (i, j) of the step (c); (e) moving to a neighboring node according to a basic direction of movement (D.mv) of step (d); And (f) selecting a basic direction of movement (D.mv) at a neighbor node of the step (e) and determining a start node position S # (i, j) i, j)) and terminating the wire weaving.

According to an embodiment of the present invention, the basic movement direction of the step (d) may be a horizontal movement (H _L , horizontal to left), a horizontal movement (H _R, horizontal to right), the diagonal upper-left _{(D LU, diagonal to left up} ), a diagonal lower left _{(D LD, diagonal to left down} ), a diagonal upper right _{(D RU, diagonal to right up} ) and the diagonal lower right (D _RD, diagonal to right down).

According to another embodiment of the present invention, when the primary direction of movement of the step (d) is selected for radial movement method of the step (b), the horizontal L (H _L, horizontal to left), a horizontal right (H _R, horizontal to right), a diagonal upper left _{(D LU, diagonal to left up} ), diagonal lower left _{(D LD, diagonal to left down} ), diagonal idols _{(D RU, diagonal to right up} ), diagonal lower right (D _RD, diagonal to right down, vertical up (V _U ), and vertical down (V _D , vertical to down).

According to another embodiment of the present invention, the method further comprises: after step (e): (e-1) moving from the neighbor node to another neighbor node of step (e) and moving in accordance with the basic direction of movement.

According to another embodiment of the present invention, the node shape of the neighbor node of the step (e) is a node selected from the hook and the cross composed of Table 3, Fig. 45 to 51 and Fig.

According to a further embodiment of the present invention, the method further comprises the step of (g) expressing the manufacturing notation after the step (f) and confirming the deployment network.

According to another embodiment of the invention, the method is carried out according to the flow chart of Figure 64a.

According to another aspect of the present invention, the present invention provides a method of multi-alterable structural patterning of a wire-woven stent comprising the steps of: (a) providing a primitive n- gon) selected, the rotation angle (θ _rot) selected, the direction of rotation selected, the sides (side) and a single layer (section layer) per cross (cross) the number selection, the circular single-layer (primitive section layer) number of selection, skip select whether (skip) A patterning policy step of making at least one selection from a selection group consisting of a selection of a loop type and a selection of a loop type; (b) a parameter design step of setting a design parameter value according to the selection of step (a) and confirming the design parameter value, compression ratio, symmetry and circularity; (c) determining a circular node pattern exponent, constructing a circular development matrix, setting a nut node line, selecting a technical hook and a cross, configuring a connection node pattern, and configuring a deployment matrix, step; And (d) a fabrication expression step of selecting a weaving movement method, constructing a manufacturing notation formula, and constructing a circular development network.

According to an embodiment of the present invention, the primitive n-gon of the step (a) is a regular or irregular polygon, n is an integer of 3 to 8, 8 &lt; / RTI &gt;

According to another embodiment of the present invention, the rotation angle? _Rot of the step (a) is a range defined by the following expression (15), and the rotation direction is a clockwise (cw) counterclockwise, ccw, reverse):

Equation  15

0 ≤ θ _rot < 360 °

If in the equation (15), a circular prismatic n- (primitive n-gon) the information of (regular) polygonal θ _rot is the rotation angle of other than an integer multiple of the number of ∥360 / Vertex (n) ∥.

According to another embodiment of the present invention, the number of primitive section layers in the step (a) is the number of the selected primitive n-gon when the rotation angle? _Rot is 0 °. And is equal to or less than the number of angle division (N _ang ) and greater than or equal to the number of the selected n-gon when the rotation angle (θ _rot )> 0 ° And the division angular number is an integer satisfying the following expression (16): &quot; (16) &quot;

Equation  16

N _ang = 360 ° / _rot

According to another embodiment of the present invention, in the step (a), whether or not to skip is selected from a missing skip and a pushing skip, and in the case of skipping skip, The number of monolayers is the same but the number of monolayers satisfying the following equation (17)

Equation  17

N _{lay .after} = N _{lay .before} + N _{skip .push}

In the above Equation 17 is N _{lay .after} number of circular single-layer then omitted, and the _{lay .before} N is not the number of a single layer around the circle, and the N _{skip .push} represents the number of single-layer extrusion.

According to another embodiment of the present invention, the loop type of step (a) is an open loop type or a close loop type.

According to another embodiment of the present invention, the method further comprises the step of (a-1) selecting whether or not to choose a combination or to perform an outburst selection after the step (a).

More preferably, the combination of step (a-1) is a parameter combination or a pattern combination.

Still more preferably, the combination of elements selects and combines at least one of the group consisting of a rotation angle, a rotation direction, a circular n-square and a cross.

Still more preferably, the pattern combination is a positive pattern combination or a reverse pattern combination.

According to another embodiment of the present invention, the compression ratio of step (b) is defined by the following equation:

Equation  One

In Equation (1), D _stent represents a diameter of stent before compression, D _ob represents a diameter of stent after compression, D _ob = 2R _ob , R _ob represents the radius of the outmost boundary.

The content of compressibility in the polymodal structure patterning method of the wire weaving stent of the present invention overlaps with the wire-mesh stent of the present invention described above, so that the excessive complexity of the specification according to the repeated specification is avoided , The description thereof is omitted.

According to another embodiment of the present invention, the symmetry (Q _symm ) of the step (b) is defined by the following equation (18)

Equation  18

Q _symm  = 1 - ( CV _{N .h. horiz}  + CV _{N .h.vert}  + CV _{△ .h. horiz} ) / 3

Here, the CV _{N .h. horiz = (SD / MV) Nh} horiz ( Equation 19), and is the _{CV N .h.vert = (SD / MV} ) Nhvert ( Equation 20), the CV _{△ .h. horiz} = (SD / MV) _{? h . horiz = Σ (CV △ .h.} horiz .i-th) i, i = 1 to N.lay / N lay ( Equation 21), and the △ .h.horiz = N _HH.vert (equation 22) Wherein CV is a coefficient of variation, SD is a standard deviation, MV is a mean value, and Nhhoriz is a number of hooks for horizontal node horizontal node line), Nhvert is the number of hooks for the vertical node line, and [Delta]. h.horiz is the distance between neighboring hook lines for the horizontal node line ). H.horiz.i-th is a distance between neighbor hooks per horizontal line, and N.lay (Or N _lay ) is the number of four or more primitive section layers applied excluding the skip node line, N _HH.vert is the number of vertical node lines between hooks per horizontal node line the vertical symmetry (Q _symm ) value of the reference node is excluded from the variation calculation, and the vertical node line in which the entire vertical node line is composed of the null node is excluded from the variation calculation. 0.5 or more.

The higher the symmetry value (Q _symm ) is, the more preferable, and the most preferable is 1. [

According to a further embodiment of the present invention, N _HH.vert of Equation (22) is defined by Equation (23) below:

Equation  23

N _H-H.vert =? _H-H  / θ _div

Here, the included angle between the _HH = θ N θ _HH.vert x _div N = _HH.vert x W _{n .line} (Equation 24), and wherein θ _HH is adjacent hook (hook) the hook (hook) Fig. represents a contained angle between neighbor hooks, θ _div represents an angle division between nodes, and W _{n .line} represents a node line width.

According to another embodiment of the present invention, the circularity (Q _circ ) of the step (b) is defined by the following equation:

Equation  25

Q _circ  = Q _{circ .simple}  x (1 - CV _avg )

Here, the _{Q circ .simple = nx sin (180} ° / n) / π ( Equation 26), and the _{CV avg = (CV △ h.radial +} CV N .h.vert) / 2 ( equation (27) ), and the _{CV .h.radial = (SD / MV)} △ .h.radial ( equation 28), and the _{CV n .h.vert = (SD / MV} ) Nhvert ( equation 29), and the n = Nhradial (or N _{.radial h)} denotes the (formula 30), and wherein Q is defined _{circ .simple} n- square (simple circularity) simple circle formed on the presumption of (regular n-gon), the CV _avg is the average Wherein CV is a coefficient of variation, SD is a standard deviation, MV is a mean value, and n is an average value of variance, The number of sides of regular n-gon (= total no. Of hooks on the axial view), and _{N.h. radial} is the total number of hooks in the axial direction (total no. of hooks on the axial view), and the △ _.h.radial the hook spacing in the axial direction of the reference (p wherein the _N.h.vert is a number of hooks for a vertical node line and the entire vertical node line is composed of a null node The vertical node line is excluded from the variation calculation, and the reference circle (Q _circ ) value is 0.4 or more. The higher the value of the circle formation (Q _circ ) is, the more preferable, but the most preferable is 1. [

According to another embodiment of the present invention, the circular node pattern index of step (c) is an integer of 1 or more, and more preferably an integer of 1 to 60. [

According to another embodiment of the present invention, at least one or more of the technical hooks and crosses of step (c) are selected from the hooks and crosses constituted by Table 3, Figs. 45 to 51 and Fig.

According to another embodiment of the present invention, the weaving movement method of step (d) is a sandglass type movement (6-way) or a radial movement (8-way) of FIG.

According to another embodiment of the present invention, the polymodal structure of the wire weaving stent has a structure selected from the group consisting of Figs. 84C, 85C, 88C to 91C, 92D, 93C, 94C and 95D .

The features and advantages of the present invention are summarized as follows:

(a) The present invention relates to a wire-mesh stent having a compression ratio (or a compression ratio, r _comp ) defined by Equation (1) and consisting of a combination of a hook and a cross, And a method of patterning the multidomorphic structure.

(b) The present invention takes stent and delivery device, which are the main components of the stent system, not in isolation, but in consideration of loadability that can be applied to a delivery mechanism that is a practical necessity Respectively.

(c) The present invention also microscopically approaches and analyzes and quantifies the basic structure of the wire-wound stent in order to assure feasible mounting properties.

(d) The present invention facilitates the description and structural modification of the wire-wired stent structure pattern through the description of the implementation method (manufacturing method) and easy understandable symbolic expression.

(e) On the other hand, a variety of technical implementations have been developed for hooks and crosses, which are the basic elements of the wire weaving stent, which can diversify the function, performance and implementation method (manufacturing method) of the wire weaving stent .

(f) The present invention has formed a multi-deformable structure pattern capable of changing various application structures in order to implement a specific performance required not a specific one stent structure.

) 및 방사형 이동(radial movement, 8-way,

)을 보여준다.
도 45는 본 발명의 기술적 훅의 일 형태인 수평훅(horizontal hook)을 보여준다.
도 46은 본 발명의 기술적 훅의 일 형태인 수직훅(vertical hook)을 보여준다.
도 47은 본 발명의 기술적 훅의 일 형태인 수평개방훅(horizontal open hook)을 보여준다.
도 48은 본 발명의 기술적 훅의 일 형태인 수직개방훅(vertical open hook)을 보여준다.
도 49는 본 발명의 기술적 훅의 일 형태인 수평반훅(horizontal half hook)을 보여준다.
도 50은 본 발명의 기술적 훅의 일 형태인 수직반훅(vertical half hook)을 보여준다.
도 51은 기술적인 훅(technical hook)의 추가적인 형태를 보여준다.
도 52는 3개의 와이어를 사용해서 구조패턴이 완성되는 제조방법(엮기방법)에 대한 제조 표기식(fabrication expression)의 정형 형식(formatted type)을 보여준다.
도 53은 크로스(cross) 노드에 대해 반크로스(half cross)를 적용하는 경우, 특정 크로스(cross) 노드를 지나가는 방향에 따른 표기를 보여준다.
도 54는 훅(hook)으로만 구성된 MODEL A 및 훅(hook)과 크로스(cross) 조합으로 구성된 MODEL B의 구조패턴의 원형전개행렬식(primitive planar matrix formula)을 보여준다.
도 55는 MODEL A의 위쪽 연결노드패턴(interface node pattern) 및 아래쪽 연결노드패턴을 보여준다.
도 56은 도 55의 연결노드패턴으로 하여, 훅(hook) 중심으로 시작점에서 종료점까지 순차적으로 표시한 꼬임선이 없는 제조 표기식을 보여준다.
도 57은 도 56의 제조 표기식의 순서에 따라 와이어 엮기가 완료된 전개그물망(planar mesh)을 나타낸다.
도 58은 MODEL B의 위쪽 연결노드패턴(interface node pattern) 및 아래쪽 연결노드패턴을 포함하는 전개행렬을 보여준다.
도 59는 도 55의 연결노드패턴으로 하여, 훅(hook) 중심으로 시작점에서 종료점까지 순차적으로 표시한 꼬임선이 없는 제조 표기식을 보여준다.
도 60은 도 59의 제조 표기식의 순서에 따라 와이어 엮기가 완료된 전개그물망(planar mesh)을 나타낸다.
도 61은 MODEL B에 대해서 원형노드패턴지수(exponent of primitive node pattern) 값이 n=2인 경우, 원형전개행렬식(primitive planar matrix formula) 및 전개행렬(planar matrix)을 보여준다.
도 62는 도 61에 따른 제조 표기식(fabrication expression)을 보여준다.
도 63은 도 61 및 도 62에 따른 와이어 엮기가 완료된 전개그물망(planar mesh)을 보여준다.
도 64a 내지 도 64c는 본 발명의 실시예에 따른 제조(엮기)방법에 대한 제조 표기식(fabrication expression)을 체계적으로 결정하기 위한 흐름도(flow chart)이다.
도 65는 와이어 엮기 스텐트의 반경단면(radial section), 즉 수평노드선(horizontal node line) 당, 적합한 훅(hook)의 개수가 3 ~ 8개라는 분석결과에 따른, 3-각형(triangle)에서 8-각형(octagon)의 기본 원형(primitive shape)을 보여준다.
도 66은 축방향에서 보는 스텐트의 반경방향 단면을 보여준다.
도 67은 축(axis)을 기준으로 입체적인 등각투영도(isometric view) 형식으로 노드반경단면(node radial section)을 순차적으로 정렬한 결과를 보여준다.
도 68은 노드반경단면(node radial section)에 내접(inscribed)하는 삼각형(triangle)을 각 노드반경단면에 배치한 경우를 보여준다.
도 69는 상기 도 67에 기타 다른 '원형 n-각형'을 적용하여, 원형 n-각형의 꼭지점에 훅(hook) 노드를 배치한 결과를 보여준다.
도 70은 도 68 및 69의 순차 정렬된 노드반경단면(node radial section)에 대한 등각투영도(isometric view)를 일직선상의 축 방향에서 본 결과를 보여준다.
도 71은 다변형성의 두 번째 개념인 '회전(rotation)'을 적용하여 원형 정삼각형(primitive regular triangle)의 꼭지점에 위치하는 훅(hook) 노드의 위상(phase)을 변경할 수 있음을 보여준다.
도 72는 '회전(rotation)' 및 '단층(section layer)' 개념을 조합하여, 대칭성(symmetry) 및 원형성(circularity) 상태를 비교한 결과를 보여준다.
도 73은 회전각(θ_rot)이 90^o 일 경우 각 '단층(section layer)'에서 누적되는 회전각 0^o, 90^o, 180^o, 270^o, 360^o(=0^o) 중에서 180^o가 되는 '단층(section layer)'을 건너뛰기(missing) 및 밀어내기(pushing) '생략(skip)'을 한 결과를 보여준다.
도 74는 도 73을 원형전개행렬식(primitive planar matrix formula)으로 표현한 결과를 보여준다.
도 75는 2개의 조합, 즉 k=2인 경우에, 첫 번째 '생략(skip)'은 누적회전각(θ_accu)이 180^o, 두 번째 '생략(skip')은 누적회전각(θ_accu)이 90^o에서 발생한 경우, 건너뛰기(missing) 및 밀어내기(pushing) '생략(skip)'을 적용한 원형전개행렬식을 나타낸다.
도 76은 필요에 따라 연결노드패턴(interface node pattern)이 필요함을 보여주는 패턴조합을 나타낸다.
도 77a는 패턴조합(pattern combination) 중 대칭조합(symmetry combination)을 보여준다.
도 77b는 패턴조합(pattern combination) 중 역대칭 조합(reverse symmetry combination)을 보여준다.
도 78은 원형 정삼각형(primitive regular triangle)과 원형 정사각형(primitive regular tetragon)을 동시에 적용하고 회전각(θ_rot) 90^o를 적용시킨 경우의 요소조합(parameter combination)을 보여준다.
도 79는 본 발명의 실시예에 따른 크로스(cross) 노드를 배치하는 방법으로서, 원형 정삼각형(primitive regular triangle)의 변(sides)에 각 3개씩 배치하고 회전각(rotation angle)을 90^o를 적용한 이전의 예에 적용한 원형전개행렬식(primitive planar matrix formula)을 보여준다.
도 80은 다변형성 구조패턴의 대칭성(symmetry) 평가에서 동일 위상(phase)에 존재하는 훅(hook) 개수가 다를 수 있음을 보여준다.
도 81은 다변형성 구조패턴의 원형성(circularity)을 평가하는 기본 개념을 보여준다.
도 82a 내지 도 82e는 본 발명의 실시예에 따른 다변형성 구조패턴닝(multi-alterable structural patterning) 절차에 대한 간략 흐름도(simple flow chart)이다.
도 83a 내지 도 83d는 도 82a의 흐름도를 보다 상세하게 표현한 상세 흐름도(detail flow chart)이다.
도 84a, 도 84b 및 도 84c는 정삼각형(regular triangle) '원형n-각형(primitive n-gon)'을 적용한 원형노드패턴지수(exponent of primitive node pattern)가 2인, 즉 n=2 다변형성 구조패턴팅의 예시1(REG-TRIA-90-L-12)을 보여준다.
도 85a, 도 85b 및 도 85c는 정삼각형(regular triangle) '원형n-각형(primitive n-gon)'을 적용한 원형노드패턴지수(exponent of primitive node pattern)가 4인, 즉 n=4 다변형성 구조패턴팅의 예시2(REG-TRIA-180-L-12)를 보여준다.
도 86a 및 도 86b는 본 발명의 예시1(REG-TRIA-90-L-12)과 예시2(REG-TRIA-180-L-12)에 대해 대칭성 평가식(equation of symmetry evaluation)을 적용하는 과정을 보여준다.
도 87a 및 도 87b는 본 발명의 예시1(REG-TRIA-90-L-12)과 예시2(REG-TRIA-180-L-12)에 대해 원형성 평가식(equation of circularity evaluation)을 적용하는 과정을 보여준다.
도 88a, 도 88b 및 도 88c는 정삼각형(regular triangle) '원형n-각형(primitive n-gon)'을 적용한 원형노드패턴지수(exponent of primitive node pattern)가 2인, 즉 n=2 다변형성 구조패턴팅의 예시3(REG-TRIA-15-R-COMB-12)을 보여준다.
도 89a, 도 89b 및 도 89c는 정사각형(regular tetragon) '원형n-각형(primitive n-gon)'을 적용한 원형노드패턴지수(exponent of primitive node pattern)가 2인, 즉 n=2 다변형성 구조패턴팅의 예시4(REG-TETR-18-R-SKIP-20)를 보여준다.
도 90a, 도 90b 및 도 90c는 정사각형(regular tetragon) '원형n-각형(primitive n-gon)'을 적용한 원형노드패턴지수(exponent of primitive node pattern)가 3인, 즉 n=3 다변형성 구조패턴팅의 예시5(REG-TETR-45-RL-SKIP-20)를 나타낸다.
도 91a, 도 91b 및 도 91c는 정오각형(regular pentagon) '원형n-각형(primitive n-gon)'을 적용한 원형노드패턴지수(exponent of primitive node pattern)가 1인, 즉 n=1 다변형성 구조패턴팅의 예시6(REG-PENT-24-RL-COMB-20)을 나타낸다.
도 92a, 도 92b, 도 92c 및 도 92d는 정삼각형(regular triangle), 정사각형(regular tetragon), 정오각형(regular pentagon) 및 정육각형(regular hexagon) '원형n-각형(primitive n-gon)'을 '조합(combination)' 적용한 원형노드패턴지수(exponent of primitive node pattern)가 3인, 즉 n=3 다변형성 구조패턴팅의 예시7(REG-TRPH-0-L-COMB-12)을 보여준다.
도 93a, 도 93b 및 도 93c는 정삼각형(regular triangle), 정사각형(regular tetragon), 정오각형(regular pentagon) 및 정육각형(regular hexagon) '원형n-각형(primitive n-gon)'을 대칭조합(symmetry combination) 적용한 원형노드패턴지수(exponent of primitive node pattern)가 1인, 즉 n=1 다변형성 구조패턴팅의 예시8(REG-TRPH-0-L-COMB-SYMM-12)을 보여준다.
도 94a, 도 94b 및 도 94c는 반훅(half hook)을 적용한 복합구조 다변형성 구조패턴팅의 예시9(REG-HXTR-30/90-LR/L-COMB-PATN-18/12)를 나타낸다.
도 95a, 도 95b, 도 95c 및 도 95d는 비정형(irregular) '원형-n-각형(primitive n-gon)' 및 반크로스(half cross)를 적용한 다변형성 구조패턴팅의 예시10(IRR-TRPH-20-L-COMB-14)을 나타낸다.
도 96a, 도 96b, 및 도 96c는 비정형 사각형(irregular tetragon)을 적용하여 8-노드(8-node), 10-노드(10-node) 및 14-노드(14-node)로 구성된 복합구조패턴(compound structure pattern)을 역대칭 조합(reverse symmetry combination)으로 구성한 패턴의 예시 11(IRR-TETR-NA-L-COMB-REVS-8/10/14)를 나타낸다.BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows a stent which is a cylindrical medical device inserted into a body for the purpose of maintaining a human lumen.
Fig. 2 shows a plastic stent, a tube stent, and a wire stent depending on the kind and shape of a material.
FIG. 3 shows a delivery device for transferring (moving) the stent to a target site.
FIG. 4 shows a method of mounting the stent, that is, pushing the stent and pushing the stent into the delivery mechanism, or pulling the stent in the pulled manner.
Figure 5 shows the structure of a tubular stent according to the strut and cell configuration and arrangement.
Figure 6 shows a tubular stent having a single layer.
Figure 7 shows the hook and cross of a wire-wired stent.
Figure 8 shows a wall stent (US Pat. No. 4,655,771) that is a stent consisting solely of a cross.
Fig. 9 shows a stent structure (Korea Patent No. 267019) composed of only hooks by hand.
Figure 10 shows a twisted line created in a stent consisting solely of a hook.
Figure 11 shows an image of a 3D scan of a stent having both a hook, a cross, and a twisted line.
Figure 12 shows a model of a hook, a cross, and a twisted line of a stent according to three directions (top-side, side-side, section-section).
Figure 13 shows a twisted line formed on a hook and a cross.
14 is a cross-sectional view showing a Model A consisting of only 13 hooks on the basis of the radial section of the stent, and a Model B in which six hooks and seven crosses are crossed at a constant angle with each other.
FIG. 15 shows a schematic compression modeling without mutual interference for Models A and B of FIG. 14. FIG.
Figure 16 shows model and physical interference in a hook and cross node model.
Figure 17 shows the determination of the radius of outmost boundary (R _ob ), which is an important factor in the compression ratio estimation, using the hook and cross node model described in the present invention.
Fig. 18 shows the finding of an inscribed circle radius (inradius) of a regular n-gon.
FIG. 19 shows that a nominal width (W _hook ) of a _hook node is introduced to form a regular n-square having the same side length to obtain R _ib through the number of hook nodes N _{x i} .
Figure 20 shows the setting of boundary (range) conditions for N _{x i} .
21 shows that the circumcenter of R _ob is the same as the incenter of R _ib in obtaining the outermost border radius R _ob .
Fig. 22 shows that the radius R _ob of the circumscribed circle is obtained through the number of sides (N _xo ) formed by a hook node having a length of W _hook in contact with a circumscribed circle.
Figure 23 shows that not only the circumcircle of the hook node but also the incircle are present.
Figure 24 shows a twisted line in a hook and cross node model.
Figure 25 shows modeling for the twisted line of Figure 24;
Figure 26 shows MODEL A and MODEL B applied to comparisons of compressibility for the twisted-pair node model.
27 shows the structure of a stent divided into a body and a head.
28 shows a head of a stent having a shape of a flare type, a dumbbell type, and a jar type.
29 shows a section of the stent.
Fig. 30 shows a cross section of a stent consisting of a hook, a cross, or a combination of a hook and a cross.
FIG. 31 shows the positions of nodes when a plurality of sections are not superposed in a single section but superposed continuously.
32 shows a plane view or top view for widely, clearly, and systematically grasping the structural pattern of the stent.
Figure 33 shows a top view of a stent having a cylindrical shape.
Fig. 34 shows the result of showing the cylindrical shape in the form of a planar figure in relation to the structural pattern on the plan view of the stent.
FIG. 35 shows a result of expressing the developed or expanded network of the stent by a planar grid and a matrix coordinate expression.
FIG. 36 illustrates a method of weaving using 12 expansion matrices and finally shows a result of superimposing a single structure pattern (Korean Patent Application No. 10-2008-0076586).
FIG. 37 is a diagram illustrating a MODEL B structure composed of a MODEL A structure composed only of hooks and a combination of a hook and a cross, and a development matrix of a planar structure represented by a symbolic expression (planar matrix formula.
Figure 38 shows a primitive planar matrix formula according to an embodiment of the present invention.
Figure 39 shows a primitive node pattern composed of an element of node pattern.
Figure 40 shows the open loop type and the closed loop type of the primitive planar matrix formula.
Figure 41 shows a closed circular representation in a primitive planar matrix formula.
FIG. 42 shows an element of node pattern, that is, an interface node pattern, of a portion connecting the body portion and the head portion of the stent.
Figure 43 shows a schematic illustration of the structural pattern making up the wire weaving stent.
FIG. 44 is a perspective view illustrating a sandglass type movement (6-way) movement according to an embodiment of the present invention, with respect to a method of manufacturing a wire weaving stent (a weaving method)

) And radial movement (8-way,

).
Figure 45 shows a horizontal hook, which is one form of the technical hook of the present invention.
Figure 46 shows a vertical hook, which is one form of technical hook of the present invention.
Figure 47 shows a horizontal open hook, which is one form of technical hook of the present invention.
Figure 48 shows a vertical open hook, which is a form of technical hook of the present invention.
Figure 49 shows a horizontal half hook, which is one form of technical hook of the present invention.
Figure 50 shows a vertical half hook, which is one form of technical hook of the present invention.
Figure 51 shows an additional form of a technical hook.
Figure 52 shows a formatted type of fabrication expression for a manufacturing method (weaving method) in which a structural pattern is completed using three wires.
Figure 53 shows the notation according to the direction passing through a particular cross node when a half cross is applied to a cross node.
Figure 54 shows a primitive planar matrix formula of MODEL A consisting of a hook only and a structure pattern of MODEL B consisting of a hook and a cross combination.
FIG. 55 shows an upper interface node pattern and a lower connecting node pattern of MODEL A. FIG.
56 shows a manufacturing notation expression in which there is no twisted line sequentially displayed from the starting point to the ending point with the hook center as the connection node pattern of FIG.
Fig. 57 shows a planar mesh in which the wire weaving is completed according to the manufacturing notation formula in Fig. 56; Fig.
FIG. 58 shows a deployment matrix including an upper interface node pattern and a lower connection node pattern of MODEL B. FIG.
FIG. 59 shows a manufacturing notation expression in which there is no twisted line sequentially displayed from the starting point to the ending point with the hook center as the connection node pattern of FIG.
Fig. 60 shows a planar mesh in which the wire weaving is completed in accordance with the manufacturing notation in Fig. 59.
FIG. 61 shows a primitive planar matrix formula and a planar matrix when the value of the exponent of primitive node pattern is n = 2 for MODEL B. FIG.
Figure 62 shows a fabrication expression according to Figure 61;
Fig. 63 shows a planar mesh in which the wire weaving according to Figs. 61 and 62 is completed.
64A to 64C are flow charts for systematically determining a fabrication expression for a manufacturing (weaving) method according to an embodiment of the present invention.
FIG. 65 is a graph showing the results of a triangle according to the analysis result that the number of hooks suitable for a radial section of a wire-wired stent, that is, a horizontal node line, Shows the primitive shape of an 8-octagon.
66 shows a radial section of the stent seen in the axial direction.
67 shows the result of sequentially aligning node radial sections in a three-dimensional isometric view format with respect to an axis.
68 shows a case where a triangle inscribed in a node radial section is arranged in each node radius section.
FIG. 69 shows a result of arranging hook nodes at apexes of a circular n-angled shape by applying another 'circular n-corner type' to the above FIG. 67.
Figure 70 shows the isometric view of the sequential aligned node radial section of Figures 68 and 69 as viewed in a linear axial view.
71 shows that the phase of a hook node located at a vertex of a primitive regular triangle can be changed by applying rotation, which is a second concept of polymorphism.
72 shows a result of comparing symmetry and circularity states by combining the concepts of 'rotation' and 'section layer'.
FIG. 73 shows that when the rotation angle? _Rot is 90 ^° , 180 ^° is selected among the rotation angles 0 ^o , 90 ^o , 180 ^o , 270 ^o and 360 ^o (= 0 ^o ) accumulated in each ' Skipping 'the missing' section layer 'and pushing it' skip '.
FIG. 74 shows the result of expressing FIG. 73 as a primitive planar matrix formula.
75 is a combination of the two, that is, in the case of k = 2, the first 'omit (skip), the cumulative rotation angle (θ _accu) is 180 ^o, the second "skip (skip") is the cumulative rotation angle (θ _accu Represents a circular development matrix using 'missing' and 'pushing''skip' when it occurs at 90 ^° .
Figure 76 shows a pattern combination showing the need for an interface node pattern as needed.
Figure 77a shows a symmetry combination in a pattern combination.
Figure 77 (b) shows a reverse symmetry combination among the pattern combinations.
78 shows a parameter combination when a primitive regular triangle and a primitive regular tetragon are simultaneously applied and a rotation angle? _Rot 90 ^o is applied.
79 illustrates a method of arranging cross nodes according to an embodiment of the present invention. The method includes arranging three each on the sides of a primitive regular triangle and applying a rotation angle of 90 ^o It shows the primitive planar matrix formula applied to the previous example.
80 shows that the number of hooks existing in the same phase may differ in the symmetry evaluation of the polymorphic structure pattern.
81 shows the basic concept of evaluating the circularity of a polymorphic structural pattern.
Figures 82a through 82e are simplified flow charts of a multi-alterable structural patterning procedure according to an embodiment of the present invention.
Figures 83A to 83D are detail flow charts illustrating the flow chart of Figure 82A in more detail.
FIGS. 84A, 84B and 84C are diagrams showing a case where a circular node pattern exponent applying a regular triangle 'primitive n-gon' is 2, that is, n = 2, Example 1 of patterning (REG-TRIA-90-L-12) is shown.
FIGS. 85A, 85B and 85C are diagrams showing a case where a circular node pattern exponent applying a regular triangle 'primitive n-gon' is 4, that is, n = 4, Example 2 of patterning (REG-TRIA-180-L-12) is shown.
Figures 86a and 86b illustrate the use of an equation of symmetry evaluation for Example 1 (REG-TRIA-90-L-12) and Example 2 (REG-TRIA-180-L-12) Show the process.
Figures 87a and 87b illustrate the application of the equation of circularity evaluation to Example 1 (REG-TRIA-90-L-12) and Example 2 (REG-TRIA-180-L-12) .
FIGS. 88A, 88B and 88C are diagrams illustrating a case where a circular node pattern exponent applying a regular triangle 'primitive n-gon' is 2, that is, n = 2, Example 3 of patterning (REG-TRIA-15-R-COMB-12) is shown.
FIGS. 89A, 89B and 89C illustrate the case where a primitive n-gon with a regular tetragon is applied and the exponent of primitive node pattern is 2, that is, n = 2. Example 4 of patterning (REG-TETR-18-R-SKIP-20) is shown.
FIGS. 90A, 90B and 90C are diagrams showing a case where a circular node pattern exponent (primitive n-gon) applied with a regular tetragon 'primitive n-gon' Example 5 of patterning (REG-TETR-45-RL-SKIP-20).
FIGS. 91A, 91B and 91C are diagrams showing a case where a circular node pattern index (exponent of primitive node pattern) using a regular pentagon 'primitive n-gon' is 1, that is, n = Example 6 of structure patterning (REG-PENT-24-RL-COMB-20).
Figures 92a, 92b, 92c and 92d illustrate that a regular triangle, a regular tetagon, a regular pentagon, and a regular hexagon 'primitive n-gon' Shows an example 7 (REG-TRPH-0-L-COMB-12) of multivariate structure patterning with an exponent of primitive node pattern of 3, i.e. n = 3.
FIGS. 93A, 93B and 93C illustrate symmetry of a regular triangle, a regular tetagon, a regular pentagon, and a regular hexagon 'primitive n-gon' (REG-TRPH-0-L-COMB-SYMM-12) where the exponent of the primitive node pattern is 1, that is, n = 1.
94A, 94B and 94C show Example 9 (REG-HXTR-30/90-LR / L-COMB-PATN-18/12) of a composite structure polydomplex structure patterning using a half hook.
Figures 95a, 95b, 95c and 95d illustrate an example 10 of a polymorphic structural patterning applying an irregular 'primitive n-gon' and a half-cross (IRR-TRPH -20-L-COMB-14).
FIGS. 96A, 96B and 96C illustrate a complex structure pattern composed of 8-node, 10-node and 14-node by applying an irregular tetragon. (IRR-TETR-NA-L-COMB-REVS-8/10/14) in which a compound structure pattern is constituted by a reverse symmetry combination.

Hereinafter, a wire-mesh stent of the present invention, a method for manufacturing the same, and a method for patterning a polymodal structure will be described in detail with reference to the drawings. Hereinafter, And the scope of the present invention is not limited to these embodiments.

Microscopic structure analysis of wire-mesh stent

In order to apply the polymorphic structure patterning method, microstructure analysis of the wire-wound stent is required.

Microstructural analysis is a fundamental step to be taken for the application of multi-deformable structure patterning technology which ensures the basicity and common requirement of the wire weaving stent structure and the mountability of the transmission mechanism.

For the microscopic structure analysis, it is necessary to model hook and cross which is the minimum structure type of the wire weaving stent, and it is necessary to model the twisted wire which can occur in the manufacturing method of the wire weaving structure including the hook. line model as well as comparative analysis.

To facilitate understanding of the modeling process, a stent having both a hook, a cross, and a twisted line will be described using a 3D scanned image (FIG. 11).

The hook, cross, and twisted line models of the stent were modeled according to the three directions (top-side, side-side, section-section) (Table 1).

[Table 1]

Because the twisted lines can be formed on hooks and can also be formed on a cross (Figure 13), a separate schematic shape for each case is modeled (Table 2).

[Table 2]

Since a single wire stitched together with many hooks and crosses is called a node instead of a model because it acts as a connection point on the network, node).

 In the shape modeling, a scale factor is defined as the distance between neighboring hooks and cross nodes when determining the physical height, width, and length of each node, As a marginal factor to avoid interference, the height, width, and length considering the metrics in each node are called nominal height, nominal width, nominal length, ).

 For example, when a wire with a diameter of 0.1 mm is used, the nominal height of the hook node is 0.3 mm, the nominal width is 0.33 mm, and the nominal length is 0.4 mm.

A description of the interference will be given later.

Based on the modeling, the following virtual stent structure is set for comparative analysis of the loadability in the delivery mechanism of the stent.

The diameter of the wire is Φ and the radial cross section of the stent is Model A consists of only 13 hooks and Model B consists of 6 hooks and 7 crosses crossed at a constant angle (Fig. 14).

Loadability is excellent when the stent can be compressed (compressed) as much as possible without interfering with neighboring hooks or crosses when compressing (compressing) the stent in the radial direction.

The graphical compression modeling without mutual interference for the two virtual stent structures is as follows (FIG. 15).

The smaller the radius of outmost boundary R _ob after stent compression, the greater the compression rate.

The formula for obtaining R _ob will be discussed later and we will first examine the interference.

Interference can be classified into model interference and physical interference.

Model interference is a kind of logical interference between hexahedral blocks when a cubic block considering a scale factor is applied in a hook and a cross node model proposed in the present invention. interference, and physical interference refers to actual interference in which physical mutual contact occurs in hooks and cross nodes formed by actual wires (FIG. 16).

Therefore, the evaluation of the compressibility of the stent structure to compare the mountability in the delivery device is performed under the conditions without model and physical interference, ie, the tangent on boundary condition.

The compression ratio of the stent can be defined as a compression ratio (r _comp , compression ratio) expressed by the following equation (1).

Equation 1

r _comp  = ( D _stent  - D _ob ) / D _stent

Here, D _stent represents the diameter of the stent before compression, D _ob represents the diameter of the stent after compression, and D _ob = 2R _ob .

However, since the comparison of the compression ratios according to the structure patterns can be made simply by comparing the radii (R _ob ) of the outermost boundary lines when compressed under the condition of no mutual interference, R _ob is used in the present invention.

Since quantitative analysis of the compression ratio is necessary to construct a structural pattern with improved mounting performance by using the hook and cross node model described in the present invention, the radius of outmost boundary (R _ob ) Let's look at how to make a decision.

R _ob can be obtained from the inradius radius of a regular n-gon, the circumradius equation, and some boundary conditions.

However, among the stent structures described above, for example, MODEL A composed of only hooks has the same base (W _hook ), so that the radius R _ib of the circumscribed circle can be easily obtained, but a combination of hook and cross In the case of the constructed MODEL B, R _ib can not be obtained directly but can be obtained by setting several boundary conditions.

Therefore, a method for obtaining the radius R _ib and radius R _oc of the outermost circumferential line (R _ib ) and the outermost circumferential line (R _ob ) in a manner that can be applied to a structure such as MODEL B composed of a combination of a hook and a cross will be described .

The present method is equally applicable to a structure composed of only a hook or a cross.

When a structure composed of a combination of hook and cross is compressed to a tangent on boundary condition, all hooks and cross nodes are in the outermost border radius (R _ob ) (Fig. 17).

At this time, since the H _{hook of the hook} is larger than the nominal height H _{cross of the cross} (H _hook > H _cross ), the boundary line touching the hook node is the inmost boundary. And R _ib is obtained from the expression of the incircle that contacts the base of the hook node.

However, as can be seen from FIG. 17, since the base of the hook node contacting the boundary line of the minimum internal angle does not form a regular n-gon as shown in FIG. 18, the in- It can not be applied.

17, the radius R _ib of the boundary line of the innermost cabinets is inscribed with the base of all the hook nodes in the incenter so that the width of the hook node is the same as the width W of the _hook node (Fig. 19). Thus, if the number of hook nodes N _xi is known, R _ib can be easily obtained (FIG. 19).

However, the radius of the inscribed circle, the circumference length consisting of R _ib , S _ib must satisfy the condition that it should be less than or equal to the total nominal width sum of nodes, W _hook x N _xi . That is, S _ib = 2? R _ib ? W _hook x N _xi .

This conditional equation is derived from the conditional formula π / (N _xi tan (180 / N _xi )) ≤ 1, which is always satisfied at the minimum polygon condition N _xi ≥ 3, so the boundary (range) for N _xi (or R _ib ) Without the condition, the answer can not be obtained.

Therefore, a boundary condition for N _{x i} is required. In the case of a combination of a hook and a cross node, the following boundary conditions can be set. On the other hand, if N _xi = N _t = N _{h in the} case of only hook nodes, and N _xi = N _t = N _{c in} case of only cross nodes, the following boundary condition is not necessary.

N _xi is the largest integer value (max {n}) among the values that are larger than the number of hook nodes (N _h ) and the circumference length is less than the sum of the nominal widths (W _total ) of hooks and crosses, N _{x i} } (Fig. 20).

The above condition is defined as follows.

2? R _ib ? W _hook x N _xi <2? R _ib.max ? W _avg x N _t

W _hook x N _xi <W _avg x N _t

N _xi < (W _avg x N _t ) / W _hook

N _h < N _xi < (W _avg x N _t ) / W _hook

Here, since N _{x i} is an integer,

N _h < Max {N _xi } &lt; || (W _avg x N _t ) / W _hook || .

Here, wherein N _t = N _h + N _c, wherein W _avg = (W _hook x N _h + W _cross x N _c) / (N _h + N _c), and the W _hook is the nominal width of the hook ( nominal width of hook) represents the W _cross represents the nominal width (nominal width of cross) of the cross, the N _h is the number (number of hook) of the hook, wherein N _c is the number of cross (number of cross ) to be.

According to the above conditions, the radius R _ib of the innermost radius can be obtained as follows.

On the other hand, the radius R _ob of the outermost boundary is obtained as follows.

21, since the distance (R _ob ) from the center to the vertex of the hook node is the same, there is a circumcircle that passes through each vertex, and the center of the circumscribed circle, that is, R _ob The circumcenter of R _ib is the same as the incenter of R _ib .

Therefore, if we know the number of nodes (N _xo ) formed by a hook node with a length of W _hook in the circumscribed circle, or the number of inradius (R _tb ) and number of sides (N x) of a hook node, The radius R _ob of the circumscribed circle can be obtained from the condition (Fig. 22).

22, since not only the circumcircle of the hook node but also the incircle exist (FIG. 23), the radius of the hook from the inradius (R _tb ) The number of sides of the hook node, N _xo , can be obtained.

Since N _xo is an integer, round-to-nearest integer numbers can be chosen.

The outermost radius R _ob can be obtained as follows from the N _xo values obtained above.

Since the following conditions are satisfied for the circumscribed circle (R _ob ) and the inscribed circle (R _tb ) in contact with the hook node, a) the radius of the circumscribed circle, the circumference length composed of R _ob , S _ob must be greater than or equal to the sum of the nominal widths of the hook nodes, W _hook x N _xo . That is, S _ob = 2πR _ob ≥ W _hook x N _xo . B) Also, the radius of the inscribed circle, the circumference length consisting of R _tb , S _tb should be less than or equal to the sum of the nominal width of the hook node, W _hook x N _xo . That is, S _tb = 2? R _tb ? W _hook x N _xo .

From the above two conditions, N _xo must satisfy the following conditional expression.

Also, when (R _ob - R _tb ) << H _hook , since the following condition holds, N _xo = || 2? R _tb / W _hook || It can be obtained by itself.

Hook and cross node models to determine the compressibility (or compression rate or ratio, r _comp ) that are important in assessing the compressibility of the wire weaving stent combined with hooks and crosses. The calculated compressed outmost radius, R _ob, can be summarized as follows.

In this specification, R _ob is the radius of the outmost boundary, R _tb is the inradius of the outmost boundary, R _ib is the radius of the inmost boundary, N _xi is the radius of the outermost boundary, N _xo is the number of virtual hook nodes tangent on the outmost boundary, N _t is the number of virtual hook nodes tangent to the boundary line, N _t is the number of virtual hook nodes tangent to the boundary line, N _h is the number of hook nodes per section, N _c is the number of cross nodes per stent section, ), Φ _w is the wire diameter (diameter of wire), W _total is the sum total of the nominal width of the nodes per stent section (sum total of nominal width of all node per section of stent), W _avg is a stent cross-section per node the average nominal width (average nominal width of node per section of stent), W _hook is the nominal width of the hook node, W _cross is the nominal width of the cross node, H _hook is the nominal height of the hook node, SF _hh is a height scale factor of a hook node, SF _wh is a hook scale factor of a hook node, SF _wc is a width scale factor of a cross node, Respectively.

The MODEL A structure composed of only 13 hooks using the same wire having a diameter of 0.1 mm and the hook 6 (FIG. 6) using the compression outermost radius R _ob (Φ _w , N _h , N _c ) The R _ob value of MODEL B, which is composed of 7 pairs of crosses and crosses, is obtained as follows.

Comparing the R _ob of two models, MODEL B shows about 19% better than MODEL A at the compression ratio.

A more realistic explanation of the difference is that the delivery device of the stent is often called a catheter. Each company uses a thinner delivery mechanism, with a difference of 0.1fr (1fr ≒ 0.33mm) I am using it.

In the case of the two models, MODEL A has a compression diameter of 1.964 mm and MODEL B is 1.684 mm. The difference is 0.28 mm, 0.85 fr in fr, and almost 0.9 fr. From a marketing standpoint, it is the result of a difference that is nine times better.

Modeling for the twisted line (Fig. 24) was also progressed (Fig. 25) while establishing a hook and cross node model to evaluate the loadability of the stent delivery mechanism Table 2) The model of twisted-pair node is applied to MODEL A and MODEL B applied for compressibility comparison evaluation as follows (Fig. 26). Usually, twisted lines are symmetrical with each other, and two twisted lines are formed. In a severe case, six twisted lines are sometimes formed. In this example, it is assumed that there are twisted lines in only two symmetrical hook nodes for convenience.

The outermost radius of the two comparative models with twisted lines R _{ob. The} value of _tw is as follows.

The R _ob. Comparing the compressibility of R _ob for _tw without twisted lines, the compressibility of MODEL A is about 10% and that of MODEL B is about 12%. Converting fr in units of the inner diameter of the transmission mechanism increases the MODEL A to 0.6 fr and MODEL B to 0.6 fr.

As can be seen from the results of microscopic structure analysis using the hook and cross node model, the generation of twisted lines that can occur in the manufacturing method of the wire-wired stent is particularly important It is a structure pattern that should be avoided because it is very weak structure type.

Currently, wire-weaving stent manufacturing processes use nickel-titanium shape memory alloys (nitinol) wires in the range of Φ 0.11 to 0.22 mm. Most of the manufacturers that use the twisted-wire structure pattern are deployment faulty The customer complaint is experiencing considerable difficulties.

Therefore, it is very important to apply a manufacturing method that does not form a twisted wire (a weaving procedure) in a manufacturing method that implements a structural pattern because a structure that is necessarily avoided in a wire-woven stent structure is a twisted wire forming structure.

Multi-deformability wire  Weaving Stent  Structure pattern expression method

Since the multi-deformable wire-weaving stent structure patterning method having excellent compressibility in connection with a transmission mechanism to be proposed in the present invention can perform tens to hundreds of derivative structure patterning according to the degree of deformation, In order to facilitate understanding of the contents, the brief description of the parts of the stent configuration shape, the structure pattern notation method, and the manufacturing order notation method will be described.

Particularly, the structural patterning expression and the structural fabrication expression are methods that can not be found in other wire-woven stent-related patents and are proposed independently in the present invention. In other patents, Since only a single structural pattern, that is, one structure is described, the structure pattern notation scheme proposed by the present invention may not be necessary.

Particularly, the description of the other invention is very difficult to describe the manufacturing method (manufacturing procedure), and it is difficult to see the related field personnel, and it is difficult for the actual worker to get used to the structure pattern manufacturing method, . This section lacks the concept and theory of systematic structural patterning and focuses on a single structural pattern without examining the possibility of multi-deformability.

In the present invention, it is possible to express the structure pattern and the manufacturing order of various structures because a multitude of structural patterns can be formed. Therefore, a method that can be expressed in a simple and systematic form is required and the method has been proposed.

First, the structure of the stent can be simply divided into a body and a head (Fig. 27). Since the head located on both sides of the body is anti-migration It generally has a shape such as a flare type, a dumbbell type, and a jar type (Fig. 28).

The body and head can be configured to be fine or sparse depending on the function and performance of the stent. A tight structure can be a hook or cross node with many nodes Meaning and coarse structure mean the opposite. In the related art, the expression "band" is often used, but in the present invention, it is referred to as a node in order to convey an accurate meaning.

The structural pattern forming the head part may be used in the same manner as the body structure pattern or may be used by being slightly deformed according to the shape of the head. Since most of the components constituting the actual stent are the body, The pattern can be said to be a structural pattern that forms the stent body.

Therefore, in the present invention, a method of forming a multi-alterable structural pattern and a manufacturing method (order) will be described, focusing on a structural pattern constituting a body.

The following is an explanation for helping understanding of the stent structure pattern of the present invention. The cross section of the stent (Fig. 29) may be a hook, a cross, or a combination of a hook and a cross depending on the structure pattern (Fig. 30).

As described above, the position and arrangement of the hook and the cross node are easily grasped in a single view section.

However, when a plurality of sections are not superposed in a single cross section, it is difficult to grasp the position and arrangement information of nodes, that is, the structure pattern (FIG. 31).

Therefore, in order to widely, clearly, and systematically grasp the structure pattern, it should be grasped on a plane view or a top view (FIG. 32). Of course, three-dimensional CAD files (3D CAD files) can be grasped on the computer in three dimensions, but in order to clearly recognize the structural pattern at a glance, a two-dimensional plan view is advantageous.

However, even if the stent having a cylindrical shape is viewed from the top view, it is still difficult to grasp the structural pattern due to overlapping (Fig. 33).

For this reason, the structural pattern on the plan view must be made in the form of a planar figure in which the cylindrical shape is opened (FIG. 34).

In the case of the developed shape as described above, a planar mesh in which the wires are spread like a net can be obtained. Hooks and cross nodes are formed at all points connected to the wires.

The connection points (ⓢ) located on the figure cutting line (line L in FIG. 34) cut to expand the cylindrical shape are one and the same node, not two different nodes.

If all connected points of the above-mentioned planar mesh, that is, nodes are connected horizontally and vertically, a planar grid such as a checkerboard or a grid paper is generated and the intersection point of the grid (x, y) or (i, j), the position of each node can be expressed accurately (FIG. 35). Here, the method of expressing the position of a node by a matrix is referred to as a planar matrix in the present invention for convenience.

In the planar grid and the planar matrix, the lines extending from the horizontal row to the vertical column are referred to as a horizontal node line and a vertical node line, respectively, We call the node line width between the horizontal node lines and the node line height between the vertical node lines. The individual node linewidths (W _{n .line, i- th} , and node line width) and node line heights (H _{n .line, j- th} and node line height) are not the same length, This is possible.

Such a planar matrix format has been attempted in a similar manner in the conventional design of a wire weaving stent structure pattern. However, as described above, a complicated manufacturing method of a single structural pattern In the case of a planar matrix, the description is not given, so it is explained through a few expansion matrices, and finally the expansion matrices are combined to form a superposition ) To propose a single structural pattern that is finally completed. For example, Korean Patent Application No. 10-2008-0076586 describes a method of weaving using 12 large number of development matrices as shown below, and finally shows a result of superimposing a single structure pattern (FIG. 36).

Although describing only a single structure pattern is somewhat complicated and time-consuming, it may be explained using a plurality of planar matrices, but a multi-deformable structure pattern (multi since the structural patterning expression is very inefficient and low in efficiency, it is necessary to provide a simple structural patterning expression suitable for the multistortal structural pattern. Accordingly, the present invention intends to design and apply a suitable expression system.

The planar matrix unfolded on the two-dimensional plane is the simplest and most clearly recognizable structure pattern of the wire weaving stent to date. Therefore, if the location and arrangement of hooks and cross nodes in the above expansion matrix can be accurately described, it can be a sufficiently efficient and useful expression.

The expression can be used both as a graphical symbolic expression and as a textual symbolic expression. In the present invention, the symbol marking is more efficient in expressing the multidomorphic structural pattern using a planar matrix In the case of a planar mesh, the figure symbol is applied when it is judged that the figure symbol is more efficient when expressing the finished structure pattern wired with the wire. A similar example is the constitutional formula notation.

Therefore, in the present invention, a hook, a cross, and a grid intersection without additional hook and cross are referred to as null, and hook, cross, and null are all the same Node. &Lt; / RTI &gt; Symbolic representations for the three nodes are expressed as follows (Table 3). Hook nodes can be classified into horizontal hook, vertical hook, open hook and half hook. In detail, a horizontal open hook, a vertical open hook, There is a vertical open hook, a horizontal half hook, and a vertical half hook. The cross has cross and half cross, Since this is related to the method (weaving method), the following manufacturing method will be described.

[Table 3]

In the present invention, a MODEL B structure composed of a hook-shaped MODEL A structure and a combination of a hook and a cross, which are exemplified while explaining the compression ratio related to the loadability in the transmission mechanism, A planar matrix formula expressed by a symbolic expression devised in the present invention is as follows (FIG. 37). However, in both models, the hooks and crosses arranged in the cross section are repeated alternately arranged on the same axial line or on the same phase It is an expression that assumes the case.

The planar matrix formulas are marked with [], and the vertical numbers on the left (1,2,3 ,,, i) denote the numbers of the horizontal node lines and the horizontal numbers on the bottom (1, 2, 3,,, L) denotes the number of the vertical node line. In addition, the nodes located on the left and right vertical node lines indicated by red in the expansion matrix mean the same node because they are located on the figure cutting line. The same node of the previous improvement is indicated by L in the vertical node line number.

Here, the numbers of the horizontal and vertical node lines are repeated in the form of 1, 2, 3,, 8, 9, 0, 1, 2, Thus, the first 0 means 10, the second 0 means 20. The reason for this is that as it can be seen from the development matrix expression, it forms a well-formatted grid. Therefore, when two-digit numbers are written, the arrangement of each node position and vertical node number in the development matrix is shifted, This is because recognition is low.

In FIG. 37, it can be seen that the node pattern on the horizontal node line is repeated in the MODEL A and MODEL B planar matrix formulas. Therefore, to simplify the expression, we need the expression of the expansion matrix in which the repeated node pattern is abbreviated.

In the present invention, this is referred to as a primitive planar matrix formula and the abbreviated node pattern is referred to as a primitive node pattern. The circular development matrix equation at this time is expressed as follows (FIG. 38).

The exponent n in the upper right corner is a value indicating a minimum repetition in which a primitive node pattern is formed by wire weaving to form a complete structure pattern, that is, a planar mesh representation. It is called the exponent of primitive node pattern and n has a value of 1 or more. That is, n ≥ 1.

The primitive node pattern is composed of an element of node pattern (FIG. 39), and the node pattern element may be composed of a plurality of nodes.

There are two types of primitive planar matrix formulas: an open loop type and a closed loop type.

In the open loop type, the starting node pattern element and the end node pattern element are different types, and the close loop type is the starting node pattern element and the end node pattern element. The same thing. In other words, the open loop type remains the same after the primitive node pattern is repeated n times as the circular node pattern exponent value. The closed loop type repeats n times and adds the starting node pattern element (+ 1), and is terminated (Fig. 40).

The closed circulation notation is denoted by a c (close) symbol at the lower right of the primitive planar matrix formula, that is, [] c (FIG. 41).

Since the circular development matrix is a notation expressing the structural pattern of the stent body that plays a key role in the stent structure pattern, crystals for the open circulation type and the closed circulation type are formed by the body portion of the stent and the head ) Part of the node, that is, the node pattern (interface node pattern) is determined mainly. The open-circuited and closed-circuited crystals can be said to be highly variable (Fig. 42) because the stent head can be implemented in various forms to provide anti-migration function.

The interface node pattern is also applied to a compound structure pattern that forms a new structure pattern by combining different primitive planar matrix formulas, Retainability of pattern, which maintains each unique structural pattern implemented in different structural patterns, that is, primitive planar matrix formulas, connected to connectivity of pattern that easily connects different structural patterns. ).

The biggest problem that arises when forming a compound structure pattern is the problem of discrepancy of connection points or discontinuity of connection. Since it is difficult to solve this problem with conventional techniques and methods, it can be said that it is difficult to implement a wire stapling stent having a composite structure capable of securing various functions and performance.

For example, a wire-wound stent using hooks must go back to the starting point in order to complete the weaving (manufacturing) process, which is a kind of "Konigsberg's bridge problem" ) &Quot;. If there is an arbitrary number of hooks on the upper and lower sides of an arbitrary horizontal node line, it is only required to have the same number of hooks on both the upper and lower sides in order to connect all of the hooks without overlapping . The hypothetical horizontal node line that equally divides the number of hooks on both sides is called a balancing node line, and the position of the balancing node line is variable according to the structure pattern. It is not mathematically possible to connect back to the starting point by passing through the horizontal node line by the total number of hooks without overlapping the paths in the absence of the same number of hooks .

Therefore, when a composite structure formed by a combination of different structure patterns is formed by existing techniques and methods, if there is no balancing node line, it can not be connected, that is, it can not be manufactured. It is not possible to attempt a composite structure capable of realizing functions and performance, and it is possible to make a single structure pattern that can be woven regardless of the concept of the concept of a balancing node line It can be seen as concentrating.

However, since the present invention introduces the concept of an interface node pattern, the problem of connectivity is solved by matching the mathematically impossible problem to a possible problem.

In the interface node pattern, the complex structure and the multidirectional structure pattern that can be implemented in the present invention are mathematically ensured so that a perfect connection is established, that is, a number of hooks such that a balancing node line exists , The exact representation in the present invention solves the problem of discrepancy of connection points or discontinuity of connection by freely tuning the number of hook nodes. The hook to be coordinated at this time is called a balancing hook.

Also, from the position of the hook and the cross, in the conventional technique and the method, the hook is a crossing point of connection where two wires are connected to each other, Since all of the hooks that make up the stent body must be connected junctions because the wires are just crossing points of passing, it is fixed to the idea that the two wires must be connected to each other This has resulted in limiting the possibilities of various functions and capabilities that can be implemented in wire-wrapping stents.

If all the hooks that make up the stent body do not need to be a crossing point of connection, that is, if the two wires are not crossed and only one wire is passed, The hook serves as a turning point. The hook is referred to as a half hook, and the shape of the hook can be changed to give other functions and performance of the wire binding stent. Additional information on half hooks will be described in the manufacturing process.

In addition, since the number of balancing hooks can be adjusted as well as the number of balancing hooks in an interface node pattern, when a complex structure pattern is formed by combining different structure patterns, the function and performance And to maintain the shape of the hook and cross so that it can be maintained.

Therefore, a schematic illustration of a structural pattern constituting the wire-wired stent can be briefly expressed as shown in FIG.

The following is a manufacturing expression used for describing (manufacturing) a manufacturing method (weaving method) for knitting a (unfolded) structural pattern developed by a node structure pattern represented by the primitive planar matrix formula, a description of a fabrication expression.

In other conventional inventions, it can be seen that the manufacturing method (weaving method) for a single structure pattern is very long and complicated. However, it is practically inefficient to describe several tens or hundreds of structural patterns that can be constructed in the multi-alterable structural pattern proposed in the present invention, as in the conventional method. Therefore, And description requires a fabrication expression that can describe the manufacturing method (weaving method) in a simple and clear way.

First, the stent with a hook node is currently manufactured manually using an auxiliary jig. The shape of the auxiliary jig or the degree of application of the machine work will vary slightly from one manufacturer to another, but a very common form is to drill a small hole of about 0.5 to 1.0 mm, which can form a structural pattern on a cylinder- By repeating the process of winding a wire of shape memory alloy (mostly NiTi shape memory alloy) and transferring it to another metal pin by bending a metal pin acting as a supporting pin by inserting a thin metal pin, Finally, the fixing finish of the wire is fixed by knot, welding or tubing press. The stent structure pattern completed in the auxiliary fixture of the metal rod is completed through a heat treatment for shape memory setting process together with the metal rod.

Unless the edge line of the stent is the end of the head, the bending part forms a hook, if it is not for a specific design purpose but for connection between the nodes. Therefore, it is possible to form a desired structure pattern by expressing the movement path of the wire from the start point to the end point, in particular, by sequential order to the center of the hook node position. Also, since the number of wires used can be a number of wires rather than one, it is very easy to distinguish only the movement path for the starting point and the ending point of each wire, so that a manufacturing expression (fabrication expression) ).

More such imaginative illustrations for quick understanding like a very long snake (ie. Wire) are specific start rats in several places by starting from the (start point) (ie., Hook) to catch eat and come back to the starting point at the end (ie Ending is similar to ending a magnetic tail ( ie . wire fixing) still at the starting point.

The brief manufacturing method (weaving method) described above will now be described with reference to the drawings.

), 좀 더 정확히는 방사형 이동(radial movement, 8-way,

)으로 요약할 수 있다(도 44). 방사형 이동은 현재 위치를 원점이라고 가정하면 원점을 중심으로 사방 8가지 방향으로 이동이 가능하기 때문에 방사형 이동(radial movement)이라고 한다. A node structure pattern expressed in a specific structure pattern, that is, a primitive planar matrix formula, occurs in the planar matrix (FIG. 44) (movement with a connection node pattern for stenthead node pattern connection Except for. All movements in the expansion matrix can be explained by horizontal movement, vertical movement, and diagonal movement. Horizontal movement can be described as horizontal movement, vertical movement as vertical movement, and diagonal movement as vertical movement all occurring within the deployment matrix because it is movable with, i.e. horizontal left (H _L, horizontal to left), a horizontal right (H _R, horizontal to right), the vertical phase (V _U, vertical to up), perpendicular to ( V _D, vertical to down), the diagonal upper-left _{(D LU, diagonal to left up} ), a diagonal lower left _{(D LD, diagonal to left down} ), a diagonal upper right _{(D RU, diagonal to right up} ), a diagonal lower right (D _RD, diagonal to right down) are briefly referred to as sandglass type movement (6-way,

), More precisely radial movement (8-way,

) (Fig. 44). Radial movement is called radial movement because it is possible to move in eight directions in all directions, assuming that the current position is the origin.

The radial movement is a more accurate representation of the zigzag, Z movement, which is generally applied in the prior art, and the fact that four movements are possible and W movement, Since it has more dof of movement than the conventional method, it is more advantageous than the existing method in the manufacturing (weaving) method and can start from all hooks. Therefore, the position of the start point can be freely selected, It is possible to freely adjust the quantity of the water.

Therefore, if only the position (ij) _hook of the hook node to be moved in the expansion matrix is sequentially displayed and only the wire is moved in the indicated order, the desired structure pattern, that is, the node structure pattern of the circular development matrix, can be completed.

The textual symbolic expression used in the fabrication expression proposed in the present invention based on the above description is as follows (Table 4).

[Table 4]

A brief description of symbol expressions in Table 4 is as follows.

In S # (i, j), which represents the starting point, # is used to distinguish the number of wire sequences used when multiple wires are used in manufacturing. do.

In E # (i, j) indicating the end point, # is the same as described at the start point, and the start and end points are used as a set. For example, starting with wire # 1 and ending, it is denoted as S1 (i, j) ,,, E1 (i, j).

The horizontal hook is a hook shape formed when the bending movement direction of the wire in the hook node makes a horizontal movement (FIG. 45).

The vertical hook is a type of hook formed when the bending movement direction of the wire in the hook node makes a vertical movement (FIG. 46).

A horizontal open hook is a hook that is formed when the direction of bending movement of a wire in a hook node is horizontal movement or a hook form of an open state in which there is no hook (Fig. 47).

A vertical open hook is a hook that is formed when the direction of bending movement of a wire at a hook node is vertical or a hook form of an open state without a hook (Fig. 48).

A horizontal half hook is a hook that is formed when the direction of bending movement of a wire in a hook node is horizontal movement or a single hook in an open state without a hook, (Fig. 49).

A vertical half hook is a hook that is formed when the direction of bending movement of a wire in a hook node is vertical or a single hook in an open state without a hook, (Fig. 50).

A horizontal open hook, a vertical open hook, a horizontal half hook, and a vertical half hook may be used for the technical functions and performance required to implement the specific functions and performance required in the wire- It is an implementation of an in hook.

Technical hooks are usually applied in half hooks in the form of hooks related to the function, performance and manufacturing method of the stent. The basic types are in-coil half hooks, Out-coil half hooks, band half hooks, in-band half hooks, out-band half hooks, fork half hooks, In-track half hooks, out-track half hooks, close-turning half hooks, and gap-turning half hooks. (Fig. 51). A turning half hook is a half hook type that is applied to change the direction when the direction of the horizontal hook is kept the same without using a vertical hook. The technical hook type is basically applied to half hook but also applies to open hook and general hook if it does not affect compressing loadability. Is possible.

A fabrication expression for a manufacturing method (a weaving method) in which a structural pattern is completed using three wires is described in the following formatted type (FIG. 52).

(Arrow, ->), comma (","), and null space () can be used to indicate sequential order. The matrix coordinates representing the node position are indicated by double brackets, ie, (i, j), it can be naturally distinguished. In the present invention, a null space or a line feed is used to distinguish it. As will be seen in the following application example, since the manufacturing method (weaving method) has a certain repetition order, it can also be expressed as an abbreviated format for the repetition order.

For a cross node, you can also apply a crossing without crossing to optimize or optimize stent-specific performance. You can apply a cross-over to a specific cross-node by passing up or over or down (i, j) _xu or (i, j) _xd for the cross node (Fig. 53). However, even if the present invention is not used, it is considered that there is no great difficulty in explaining and understanding the manufacturing method (weaving method) of the multi-alterable structural pattern proposed in the present invention. Thus, the fabrication expression ), The notation for the cross node is omitted and proceeded.

A simple example of the above fabrication expression is as follows.

In the beginning of the present invention, MODEL A composed of hooks only, and structure pattern of MODEL B composed of a combination of hooks and crosses are exemplified while comparing the compression rates between the structure patterns. I will explain it. The primitive planar matrix formulas of the two models are shown in FIG. For the sake of simplicity, we consider the case where the exponent of the primitive node pattern is 1, that is, n = 1. (Note: The circular development matrix is a structural pattern for the stent body.)

First is the case of MODEL A. (HHHHHHHHHHHHHHH-) and the lower connection node pattern is [HHHHHHHHHHHHHH] (FIG. 55), which is a very simple and tedious repetitive structure pattern consisting of only a hook, ) The manufacturing notation with no twisted line sequentially from the starting point to the ending point centered on the center is as follows (FIG. 56). A planar mesh having completed wire weaving according to the manufacturing notation formula is shown in Fig. The deployment mesh is useful for application to visualization of hooks and crosses after wire weaving.

56 is expressed in abbreviated form, and the whole expression connected by a hook node at a hook node is S1 (1,2), (2,3), (1,4), (1, 6), (2,7), (1,8), (2,9), (1,10) (I, j), i is repeated in the order of 2->1-> 2, and j is a form of arithmetic series with interval of 1, so shorten (i, j) j + 1) _{i = 2 -> 1 -> 2, j = 2 to 25} .

The following is the case of MODEL B. An upper node pattern (interface node pattern) is composed of a combination of a hook and a cross,

The development matrix of the MODEL B when the lower connection node pattern is [HHHHHHHHHHHHHH] is as shown in FIG. 58, and the manufacturing notation expression without the twisted line sequentially from the start point to the end point with the hook center is as follows (FIG. 59) . A planar mesh in which the wire weaving is completed according to the manufacturing notation formula is shown in Fig.

For MODEL B, the case where the value of the exponent of primitive node pattern is n = 2 is as follows. The primitive planar matrix formula and the planar matrix are as shown in FIG. 61 when the connection node pattern is applied in the same manner as in the case of n = 1, and the fabrication expression and the development The planar mesh is shown in FIGS. 62 and 63, respectively.

As described in the above example, the specific wire weaving structure pattern derived from the multi-alterable structural patterning method proposed by the present invention can be represented by a primitive planar matrix formula, The entire structure pattern using the interface node pattern can be expressed as a planar matrix, and the manufacturing method (weaving method) actually implemented by the wire can be expressed as a formal manufacturing expression (fabrication expression) And the finished wire weaving stent structure pattern has a systematic implementation procedure that can be confirmed in the planar mesh.

The following is a brief description of the flow chart for systematically determining the fabrication expression for the above manufacturing (weaving) method.

The manufacturing (weaving) method for determining the manufacturing notation is basically a method of connecting a hook and a cross in a planar matrix in which a primitive planar matrix formula and an interface node pattern are combined. and the information of the node position of the cross. As described above, the expansion matrix has a horizontal node line represented by _i from 1 to N _i and a vertical node line represented by _j from 1 to N _j , The positions of all hooks and crosses can be expressed in the form (i, j). The distinction between a hook and a cross at (i, j) node position is represented by C (i, j) in the case of a cross and by H (i, j) in the case of a hook The location and type information of the node at the bottom can be indicated simultaneously.

Also, in the planar matrix, even when the node line width or the node line height are not the same, the width and the height are respectively expressed as equal distances, There is no need for a virtual node line, which is advantageous in that it can be performed more easily than determining a manufacturing expression in a planar mesh.

When composing the same node line width or node line height, it is not expressed as a direction angle or a moving angle, but simply a few delta-i space, △ i) It is easy to logic or algorithmic representation of the movement position in the form of (i, j) because it can be determined by movement, or by moving several boxes vertically and vertically (delta-j space, expression).

What is needed to move from the current position of the node to the next position of the node is the information type of the node at the current position. If the node type of the current location is a cross node, it may be applied as a cross-node or a cross-node located adjacent to the same horizontal node, If the node is a hook node, it must decide whether to send a technical hook, a horizontal hook, a vertical hook, You must decide whether to apply the open hook, the open hook, the halft hook, and the turning hook.

To summarize the above manufacturing (weaving) method, a manufacturing notation expression that can constitute a development network can be completed through an iterative procedure of moving Δi and Δj based on the starting node position, moving direction, and node type information . Detailed implementation flow procedures are shown in Figures 64A-64C.

Multi-deformability wire  Weaving Stent  rescue Patterning  Way

The following describes the 'method of multi-alterable structure loadability assured' which is provided by the present invention and is secured to a mountable structure. Hereinafter, it is abbreviated as "multi-alterable structural patterning".

As mentioned at the outset of the present invention, the stent is a medical device system incorporating a stent and delivery mechanism. In addition, the delivery mechanism is not only a natural orifice of the human body such as mouth, anus, urinary organs, eye, nose, ear, (abdomen) or through the skin to pass into the blood vessel. In some cases, it is used as an auxiliary device with an endoscope, a cystoscope, or the like.

Therefore, in order to minimize the pain of the patient, penetrated holes should be minimized and applied to the procedure.

In order to meet these basic requirements, a 'stent structure pattern with excellent compressibility with a transmission mechanism' is required.

In order to meet the above-mentioned basic requirements, the present invention conducts a microstructure analysis of a wire-wired stent structure by modeling and analyzes the micro structure of a hook and a cross node, which are basic core elements constituting a wire- The quantitative analysis of the compression ratios according to the number and arrangement confirmed the following key factors.

First, the formation of twisted lines generated in the manufacturing method (weaving method) must be removed. Second, there should be no interference between neighboring hooks and cross nodes at the time of compression, The third is the hook node which has a major impact on the compression ratio and the fourth is the number of suitable hooks per radial section of the stent, And the fifth is that the global arrangement of hooks should maintain symmetry unless it is for a specific design purpose and the symmetry should be maintained as far as possible in terms of the sustainability of the stent radial cross- circular circumference must be ensured, i.e. close to the circle.

When the above-mentioned main elements are implied, it can be expressed as 'having no interference between twisted lines and nodes, and securing symmetric circular formation when 3 to 8 hook nodes per horizontal node are compressed'. The above phrase can be referred to as a basic statement of requirements of the &quot; multivariable structure patterning &quot; proposed by the present invention.

Accordingly, the present invention derives the following concept for 'multi-alterable structural patterning' that satisfies the basic requirements described above. First, primitive n-gon; Second, rotation; Third, a section layer; Fourth, skip; Fifth, combination; And sixth, outburst.

Multidomorphism is largely divided into formatted multi-alterability and unformatted multi-alterability. The major difference is in repetition. The orthotropic polymorphism proceeds in the form of repetition in a formal form, while the atypical polymorphism repeats in a random form.

The concept proposed above is proposed to be able to secure non-interference, compressibility, symmetry, and circularity around multi-alterability without any formal or irregular relation. It is a concept element.

First, a brief description of the above six concepts will be given, followed by a description of the specific application.

The concept of a 'primitive n-gon' is an analysis that a suitable number of hooks is 3 to 8 per radial section of a wire-wired stent, that is, a horizontal node line. From the triangle to the octagon, a primitive shape was introduced according to the result (Fig. 65). Circular n-prisms apply a cyclic polygon to be inscribed in the diameter of the stent. The basic polygon adopts a regular polygon that always tangent to the circle and an irregular polygon that is inwardly tangent to the circle to further expand the multi-alterability of the 'primitive n-gon' (irregular polygon) is applied. In this case, since the circle is the circumference of the stent, the circumference of the stent becomes a circumcircle in the circular n-square.

In addition, 'primitive n-gon' means that the global arrangement of hooks should maintain symmetry, and its symmetry should be maintained at the level of sustainability of the circular circumference of the stent radius section ), That is, the circularity is ensured.

It is also a concept that can satisfy both the requirement that there is no mutual interference with neighboring hook nodes during compression.

The concept of 'primitive n-gon' is applied according to the analysis result that the number of suitable hooks is 3 ~ 8 per horizontal node line of the wire weaving stent, Since the number of hooks that can be used can be from 1 to 8, the concept including points (1) and (2) will be referred to as 'primitive n-geo'. A 'primitive n-geo' containing no more than two hooks is not represented in the primitive planar matrix formula but in the interface node pattern .

'Rotation' is related to the rotation movement of 'primitive n-gon', and its main purpose is to introduce multi-alterability, but symmetry and circle formation circularity) conditions are also satisfactory.

'Rotation' can be both clockwise and counterclockwise. The range of the rotation angle can be set freely within the range where there is no mutual interference of hook nodes during compression.

The 'section layer' is a concept for securing the multidomorphism with the concept that the 'primitive n-gon' exists in a plurality of independent layers with individual characteristics. That is, if the number of 'section layers' to which individual characteristics are given increases, the number of multivariable cases increases. It is also a concept for ensuring symmetry and circularity conditions.

'Skip' is a concept that 'primitive n-gon' does not exist in any single layer (section layer) and it is a concept to secure multi-deformity.

A 'combination' is a concept introduced for amplification or multiplication of polymorphism as a combination of multi-alterability obtained from the above concept.

'Outburst' is intended to ensure unformatted multi-alterability. It is given randomness when selecting the applied variable values for individual application of the concept, dof of formation.

A method for implementing the above concept is as follows.

First, it is assumed that the radial cross section of the stent is viewed in the axial direction as shown in Fig. If a radial section in which a hook or a cross node exists is called a node radial section, the node radius section is a horizontal node line in a planar matrix, same. That is, when a node radius section is expanded (expanded), it becomes a horizontal node line. Therefore, there exists a node radius cross section by the number of horizontal node lines. In the above concept, the 'section layer' and the horizontal node line are the same. In summary, the radial node section = the section layer = the horizontal node line.

A node radial section in the form of a three-dimensional isometric view with respect to an axis is sequentially arranged as follows (FIG. 67). That is, a plurality of 'section layers' are formed to give individual characteristics for multistability. That is, as the number of 'section layers' to which individual characteristics are given increases, the number of cases of multidomorphism increases as well.

A 'primitive n-gon' inscribed in a node radial section may be disposed. For example, assuming that a triangle is disposed at each node radius section, (Fig. 68).

A 'primitive n-gon' is a fundamental element that determines the position and symmetry arrangement of a hook node. Therefore, if it is assumed that a hook node exists at each vertex of the 'circular n-corner,' the wire weaving stent structure proposed in the present invention can be applied to a horizontal node line, That is, a symmetric hook array that satisfies the condition that the number of suitable hook nodes per node radial section is 3 to 8 can be secured systematically.

For example, if a hook node is arranged at the vertex of the circular triangle in FIG. 67, the shape is as shown in FIG. 68, and the shape is as shown in FIG. 69 when applied to another circular n-corner.

When an isometric view of the sequentially aligned node radial section is viewed in the axial direction on a straight line, a hook located at each vertex of a 'primitive n-gon' Since all of the nodes are in the same phase while maintaining symmetry, the hook nodes positioned in the radius cross section of each node are the same (Figure 70).

However, applying the second concept of 'polymorphism', 'rotation' can change the phase of the hook node located at the vertex of 'circular n-square', so that the multi-alterability ) Can be ensured. The degree of phase shifting can also be given in terms of the basic rotation direction, that is, clockwise (cw) or counterclockwise (ccw) motion, (rotation angle).

For simplicity, a simple example of a primitive regular triangle is shown in FIG. For convenience, the rotation direction is clockwise and the rotation angle (θ _rot ) is 90 ^° . In this case, the rotation of the first node radius section is 0 ^o , the second is 90 ^o , the third is 180 ^o , the fourth is 270 ^o , the fifth is 360 ^{o and} is in phase with the first node radius section. After that, it has the same repetitive pattern so that it can not distinguish repetition of the same phase in the axial direction on the straight line.

As shown in the above example of the primitive regular triangle, it can be seen that a wide variety of multi-deformability can be secured by changing the rotation angle (θ _rot ). In addition, in the 'circular n-square' . The degree of the basic transformation that can be applied to the node radial section at the rotation angle (? _Rot ), that is, the number of angle division (N _ang ), is N _ang = || 360 /? _Rot || The multidomensional expansion of the rotation angle is possible by applying a mathematical combination ( _n C _k ) in the 'combination' concept of the multivariable which will be described later.

Since 'rotation' has the directionality of forward and backward directions, direction can be set for individual division angle or combination division in order to secure multi-deformability. For example, if the rotation angle is 90 ^° , the cumulative angle of rotation (θ _accu ) will cycle from 0 ^o -> 90 ^o -> 180 ^o -> 270 ^o -> 360 ^o (0 ^o ) ^It can be set in clockwise (cw) for ^o and 180 ^o , and counterclockwise (ccw) for 270 ^o and 360 ^o .

For connection between the forward node structure pattern and the reverse node structure pattern according to the node structural pattern formed when securing the polymorphism in the combination of the forward direction (cw) and the reverse direction (ccw) in 'rotation' An interface node pattern may be required.

In order to obtain unformatted multi-alterability, atypical structure patterning can be performed by applying a random outcrossing concept to the accumulated rotation angle (θ _accu ) individually.

The notation for 'rotation' can be expressed as follows to impart directionality to the individual cumulative rotational angles: The direction of rotation (clockwise, clockwise, cw) and reverse (counterclockwise, ccw) are denoted as forward = R and reverse = L for simplicity of notation.

R _rot = (? _Rot xi, j) _{i = 1 to N. ang , j = L or R}

R _rot = (0, R) (90, R) (180, R), (270, L), and (360, L).

In addition, by combining the concepts of 'rotation' and 'section layer', symmetry can be secured. By applying a circular triangle, a rotation angle of 90 ^° and four section layers If you use this, you can see that the twelve hook nodes are arranged symmetrically and the compressed circumstance when the stent that is implemented with this wire-wrapping stent structure pattern is mounted on the deliver device. It is advantageous in securing circularity because it becomes a regular 12 square circumference (Fig. 72). If only 'section layer' is applied without 'rotation', the compression circle becomes a quadrangular prism and the compression ratio is the same (total number of nodes, N _t = N _h + N _c Is the same), it is disadvantageous in securing circularity.

When applying a 'primitive n-gon' with a large vertex to the combined concept of 'rotation' and 'section layer', the more detailed symmetry and The circularity can be ensured. However, because of the disadvantage in terms of compression ratio, tuning may be required depending on the function and performance requirements of the particular area to which the wire-wound stent is applied and the inside diameter of the delivery device on which the stent is mounted . Of course, 'skip' and 'combination', which are explained in the next section, can reduce the possibility of increasing the frictional force in the transmission mechanism due to the compression ratio reduction.

The following is the 'skip' concept for securing multiple deformability. The 'skip' is a node pattern that is intentionally formed in a node radial section, that is, a 'node layer' or a 'primitive planar matrix formula' The element of the node pattern will be missing or pushing. Skipping is to skip the node pattern and pass it by, and pushing adds a "section layer" with no hook nodes, and then continues with the original node pattern.

The 'skip' is a simple one or two, depending on the number of faults (N _lay , number of section layers) or horizontal node lines represented in the primitive planar matrix formula A skipping pattern can be formed by a mathematical combination ( _n C _k ) as in the case of a rotation angle, not a skip. There are also two ways to extend additional multivariable dof of formation: missing and pushing.

For example, to illustrate a primitive regular triangle, if a rotation angle (θ _rot ) is 90 ^° , four 'section layers' are applied to form a fixed 12-sided compressed circumference. 'Skip''isa' skip 'of a' section layer 'which is intentionally a certain accumulated rotation angle.

For example, when the rotation angle θ _rot is 90 ^° , the rotational angles accumulated in each 'section layer' are 0 ^o , 90 ^o , 180 ^o , 270 ^o , and 360 ^o (= 0 ^o ) Skipping the &quot; section layer &quot; of 180 ^o in FIG. In the case of a missing skip, the form is the same as that of A, and the pushing skip is the same as B.

The primitive planar matrix formula shown in the above example is as shown in FIG. 74. This circular development matrix is simplified by using only a hook and a null node without a cross node in order to facilitate understanding. . In practical applications, a cross node occurs naturally because the wire passes. Therefore, only a cross and a null node exist in a 'section layer' or a horizontal node line which is 'skipped'. The cross and null nodes that are naturally formed in the implementation (or manufacturing) of the polymorphic structure patterning technique are called dummy nodes and the horizontal node lines with dummy nodes are called dummy nodes node line and not in the primitive planar matrix formula. However, in the planar mesh showing the actual implementation form, 1 _dum and 2 _dum are used for distinguishing the dummy node line.

'Skip' means that a skipping pattern can be determined by a mathematical combination ( _n C _k ) by a concept of a 'multidirectional' combination. , The first 'skip' means that the cumulative rotational angle (θ _accu ) is 180 ^° and the second 'skip' is the cumulative rotational angle (θ) (&amp;thetas; _accu ) occurs at 90 ^o , a circular development determinant as shown in Fig. 75 can be obtained. Since the independent circular development matrix expresses different structure patterns, the circular development matrix formulas shown in FIGS. 74 and 75 are different wire weaving stent structure patterns derived by the concept of 'skip'. In the mathematical combination, symmetric circularity can be secured in compression when k 2.

The application of the concept of 'outburst' of polymorphism in 'skip' can secure atypical multidomorphism by randomness. It is necessary to establish and apply a policy for random selection. It is important. For example, whether to "skip" in the entire section layer, or "skip" in the repeated section layer that occurs when a rotation angle is applied Policy decisions must be made first and then the number of 'section layers' to 'skip' by random selection should be decided after policy decision.

The following is a description of the 'combination' concept of polymorphism. 'Combination' can be divided into two categories: parameter combination and pattern combination. The combination of elements is 'circular n-square,' rotation and 'skip' ( _N C _k ), and the pattern combination is a combination of the primitive planar matrix formulas generated by the combination of elements. If necessary, a combination node pattern (interface node pattern) (Fig. 76).

The pattern combination may consist of a normal combination of patterns, a symmetry combination of patterns, or a reverse symmetry combination of patterns, And the symmetric combination is to combine the circular development matrices in such a manner that they are symmetrical to each other and the reverse symmetric combination is a combination scheme in which the circular development matrix is inverted and applied in reverse order And 77b).

An example of a parameter combination is to apply one or more 'round n-angles' to a multi-alterable structural patterning in the case of a 'primitive n-gon' For example, a primitive regular triangle and a primitive regular tetragon are applied at the same time, and a rotation angle (θ _rot ) of 90 ^° is applied as follows (FIG. 78).

Finally, 'outburst' is a concept of applying randomness to ensure atypical polymorphism. However, the randomness derived from the present invention is not a confusing mass randomness, but rather an unexpected change in the order of factors (factors) such as mutation of nucleotide sequence, ) To create an outburst, which is used to increase the dof of formation of polymorphism. Randomness can also be given to the selection of 'round n-square,' 'rotation,' and 'skip.' As described in the 'skip' conceptual description, The policy that determines in advance what range to apply is the most important factor.

The deformation (multi-alterability) described above is associated with a diversity (versatility) variety is the element (factor) and the degree of freedom the product of _{(D f, degree of freedom)} , i.e. f (versatility) = factor x D f (N _def , number of cases of formatted multi-alterability) is as follows.

The number of unstructured polymorphic cases (N _undef , number of cases of unformatted multi-alterable one) is as follows.

As can be appreciated from the above equation, it can be seen that the multivariable structure patterning concept proposed in the present invention can secure a great deal of multivariable structure.

) 또는 8가지 방향의 방사형(radial type,

)으로 이동하기 때문에 와이어 엮기로 구현된 전개그물망(planar mesh)을 얻을 수 있다. 즉, 본 발명의 모든 다변형성 구조패턴닝 와이어 엮기 스텐트 구조를 완성할 수 있는 것이다.In addition, all the primitive planar matrix formulas derived from the above concept are represented by a planar matrix combined with a proper interface node pattern, and the movement of the wire in the development matrix is expressed by six types Hourglass type (sandglass type,

) Or radial type in eight directions,

), It is possible to obtain a planar mesh realized by wire weaving. That is, it is possible to complete all the polydimensional structure patterning wire weaving stent structures of the present invention.

Hereinafter, a method of arranging a cross node will be briefly described before an actual application of the above concept is introduced. The placement of the cross nodes can be applied along the sides of the 'primitive n-gon', and the number of cross nodes to be applied depends on the function of the wire- It depends on performance.

The actual arrangement of the cross node is arranged along the circumference of the circumcircle, that is, the circumference circumscribing the vertex of the 'round n-corner', but in the case of the multi- It is advantageous to utilize the sides of a 'circular n-square' because it is intuitive to arrange patterns along the sides.

For example, if three primitive regular triangles are placed on each side and a rotation angle of 90 ^° is applied to the previous example, the primitive planar matrix formula is used (Fig. 79). When writing in 'circular n-square' superimposed in the axial direction, only the first 'circular n-square' should be indicated. The graphical symbolic expression of a cross node uses X.

The symmetry and circularity evaluation of the polymorphic structural pattern should proceed on a planar matrix but the number of circular monolayers (N _lay , no. Of section layer) excluding the skip node line, Can be obtained through a primitive node pattern expressed in a primitive planar matrix formula which implicitly represents a core structure pattern. However, if the case is a circular single-layer number that make up the circular node pattern is less than four are evaluated by changing the circular nodes pattern index (n, exponent of primitive node pattern ) value meets the at least four circular single-layer the number (N _lay) conditions do.

Symmetry is an element that evaluates how uniformly the hooks are arranged in the axial direction. Therefore, both the position and the quantity of the hook must be evaluated together do. (N _{.phase h} of FIG. 80) is also uniformly arranged, when seen in the axial direction 80 as symmetry (symmetry) are seen as being held can hook (hook) which are provided in the same phase can be different from each other in position and It is necessary to evaluate by considering both quantity.

The symmetry is to evaluate the uniform dispersion of the hook, so we can evaluate the variance of the hook node. The variance factor or variance variable to be evaluated is three, including two quantity variables and one position variable.

1) Number of hooks per horizontal node line, N _{h . horiz. node.i- th} (no. of hooks per horizontal node line)

2) Number of hooks per vertical node line, N _{h .vert.node.j- th} (no. Of hooks per vertical node line)

3) spacing between hooks per horizontal node line, _{h. horiz. node.i-th} (distance between neighbor hooks per i-th horizontal node line)

Horizontal node hukgan interval per line (△ _{h. Horiz .node.i- th)} means the included angle is also (θ _HH, contained angle between neighbor hooks) between adjacent in the axial center hook (hook) the hook (hook) In the primitive node pattern, the angle of division (θ _div , angle division) between nodes is expressed as a distance between vertical node lines, ie, a node line width (W _n.line) and a node line width (N _HH.vert) , the following relation holds true: N _HH.vert is the number of vertical nodes between the hook and the hook.

θ _HH = N _HH.vert x θ _div = N _HH.vert x W _{n .line}

θ _HH / θ _div = N _HH.vert

Therefore, it is possible to evaluate the _{inter- hook} spacing ( _{H. h. Horiz . Node.i- th} ) per horizontal node line simply by the number of vertical nodes between the hook and the hook (N _HH.vert ).

The evaluation of the number of hooks per vertical node (N _{h .vert.node.j- th} ) is a variable that reflects the variation of the number of hooks existing in the same phase. The vertical node line consisting of a null node is excluded from the calculation.

In addition, since all of the three dispersion variables are independent and uncorrelated, it is possible to calculate the arithmetic dispersion of each dispersion variable. Therefore, it is possible to quantitatively evaluate variance as a coefficient of variation (CV) that can be dimensionally compared by dividing the variance by the standard deviation and dividing by the mean value. In other words, it is possible to evaluate the symmetry (Q _symm ) with the average coefficient of variation (CV _avg ) for the above three dispersion variables. The closer the mean variation coefficient is to 0, the better the symmetry. The symmetry term expression evaluated for cognitive convenience _symm = Q 1 - is calculated by (+ _Nhhoriz CV CV CV _{N .h.vert} + △ _{horiz .h.)} / 3. Therefore, the closer to 1 the symmetry value itself, the better the symmetry. In the present invention, a minimum of 0.5 is recommended.

The following is a brief summary of the formula for evaluating quantitative symmetry (Q _symm ).

Because circularity assesses the sustainability of the circular circumference of the stent radius section during stent compression (Figure 81), a structure pattern composed of many hooks in the axial direction may be advantageous . However, the presence of many hooks in one section layer is disadvantageous in terms of compression ratio, so it is advantageous to uniformly disperse each single layer to maintain circularity.

The circularity can be basically evaluated by comparison with the circularity (pi, pi). Since the ratio of the circumference (π) to the circumference (S) of the diameter (D), ie, π = S / D, the comparison of the circumferences can be evaluated by a relative comparison of the circumference. For example, if the number of sides of a positive n-prism tangent to a circle with a diameter D increases, the total length of sides becomes equal to that of the circumferential relation.

Therefore, assuming a normal n-square with a diameter D, the simple circularity (Q _{circ .simple} ) evaluation is based on the assumption that the total sum of the _sagittal lengths (S _gon ) = πD), that is, Q _circ = _simple = S _gon / S.

The length (s) of one side of the positive n-prism tangent to the diameter D can be found by the formula s = D sin (180 / n) where n is the number of sides so the total length of the sides is S _gon = nxs = nx D sin 180 / n).

Therefore, forming a circle (simple circularity) simply it can be calculated by a simplified _{Q circ .simple = S gon / S} = nx D sin (180 / n) / πD = nx sin (180 / n) / π.

However, the simple circularity assuming a quadrangular prism tangent to a circle has a number of hooks in the axial direction, dispersion according to the arrangement of the hooks, When the number of hooks is different, that is, when a variation is included, it is insufficient to evaluate the circularity only by the above equation. Therefore, it is necessary to comprehensively evaluate the variation of the number of hooks and the distribution of the array.

The parameters needed for circularity evaluation are three independent and uncorrelated variables, as in the case of symmetry evaluation.

1) the total number of hooks in the axial direction reference, N _{h. Radial} (total no. Of hooks on the axial view)

2) axial spacing, _{h. Radial} (perpendicular distance of neighbor hooks on axial view)

3) Number of hooks per vertical node line, N _{h .vert.node.j- th} (no. Of hooks per vertical node line)

Hook total sum of axially reference (N _{h .radial)} is a hook (hook) the number of the vertical line of nodes that are present (no. Of vertical node line on which hook exists), and the same simple circle form (simple circularity, Q _{circ .simple} ) is a suitable variable to apply the concept of square _nesting to the circle assumed.

The number of hooks per vertical node line (N _{h .vert.node.j- th} ) is the same as the concept and application method for the symmetry evaluation. Therefore, the vertical node line consisting of null nodes is excluded from the variation calculation.

The size of the inter-hook spacing (Δ _h . _Radial ) based on the axial direction uses the number of vertical node lines between the hook and the hook as in the case of the symmetry evaluation, but the distance between the hooks on the same horizontal node line Unlike the symmetry evaluation used, in the circularity evaluation, the vertical distance of a pair vertical node where hooks exist sequentially from the first vertical node line is used.

Therefore, when the variation of the number of hooks existing in the same phase as the above-described hook arrangement is reflected in the simple circularity (Q _{circ .simple} ), a comprehensive circularity (Q _circ ) evaluation Can be applied. That is, Q _circ = Q _{circ. Simple} x (1 - CV _avg ).

Where CV _avg is the average coefficient of variation for the number of hooks (N _{h .vert.node.j- th} ) in phase with the hook arrangement (Δ _h.radial ) , And (1 - CV _avg ), the perfect uniformity, that is, the state without variation is CV _avg = 0, so that the axial reference hook is the same as that of the normal n-prism. That is, Q _circ = Q _{circ .simple} .

The following is a brief summary of the formulas for estimating the circularity (Q _circ ).

The above-described multi-alterable structural patterning procedure is briefly summarized as follows: a phase of patterning policy, a phase of parameter design, a phase of patterning configuration ) And a phase of fabrication expression. The flowchart is shown in FIG. 82, and the detailed description is shown in FIG. 83.

An example of applying the above-described multi-alterable structural patterning method of the present invention is as follows.

Example 1 ( REG - TRIA -90-L-12)

'Primitive n-gon' is a regular triangle, the rotation angle is 90 ^o , the rotation direction is the reverse direction (ccw, left), 'skip', ' There is no 'combination' or 'outburst' but an open loop type and the exponent of the primitive node pattern is 2, ie n = 2. (REG-TRIA-90-L-12) is the same as FIGS. 84A, 84B and 84C.

Example 2 ( REG - TRIA -180-L-12)

'Primitive n-gon' is a regular triangle, the rotation angle is 180 ^o , the rotation direction is ccw, left, skip, There is no 'combination' or 'outburst' but a closed loop type and the exponent of the primitive node pattern is 4, ie n = 4. (REG-TRIA-180-L-12) is the same as FIGS. 85A, 85B and 85C.

When the above equation of symmetry evaluation is applied to Example 1 (REG-TRIA-90-L-12) and Example 2 (REG-TRIA-180-L-12) of the present invention, And Fig. 86B.

When the above equation of circularity evaluation is applied to Example 1 (REG-TRIA-90-L-12) and Example 2 (REG-TRIA-180-L-12) of the present invention, 87B.

Example 3 ( REG - TRIA -15-R-COMB-12)

'Primitive n-gon' is a regular triangle, the rotation angle is 15 ^o , the rotation direction is cw, right, and 'combination' There is no parameter combination applied to the rotation angle, there is no 'skip' and 'outburst', the open loop type is used, and the exponent of primitive node pattern is (REG-TRIA-15-R-COMB-12) of n = 2 polymorphism structure patterning is shown in FIGS. 88A, 88B and 88C.

Example 4 ( REG - TETR -18-R-SKIP-20)

The 'primitive n-gon' is a regular tetragon, the rotation angle is 18 ^o , the rotation direction is cw, right, and 'skip' There is no missing skip, 'combination' and 'outburst', the open loop type and the exponent of primitive node pattern is 2, ie n = 2 Example of multi-deformable structure patterning (REG-TETR-18-R-SKIP-20) is shown in Figs. 89A, 89B and 89C.

Example 5 ( REG - TETR -45- RL -SKIP-20)

'Primitive n-gon' is a regular tetragon, rotation angle is 45 ^o , rotation direction is cw, right, ccw, 'Skip' applies to pushing skip, 'combination' and 'outburst' are not closed loop type and exponent of primitive (REG-TETR-45-RL-SKIP-20) of the multinomorphic structure patterning is shown in FIGS. 90A, 90B and 90C.

Example 6 ( REG -PENT-27- RL -COMB-20)

The rotation angle of the primitive n-gon is a regular pentagon, the rotation angle is 27 ^o , the rotation direction is the forward direction (cw, right), the reverse direction (ccw, left) 'Combination' applies a parameter combination to the direction of rotation, 'skip' and 'outburst' are not applied, open loop type is used, and circular node pattern (REG-PENT-24-RL-COMB-20) having an exponent of primitive node pattern of 1, that is, n = 1, is shown in FIGS. 91A, 91B and 91C.

Example 7 ( REG - TRPH -0-L-COMB-12)

'Primitive n-gon' is a regular triangle, a regular tetragon, a regular pentagon, a regular hexagon, a rotation angle of 0 ^o , a rotation There is no rotation direction and the 'combination' means that there is no parameter combination application, 'skip' and 'outburst' for circular-n square and cross, (REG-TRPH-0-L-COMB-12) is an open loop type and the exponent of primitive node pattern is 3, 92a, 92b, 92c and 92d.

Example 8 ( REG - TRPH -O-L-COMB- SYMM -12)

The parameter of design is the same as Example 7 (REG-TRPH-0-L-COMB) and the policy of patterning is similar but the combination of parameter combination and pattern All combinations of patterns are applied and the pattern combination is one with an exponent of primitive node pattern with a symmetry combination of n = 1 Example of deformable structure patterning (REG-TRPH -0-L-COMB-SYMM-12) is shown in Figs. 93A, 93B and 93C.

Example 9 ( REG - HXTR -30 / 90- LR / L-COMB- PATN -18/12)

This example illustrates the formation of a multi-alterable structural patterning by forming a compound structure pattern by combining between different structural patterns, i.e., primitive planar matrix formulas The REG-TRIA-90-L-12 model and the REG-HEXA-30-LR-18 model with the exponent of primitive node pattern of 1, HEXA-30-LR-18] + [REG-TRIA-90-L-12] + [REG-HEXA-30-LR-18]. The polymorphism policy applied to the REG-HEXA-30-LR-18 model is as follows.

The rotation angle is 30 ^° , the rotation direction is the reverse direction (ccw, left), the forward direction (cw, right) shifts, and the rotation direction is a regular hexagon. 'Combination' applies a parameter combination to the direction of rotation, there is no 'skip' or 'outburst' but an open loop type and a circular node pattern index (exponent of primitive node pattern) is 1 (n = 1), and half hook is applied for connection of different compound nodes.

Examples of the multi-deformable structure patterning (REG-HXTR-30/90-LR / L-COMB-PATN-18/12) are shown in FIGS. 94A, 94B and 94C.

Example 10 ( IRR - TRPH -20-L-COMB-14)

In this example, the total number of hooks of the 'primitive n-gon' applied as an example applying the irregular 'primitive n-gon' This is an example of multi-deformable structure patterning. The polymorphism policy applied to the IRR-TRPH-20-L-COMB-14 model is as follows.

The 'primitive n-gon' is an irregular triangle, an irregular tetragon, an irregular pentagon, an irregular hexagon, a rotation angle of 20 ^° (18 x 20 ^o = 360 ^o ), the rotation direction is in the reverse direction (ccw, left), and the combination is a parameter combination applied to the circle-n square and cross, There is no 'skip' or 'outburst', the open loop type is used and the exponent of primitive node pattern is 1 (n = 1) we applied a half-cross for the linkage picture to the irregular n-gon.

An example of the multi-deformable structure patterning (IRR-TRPH-20-L-COMB-14) is shown in FIGS. 95A, 95B, 95C and 95D.

Example 11 ( IRR - TETR -NA-L-COMB-REVS-8/10/14)

This example applies a compound structure pattern composed of 8-node, 10-node and 14-node by applying an irregular tetragon A primitive planar matrix formula, a planar matrix, a planar mesh, and a fabrication expression are shown as an example of a pattern composed of a reverse symmetry combination.

An example of the multi-deformable structure patterning (IRR-TETR-NA-L-COMB-REVS-8/10/14) is shown in FIGS. 96A, 96B and 96C.

Multi-deformability wire  Weaving Stent  rescue Patterning  Method Applied materials and others

The materials applicable to the wire-weaving stent using the multi-deformable structure patterning technique are basically metal-based, polymer-based ), And natural-based polymer materials are all possible.

Examples of metal-based materials are nickel-titanium shape memory alloys, martensitic-NiTi shape memory alloys, stainless steel, tantalum tantalum, tungsten, gold, platinum, silver, nickel, titanium, chromium, chromium, and the like. A cobalt chrome alloy, a platinum-chrome alloy, a platinum-iridium alloy, a magnesium alloy, and the like. .

Synthetic polymer-based materials can be applied to both degradable and / or non-degradable materials.

For example, applicable degradable polymeric materials include aliphatic polyesters series of poly (lactic acid) and copolymers thereof, poly (glycolic acid) Poly (hydroxy butyrate), poly (e-caprolactone) and copolymers thereof, and poly (alkylene succinates), and other polyanhydrides such as poly Polyanhydrides, poly (ortho esters), and the like.

Non-degradable polymeric materials that can be applied include polyamides (nylons), poly (cyano acrylates), polyphosphazenes, thermoplastic polyurethanes, polyethylene (low density) ), Poly (vinyl alcohol), poly (ethylene oxide), poly (hydroxyethyl methacrylate), poly (methyl methacrylate) (PTFE), polydimethylsiloxane, polyethylene oxide-propylene oxide (poly-ethylene oxide), poly (vinyl methyl ether) ), Poly (N-alkyl acrylamide), polyethylene terephthalate, polypropylene, and the like. have.

Natural-based polymeric materials include protein-based polymer-based collagen, albumin, silk protein, and poly (amino acid) -based poly (L-lysine), poly (L-glutamic acid), poly (aspartic acid), polysaccharides and derivatives thereof, and botanic origin polymer. Carboxymethyl cellulose, cellulose sulphate, agarose, alginate, carrageenan, and the like, which are classified into human and animal origin polymer series Hyaluronic acid, heparin, glycosaminoglycan, and the like, and dextran and its derivatives of the microbial-derived polymer series, chitosan and derivatives thereof .

The metal and polymer wire materials can be used in combination according to a specific purpose, and it is also possible to apply a specific metal and polymer wire material to only a specific structure pattern because it is easy to form a composite structure pattern.

Having described specific portions of the present invention in detail, those skilled in the art will appreciate that these specific embodiments are merely examples of preferred embodiments and that the scope of the present invention is not limited thereto . Accordingly, the actual scope of the present invention will be defined by the appended claims and their equivalents.

Claims (6)

(a) identifying a planar matrix represented by coordinate values of (i, j) nodes, wherein a plurality of nodes formed by the horizontal node line and the vertical node line are intersected;
(b) selecting a start node position S # (i, j) by checking the number of horizontal node lines, the number of vertical node lines, the node position information, the node shape information, and the advance information;
(c) selecting one of the hourglass-type movement mode and the radial-movement mode, and selecting one basic direction of movement (D.mv) from the start node position S # (i, j) ;
(d) moving to a neighboring node according to a basic direction of movement (D.mv) of step (c); And
(e) selecting a basic direction of movement (D.mv) at a neighbor node of step (d) and selecting a start node position S # (i, j) , j)) and terminating the wire weaving,
The hourglass-type movement system is capable of six movements, the radial movement system is capable of moving eight movements,
When the arrangement of the hook and the cross is referred to as a structural pattern, a node structure of the plurality of nodes is a hook or a cross, and a different structure pattern is connected with a connection node pattern to form a composite structure pattern. Wherein a nodal node line of the composite structure pattern exists in the connection node pattern when an imaginary horizontal node line bisecting the same is defined as a nodal node line.
The method according to claim 1,
When selecting the hourglass-moving type in said step (c) the primary direction of movement is horizontal left _{(H L, horizontal to left)} , a horizontal right _{(H R, horizontal to right)} , the diagonal upper-left (D _LU, diagonal to left up), a diagonal lower left _{(D LD, diagonal to left down} ), the wire is selected from the group consisting of the diagonal upper right _{(D RU, diagonal to right up} ) and the diagonal lower right _{(D RD, diagonal to right down} ) bindings of the stent Gt;
The method according to claim 1,
When selecting a radial movement method in the above step (c) the primary direction of movement is horizontal left _{(H L, horizontal to left)} , a horizontal right _{(H R, horizontal to right)} , the diagonal upper-left (D _LU, diagonal to left up ), a diagonal lower left (D _LD, diagonal to left down), a diagonal upper right (D _RU, diagonal to right up), the diagonal lower right (D _RD, diagonal to right down), the vertical phase (V _U, vertical to up), and the vertical (V _D , vertical to down).
The method according to claim 1,
The method further comprises: after step (d), moving from a neighbor node of step (d) to another neighbor node in accordance with a basic direction of movement (D.mv) of step (c) &Lt; / RTI &gt; further comprising the step of repeating the process.
The method according to claim 1,
The node shape of the neighbor node in step (d) is a hook or a cross,
The hook may be selected from a horizontal hook, a vertical hook, a horizontal open hook, a vertical open hook, a horizontal bar hook, and a vertical bar hook, or an in-coil half hook, an out-coil half hook Band half hooks, in-band half hooks, out-band half hooks, fork half hooks, in-track half-hooks, a half-hook, an out-track half-hook, a close-turning half hook and a gap-turning half-hook.
The method according to claim 1,
The method further comprises, after step (e), (f) expressing the manufacturing notation and identifying the deployment mesh.

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