Method for manufacturing stent
10449068 ยท 2019-10-22
Assignee
Inventors
- Hun Kuk PARK (Pyeongtaek-si, KR)
- Jong Pil Moon (Gunpo-si, KR)
- Bong Seok JANG (Osan-si, KR)
- Ho YUN (Asan-si, KR)
Cpc classification
A61F2/90
HUMAN NECESSITIES
A61F2/86
HUMAN NECESSITIES
A61F2002/9155
HUMAN NECESSITIES
A61F2002/91508
HUMAN NECESSITIES
A61F2002/91525
HUMAN NECESSITIES
A61F2002/91516
HUMAN NECESSITIES
International classification
Abstract
The present invention relates to a method for manufacturing a stent, the method using a jig in which detachable protruding pins are installed at all respective location points at which circumference division lines and length division lines intersect each other, the method forming cells through intersection of wire by setting any one of the location points as a start point and repeatedly bending and moving the wire from the start point upward and downward to pass over the protruding pins located in diagonal directions, wherein a first stent woven such that intersection portions formed through the intersection of a wire are spaced apart from each other in a diagonal direction and arranged one for each length division line and a second stent woven to maintain the structural stability of the first stent and to prevent the first stent from being twisted can be provided as a single stent.
Claims
1. A method for manufacturing a stent, the method using a jig in which detachable protruding pins are installed at all respective location points at which circumference division lines and length division lines, set by equally dividing a circumference (W) and length (L) of a cylinder having a diameter (R) and the length (L) identical to those of a stent to be manufactured, intersect each other, the method forming cells through intersection of a wire by setting any one reference point of the location points as a start point and repeatedly bending and moving the wire from the start point upward and downward to pass over the protruding pins located in diagonal directions, the method comprising: step A of forming part of a first body by moving a first wire in a zigzag form from a first start point at one end of the jig to a first point at the other end of the jig; step B of forming a lower first head by repeating a pattern of bending the first wire in a zigzag form from the first point to a first change point at the other end of the jig; step C of forming part of the first body by bending and moving the first wire in a zigzag form from the first change point to a second point at the one end of the jig; and step D of forming an upper first head by repeating a pattern of bending the first wire in a zigzag form from the second point to the first start point; wherein step A comprises: step A-1 of moving the first wire from the first start point along an upward diagonal line by l, wherein l is a distance of a diagonal line extending by one interval between the length division lines with respect to one interval between the circumference division lines; and step A-2 of spacing a corresponding location point from a portion formed at step A-1 by moving the first wire from an end point of step A-1 along a downward diagonal line by 2l; wherein step C comprises: step C-1 of repeating a zigzag bent pattern formed by moving the first wire from the first change point along a downward diagonal line by l and then moving the first wire from a corresponding location point along an upward diagonal line by l; and step C-2 of spacing a corresponding location point from a portion formed at step C-1 by moving the first wire from an end point of step C-1 along an upward diagonal line by 2l; wherein step A comprises alternately repeating patterns of step A-1 and step A-2; and wherein step C comprises alternately repeating patterns of step C-1 and step C-2.
2. The method of claim 1, wherein a number of circumference division lines is 6+4x, wherein x is 0 or a natural number, and a number of length division lines is 11+5y, wherein y is 0 or a natural number.
3. The method of claim 2, wherein: the first point corresponds to an end point which is one of a plurality of end points of step A-1 formed during the repetition of step A-1 and step A-2 and which is also located on a length division line symmetrical to a length division line where the first start point is located; and the second point corresponds to an end point which is one of a plurality of end points of step C-1 formed during the repetition of step C-1 and step C-2 and which is also located on a same length division line as the first start point.
4. The method of claim 3, wherein: step B comprises: step B-1 of moving the first wire from the first point along a downward diagonal line by 2l; step B-2 of repeating a zigzag bent pattern formed by moving the first wire from a location point, reached at step B-1, along an upward diagonal line by l and then moving the first wire from a corresponding location point along a downward diagonal line by l; and step B-3 of locating the first wire at the first change point by moving the first wire from a location point, reached at step B-2, along an upward diagonal line by 2l; and the location point reached at step B-2 is located on a same circumference division line as the first point.
5. The method of claim 3, wherein: step D comprises: step D-1 of moving the first wire from the second point along an upward diagonal line by 2l; step D-2 of repeating a zigzag bent pattern formed by moving the first wire from a location point, reached at step D-1, along a downward diagonal line by l and then moving the first wire from a corresponding location point along an upward diagonal line by l; and step D-3 of locating the first wire at the first start point by moving the first wire from a location point, reached at step D-2, along a downward diagonal line by 2l; and the location point reached at step D-2 is located on a same circumference division line as the second point.
6. The method of claim 1, further comprising: step E of forming part of a second body by bending and moving a second wire in a zigzag form from a second start point at the other end of the jig to a third point at the one end of the jig; step F of forming an upper second head by repeating a pattern of bending the second wire in a zigzag form from the third point to a second change point at the one end of the jig; step G of forming part of the second body by bending and moving the second wire in a zigzag form from the second change point to a fourth point at the other end of the jig; and step H of forming a lower second head by repeating a pattern of bending the second wire in a zigzag form from the fourth point to the second start point; wherein step E comprises: step E-1 of repeating a zigzag bent pattern formed by moving the second wire from the second start point along a downward diagonal line by l and then moving the second wire from a corresponding location point along an upward diagonal line by l; and step E-2 of spacing a corresponding location point from a portion formed at step E-1 by moving the second wire from an end point of step E-1 along an upward diagonal line by 2l; wherein step G comprises: step G-1 of repeating a zigzag bent pattern formed by moving the second wire from the second change point along an upward diagonal line by l and then moving the second wire from a corresponding location point along a downward diagonal line by l; and step G-2 of spacing a corresponding location point from a portion formed at step G-1 by moving the second wire from an end point of step G-1 along a downward diagonal line by 2l; wherein step E comprises alternately repeating patterns of step E-1 and step E-2; wherein step G comprises alternately repeating patterns of step G-1 and step G-2; and wherein step E-2 comprises moving the second wire so that during the movement of the second wire, the second wire is located over the first wire at one of two points at which the first wire and the second wire woven on the jig intersect each other and the second wire is located beneath the first wire at a remaining point of the two points.
7. The method of claim 6, wherein the second start point corresponds to a location which is reached by moving a corresponding circumference division line by an odd number of intervals in a circumferential direction along a length division line symmetrical to a length division line where the first start point is located.
8. The method of claim 7, wherein: the third point corresponds to an end point which is one of a plurality of end points of step E-1 formed during the repetition of step E-1 and step E-2 and which is also located on a length division line symmetrical to a length division line where the second start point is located; and the fourth point corresponds to an end point which is one of a plurality of end points of step G-1 formed during the repetition of step G-1 and step G-2 and which is also located on a same length division line as the second start point.
9. The method of claim 6, wherein: step F comprises: step F-1 of moving the second wire from the third point along an upward diagonal line by 2l; step F-2 of repeating a zigzag bent pattern formed by moving the second wire from a location point, reached at step B-1, along a downward diagonal line by l and then moving the second wire from a corresponding location point along an upward diagonal line by l; and step F-3 of locating the second wire at the second change point by moving the second wire from a location point, reached at step F-2, along a downward diagonal line by 2l; wherein the location point reached at step F-2 is located on a same circumference division line as the third point.
10. The method of claim 6, wherein: step H comprises: step H-1 of moving the second wire from the fourth point along a downward diagonal line by 2l; step H-2 of repeating a zigzag bent pattern formed by moving the second wire from a location point, reached at step H-1, along an upward diagonal line by l and then moving the second wire from a corresponding location point along a downward diagonal line by l; and step H-3 of locating the second wire at the second start point by moving the second wire from a location point, reached at step H-2, along an upward diagonal line by 2l; and the location point reached at step H-2 is located on a same circumference division line as the fourth point.
Description
DESCRIPTION OF DRAWINGS
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
MODE FOR INVENTION
(12) Preferred embodiments of the present invention will be described in greater detail below with reference to the accompanying drawings. Well-known technical portions will be omitted or abridged for brevity of description.
(13) 1. <Description of a Method for Manufacturing a Stent>
(14) A process in which a method for manufacturing a stent according to the present invention is performed will be described in detail below with reference to the flowchart of
(15) First,
(16) In the drawings, the dotted lines represent the paths of moved wires, and the solid lines represent the paths of wires to be moved at corresponding steps of individual drawings. In
(17) In this case, in the jig, detachable protruding pins P are installed at all the location points at which circumference division lines a.sub.1, a.sub.2, a.sub.3, . . . , a.sub.14 and length division lines b.sub.1, b.sub.2, b.sub.3, . . . , b.sub.21, set by equally dividing the circumference W and length L of a cylinder having a diameter R and the length L identical to those of a stent to be manufactured, intersect each other. Using the jig, a stent is manufactured by setting any one of the location points as a start point and repeatedly bending and moving the wire 10 from the start point upward and downward to pass over the protruding pins P located in diagonal directions, thereby making intersections and thus forming cells.
(18) Furthermore, the number of circumference division lines of the jig is defined as 6+4x (x: 0 or a natural number). The number of circumference division lines of the jig, which is a basis for the following description based on an embodiment of the present invention, is 14 in the case where x=2.
(19) Moreover, the number of length division lines of the jig is defined as 11+5y (y: 0 or a natural number). The number of length division lines of the jig, which is a basis for the following description based on the embodiment of the present invention, is 21 in the case where y=2.
(20) (1) First Wire Lowering Step <S100>
(21) As shown in
(22) This process includes: a movement step (step A-1) of moving the first wire 10 from the location point S1 along an upward diagonal line by (the distance of a diagonal line extending by one interval between the length division lines with respect to one interval between the circumference division lines), as shown in
(23) The patterns of the movement step and the first spacing step are alternately repeated, and the movement step to be performed after the first spacing step starts from a location point a.sub.7/b.sub.4 reached by spacing the first wire 10 via the previously performed first spacing step. As shown in
(24) As a result, a first point, which is the last location point of the first wire lowering step S100 and which is also the start location point of a lower first head formation step S200, corresponds to the last end point F18 of a plurality of end points F1, F2, F3, . . . , F18 formed during the process in which the movement step and the first spacing step are alternately performed. This first point F18 refers to an end point which is one of the plurality of end points F1, F2, F3, . . . , F18 formed during the process in which the movement step and the first spacing step are alternately performed and which is also located on the length division line b.sub.19 symmetrical to the length division line b.sub.3 where the first start point S1 is located.
(25) (2) Lower Head Formation Step <S200>
(26) As shown in
(27) In this case, the first wire 10 is moved from the first point F18 along a downward diagonal line by 2l, as shown in
(28) Thereafter, a zigzag bent pattern formed by moving the first wire 10 from a corresponding location point a.sub.2/b.sub.21 along an upward diagonal line by l and then moving the first wire 10 from a corresponding location point a.sub.3/b.sub.20 along a downward diagonal line by l is repeated until the first wire 10 is located on the same circumference division line a.sub.14 as the first point F18 (step B-2).
(29) Finally, the first wire 10 is located at the first change point C1 by moving the first wire 10 from a location point a.sub.14/b.sub.21, reached as a result of the above step, along an upward diagonal line by 2l (step B-3).
(30) (3) First Wire Raising Step <S300>
(31) As shown in
(32) As shown in
(33) The patterns of the first zigzag movement step and the second spacing step are alternately repeated, and the first zigzag movement step to be performed after the first second spacing step starts from a location point a.sub.13/b.sub.18 reached by moving the first wire 10 at the previously performed second spacing step. As shown in
(34) As a result, a second point, which is the last location point of the first wire raising step S300 and which is also the start location point of an upper first head formation step S400, corresponds to the last end point F17 of many end points F1, F2, F3, . . . , F17 formed during the process in which the first zigzag movement step and the second spacing step are alternately performed. The second point F17 refers to an end point which is one of many end points F1, F2, F3, . . . , F17 formed during the process in which the first zigzag movement step and the second spacing step are alternately performed and which is located on the same length division line as the first start point S1.
(35) (4) Upper First Head Formation Step <S400>
(36) As shown in
(37) In this case, the first wire 10 is moved from the second point F17 along an upward diagonal line by 2l, as shown in
(38) Thereafter, a zigzag bent pattern formed by moving the first wire 10 from a corresponding location point a.sub.4/b.sub.1 along a downward diagonal line by l and then moving the first wire 10 from a corresponding location point a.sub.5/b.sub.2 along an upward diagonal line by l is repeated until the first wire 10 is located on the same circumference division line a.sub.2 as the second point F17 (step D-2).
(39) Finally, the first wire 10 is located at the first start point S1 by moving the first wire 10 from a location point a.sub.2/b.sub.1, reached as a result of the above step, along an upward diagonal line by 2l (step D-3).
(40) As shown in
(41) In other words, as shown in
(42) In other words, as shown in
(43) For the structural reinforcement of the first stent manufactured as described above, the designer manufactures a second stent disposed outside the first stent as a reinforcing member by additionally selecting and performing the following steps S500 to S800 via a second wire 20, and connects the first stent and the second stent to each other, thereby enabling a single stent, including the two stents having respective wire structures, to be manufactured.
(44) (5) Second Wire Raising Step <S500>
(45) As shown in
(46) It is preferred that the present step (step E) is performed on the jig, on which the first wire 10 has been manufactured, after steps S100 to S400 via the first wire 10 have been all performed.
(47) In this case, the second start point S2 corresponds to a location reached by moving a corresponding circumference division line by an odd number of intervals in the circumferential direction along the length division line b.sub.19 symmetrical to the length division line b.sub.3 where the first start point S1 is located. More specifically, based on the length division line b.sub.19 symmetrical to the length division line b.sub.3 where the first start point S1 is located, the circumference division line where the second start point S2 is located corresponds to the circumference division line reached by moving the circumference division line a.sub.4, where the first start point S1 is located, by five intervals, as shown in
(48) Furthermore, the second start point S2 is located on the length division line b.sub.19 on the other end side of the jig symmetrical to the length division line b.sub.3 on a one end side of the jig where the first start point S1 is located. This allows the locations, at which knots are formed during a process of performing final connection after the overall movement of the wire has been completed, to be distributed between both end sides, thereby preventing imbalance in the overall volume of the stent which occurs when the knots are concentrated on one end side. Furthermore, for ease of design, it is preferred that the designer turns the jig upside down and manufactures the stent by moving the wire in the state in which the second start point is set on an upper side.
(49) This process includes: a second zigzag movement step (step E-1) of repeating a zigzag bent pattern formed by moving the second wire 20 from the second start point S2 along a downward diagonal line by l (the distance of a diagonal line extending by one interval between the length division lines with respect to one interval between the circumference division lines) and then moving the second wire 20 from a corresponding location point a.sub.8/b.sub.20 along an upward diagonal line by l, as shown in
(50) The patterns of the second zigzag movement step and the third spacing step are alternately performed, and the second zigzag movement step to be performed after the first third spacing step starts from a location point a.sub.2/b.sub.18 reached by spacing the second wire 20 via the previously performed third spacing step. As shown in
(51) In this case, as shown in
(52) As shown in
(53) In other words, in the connection structure of the first wire 10 and the second wire 20 formed via the above process, the second wire 20 is passed beneath the first wire 10 (see X2) only in spaces between the circumference division line a.sub.2 and the circumference division line a.sub.3 and between the circumference division line a.sub.9 and the circumference division line a.sub.10, as shown in
(54) As a result, a third point, which is the last location of the second wire raising step S500 and which is also the start location of an upper second head formation step S600, corresponds to the last end point f18 of many end point f1, f2, f3, . . . , f18 formed during the process in which the second zigzag movement step and the third spacing step are alternately performed. This third point f18 refers to an end point which is one of many end point f1, f2, f3, . . . , f18 formed during the process in which the second zigzag movement step and the third spacing step are alternately performed and which is also located on the length division line b.sub.3 symmetrical to the length division line b.sub.19 where the second start point S2 is located.
(55) (6) Upper Second Head Formation Step <S600>
(56) As shown in
(57) In this case, as shown in
(58) Thereafter, a zigzag bent pattern formed by moving the second wire 20 from a corresponding location point a.sub.8/b.sub.1 along a downward diagonal line by l and then moving the second wire 20 from a corresponding location point a.sub.8/b.sub.2 along an upward diagonal line by is repeated until the second wire 20 is located on the same circumference division line a.sub.11 as the third point f18 (step F-2).
(59) Finally, the second wire 20 is located at the second change point c1 by moving the second wire 20 from a location point a.sub.11/b.sub.1, reached as a result of the above step, along a downward diagonal line by a (step F-3).
(60) (7) Second Wire Lowering Step <S700>
(61) As shown in
(62) As shown in
(63) The patterns of the third zigzag movement step and the fourth spacing step are alternately performed, and the third zigzag movement step to be performed after the first fourth spacing step starts from a location point a.sub.2/b.sub.4 reached by spacing the second wire 20 via the previously performed fourth spacing step. As shown in
(64) As a result, a fourth point, which is the last location of the second wire lowering step S700 and which is also the start location of a lower second head formation step S800, corresponds to the last end point F18 of a plurality of end points F1, F2, F3, . . . , F18 formed during the process in which the third zigzag movement step and the fourth spacing step are alternately performed. This fourth point F15 refers to an end point which is one of the plurality of end points F1, F2, F3, . . . , F18 formed during the process in which the third zigzag movement step and the fourth spacing step are alternately performed and which is located on the same length division line as the second start point S2.
(65) (8) Lower Second Head Formation Step <S800>
(66) As shown in
(67) In this case, the second wire 20 is moved from the fourth point F18 along an downward diagonal line by 2l, as shown in
(68) Thereafter, a bent pattern formed by moving the second wire 20 from a corresponding location point a.sub.9/b.sub.21 along an upward diagonal line by l and then moving the second wire 20 from a corresponding location point a.sub.8/b.sub.20 along a downward diagonal line by l is repeated until the second wire 20 is located on the same circumference division line a.sub.11 as the fourth point F18 (step H-2).
(69) Finally, the second wire 20 is located at the second start point S2 by moving the second wire 20 from a location point a.sub.11/b.sub.21, reached as a result of the above step, along an upward diagonal line by 2l (step H-3).
(70) As shown in
(71) 2. <Description of Characteristics of the Stent Manufactured by the Method for Manufacturing a Stent According the Present Invention>
(72) First, in the case of the first stent manufactured via steps S100 to S400 of the method for manufacturing a stent according to the present invention, the intersection portions B1 to B19 are formed in a diagonal direction in a spiral form one for each length division line, and ring-shaped portions A are formed in the remaining portions, as shown in
(73) In this case, as shown in
(74) Furthermore, on the respective length division lines, the plurality of intersection portions B2, B3, B4, . . . , B19 are sequentially formed from the intersection portion B1, formed at the specific location point a.sub.3/b.sub.2 on the second length division line b.sub.2, along a diagonal line having a predetermined slope at regular intervals one for each length division line. These intersection portions B1 to B19 provide resisting force-type stress adapted to maintain the structure and location of the stent against forces applied in a direction toward the center of the stent after the placement of the stent, including external force applied to both side ends of the stent due to movement continuously occurring in a stenosed region of a patient after the placement of the stent in the stenosed region.
(75) However, in the case of the conventional stent, structures based on a predetermined intersection method are regularly formed in the lengthwise direction of the stent. In particular, the stent is formed in a manner in which intersection portions are provided on a specific circumference division line in the lengthwise direction of the stent. Accordingly, the resisting force-type stress generated in the intersection portions is cancelled out by force generated in the portions formed based on an intersection method, different from the intersection method of the intersection portions, on the circumference division lines on both sides of the circumference division line where the intersection portion are formed. As a result, sufficient stress cannot be provided against external force applied to the stent, and thus the conventional stent is problematic in that a wire structure is bent or the stent is dislodged from a stenosed region where the stent has been placed.
(76) In contrast, in the first stent manufactured via steps S100 to S400 of the method for manufacturing a stent according to the present invention, the intersection portions B1 to B19 are spaced apart from each other in a diagonal direction one for each length division line and form a spiral arrangement structure. Accordingly, the first stent has not only structural flexibility but also resisting force sufficient to maintain the structure and location of the stent against external force applied to both ends of the stent.
(77) Furthermore, in the case of the second stent additionally manufactured via steps S500 to S800 of the method for manufacturing a stent according to the present invention on the jig used for manufacture after the first stent has been manufactured, the intersection method for wire sections located on the specific circumference division lines a.sub.3 and a.sub.10 forms the intersection portions B in each of which one wire section simply passes over another wire section, and the intersection method for wire sections on the remaining circumference division lines forms ring-shaped portions A in each of which wire sections surround both sides of a corresponding protruding pin P and a circular space portion is provided, as shown in
(78) In this case, when a hollow cylindrical stent is implemented by connecting the circumference division lines a1 at both side ends of the development shown in
(79) In the second stent, the part of the second body is formed such that the second wire 20 is located over the first wire 10 at one intersection point (an intersection point formed in a space between a.sub.3 and a.sub.4 and between b.sub.19 and b.sub.20) of the two intersection points formed during the process of moving the second wire 20 from each of the end points of the second zigzag movement step along an upward diagonal line via the third spacing step of the second wire raising step S500 (which is indicated by a small circle in
(80) In other words, the second stent is coupled to the first stent in the space between a.sub.2 and a.sub.3 and between b.sub.18 and b.sub.19 to form a restraining structure in the lengthwise direction, thereby preventing the first stent from being twisted and also providing more improved structural flexibility to the overall stent structure.
(81) In other words, the stent completed via the manufacturing method according to the present invention is located suitable for the shape of a lumen, in which a stenosis has occurred, based on high-level flexibility, and has axial force close to 0 acting in the axial direction of the stent and high-level radial force inflating the stent to the outside. Accordingly, outstanding durability based on low wire fatigue can be provided. Furthermore, the stent provides sufficient resisting force against external force applied from both ends of the stent in a direction toward the center of the stent due to movement occurring in a region where the stent has been placed after the placement of the stent, thereby preventing the stent from being bent and dislodged.
(82) As a result, the present invention takes into account a demand for a method for manufacturing a stent which can maintain the structural flexibility of a recent stent requiring improvements in durability and service life as the average life span of cancer patients increases and which can also provide a sufficient service life.
(83) The embodiments disclosed in the present invention are not intended to limit the technical spirit of the present invention, but are intended to illustrate the technical spirit of the present invention. The scope of the technical spirit of the present invention is not limited by these embodiments. The range of protection should be interpreted based on the attached claims, and all technical spirits falling within the equivalent range of the claims should be interpreted as being included in the range of rights of the present invention.
DESCRIPTION OF REFERENCE SYMBOLS
(84) 10: first wire 20: second wire P: protruding pin A: ring-shaped portion B: intersection portion