CN106308867B - Plugging device production method and plugging device make mold - Google Patents

Plugging device production method and plugging device make mold Download PDF

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Publication number
CN106308867B
CN106308867B CN201510377505.4A CN201510377505A CN106308867B CN 106308867 B CN106308867 B CN 106308867B CN 201510377505 A CN201510377505 A CN 201510377505A CN 106308867 B CN106308867 B CN 106308867B
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China
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height
plugging device
mold
cavity
disk
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CN201510377505.4A
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CN106308867A (en
Inventor
张�杰
刘香东
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Lifetech Scientific Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12031Type of occlusion complete occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/12145Coils or wires having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00778Operations on blood vessels

Abstract

The present invention relates to a kind of plugging device production method and production molds, the plugging device production method includes: the first shape body including the first disk-like structure and kidney-shaped structure to be made in network management shape knitted body, and form the plication region with the first height in the circumferential of the kidney-shaped structure;By the plication region be formed to more than first height second height, formed the second bodies.It will not be distorted using the plugging device waist that plugging device production method of the invention and its production mold are formed, qualification rate is high.

Description

Plugging device production method and plugging device make mold
Technical field
The present invention relates to a kind of medical instrument production methods and medical instrument to make mold, more specifically to a kind of envelope Stifled device production method and plugging device make mold.
Background technique
With the continuous development of intervention material instrument and Interventional cardiology, transcatheter occlusion device minimally-invasive treatment room Become important method every congenital heart diseases such as defect, ventricular septal defect, patent ductus arteriosus and acleistocardias.Same use is situated between Enter mode and carries out Endovascular closure and well accepted treatment means.
Waist has the plugging device of ripple or zigzag fold, in its natural state compared to the closure long with identical waist Device, the length after the waist with fold elongates is longer, and flexible angle is bigger, can block with different shape and not With the long defect of waist, adaptation range is wider.Plugging device waist in its preparation process is easy distortion, and yield is lower.
Summary of the invention
The present invention provides a kind of plugging device production method and its production mold, to solve the production plugging device work of the prior art Sequence is complicated, and the waist of formation is easy the defect of distortion.
The present invention provides a kind of plugging device production method, comprising: network management shape knitted body is made including the first disk-like structure And the first shape body of kidney-shaped structure, and the plication region with the first height is formed in the circumferential of the kidney-shaped structure;It will Second height of the plication region sizing to more than first height, forms the second bodies.
In one embodiment, the plugging device production method further includes that the second plate-like knot is made on the knitted body Structure, second disk-like structure and first disk-like structure are located at the both ends of the kidney-shaped structure.
In one embodiment, the plugging device production method further includes closing both ends open and middle section diameter is less than The knitted body of the network management production network management shape of both ends diameter.
In one embodiment, the production of the first shape body includes: that the knitted body is placed in the of the first mold In one cavity;The knitted body is compressed axially to forming first disk-like structure and second disk using first mold Shape structure, and the plication region is formed on the waist;Plication region described in thermal finalization is hot respectively to first height It is formed first disk-like structure and second disk-like structure.
In one embodiment, the production of second bodies includes: to provide second mold with the second cavity, institute Stating the second mold includes the core model that can be removed from second cavity;The core model is placed in the first shape body, is adopted The plication region with the first height is axially strutted to the second height, and by the core model together with described first with the core model Bodies is placed in second cavity and thermal finalization, obtains second bodies.
In one embodiment, the production method of the first shape body and the second bodies includes: and provides to have height The third mold of adjustable third cavity;The knitted body is placed in the third cavity, and adjusts the third cavity The knitted body is compressed axially until forming the fold with first height in the middle section of the knitted body by height Region is respectively formed first disk-like structure and second disk-like structure in the both ends part of the knitted body;It adjusts The height of the third cavity makes the plication region axially recoil to second height and thermal finalization.
In one embodiment, the heat setting temperature range is 400 DEG C~550 DEG C, and heat-setting time range is 1~10 Minute.
Originally it returns and provides a kind of for making the mold of plugging device, the plugging device has a waist, the mold packet Include the first mold and the second mold, first mold has the first cavity, second mold have the second cavity and The core model that can be removed out of described second cavity, the height of second cavity are greater than the height of first cavity;Described One housing depth is less than the axial height of the plugging device under natural conditions, and the height of second cavity is substantially equal to the envelope The axial height of stifled device under natural conditions.
In one embodiment, the core model includes a stylolitic part, and the stylolitic part can be placed in the closure In the waist of device, and the height of the stylolitic part is substantially equal to the height of plugging device waist under natural conditions.
The present invention also provides a kind of for making the mold of plugging device, and the plugging device has a waist, the mold Height for the mold with cavity, the cavity is adjustable, and the minimum constructive height of the cavity is substantially equal or smaller than the closure Device be compressed axially after minimum constructive height, the maximum height of the cavity is substantially equal or larger than the plugging device waist nature state Under axial height.
In one embodiment, the mold includes upper mold and lower die, and the upper mold and lower die are enclosed jointly to be set to be formed The cavity;The upper mold be equipped at least one upper limb, the lower die be equipped at least one lower edge, at least one described upper limb with And at least one described lower edge surrounds the cavity setting, the upper limb and the lower edge are correspondingly arranged and by least one A connector can mutually be connected close to or far from ground.
In one embodiment, the lower edge is equipped at least one threaded hole, and the upper limb is equipped at least one through-hole, often A connector includes a bolt and two nuts, and each bolt free end, which sequentially passes through, to be correspondingly arranged down The threaded hole of edge and the through-hole of upper limb, the bolt are connected with the screw thread of the lower edge;Two nuts are combined on institute It states on bolt, and the upper limb is located between two nuts.
During plugging device production method of the invention, by the waist for being initially formed the plication region with the first height Shape structure, later further by the plication region sizing in kidney-shaped structure with the first height in the second height, wherein first Height is by stretching kidney-shaped structure either kidney-shaped structure less than the second height, then when by plication region sizing in the second height Natural resiliency deformation is formed, therefore the phenomenon that be not in kidney-shaped structural distortion;In addition it is being formed in the present invention with first When the kidney-shaped structure of height plication region, it is formed simultaneously the first disk-like structure and the second disk-like structure, then due to that will have When the plication region sizing of one height is in the second height, do not need further to form the first disk-like structure of formation and the second plate-like Structure, then the phenomenon that further avoiding kidney-shaped structural distortion.Since kidney-shaped structure ultimately forms the waist of plugging device, The plugging device qualification rate arrived is high.
Detailed description of the invention
Present invention will be further explained below with reference to the attached drawings and examples, in attached drawing:
Fig. 1 is the structural schematic diagram for the knitted body that the present invention is used to form plugging device, which includes a network management;
Fig. 2 is the structural schematic diagram for being used to form the mould stick of network management;
Fig. 3 is the structural schematic diagram of network management;
Fig. 4 is the structural representation of the first mold that knitted body is shaped to first shape body of first embodiment in the present invention Figure;
Fig. 5 is the structural schematic diagram being placed in knitted body in the first mold;
Fig. 6 is the structural schematic diagram of first shape body;
Fig. 7 is the portion A enlarged drawing in Fig. 6;
Fig. 8 be for by first shape it is body formed be the second bodies the second mold structural schematic diagram;
Fig. 9 is the structural schematic diagram being placed in first shape body in the second mold;
Figure 10 is the structural schematic diagram of the second bodies;
Figure 11 is the structural schematic diagram after connector is arranged in the second bodies end;
Figure 12 is the structure of the third mold for knitted body to be shaped to the second bodies of second embodiment of the invention Schematic diagram;
Figure 13 is the structural schematic diagram that knitted body is shaped to first shape body using third mold;
Figure 14 is the structural schematic diagram that knitted body is shaped to the second bodies using third mold.
Specific embodiment
For a clearer understanding of the technical characteristics, objects and effects of the present invention, now control attached drawing is described in detail A specific embodiment of the invention.
In congenital cardiac intervention medical field, definition is proximal end away from the relatively near one end of operator, away from operator's phase It is distal end to remote one end.
By shape point, plugging device generally includes two kinds of structures of approximate " I " fonts and approximate " T " font.The " I " fonts It can be understood as including double plate and a waist and the structure big in waist shallow bid.Classify by applicable heart defect position, plugging device Mainly include ventricular septal defect (VSD) plugging device, atrial septal defect (ASD) plugging device, patent ductus arteriosus (PDA) plugging device, With acleistocardia (PFO) plugging device.Wherein, VSD plugging device, ASD plugging device and PFO plugging device have double plate and a waist Approximate dies, PDA plugging device have approximation " T " font structure of single-deck and a waist.
Below for the plugging device just with double plate and a waist, illustrate plugging device production method and envelope provided by the invention Stifled device makes mold.
Embodiment one:
It please refers to shown in Fig. 1, Fig. 6, Figure 10 and Figure 11, the plugging device production method in the present embodiment, including forms two Hold closed network management shape knitted body 100 (referring to Fig. 1);The knitted body 100 is formed into first shape body 200, first shape body 200 include first disk-like structure 210, second disk-like structure 220, and is connected to the first disk-like structure 210 and the A kidney-shaped structure 230 between two disk-like structures 220,230 circumferential direction of kidney-shaped structure are equipped with plication region 231, and the pleat Region 231 wrinkle with the first height (referring to Fig. 6);By plication region 231 be formed to more than first height second height, First shape body 200 is formed the second bodies 300 (referring to Figure 10);One end of the second bodies 300 is arranged and is connected Fitting 140, for being connected with each other (referring to Figure 11) with conveyer.
Wherein the first disk-like structure 210, the double plate that the second disk-like structure 220 is final finished plugging device, kidney-shaped structure 230 For the waist of final finished plugging device, but waist height be different from final finished waist it is high.
Wherein, the production method of knitted body 100 comprises the following steps:
As shown in Figure 1, Figure 2, Figure 3 shows, provide the big centre in a both ends small mould stick 130 first, using on mould stick 130 will The mode that grid lines is cross-woven forms network management 110 and heat-shaping.The network management 110 of formation includes middle section 112 and two End part 111, the diameter of both ends part 111 are greater than the diameter of middle section 112.
Wherein, grid lines has shape memory function and can be heated to form predetermined shape, for example, Nitinol etc..Heat is fixed Type temperature is 400 DEG C~550 DEG C, and heat-setting time is 1~10 minute.It is understood that heat-setting time can also basis The thickness of grid lines is adjusted, i.e. the thicker heat-setting time of grid lines is long, and the thinner heat-setting time of grid lines is short.
Referring again to Fig. 1, is formed after network management 110, consolidated the grid lines at 110 both ends 111 of network management with fixed ring 120 It is fixed, to form knitted body 100 closed at both ends.It is understood that the fixed ring 120 for fettering 110 proximal end of network management is ring Shape body, preferably steel screw bushing.It is understood that fixed ring 120 or other components, do not do specific limit herein It is fixed.
By knitted body 100 be made first shape body 200 method the following steps are included:
It is shown in Figure 4, firstly, provide first mold 400, first mold 400 include the first upper mold 420 with And first lower die 430, first upper mold 420 and first lower die 430 enclose and set to form first cavity 410.First Cavity 410 is in the form of annular discs, and the height of the first discoid cavity 410 is less than the axial height of plugging device under natural conditions.It is preferred that The height of first cavity 410 is substantially equal to the minimum constructive height after knitted body 100 (or plugging device of required preparation) is compressed axially, the The diameter of one cavity 410 is substantially equal to the maximum compression diameter at 100 both ends of knitted body, and (maximum compression at 100 both ends of knitted body is straight Diameter refers to when knitted body 100 is compressed axially extreme position, the maximum gauge that 100 both ends of knitted body are presented).First First locating slot or location hole 411 are respectively equipped on two opposing end surfaces of cavity 410, it is preferable that the first locating slot or positioning Hole 411 is respectively placed in the center of two opposing end surfaces of the first cavity 410.
Wherein, the diameter of the first cavity 410 is substantially equal to the maximum compression diameter at 100 both ends of knitted body, the first cavity 410 Height " basic " that is substantially equal in the minimum constructive height after knitted body 100 is compressed axially refer to: the diameter of the first cavity 410 is big It is equal to the maximum compression diameter at 100 both ends of knitted body on body, the height of the first cavity 410 is essentially equal to 100 axis of knitted body To compressed minimum constructive height, allow that there are slight deviations.
First upper mold 420 and the first lower die 430 are connected with each other by the first connector 440.Specifically, the first upper mold 420 set there are two the first upper limb 421, and the first lower die 430 sets that there are two the first lower edge 431, the first upper limb 421 and the first lower edges 431 are correspondingly arranged, and the first upper limb 421 and the first lower edge 431 are set to the first cavity 410 circumferentially.First connector 440 Quantity is identical as the quantity of the first upper limb 421 and is two.It is understood that the first upper limb 421 and the first lower edge 431 There is no particular limitation for quantity, when the quantity of the first upper limb 421 or the first lower edge 431 be one when, first upper limb 421 or The first lower edge of person 431 substantially surrounds the ring structure of the first cavity 410, and at this time, the number of the first connector 4 can be one It is a, two or more, can set as needed;When the number of the first upper limb 421 or the first lower edge 431 be three or Person more when, multiple first upper limb 421 or the setting of multiple first lower edges 431 interval, and set around first cavity 410 It sets, at this point, there is no particular limitation for the number of the first connector 440, can be realized the first upper mold 420 and the first lower die Being bonded between 430.
Each first upper limb 421 is equipped with a first through hole 422, and one the is correspondingly provided on each first lower edge 431 One threaded hole 432.Each first connector 440 includes that first bolt 441 and one are used to screw with the first bolt 441 The first nut 442.The external screw thread of first bolt 441 and the internal screw thread of the first threaded hole 432 match.First bolt 441 can The first threaded hole 432 and first through hole 422 are sequentially passed through, and is spirally connected with the first bolt 441, thus by the first upper mold 420 and One lower die 430 links together.
Further, as shown in connection with fig. 5, knitted body 100 closed at both ends is placed in the first cavity 410, and makes knitted body Each of 100 end accommodations with fixed ring 120 are in the first locating slot or first positioning hole 411.Later by the first spiral shell 441 free end of bolt sequentially passes through the first threaded hole 432, first through hole 422, and makes on first along the axial direction of the first bolt 441 Mould 420 and the first lower die 430 are close to each other until being compressed axially knitted body 100 to its minimum constructive height, further, by by the Realize that the position between the first upper mold 420 and the first lower die 430 is solid in the free end that one nut 442 is combined on the first bolt 441 It is fixed.
It should be noted that being located in first during by the first upper mold 420 and the first lower die 430 close to each other Knitted body 100 in cavity 410 is compressed in the axial direction, when knitted body 100 is compressed into minimum constructive height, knitted body 100 Both ends are respectively formed the first disk-like structure 210 and the second disk-like structure 220, and the middle section of knitted body 100 is formed along axis To several folds 232 of arrangement, which forms plication region 231, at this point, the plication region 231 has first Highly, the two sides of each fold 232, which are superimposed with each other, makes fold 232 in flat form (please referring to Fig. 6, Fig. 7).
It should also be noted that, preferably, the diameter of first through hole 422 is slightly larger than the outer diameter of the first bolt 441, it is first Relative motion of the upper mold 420 with respect to the first lower die 430 provides guiding role.
Next, by the first mold 400 together with deformed 100 thermal finalization of knitted body, and by the knitted body after thermal finalization 100 can be obtained first shape body 200 from the taking-up of the first mold 400.Wherein heat setting temperature is 400 DEG C~550 DEG C, thermal finalization Time is 1~10 minute.It can also be appreciated that heat-setting time can be adjusted according to the thickness of grid lines, i.e., compared with Thick grid lines heat-setting time is long, and thinner grid lines heat-setting time is short.
The production method of second bodies 300 comprises the following steps:
It please refers to shown in Fig. 8, second mold 500 is provided first, which includes the second upper mold 520, the Mould 530 and the second lower die 540 in two.Mould 530 and the second lower die 540 enclose and set to form the second chamber in second upper mold 520, second Body 510.Specifically, mould 530 and the second upper mold 520 enclose and set to form the second epicoele 511 in second, the shape of the second epicoele 511 with The shape of first disk-like structure 210 is adapted;Mould 530 and the second lower die 540, which are enclosed, in second sets to form the second cavity of resorption 512, and second The shape of cavity of resorption 512 and the shape of the second disk-like structure 220 are adapted.530 middle part break-through of mould forms the second lumen in second 513.Second epicoele 511 and the second epicoele 511 be respectively equipped on the inner surface far from mould 530 in second second locating slot or Location hole 514.
Be equipped with removable core model 550 in second cavity 510, core model 550 include a stylolitic part 551 and with the column A connected disk portions 552 of shape part 551, i.e. 550 longitudinal section of core model are " T " shape.The stylolitic part 551 of core model 550 The plugging device that height obtains needed for being substantially equal to descends the height of waist in the raw, and the diameter of stylolitic part 551 is slightly less than Plugging device descends the internal diameter of waist, the shape phase of the disk portions 552 of core model 550 and the second disk-like structure 220 in the raw It adapts to, and the inside of the second disk-like structure 220 can be placed in.It is preferred that the height of the stylolitic part of core model 550 is 2-3mm.It can With understanding, core model 550 can also be in the form of a column on the whole, the closure that columnar core model 550 obtains needed for being highly substantially equal to Device descends the height of waist in the raw, and diameter is slightly less than the internal diameter that plugging device descends waist in the raw.
Second mold 500 includes at least one second connector 560, and each second connector 560 includes second spiral shell Bolt 561 and second nut 562.Mould 530, the second lower die 540 are equipped with position pair in each second upper mold 520, second The fringe region answered, each fringe region are located on the circumferential direction of the second cavity 510, can be somebody's turn to do by passing through the second bolt 561 The second nut 562 is screwed after the fringe region of three to realize in the second upper mold 520, second between mould 530, the second lower die 540 Interconnection.
Later, as shown in figure 9, being placed in core model 550 inside the first shape body 200 taken out in the first mold 400, The stylolitic part 551 of core mould 550 is placed in the kidney-shaped structure 230 of first shape body 200, and the disk portions 552 of core model 550 are set In the second disk-like structure 220;And core model 550 is placed in the second cavity 510 together with first shape body 200, core model 550 at this time Stylolitic part 551 be set to the inside of 200 kidney-shaped structure 230 of first shape body, the disk portions 552 of core model 550 are placed in The inside of two disk-like structures 220.Specifically, first disk-like structure 210 is set when first shape body 200 is placed in the second cavity 510 In the second epicoele 511, the second disk-like structure 220 is placed in the second cavity of resorption 512 together with the disk portions 552 of core model 550, kidney-shaped Structure 230 is set in the second lumen 513 together with the stylolitic part 551 of core model 500.Due to the height of 550 stylolitic part 551 of core model Degree is substantially equal to the height that plugging device descends waist in the raw, therefore core model 550 is placed in 200 inside of first shape body Afterwards, plication region 231 is softened, and the two sides expansion shape of each fold 232 of plication region 231 is at an angle, to be formed Wavy or zigzag fold, the height of plication region 231 increases to the second height at this time.
Next, as shown in figure 9, the second mold 500 is handled together with deformed 200 thermal finalization of first shape body, and The first shape body 200 of deformation after thermal finalization be can be obtained into the second bodies 300 from the taking-up of the second mold.Wherein thermal finalization Temperature is 400 DEG C~550 DEG C, and heat-setting time is 1~10 minute.It can also be appreciated that heat-setting time can basis The thickness of grid lines is adjusted, i.e. crin heat-setting time is long, and filament heat-setting time is short.
Further, as shown in figure 11, it takes out and is provided with spiral shell in one of fixed ring 120 of the second bodies 300 The connector 140 of line, to be connected by connector 140 with conveyer.Specifically, the screw thread of connector 140 is internal screw thread, connection Part 140 is connected with fixed ring 120 by welding.
Optionally, the step of forming plugging device further includes that choked flow film is arranged in the inside of the second bodies 300, or the The surface of two bodies 300 wears litzendraht wire, setting overlay film etc., does not specifically describe herein.
It should be noted that being initially formed the first disk-like structure 210, the second disk-like structure 220, and tool in the present embodiment There is the kidney-shaped structure 230 of the plication region 231 of the first height, later further by the plication region 231 with the first height Sizing to the second height, such production method makes when being molded into kidney-shaped structure 230 for the first time by the first plate-like knot Structure 210 and the molding of the second disk-like structure 220, thus second it is molding during do not need to the first disk-like structure 210 and Second disk-like structure 220 is handled, so as to avoid the first disk-like structure 210 and the opposite kidney-shaped of the second disk-like structure 220 Structure 230 shifts, or the case where so that kidney-shaped structure 230 is distorted.In addition, since kidney-shaped structure 230 ultimately forms Plugging device waist, then avoid finally formed plugging device waist distortion the case where.
In addition, in first time forming process, due to the mode merely by extruding can obtain having it is first high The plication region 231 of degree, therefore the molding mode of plication region 231 is relatively simple, it is easy to operate;When forming for second, due to The kidney-shaped structure 230 of plication region 231 with the first height is only by the axial force of core model 550 with by fold 232 It struts, therefore lateral shift can't occur for kidney-shaped structure 230 at the time of molding.
Embodiment two:
It please refers to shown in Fig. 1, Fig. 6, Figure 10 and Figure 11, with the plugging device production method generally phase in first embodiment Together, the plugging device production method of the present embodiment includes forming knitted body 100 (please referring to Fig. 1) closed at both ends;By the braiding Body 100 forms first shape body 200, and first shape body 200 includes first disk-like structure 210, second disk-like structure 220, and a kidney-shaped structure 230 being connected between the first disk-like structure 210 and the second disk-like structure 220, the kidney-shaped 230 circumferential direction of structure is equipped with plication region 231, and the plication region 231 has the first height (please referring to Fig. 6);By folded region The height in domain 231 is formed to more than the second height of first height, and first shape body 200 is formed the second bodies 300 (please referring to Figure 10);Connector 140 is arranged in one end of the second bodies 300, for being connected with each other with conveyer (please referring to Figure 11).
It the difference is that only, the fold for being used to form the plication region 231 of the first height and there is the first height The sizing of region 231 to the plication region with the second height is formed in a mold, i.e., the second bodies 300 is one It is formed in a mold.
The production method of second bodies 300 comprises the following steps:
Firstly, providing a third mold 600 referring to Figure 12, third mold 600 includes third upper mold 620, third lower die 630, it is enclosed between third upper mold 620 and the third lower die 630 and sets to form a third cavity 610,610 height of third cavity It is adjustable.Third cavity 610 is cylindrical, and the diameter of third inner cavity is the maximum compression diameter of knitted body 100.Cylindrical third A third locating slot or location hole 611 are respectively equipped on two opposing end surfaces of cavity 610.Third upper mold 620 and third Lower die 630 is connected with each other by third connector 640, can realize third upper mold 620 and the by the third connector 640 Between three lower dies 630 close to or far from.Specifically, third upper mold 620 is set there are two third upper limb 621, third lower die 630 is set There are two third lower edge 631, third upper limb 621 is correspondingly arranged with third lower edge 631.At this point, in third connector 640 and third The quantity of edge 621 and third lower edge 631 is identical, and specially two.It is understood that under third upper limb 621 and third There is no particular limitation for the quantity of edge 631, when the quantity of third upper limb 621 and third lower edge 631 is one, in the third Edge 621 and third lower edge 631 are substantially in the ring structure around third cavity 610.When third upper limb 621 and third lower edge When 631 number is three or more, multiple third upper limb 621 and the setting of multiple third lower edges 631 interval, and surround The third cavity 610 setting, at this point, the number of third connector 640 is not particularly limited, as long as can be realized third upper mold Being bonded between 620 and third lower die 630.
Each third upper limb 621 is equipped with a third through-hole 622, is correspondingly provided with a third on each third lower edge 631 Threaded hole 632.Each third connector 640 includes that a third bolt 641 and two are used to screw with third bolt 641 Third nut 642, the internal screw thread of the external screw thread and third threaded hole 632 of third bolt 641 matches, and third bolt 641 can Across third through-hole 622.
Further, incorporated by reference to shown in Figure 13, knitted body 100 closed at both ends is placed in third cavity 610, and make to weave There is each of body 100 end of fixed ring 120 to be placed in a third locating slot or location hole 611.By third bolt 641 free ends sequentially pass through 632, third nuts 642 of third threaded hole, third through-hole 622 and another third nut 642.Along the axial that third upper mold 620 and third lower die 630 is close to each other until by 100 axis of knitted body of third bolt 641 To the axial height being compressed to less than plugging device under natural conditions, it is preferable that knitted body 100 is axially compressed to its minimum constructive height; Screw the third nut 642 being arranged on third bolt 641, make third upper limb 621 be tightly held on two third nuts 642 it Between, to realize the fixation of position between third upper limb 621 and third lower edge 631, knitted body 100 is in first by deformation at this time Bodies 200.It is appreciated that being located in third cavity during third upper mold 620 and third lower die 630 are close to each other Knitted body 100 in 610 is compressed in the axial direction, when knitted body 100 is compressed into minimum constructive height, the both ends of knitted body 100 111 the first disk-like structures 210 for being respectively formed plate-like and the second disk-like structure 220, the middle section of knitted body 100 are formed Several folds 232 axially arranged, that is, form plication region 231, which has the first height, often at this time The two sides of a fold 232, which are superimposed with each other, makes fold in flat form.
Furthermore incorporated by reference to the opposite third of two third nuts 642 shown in Figure 14, adjusted set on 620 two sides of third upper mold The position of bolt 641 keeps third upper mold 620 separate with respect to third lower die 630, until in the axial direction of obtained third cavity 610 Height be equal to the height of required obtained plugging device under natural conditions, later by adjusting being set to 620 two sides of third upper mold Two third nuts 642 position, the relative position between third upper mold 620 and third lower die 630 is fixed, thus by One bodies 200 is deformed into the second bodies 300.At this time the plication region 231 of the first height due to itself in the axial direction return Bullet effect, height in the axial direction increase.Specifically, the two sides of each fold 232 of plication region 231 are unfolded, formed One angle, to form wavy or zigzag fold.It should be noted that the height of plication region 231 increases at this time Two height.As can seen above, need to obtain the plication region 231 with the second height, the altitude range of third cavity 610 has centainly Restriction, i.e., it is high that the minimum constructive height of the described third cavity 610 is substantially equal or smaller than the minimum after the plugging device is compressed axially Degree, the maximum height of the third cavity 610 are substantially equal or larger than the axial height under plugging device waist nature state.
In the present embodiment, the other steps for forming plugging device are identical with first embodiment, are just no longer described in detail herein.
It is identical with the first embodiment, is being in the mistake of the second bodies 300 from the sizing of first shape body 200 in the present embodiment It does not need to handle the first disk-like structure 210 and the second disk-like structure 220 in journey, so as to avoid the first disk-like structure 210 and second the opposite kidney-shaped structure 230 of disk-like structure 220 shift, or feelings for making kidney-shaped structure 230 be distorted Condition.In addition, being turned round since waist that waist type structure 230 ultimately forms plugging device avoids finally formed plugging device waist The phenomenon that song offset.
In addition, in the present embodiment, during the entire process of forming the second bodies 300 it is only necessary to knitted body 100 into Thermal finalization of row.According to the mechanics of materials, nickel-titanium metal silk after a thermal finalization, than the nickel after thermal finalization twice Titanium silk elastic property is more preferable, therefore obtained plugging device waist elasticity is good, is adapted to defect of different shapes.
In addition, due to will have the plication region 231 of the first height sizing to the second height be by plication region 231 from The rebound effect of body realizes, therefore the phenomenon that be not in the offset or distortion of kidney-shaped structure 230 in the axial direction.Furthermore The second bodies 300 is formed only with a third mold 600, has also only passed through a process, therefore mold is simple, behaviour Facilitate.
To sum up, by implementing plugging device production method and its production mold of the invention, moulding process is simple, after molding Kidney-shaped structure 230 is not in distortion.In addition, since waist type structure ultimately forms the waist of plugging device, therefore plugging device qualification rate It is high.
The embodiment of the present invention is described with above attached drawing, but the invention is not limited to above-mentioned specific Embodiment, the above mentioned embodiment is only schematical, rather than restrictive, those skilled in the art Under the inspiration of the present invention, without breaking away from the scope protected by the purposes and claims of the present invention, it can also make very much Form, all of these belong to the protection of the present invention.

Claims (12)

1. a kind of plugging device production method, comprising:
The first shape body including the first disk-like structure and kidney-shaped structure is made in network management shape knitted body, and in the kidney-shaped knot The circumferential of structure forms the plication region with the first height;
By the plication region be formed to more than first height second height, formed the second bodies.
2. plugging device production method according to claim 1, which is characterized in that the plugging device production method further include The second disk-like structure is made on the knitted body, second disk-like structure and first disk-like structure are located at the waist The both ends of shape structure.
3. plugging device production method according to claim 1 or 2, which is characterized in that
The plugging device production method further includes the network management production that closing both ends open and middle section diameter are less than both ends diameter The knitted body of network management shape.
4. plugging device production method according to claim 2, which is characterized in that
The production of the first shape body includes: to be placed in the knitted body in the first cavity of the first mold;Utilize described One mold is compressed axially the knitted body to forming first disk-like structure and second disk-like structure, and in the waist It is upper to form the plication region;Plication region described in thermal finalization distinguishes the first plate-like knot described in thermal finalization to first height Structure and second disk-like structure.
5. plugging device production method according to claim 2, which is characterized in that
The production of second bodies includes: to provide second mold with the second cavity, and second mold includes can be from The core model removed in second cavity;
The core model is placed in the first shape body, is axially supportted the plication region with the first height using the core model It opens to the second height, and
The core model is placed in simultaneously thermal finalization in second cavity together with the first shape body, obtains second shape Body.
6. plugging device production method according to claim 2, which is characterized in that
The production method of the first shape body and the second bodies includes:
The third mold for having height-adjustable third cavity is provided;
The knitted body is placed in the third cavity, and the height for adjusting the third cavity axially presses the knitted body Contracting is until form the plication region with first height in the middle section of the knitted body, at the both ends of the knitted body Part is respectively formed first disk-like structure and second disk-like structure;
The height for adjusting the third cavity makes the plication region axially recoil to second height and thermal finalization.
7. plugging device production method according to claim 5 or 6, which is characterized in that the heat setting temperature range is 400 DEG C~550 DEG C, heat-setting time range is 1~10 minute.
8. a kind of for making the mold of plugging device, the plugging device has a waist, which is characterized in that the mold includes First mold and the second mold, first mold have the first cavity, and second mold has the second cavity and can The core model removed out of described second cavity, the height of second cavity are greater than the height of first cavity;
First housing depth is less than the axial height of the plugging device under natural conditions, and the height of second cavity is basic Equal to the axial height of the plugging device under natural conditions.
9. according to claim 8 for making the mold of plugging device, which is characterized in that the core model includes a column Part, the stylolitic part can be placed in the waist of the plugging device, and the height of the stylolitic part is substantially equal to described The height of plugging device waist under natural conditions.
10. a kind of for making the mold of plugging device, the plugging device has a waist, which is characterized in that the mold tool There is height-adjustable cavity, it is high that the minimum constructive height of the cavity is substantially equal or smaller than the minimum after the plugging device is compressed axially Degree, the maximum height of the cavity are substantially equal or larger than the axial height under the plugging device waist nature state.
11. according to claim 10 for making the mold of plugging device, which is characterized in that the mold include upper mold with And lower die, the upper mold and lower die enclose jointly and set to form the cavity;
The upper mold is equipped at least one upper limb, and the lower die is equipped at least one lower edge, at least one described upper limb and institute It states at least one lower edge and surrounds the cavity setting, the upper limb and the lower edge are correspondingly arranged and are connected by least one Fitting can mutually be connected close to or far from ground.
12. according to claim 11 for manufacturing the mold of plugging device, which is characterized in that the lower edge is equipped at least one A threaded hole, the upper limb are equipped at least one through-hole,
Each connector includes a bolt and two nuts, and each bolt free end sequentially passes through correspondence and sets The threaded hole for the lower edge set and the through-hole of upper limb, the bolt are connected with the screw thread of the lower edge;Two nuts revolve Together on the bolt, and the upper limb is located between two nuts.
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CA3161166A1 (en) * 2019-12-20 2021-06-24 Lifetech Scientific (Shenzhen) Co., Ltd. Occluder, occluding system and conveying device
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CN112773419B (en) * 2020-12-31 2022-01-07 上海锦葵医疗器械股份有限公司 Heart patent foramen ovale plugging device with flat two end surfaces and manufacturing method thereof
CN112932561A (en) * 2021-02-01 2021-06-11 上海锦葵医疗器械股份有限公司 Heart ventricular septal defect occluder with flat two end surfaces and manufacturing method thereof
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