CN207520158U - Plugging device - Google Patents
Plugging device Download PDFInfo
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- CN207520158U CN207520158U CN201720115376.6U CN201720115376U CN207520158U CN 207520158 U CN207520158 U CN 207520158U CN 201720115376 U CN201720115376 U CN 201720115376U CN 207520158 U CN207520158 U CN 207520158U
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- plugging device
- closure
- connecting portion
- film
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Abstract
The utility model is related to a kind of plugging device, the plugging device includes at least one closure disk;The closure disk includes central end, first blocks face, second blocks face and connecting portion, wherein described first closure face is made of the more mobile jibs directly dissipated to closure face edge direction from the central end, the second closure face is connect by the connecting portion with the described first closure face, the connecting portion is made of the more root bars separated from mobile jib every described, the more sub bars, which are cross-woven, forms fenestral fabric, bending section is provided on the sub bar, the crosspoint of the more piece sub bar adjacent with the described first closure face is first crosspoint in the fenestral fabric, described first blocks face film.The utility model solves the prior art using traditional series of problems for interting braiding structure alternatively up and down and can not realizing overlay film initiation;It is easy to overlay film, blocks complete, bodily form smaller after compression, anatomic form adaptability is more preferably, easy to make.
Description
Technical field
The utility model is related to a kind of percutaneous medical instruments fields, pass through sheath conveying technology more particularly, to one kind
It is transmitted in human body and/or animal body using the method for intervention, for blocking its defect opening or tissue cut, inner cavity, organ
A kind of plugging device of channel etc..
Background technology
Interventional treatment is the emerging therapeutic method between surgery, medical treatment, including intravascular intervention and non-vascular
Interventional treatment.By the development of more than 30 years, it is collectively referred to as three big pillar subjects with surgery, internal medicine now.It simply says, is situated between
It is exactly to make the minim channel of several millimeters of diameter in the case of not operating on exposed lesion on blood vessel, skin or through human body to enter treatment
Original pipeline locally controls lesion under the guiding of image documentation equipment (angiography machine, fluoroscopic machine, CT, MR, B ultrasound etc.)
The therapy of the wound minimum for the treatment of.Interventional treatment have wound it is small, it is easy, safely, effectively, few intercurrent disease and be obviously shortened
The advantages that institute's time.
As the implantation material of interventional treatment, plugging device can be used for blocking defect opening or group in human body and/or animal body
Knit cut, inner cavity, organ channel.For example, the congenital heart disease treatment being widely applied clinically, including atrial septum
The closure of the defects such as defect (as shown in Figure 1), ventricular septal defect, Arterial sheath patent opening, main principle are by left and right
The channel between " loophole ", aorta and pulmonary artery between Interatrial " loophole ", left and right ventricles is blocked.For another example in recent years
Treatment structural heart disease is developed for, inner cavities, the oral area of organ channel or inside, such as put plugging device including left auricle of heart etc.
In left auricle of heart, to block the blood flow into left auricle of heart, eliminate due to atrial fibrillation and cause the thrombosed risk of left auricle of heart, in prevention
Wind.
However plugging device is sent to by defect in human body and/or animal body by interventional method and is open or tissue cut, interior
The approach that chamber, organ channel are passed through is excessively tortuous including human body arteriovenous and/or heart, it is desirable that outer diameter is very small
And flexible sheath, while require plugging device can be easily into can easily be released in sheath and from sheath, therefore block
Device should have the performance of the bodily form small (low profile) after compression.In addition, plugging device should be able to accurately reach predetermined position and completely
Defect opening, inner cavity, organ channel are effectively blocked, this requires plugging device to have good mechanical requirements and hemodynamic requirement,
The structure of plugging device must have quite reasonable design.
In the prior art, the basic structure of plugging device is hyperelastic nitinol alloy wire through interting intensive braiding alternatively up and down
The structures such as the self-inflated double plate shape formed or mushroom, to form rack body, the inside of rack body filled with polyester or is gathered
Film made of tetrafluoroethene etc. flows in or out defect opening or tissue cut, inner cavity, organ channel for obstructing blood.Example
Such as atrial septal defect class plugging device, left auricle of heart class plugging device, the position in cardiac anatomy is as shown in Figures 2 and 3.Its
Have the advantages that it is simple in structure, but there are shortcomings, including
(1) plugging device interts braiding structure alternatively up and down using traditional, causes:
A. the closure disk of plugging device, which is compressed into the reduction length after sheath, is far longer than it from nature after sheath release
Length, and the reversible deformation of film is limited, therefore can not use overlay film (film of all areas is fixedly connected with silk) design;
B. it is limited between the silk and silk of closure disk by position, defect opening, inner cavity, organ channel is placed on when blocking disk
When, it is as shown in Figs. 4a and 4b due to mutually involving between silk, it blocks disk and is difficult in adapt to the rough shape of oral area, formed
Interstice coverage (as shown in the reference numeral 6) causes that target site cannot be blocked completely, as shown in Figures 2 and 3, postoperative to have residual shunt, mesh
Preceding this phenomenon is clinically commonplace.
(2) existing plugging device can only pass through simple several point suture companies of being achieved by placing film inside rack body
It connects, causes:
A. outside the edge of membrane removal, relative position is unlocked between film and the silk for blocking disk, blocks disk compression and enters conveying sheath
Guan Hou, film arrange in sheath and confusing lead to larger gap, therefore the bodily form (profile) is larger after plugging device compression, causes
It is relatively large in diameter sheath used, such as left auricle of heart class plugging device, minimum sheath adaptable at present is 8-10F;This is still to blood vessel
And the requirement of blood vessel approach is higher, i.e., there are certain adaptation limitations for current plugging device;
B. though film is attached with rack body by suture way, intert alternatively up and down braiding structure fail to make film with
Stent fixation can make the silk of film opposite brackets main body slide or even make sutures breaking that film be caused to contract when coming in and going out sheath
Cheng Yituan will appear film when discharging plugging device and incomplete phenomenon be unfolded, and causes to block not exclusively, there is residual shunt;
C. since position is not relatively fixed between the silk of closure disk, after plugging device implantation, bounce and blood with heart
Liquid constantly impacts, and easily leads to the phase mutual friction between silk, leads to the high risk of silk long term fatigue fracture;
D. there is the fine mesh for the rack body for interting braiding structure alternatively up and down (such as Fig. 4 a institutes by what is formed
Showing) film is placed into inside rack body, again spreads out into film inside rack body by this very narrow operating walk way
It is discoid and that the silk of the film inside rack body and main body circumferential edges finally is carried out the sequence of maneuvers such as suture connection is relatively tired
It is difficult;
E. since the film of use is essentially polyester or the non-woven fabrics of polytetrafluoroethyl-ne alkenes, though this non-woven fabrics biocompatibility
Well, it is soft, but be not suitable for suture, this is easily caused, and film is detached from plugging device or film is torn, and is caused effectively to block, be led to
The experiment for spending early period has been verified with using;
F. for film in the inside for blocking disk, blocking the nitinol alloy wire of disk and blood etc. and being in direct contact causes nickel ion to be precipitated
The risk of toxicity, sensitization and teratogenesis is eventually led to, biocompatibility is not good enough;Also it easily leads to and forms blood on panel surface is blocked
The complication such as bolt.
(3) quantity of silk is more used in the disk of braiding closure at present, such as 32 pairs, 64 pairs, causes:
A. metal coverage rate is higher, and nickel ion precipitation causes the risk of toxicity, sensitization and teratogenesis high;
B. the whole bodily form is larger after plugging device compression, sheath used is caused to be relatively large in diameter, i.e., current plugging device still remains
Certain adaptation limitation.
Invention content
It can not using traditional braiding structure interspersed alternatively up and down the purpose of this utility model is that solving the prior art
It realizes the series of problems that overlay film causes, one kind is provided and is easy to overlay film, block complete, bodily form smaller and anatomic form adaptation after compression
Property more preferably plugging device.
The utility model aim is achieved through the following technical solutions:
A kind of plugging device, the plugging device include at least one closure disk;The closure disk includes central end, the first envelope
Stifled face, second block face and connecting portion, wherein described first blocks face from straight from the central end to face edge direction is blocked
The more mobile jibs that sending and receiving dissipate are formed, and the second closure face is connect by the connecting portion with the described first closure face, the company
Socket part is made of the more root bars separated from mobile jib every described, and the more sub bars, which are cross-woven, forms fenestral fabric,
Bending section is provided on the sub bar, the more piece sub bars adjacent with the described first closure face in the fenestral fabric
Crosspoint is first crosspoint, and described first blocks face film.
The utility model aim is also further realized by following preferred technical solution:
Preferably, the bending section is arranged on the connecting portion and the tie point in the first closure face intersects with first
Between point.
Preferably, the bending section is arranged on first crosspoint and the second closure face and the connecting portion
Between tie point.
Preferably, using first crosspoint as separation, the plugging device quilt positioned at the described first closure face side
Overlay film.
Preferably, the first closure face is covered by film.
Preferably, the mobile jib in the first closure face is fixed on by interspersed on film.
Preferably, the more sub bars of the connecting portion extend to the direction that face is blocked far from described first, through intersecting
Fenestral fabric is knitted to form, and converges to form the second closure face to connection central part.
Preferably, the second closure face is provided centrally with connection central part, and described second block face by from the company
The more mobile jibs that the edge direction for connecing central part to the described second closure face directly dissipates are formed, and the every mobile jib is in edge
More root bars are separated into, and are correspondingly connected with the sub bar of the connecting portion.
Preferably, described second face film is blocked.
Preferably, fixed connection structure is equipped between the adjacent mobile jib.
Preferably, the every mobile jib is made of plurality of rods, and the more bars are merged or more by fixing piece
The bar, which is mutually wound, to be woven together.
Preferably, every mobile jib is equipped with string holes, series line by the string holes make the more main rod part in series into
One.
Preferably, it is fixedly connected positioned at the sub bar in the crosspoint of the fenestral fabric.
Preferably, the every mobile jib is made of plurality of rods, and the part interlacing composition of the more bars is latticed
The connecting portion of structure is provided with bending section on the bar of the connecting portion with the junction in the described first closure face;More
Another part of the bar continues to extend, and the continuation separated with the adjacent mobile jib extends to circumferential edges direction
The more bars connect respectively, form the described first extension for blocking face.
Preferably, described first block face for the curved surface of plane or middle part indent or described first block the edge in face to
Described second blocks face bending.
Preferably, the setting angle of the bending section enables to the first closure face described in free state and the company
Socket part and described second blocks face paste conjunction.
Preferably, the setting angle of the bending section enable to the connecting portion in free state to be cylindric or
Round table-like or carnival hat shape.
It is furthermore preferred that the material in the closure face for Nitinol, cochrome, stainless steel, titanium, tantalum, platinum, iridium, tungsten,
The metal materials such as gold, magnesium, zinc and its alloy or polyamide, polyether block amide, polyimides, polyurethane, polyketone, polyolefin
Wait high molecular materials.
It is furthermore preferred that the material of the film is polytetrafluoroethylene (PTFE), expanded PTFE, polyester, silicone, polyurethane, is gathered
The degradation materials such as amide, silica gel, polyolefin or polylactic acid, polyvinyl alcohol or the film are selected from animal tissue.
Preferably, the central end is detachably connected with push rod.
Compared with prior art, the beneficial effects of the utility model are mainly reflected in:
1. the more mobile jibs set in the plugging device of the utility model are direct to the edge direction in the face of closure from central end
The first closure face structure that diverging is formed so that the first closure face pressure of the closure disk of plugging device is retracted the pressure after delivery sheath
Contracting length is equal to its length from nature after delivery sheath release, so as to finally enable the overlay film reality on the first closure face
It is existing, it avoids not realizing overlay film in the prior art, and the placement film inside plugging device mesh grid is used to be stitched by simple several points
Close a series of problems caused by realization film is connect with rack body.In addition, the position between mobile jib on the first closure face is basic
Unrestricted, movement is relatively independent, is not only convenient for the producer and easily carries out the operation of the produced in series such as overlay film so that making side
Just;The shape of the wall of rough defect open area is also accommodated, the closure disk and defect for avoiding traditional plugging device are open
Interstice coverage is formed between the spaced walls in region, greatly improves the anatomic form adaptability for blocking disk, enhances plugging effect.
2. the first closure face is covered by film in the utility model or the mobile jib in the first closure face is interspersed on film, have
Have many advantages, such as:The relative position of more mobile jibs and film in first closure face is fixed, and the first closure face pressure is retracted into defeated
After sending sheath, film in sheath ordered arrangement and realize tightly packed, reduce the bodily form after the compression in closure face, reduce used defeated
The minimum diameter of sheath is sent, reduces the requirement to operative approach, expands the scope of application of plugging device;Plugging device is placed into target position
It postpones, what is be in direct contact or completely attach to large area such as blood is the excellent film of biocompatibility, substantially reduces traditional closure
The nitinol alloy wire of device and being in direct contact for blood etc. cause nickel ion precipitation to eventually lead to toxicity, sensitization and teratogenesis, with
And on plugging device surface thrombosis risk, the first closure face is covered by film or even can avoid this risk completely;It is high
The friction coefficient of the film of molecular material is lower than the metal materials such as Nitinol, discharges or recycled from conveying sheath in plugging device
Cheng Zhong, frictional resistance are minimized so that operator's operating handle is more preferably.
3. the first closure face can set fixed connection structure in the plugging device of the utility model so that it is recycled in plugging device,
Or during release and after being discharged into target location, all mobile jibs in the first closure face are equal on the central shaft of central end
Rotational symmetry is remained, such as during repeating to recycle, after the first closure face pressure is retracted delivery sheath, film is in sheath into one
It walks ordered arrangement and further tightly packed, therefore is further reduced the bodily form after the compression in the first closure face, subtracts to the maximum extent
The diameter of small delivery sheath used further reduces the requirement to operative approach, expands the scope of application of plugging device;Simultaneously
Improve the rounding property of plugging device.
4. first blocks the curved surface or the first closure that face can be plane or center indent in the plugging device of the utility model
The curved surface that the edge in face blocks the arbitrary shapes such as face bending to second, the connecting portion can be plane or circle in free state
The curved surface and the connecting portion of mesa-shaped or cylindric or carnival hat shape or other arbitrary shapes are optionally provided to be handed over up and down
Fork braiding or the mutually structure of winding braiding, adjustable plugging device to the anatomic form adaptability of target location to best, into
One step enhances plugging effect.
5. the first closure face can also set extension in the plugging device of the utility model, expand the first closure for blocking face
Area further enhances plugging effect.
Description of the drawings
Fig. 1 is the position view of atrial septal defect and left auricle of heart in cardiac anatomy;
Fig. 2 is form schematic diagram of the atrial septal defect class plugging device of the prior art in heart;
Fig. 3 is form schematic diagram of the left auricle of heart class plugging device of the prior art in heart;
Fig. 4 a-4b are the structure chart in the closure face (containing connecting portion) of the plugging device of the prior art, and wherein Fig. 4 a are Fig. 4 b's
Left view;Fig. 4 b are the side view for blocking disk;
Fig. 5 a-5b are the structure diagram of the non-overlay film of first embodiment of the utility model plugging device, and wherein Fig. 5 a are figure
The left view of 5b, Figure 5b shows that the sectional views along central end axle center;
Fig. 6 a-6c are the structure chart after the first closure face film of the first embodiment of the utility model plugging device,
Middle Fig. 6 a are the left view of Fig. 6 b, and Fig. 6 b show the sectional view along central end axle center, and Fig. 6 c are the A-A sectional views of Fig. 6 b;
Fig. 7 is the structure diagram after the first closure face film of second embodiment of the utility model plugging device;
Fig. 8 a-8c are the structure diagram of the third embodiment of the utility model plugging device, and wherein Fig. 8 a are Fig. 8 b's
Left view, the view only show the first of non-film and block face structure and the structure of part connecting portion (bending section), Fig. 8 c
For the A-A sectional views of Fig. 8 b, which only shows the structure in the second closure face and the structure of part connecting portion;
Fig. 9 a-9e are the structure diagram of the 4th embodiment of the utility model plugging device, and wherein Fig. 9 a, 9b are figure
The left view of 9c, the view only show that the first of non-film blocks face structure and part connecting portion (bending section) structure, Fig. 9 d
For the right view of Fig. 9 c, which only shows that the second of non-film blocks the knot of face structure and part connecting portion (bending section)
Structure, Fig. 9 e are the sectional view along central end axle center after the first closure face of Fig. 9 c and the second closure equal film in face;
Figure 10 is that the 5th embodiment only first of the utility model plugging device is blocked after the overlay film of face and along central end axis
The sectional view of the heart.
Wherein, 1 is plugging device, and 3 be defect opening, and 4 be atrium sinistrum, and 5 be atrium dextrum, and 6 be interstice coverage, and 7 inner cavities, 10 be envelope
Stifled disk, 11 be anchor frame, and 40 be the atrium sinistrum inner wall at left auricle of heart open area, and 41 be left auricle of heart inner wall, and 42 be left auricle of heart, 50
It is the room next door at defect open area, 100 be central end, and 101 be the first closure face, and 101 ' be the second closure face, 102
It is film, 103 be connecting portion, and 104 be extension, and 105 be connection central part, and 1001 be attaching nut, and 1010 be the first closure face
Mobile jib, 1010 ' be the mobile jib in the second closure face, and 1011 be bar, and 1012 be fixing piece, and 1013 be series line, and 1014 be string holes,
1015 be the fixed connection structure in the first closure face, and 1015 ' be the fixed connection structure in the second closure face, and 1016 be fixing line,
1031 be the sub bar in the first closure face, and 1031 ' be the sub bar in the second closure face, and 1032 be bending section, and 1033 be the first crosspoint.
Specific embodiment
For the purpose of this utility model, technical solution and advantage is more clearly understood, develop simultaneously implementation below in conjunction with attached drawing
The utility model is further described in example.It should be appreciated that specific embodiment described herein is only explaining this practicality
It is novel, it is not used to limit the utility model.
Embodiment one:
The plugging device of one embodiment of the utility model is open available for defect, and such as atrial septal defect, interventricular septum lacks
Damage,
And the closure of tissue cut such as blood vessel etc..
As shown in Fig. 5 a-5b and Fig. 6 a-6c, plugging device includes two closure disks 10, and any of which blocks disk 10 and wraps
Include central end 100, the first closure face 101, the second closure face 101 ' and connecting portion 103, two block disks 10 by with center
The connection central part 105 of the central axis of end 100 is attached.It blocks the first of disk 10 and blocks the closure of face 101 and second
Face 101 ' is respectively from from central end 100 and connection central part 105 to the more mobile jibs directly dissipating of edge direction for blocking disk
1010 and mobile jib 1010 ' form.The second closure face 101 ' is connected by the connecting portion 103 and the first closure face 101
It connects, the connecting portion 103 is made of the more root bars 1031 separated from mobile jib every described 1010, and the more sub bars 1031 are handed over
Fork braiding form fenestral fabric, be provided with bending section 1032 on the sub bar 1031, in the fenestral fabric with institute
The crosspoint for stating the more adjacent sub bars 1031 of the first closure face 101 is first crosspoint 1033, and described first blocks
101 film of face.
In this structure, more mobile jibs 1010 and mobile jib 1010 ' are respectively from central end 100 and connection central part 105
Edge direction to the face of closure directly dissipates to form the first closure face 101 and the second closure face 101 ', and this design has many
Advantage:Just it is equal to it into the reduction length after delivery sheath from conveying sheath 1. blocking the first of disk 10 and blocking the compression of face 101
The length of nature after pipe release so as to finally make it possible that overlay film is carried out on entire first closure face 101, avoids existing
Overlay film can not be realized by having in technology, and has to use and film is placed inside plugging device mesh grid, then pass through simple several points and stitch
Close a series of problems caused by realization film is connect with rack body;2. first block face 101 on mobile jib 1010 between and
Second position blocked between the mobile jib 1010 ' on face 101 ' is substantially unrestricted, and movement is relatively independent, not only so that the first envelope
Stifled face 101 and second blocks the shape that face 101 ' adapts to the spaced walls of rough defect open area, avoids traditional closure
Blocking for device forms interstice coverage 6 (as shown in Figure 2) between disk and the spaced walls 50 of defect open area, substantially increase closure disk
10 anatomic form adaptability enhances plugging effect, is also convenient for the producer and easily carries out a series of overlay films manufacturing, including
Enter the inside for blocking disk 10 by the soft film of the huge gap placement between mobile jib 1010 or between mobile jib 1010 ', by film
It spreads out and is finally sutured its internal film or other connections etc. with mobile jib 1011 inside it so that is easy to make.
In one embodiment, every mobile jib 1010 or mobile jib 1010 ' are by two bars 1011 or 1011 ' it forms, and
It is woven together the braiding structure to be formed and mutually wound through mutually winding the modes such as braiding, the braiding structure mutually wound causes often
Two bars 1011 or 1011 of root mobile jib 1010 or mobile jib 1010 ' ' between relative position fixed.Second blocks face 101 '
It is connect by connecting portion 103 with the first closure face 101, connecting portion 103 is by the two root bars 1031 that are separated from every mobile jib 1010
Composition, more root bars 1031 of connecting portion 103 are corresponded and are connect with the plurality of rods 1011 in the first closure face 101, the second envelope
The every mobile jib 1010 ' in stifled face 101 ' is split into two root bars 1031 ', and and connecting portion in the circumferential edges punishment for blocking face 101 '
The other end of 103 sub bar 1031 is connected respectively, and more root bars 1031 of connecting portion 103 form grid by being cross-woven
Shape structure.Being cross-woven the design of composition fenestral fabric is advantageous in that:Enter 1. blocking the first of disk 10 and blocking the compression of face 101
Delivery sheath or when being released from delivery sheath, first blocks face 101 coaxially blocks face 101 ', and then keep away in second always
Support force unevenness causes to block two 101 and 101 ' shapes of closure face of disk 10 between exempting from each sub bar 1031 because of connecting portion 103
Into dog-ear so increase the resistance for the sheath that comes in and goes out and plugging device is avoided to be positioned when discharging after bad, release form is bad causes
The not exclusively generation of closure etc.;2. the certain flexible and bending function of the connecting portion 103 for assigning closure disk 10, connecting portion 103
Telescopic make closure disk 10 more adaptive deeper defect opening or tissue cut, so as to first block face 101 with
Second, which blocks face 101 ', is open or organizes adherent, the room at defect open area as shown in Figure 2 at cut region with defect
Next door 50 enhances plugging effect;Certainly bending function can make the first closure face 101 and the second closure face 101 ' not coaxial, thus
Adapt to out-of-alignment defect opening or tissue cut.
Bending section 1032 is provided on the sub bar 1031 of connecting portion 103, bending section 1032 may be provided in connecting portion 103 and
One blocks between the tie point in face 101 and the first crosspoint 1033, may be alternatively provided at being blocked close to second for the first crosspoint 1033
The side (being located between the first crosspoint 1033 and the tie point of the second closure face 101 ' and connecting portion 103) in face 101 ',
In first crosspoint 1033 be defined as adjacent with the first closure face 101 in the fenestral fabric of connecting portion 103 more
The crosspoint of sub bar 1031, certain bending section 1032 can also be located on entire connecting portion.The design of bending section 1032 to seal
The first closure face 101 compression of stifled disk 10 is smoothly suitable into delivery sheath or the whole process released from delivery sheath
Freely, operator is avoided to be operated in whole process, and resistance is larger so that operating handle is bad;In addition, by setting different bendings
Section angle (that is,:The degree of bending) enable to described in free state the first closure face 101 and connecting portion 103 and the
Two, which block face 101 ', is bonded, and the first closure face 101 and second of reducing blocks the thickness between face 101 ', and such plugging device discharges it
The first closure face 101 more fits in the room next door of defect open area together with the second closure face 101 ' afterwards, further enhances
Plugging effect.
The mobile jib 1010,1010 ' or bar 1011 or sub bar 1031,1031 ' of closure disk 10 are made of shape-memory material,
Shape-memory material be selected from NiTi (NiTi) alloy, cobalt chromium (CoCr) alloy etc. have shape memory function metal material or
Other metal materials such as stainless steel, titanium, tantalum, platinum, tungsten, gold, magnesium, zinc and its alloy or polyamide, polyether block amide, polyamides
The high molecular materials such as imines, polyurethane, polyketone, polyolefin.Shape as shown in Figure 5 a blocks disk 10 and more Nitinols can be used
Silk merges the volume to be formed and mutually wound in a manner of mutually winding braiding two-by-two as bar 1011 by preliminary heat treatment
Knit structure so that the relative position of multipair bar 1011 fixes and forms the more mobile jibs 1010 in the first closure face 101, then more
Bar 1011 continues the circumferencial direction extension to closure face 101, the fenestral fabric of connecting portion 103 is formed through being cross-woven, then
The bar of each pair of intersection in fenestral fabric merges shape in a manner of mutually winding braiding two-by-two by preliminary heat treatment
Into the braiding structure mutually wound so that the relative position of multipair bar fixes and forms the more mobile jibs in the second closure face 101 '
1010 ', connecting portion 103 and closure face are finally shaped into required shape through Overheating Treatment with the final shaping mold.
The both sides in the closure face 101 of one embodiment are all covered with film 102, and film 102, which plays, prevents blood from flowing into or flow
Go out the effect of the tissue cut such as defect opening and blood vessel.The material of the film 102 in face 101 is blocked suitable for block disk 10 first
Including polytetrafluoroethylene (PTFE), expanded PTFE, polyester, silicone, polyurethane elastomer, polyamide, silica gel, polyolefin, can drop
Solve material such as polylactic acid, polyvinyl alcohol and animal tissue etc..Film 102 blocks mobile jib 1010 or bar in face 101 by first
1011 are coated on inside completely, and as shown in Figure 6 b, this design has many advantages, such as:1. first blocks more masters in face 101
Bar 1010 or plurality of rods 1011 and the relative position of film 102 are fixed, and first, which blocks face 101, compresses into after delivery sheath,
Film in sheath ordered arrangement and realize that the confusing of film of tightly packed rather than traditional plugging device leads to larger gap,
Therefore the bodily form after blocking the first of disk 10 compression for blocking face 101 of plugging device is reduced, reduces the diameter of delivery sheath used,
The requirement to operative approach is reduced, expands the scope of application of plugging device;2. the biocompatibility due to film is excellent, plugging device is placed
To after target location, what is be in direct contact with blood etc. is film, avoids the direct of the nitinol alloy wire of system plugging device and blood etc.
Thrombosis on the phenomenon that contact causes nickel ion precipitation to eventually lead to toxicity, sensitization and teratogenesis and plugging device surface
Generation;3. the friction coefficient of the film of high molecular material is lower than the metal materials such as Nitinol, in plugging device from conveying sheath
In release or removal process, frictional resistance is minimized so that operator's operating handle is more preferably.
It is separation with the first crosspoint 1033, the connecting portion 103 positioned at the side that separation blocks face 101 close to first
Also film is answered, as shown in fig. 6a-6c, this causes the edge of film 102 to be securely fixed with the first closure face 101, avoids macromolecule
Attachment force is substantially not present between first closure face 101 of the metal materials such as the film and Nitinol of material, and plugging device is in weight
During release after return receipts there is friction in film with delivery sheath inner wall and plugging device is discharged into blood pair behind target location
The continuous impact of film causes film that the slip to 100 direction of central end occurs relative to the mobile jib 1010 in the first closure face 101,
Film is shunk along the mobile jib 1010 in the first closure face 101 to central end 100, film 102 is finally caused to block incomplete.
If selecting the film with microcellular structure, such as expanded PTFE (ePTFE), 101 both sides of face can be blocked by first
Film 102 be fused into one by modes such as heat-agglomerating, hot melts, carry out overlay film.It also can be viscous by adding between film and film
It connects agent and connection is realized in a manner that glue connects, bonding agent includes but not limited to polyurethane (TPU) solution, fluorinated ethylene propylene copolymer
(FEP) lotion, glue loctite3011,3321,3493,3494,3751,4011,4013, EAM-31CL;Glue
Dymax203a-cth-f、204-cth-f、1201-m-sc、1128a-m;Glue NuSil MED-2000P;Glue Dow
Corning SILASTIC MEDICAL ADHESIVE SILICONE, TYPE A.Certainly the first closure face 101 can also be used
The modes such as dip-coating or spraying make polyurethane (TPU) etc. be covered on closure disk, are finally completed overlay film.In addition, suture also can be used
Line makes film link together with film suture, and suture can be polypropylene, polyamide, polyester, ultra-high molecular weight polyethylene, polytetrafluoro
The absorbable sutures such as the nonabsorables such as ethylene suture or sheep intestinal tissue, polylactic acid, polyethanol acids.
In one embodiment, central end 100 can be equipped with the attaching nut 1001 with internal thread structure, connect spiral shell
Mother 1001 is detachably connected with the push rod in transport system, rotates push rod, discharges plugging device in the defect opening of target,
It may also set up other structures such as buckle on central end 100 and be detachably connected with realizing with push rod.
Embodiment two:
As shown in fig. 7, based on one embodiment, the difference of second embodiment and one embodiment exists
In in any the first closure face 101 for blocking disk 10, the plurality of rods 1011 of composition mobile jib 1010 are substantially parallel to one another, and mobile jib
1010 are interspersed on film 102.So that film 102 and the relative position of mobile jib 1010 further fix, first blocks face for this design
After 101 compressions enter delivery sheath, film in sheath ordered arrangement and realize the film of tightly packed rather than traditional plugging device
Confusing to lead to larger gap, which blocks the 101 compressed size of the first closure face of disk 10 because of reducing,
The minimum diameter of delivery sheath used is reduced, the requirement to operative approach is reduced, expands the scope of application of plugging device.
The plurality of rods 1011 of every mobile jib 1010 such as merge one in the edge in closure face 101 through fixing piece 1012 in subregion
It rises so that 1011 relative position of plurality of rods on the first closure face 101 is fixed.Fixing piece 1012 can be selected common medical
Material, including NiTi (NiTi) alloy, cobalt chromium (CoCr) alloy, 316L stainless steels, 304 stainless steel and other metal materials, Yi Jiju
The high molecular materials such as amide (PA), polyether block amide (Pebax), polyurethane (TPU) can also have development work(by addition
The material of energy, such as titanium, tantalum, platinum, iridium, tungsten, gold metal and its compounds such as alloy and barium sulfate, bismuth oxide, forcing
Effect, to enhance visualization in surgical procedure and the observation convenient for the closure 10 final form of disk of plugging device after operation.
On the periphery of fixing piece 1012, fixing line 1016 can be also introduced so that the plurality of rods 1011 of every mobile jib 1010 and the opposite position of film
It puts and is further fixed, between the first closure face 101 for avoiding the metal materials such as film and the Nitinol of high molecular material
Attachment force is substantially not present, and there is friction with delivery sheath inner wall in plugging device film during the release after repeating to recycle, with
And plugging device is discharged into continuous impact of the blood to film behind target location, leads to mobile jib of the film relative to the first closure face 101
1010 occur the slip to 100 direction of central end, and film is received along the mobile jib 1010 in the first closure face 101 to central end 100
Contracting finally causes film 102 to block incomplete.
Embodiment three:
The plugging device of the utility model third embodiment can be used for inner cavity, such as organ channel, patent ductus arteriosus, Zuo Xin
The closure of ear etc..
As shown by figures 8 a-8 c, based on one embodiment, first of third embodiment and one embodiment
The difference lies in plugging device includes one and blocks disk 10 and an anchor frame 11.Anchor frame 11 is placed in inner cavity or organ leads to
Fixed plugging device is played the role of in the inside in road.String holes 1014 is provided on the mobile jib 1010 in the first closure face 101 or is utilized
Gap between sub bar 1011 with mutual winding braiding structure forms string holes, and series line 1013 makes more by string holes 1014
Mobile jib 1010 is connected integrally, and as shown in Figure 8 a, and the first closure face 101 is wrapped in the inside of film 102, such as Fig. 8 b institutes
Show, this design causes the film 102 of 101 both sides of the first closure face to be securely fixed with the first closure face 101, the film of high molecular material
Attachment force is substantially not present between the first closure face 101 of the metal materials such as Nitinol, and plugging device is after repeating to recycle
Release during film and delivery sheath inner wall there is friction and plugging device be discharged into target location after blood to the continuous of film
Impact causes film to occur the slip to 100 direction of central end relative to the mobile jib 1010 in the first closure face 101, and film is along the
The mobile jib 1010 in one closure face 101 is shunk to central end 100, film 102 is finally caused to block incomplete.Certainly, using suture
Same fixed effect can also be reached by carrying out suture connection by string holes 1014 and film 102.The material of series line 1013 can make
With the suture as described in one embodiment, fibers and the animal tendon tissues such as carbon fiber, polyarylate also can be used.
In one embodiment, it may also set up string holes 1014 on the mobile jib 1010 ' in the second closure face 101 ' or mutually wound using having
Gap between the sub bar of braiding structure forms string holes, and series line 1013 is connected into more mobile jibs 1010 ' by string holes 1014
One.
Second curve form the difference lies in indent centered on the first closure face 101, and first blocks face 101
Edge blocks face 101 ' to second and is bent, as shown in Figure 8 b rather than as described the attached shown in figure flat of one embodiment
Face, this can make the first closure face 101 and the second closure face 101 ' and connecting portion 103 more adapt to inner cavity or the end of organ channel
The rough anatomical shape in face, can also making central end 100, the inside of organ channel embeds, reduces because of center-side to inner cavity
The risk of thrombosis caused by portion 100 is protruded.
It is to continue on through intersection by more root bars 1031 of connecting portion 103 that third blocks face 101 ' the difference lies in second
Fenestral fabric is knitted to form, and is formed to center convergence, as shown in Figure 8 c.The of the fenestral fabric of top-bottom cross braiding
Two closure faces 101 ', which can further enhance, equally has the function of the connecting portion of fenestral fabric, including:1. block the company of disk 10
During the discrepancy sheath of socket part 103, further ensure that two closure faces 101 and 101 ' are always maintained at coaxially, avoiding because of connecting portion 103
Support force unevenness causes two closure faces 101 and 101 ' for blocking disk 10 to form dog-ear and then increases discrepancy between each sub bar 1011
Bad, the bad generation for causing incomplete closure etc. of form after release is positioned when resistance and the plugging device release of sheath;2. into
One step improves flexible and bending function, when the anchor frame 11 of plugging device 1 place it is too deep or excessively shallow, second block face 101 ' together with
The Telescopic of connecting portion 103 makes closure the disk 10 more inner cavity of adaptive different depth or organ channel;Function is bent to assign
The malaignment for blocking disk 10 and anchor frame 11 is given, is suitable for out-of-alignment inner cavity or organ channel, such as the left auricle of heart of chicken wings shape,
It reduces the prior art and has to add the design complexities of flexible connecting structure to reach this purpose.
Example IV:
As shown in Fig. 9 a-9e, based on third embodiment, first of the 4th embodiment and third embodiment
The difference lies in plugging device only includes a closure disk 10.Be provided between the more mobile jibs 1010 in the first closure face 101 by
The fixed connection structure 1015 that bar 1011 forms, this design can not only play identical with the series line that third embodiment is set
Effect, can also further limit the relative position between all mobile jibs 1010 in the first closure face 101 so that in any feelings
Under condition, including plugging device during repeating to recycle or during repetition release or after being discharged into target location, first blocks
All mobile jibs 1010 in face 101 remain rotational symmetry on the central shaft of central end 100, are such as repeating removal process
In, first blocks after the compression of face 101 enters delivery sheath, film in sheath further ordered arrangement and it is further tightly packed,
Therefore be further reduced plugging device 1 closure disk 10 the first closure face 101 compression after the bodily form, to the maximum extent reduce used in
Delivery sheath diameter, further reduce requirement to operative approach, expand the scope of application of plugging device.Implement in another kind
In mode, fixed connection structure 1015 may also set up for from bar 1011 form to 101 outward radial flex of the first closure face into
Arc-shaped or the shape for being bent into dog-ear, as shown in figure 9d.
Second the difference lies in the every mobile jib 1010 in the first closure face 101 is made of plurality of rods 1011, plurality of rods
1011 part is cross-woven the connecting portion 103 for forming fenestral fabric, and another part continues to extend, and with adjacent master
The continuation that bar 1010 is separated connects respectively to the plurality of rods 1011 that circumferential edges direction extends, and forms first and blocks face 101
Extension 104, as is shown in fig. 9 c.This design is advantageous in that, expands the first closure area for blocking face 101, such as Fig. 9 b
Shown I regions further enhance the plugging effect of plugging device.
Third the difference lies in, block the connecting portion 103 of disk 10 by more root bars 1011 (that is,:Above-mentioned more
A part for bar 1011) three-dimensional fenestral fabric is knitted to form using top-bottom cross, global shape is round table-like, such as Fig. 9 c institutes
Show or cylindric or carnival hat shape and the curved surface of other arbitrary shapes.Top-bottom cross be knitted to form three-dimensional fenestral fabric this
Kind design can not only play the latticed function as described in one embodiment, it is also possible that more roots of connecting portion 103
Position between bar 1011 limits but is not fixed relatively, therefore connecting portion has stronger shape variability, when plugging device is placed
To after target location, the inner wall of inner cavity or organ channel can be placed directly within, and the inner wall for being suitable for different surfaces state ensures two
Person's fitting is secured, plays the fixed function of the anchor frame 11 set such as third embodiment, meanwhile, also generate secondary seal work(
Effect further improves the sealing effect of plugging device, in addition, curved connecting portion 103 can also enhance the anatomic form of plugging device 1
Adaptability reduces the stimulation of the inner wall to inner cavity or organ channel.Certainly, anchor mechanism can be also set on connecting portion 103, such as
Hangnail further improves the fixed effect of plugging device.In addition, the bar of the junction in face 101 is blocked in connecting portion 103 and first
Bending section 1032 is provided on 1011, such as Fig. 9 c, shown in 9e so that block the first of disk 10 and block the compression of face 101 and enter conveying
Sheath or the whole process smooth released from delivery sheath, avoid operator operated in whole process resistance compared with
Greatly so that operating handle is bad;In addition, by the way that the angle of different bending sections is set to enable to connecting portion 103 in free state
When always remain as preset round table-like or cylindric or carnival hat shape and the curved surface of other arbitrary shapes.
4th the difference lies in addition to block disk 10 first blocks face 101, second blocks the also film of face 101 '
102, second blocks 101 ' film of face, can increase the space of closure, improves plugging effect.
Embodiment five:
As shown in Figure 10, based on the 4th embodiment, the difference of the 5th embodiment and the 4th embodiment
It is, the connecting portion 103 of closure disk 10 is mutually wound by more root bars 1031 using discontinuous is knitted to form space network.
Discontinuous mutually winds braiding structure and the sub bar 1031 for being located at the crosspoint of the fenestral fabric of connecting portion 103 is connected by fixed
It connects, the position between more root bars 1031 is relatively fixed, and the shape of connecting portion 103 keeps good, provides sufficiently strong radial direction branch
Support force, after plugging device is placed into target location, connecting portion 103 is placed in inner cavity or organ channel interior, plays as third is real
Apply the fixed function of the anchor frame 11 of example setting.Certainly also may be used other than the fixing means of winding braiding in the position in crosspoint
By introducing the parts such as other fixing pieces or fixing line so that each crosspoint of fenestral fabric is fixed, generates and twines
Around weaving method it is identical the effect of.
Finally it should be noted that the foregoing is merely the utility model preferred embodiment, be not used to limit
The utility model processed, all any modification, equivalent and improvement made within the spirit and principles of the present invention etc.,
It should be included within the scope of protection of this utility model.
Claims (17)
1. a kind of plugging device, it is characterised in that:The plugging device includes at least one closure disk (10);The closure disk (10) is wrapped
Central end (100), the first closure face (101), the second closure face (101 ') and connecting portion (103) are included, wherein first envelope
Stifled face (101) are made of the more mobile jibs (1010) directly dissipated to closure face edge direction from the central end (100), institute
It states the second closure face (101 ') to connect with the described first closure face (101) by the connecting portion (103), the connecting portion
(103) it is made of the more root bars (1031) separated from mobile jib every described (1010), the more sub bars (1031), which are intersected, compiles
Be configured to fenestral fabric, bending section (1032) be provided on the sub bar (1031), in the fenestral fabric with institute
The crosspoints of the more adjacent sub bars (1031) of the first closure face (101) is stated as first crosspoint (1033), described the
One blocks face (101) film.
2. plugging device according to claim 1, it is characterised in that:The bending section (1032) is arranged on the connecting portion
(103) it is blocked between the tie point of face (101) and the first crosspoint (1033) with described first.
3. plugging device according to claim 1, it is characterised in that:The bending section (1032) is arranged on described first
Crosspoint (1033) and described second is blocked between face (101 ') and the tie point of the connecting portion (103).
4. plugging device according to claim 1, it is characterised in that:With first crosspoint (1033) for separation,
The plugging device film for blocking face (101) side positioned at described first.
5. plugging device according to claim 1, it is characterised in that:Described first, which blocks face (101), is covered by film.
6. plugging device according to claim 1, it is characterised in that:Described first blocks the mobile jib of face (101)
(1010) it is fixed on film by interspersed.
7. plugging device according to claim 1, it is characterised in that:The more sub bars of the connecting portion (103)
(1031) extend to the direction that face (101) are blocked far from described first, fenestral fabric is formed, and into connection through being cross-woven
Central member (105) convergence forms the second closure face (101 ').
8. plugging device according to claim 1, it is characterised in that:Described second blocks the company of being provided centrally with of face (101 ')
Central part (105) is connect, described second blocks face (101 ') from blocking face to described second from the connection central part (105)
The more mobile jibs (1010 ') that the edge direction of (101 ') directly dissipates are formed, and the every mobile jib (1010 ') separates in edge
It is correspondingly connected with into more root bars (1031 '), and with the sub bar (1031) of the connecting portion (103).
9. the plugging device according to claim 1 or 8, it is characterised in that:Described second blocks face (101 ') film.
10. plugging device according to claim 8, it is characterised in that:The adjacent mobile jib (1010 or 1010 ') it
Between be equipped with fixed connection structure (1015 or 1015 ').
11. plugging device according to claim 8, it is characterised in that:The every mobile jib (1010 or 1010 ') is by plurality of rods
(1011 or 1011 ') form, the more bars (1011 or 1011 ') merged by fixing piece (1012 or 1012 ') or
The mutually winding of the more bars (1011 or 1011 ') is woven together.
12. plugging device according to claim 8, it is characterised in that:The every mobile jib (1010 or 1010 ') is equipped with line
Hole (1014), series line (1013) make the more mobile jibs (1010 or 1010 ') connect integrally by the string holes (1014).
13. the plugging device according to claim 1 or 6, it is characterised in that:Institute positioned at the crosspoint of the fenestral fabric
Sub bar (1031 or 1031 ') is stated to be fixedly connected.
14. plugging device according to claim 1, it is characterised in that:The every mobile jib (1010) is by plurality of rods (1011)
Composition, a part for the more bars (1011) is cross-woven the connecting portion (103) for forming fenestral fabric, in the connecting portion
(103) it is provided with bending section (1032) on the bar (1011) for the junction for blocking face (101) with described first;Described in more
Another part of bar (1011) continues to extend, and with the continuation that the adjacent mobile jib (1010) is separated to circumferential edges side
It is connected respectively to the more bars (1011) of extension, forms the described first extension (104) for blocking face (101).
15. plugging device according to claim 1, it is characterised in that:Described first blocks face (101) as plane or middle part
The curved surface of indent or the described first edge for blocking face (101) block face (101 ') bending to described second.
16. plugging device according to claim 1, it is characterised in that:The setting angle of the bending section (1032) can make
The first closure face (101) described in free state is obtained to be bonded with the connecting portion (103) and second closure face (101 ').
17. plugging device according to claim 1, it is characterised in that:The setting angle of the bending section (1032) can make
It is cylindric or round table-like or carnival hat shape in free state to obtain the connecting portion (103).
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CN201720115376.6U CN207520158U (en) | 2017-02-08 | 2017-02-08 | Plugging device |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107049373A (en) * | 2017-02-08 | 2017-08-18 | 宁波迪创医疗科技有限公司 | Plugging device |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107049373A (en) * | 2017-02-08 | 2017-08-18 | 宁波迪创医疗科技有限公司 | Plugging device |
CN107049373B (en) * | 2017-02-08 | 2023-09-26 | 宁波迪创医疗科技有限公司 | Plugging device |
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