CN106923885B - Occluder for left auricle - Google Patents
Occluder for left auricle Download PDFInfo
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- CN106923885B CN106923885B CN201511033726.6A CN201511033726A CN106923885B CN 106923885 B CN106923885 B CN 106923885B CN 201511033726 A CN201511033726 A CN 201511033726A CN 106923885 B CN106923885 B CN 106923885B
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- China
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- fixing piece
- left auricle
- sealing element
- occluder
- connector
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12177—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Reproductive Health (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Surgical Instruments (AREA)
Abstract
The present invention relates to a kind of occluder for left auricle, including sealing element, the fixing piece positioned at sealing element side, and the connector of the connection sealing element and the fixing piece；The sealing element includes skeleton and the overlay film that is arranged on the skeleton, and the skeleton includes proximal side and connect with the proximal side and to the support circumferential surface that distal end extends, and the overlay film at least covers the proximal side；The fixing piece is cylindricality silk braiding structure, and the connector is flexible connector.In occluder for left auricle of the present invention, fixing piece is braiding structure, and have without salient point, smooth appearance, after fixing piece is placed on left auricle of heart corresponding position, the irregular cavity wall shape for adapting to left auricle of heart cavity depths can not only be deformed, but also can adapt to enhance the frictional force of itself and cavity wall by the deformation, to be set to what occluder for left auricle consolidated in left auricle of heart cavity, no setting is required simultaneously for fixing the anchor thorn of plugging device, and anchor thorn is avoided to be pierced into relatively thin left auricle of heart cavity wall.
Description
Technical field
The present invention relates to medical instrument more particularly to a kind of occluder for left auricle.
Background technique
Plugging device can be placed by intubation intervention method at present into left auricle of heart, prevention causes left auricle of heart to be formed due to atrial fibrillation
Thrombus avoids the thrombus from going upward to apoplexy caused by brain；Or prevents the thrombus and body is reached by blood circulation of human body system
Other positions, caused by systematicness embolism.Such occluder for left auricle can generally comprise Integral plugging device and be divided from structure
Body formula plugging device.For example, split type plugging device generally includes the fixation member and seal member being connected to each other, fixation member is placed in
With the entire plugging device of fixation in left auricle of heart cavity, seal member seals the oral area of left auricle of heart, flows into left auricle of heart for blocking blood flow
In cavity.
Fixation member is placed in left auricle of heart cavity by the form for generalling use anchor, and being pierced into left auricle of heart wall by anchor makes to fix
Component is fixed in left auricle of heart cavity.In order to reduce the risk that plugging device falls off, fixation member is usually placed in left auricle of heart
Intracavitary deep part.But the intracavitary deep part of left auricle of heart is also the relatively thin position of left auricle of heart wall, and fixation member is easy to cause to puncture
Thus left auricle of heart wall causes the adverse consequences such as hydropericardium or even pericardial tamponade.
Summary of the invention
Based on this, it is necessary in view of the above-mentioned problems, providing a kind of can ensure stablizes fixed effect, and the left heart will not be punctured again
The occluder for left auricle of ear wall.
The technical solution adopted by the present invention to solve the technical problems is: providing a kind of occluder for left auricle, including close
The connector of sealing, the fixing piece positioned at sealing element distal end side and the connection sealing element and the fixing piece；Institute
State the overlay film that sealing element includes skeleton and is arranged on the skeleton, the skeleton include proximal side and with the proximal end
Support circumferential surface side connection and extended to distal end, the overlay film at least cover the proximal side；The fixing piece is cylindricality
Silk braiding structure, the connector are flexible connector.
In occluder for left auricle according to an embodiment of the present invention, the radial deformation capabilities of the sealing element are greater than described solid
The axial deformation ability of the radial deformation capabilities and/or the sealing element of determining part is greater than the axial deformation ability of the fixing piece.
In occluder for left auricle according to an embodiment of the present invention, under the effect of same radial power, the diameter of the sealing element
Long variable quantity is greater than the path length variable quantity of the fixing piece；Or under the effect of same radial power, the path length of the sealing element becomes
Rate is greater than the path length change rate of the fixing piece；Or under the effect of same axial power, the sealing element is along the axial force
The displacement in direction is greater than the fixing piece along the displacement in the axial force direction.
In occluder for left auricle according to an embodiment of the present invention, the connector passes through the space that the skeleton surrounds,
One end is connect with the proximal side of the skeleton, the other end is connect in the near proximal ends of the fixing piece with the fixing piece.
In occluder for left auricle according to an embodiment of the present invention, the skeleton includes multiple elastic supporting bars, described more
A support rod is stretched out from the radiation of the proximal hub of the sealing element to be formed after the proximal side, bending to distally extending to form institute
State support circumferential surface；Or the skeleton includes multiple grids surrounded by elastic supporting bar interconnection.
It is proximally facing that at least one is additionally provided in occluder for left auricle according to an embodiment of the present invention, on the skeleton
Anchor thorn.
In occluder for left auricle according to an embodiment of the present invention, the end face that the fixing piece is connect with the connector exists
Junction is formed about recess.
There is at least one braiding in occluder for left auricle according to an embodiment of the present invention, on the cylinder of the fixing piece
Protrusion.
In occluder for left auricle according to an embodiment of the present invention, the connection between the connector and the fixing piece is
The flexible connection of adjustable angle.
In occluder for left auricle according to an embodiment of the present invention, the connector includes proximal connecting end, distal end connection
Hold and be connected to the connector between the proximal connecting end and the Distal coupling end；The proximal connecting end with it is described close
Sealing connection, the Distal coupling end are connect with the fixing piece；The Distal coupling end includes distal end ball-and-socket, the connector
Distal end include with the distal end ball-and-socket cooperation distal end bulb.
In occluder for left auricle according to an embodiment of the present invention, the connection between the connector and the sealing element is
The flexible connection of adjustable angle.
In occluder for left auricle according to an embodiment of the present invention, the connector includes proximal connecting end, distal end connection
Hold and be connected to the connector between the proximal connecting end and the Distal coupling end；The proximal connecting end with it is described close
Sealing connection, the Distal coupling end are connect with the fixing piece；The Distal coupling end includes distal end ball-and-socket, the connector
Distal end include with the distal end ball-and-socket cooperation distal end bulb, the proximal connecting end includes proximal end ball-and-socket, the connector
Proximal end include with the proximal end ball-and-socket cooperation proximal end bulb.
In occluder for left auricle according to an embodiment of the present invention, the connector is connecting rod, spring structure or metal
The fried dough twist structure that tow twists into.
In occluder for left auricle of the invention, fixing piece is braiding structure, and is had without salient point, smooth appearance, when
After fixing piece is placed on left auricle of heart corresponding position, the irregular cavity wall shape of adaptive left auricle of heart cavity depths can not only be deformed,
But also can adaptively enhance the frictional force of itself and cavity wall by the deformation, to be set to a left side for what occluder for left auricle consolidated
In auricle cavity, while no setting is required for fixing the anchor thorn of plugging device, also it is avoided that anchor thorn is pierced into relatively thin left auricle of heart cavity wall,
Hydropericardium caused by avoiding thus or even pericardial tamponade.
Detailed description of the invention
Fig. 1 is the status diagram that the occluder for left auricle that one embodiment of the invention provides is implanted into left auricle of heart.
Fig. 2 is the structural schematic diagram for the occluder for left auricle that one embodiment of the invention provides.
Fig. 3 is another schematic diagram of occluder for left auricle shown in Fig. 2, and wherein the film on sealing element is removed.
Fig. 4 be another embodiment of the present invention provides occluder for left auricle in sealing element skeleton structure schematic diagram.
Fig. 5 is the structural schematic diagram of the fixing piece in occluder for left auricle shown in Fig. 2.
Fig. 6 be another embodiment of the present invention provides occluder for left auricle in fixing piece structural schematic diagram.
Fig. 7 is the structural schematic diagram of the connector in occluder for left auricle shown in Fig. 2.
Fig. 8 is the modular construction cross-sectional view of connector shown in Fig. 7.
Fig. 9 is the test method schematic diagram of the radial deformation capabilities of the fixing piece of occluder for left auricle shown in Fig. 2.
Figure 10 is the test method schematic diagram of the radial deformation capabilities of the sealing element of occluder for left auricle shown in Fig. 2.
Figure 11 is another specific survey of sealing element/fixing piece radial deformation capabilities of occluder for left auricle shown in Fig. 2
Try structural schematic diagram.
Figure 12 is the first test method signal of the axial deformation ability of the fixing piece of occluder for left auricle shown in Fig. 2
Figure.
Figure 13 is the first test method signal of the axial deformation ability of the sealing element of occluder for left auricle shown in Fig. 2
Figure.
Figure 14 is second of test method signal of the axial deformation ability of the fixing piece of occluder for left auricle shown in Fig. 2
Figure.
Figure 15 is second of test method signal of the axial deformation ability of the sealing element of occluder for left auricle shown in Fig. 2
Figure.
Specific embodiment
In order to clearly describe the structure of occluder for left auricle, the present invention limits term " distal end " and " proximal end ", on
State the common terminology that term is interventional medical device field.Specifically, " distal end " indicates separate operator in surgical procedure
One end, " proximal end " indicate one end that proximal operator is depended in surgical procedure.
Fig. 1 show occluder for left auricle according to an embodiment of the present invention implantation left auricle of heart after schematic diagram, left auricle of heart 2
In in atrium sinistrum 1.Occluder for left auricle includes sealing element 21, the fixing piece 22 positioned at 21 distal end side of sealing element and connection
The connector 23 of sealing element 21 and fixing piece 22.
With reference to Fig. 2 and Fig. 3, fixing piece 22 is silk braiding structure and smooth in appearance, such as can be the braiding of cylindricality silk
Structure is placed in left auricle of heart 2 and is bonded with the cavity wall 3 of left auricle of heart 2.Fixing piece 22 has elasticity, can deform when by external force.When solid
Determine after part 22 is placed on 2 corresponding position of left auricle of heart, the extrusion deformation of the cavity wall 3 by left auricle of heart 2 and cavity wall 3 generate frictional force
And then effectively fitting is formed, ensure the firm of occluder for left auricle.It, can be by fixing piece 22 due to 22 smooth in appearance of fixing piece
It is placed at the deep place of left auricle of heart 2 and does not have to the cavity wall 3 for worrying that left auricle of heart 2 can be punctured, while the deformability of fixing piece 22
It can also adapt to each position and the various shape of left auricle of heart 2.
As shown in Figures 2 and 3, sealing element 21 includes skeleton 215 and the overlay film 212 being incorporated on skeleton 215.Skeleton 215
Corresponding shape can be cut by metal (preferably niti material) pipe, using heat-treating profiled, formation frame structure.Skeleton
The 215 support circumferential surfaces for including proximal side in natural unfolded state and connecting with the proximal side and extending to distal end.Implantation
Afterwards, which is located at left auricle of heart oral area and blocks left auricle of heart oral area, and support circumferential surface is located at left auricle of heart cavity inner close fitting cavity wall,
And it is fixed in left auricle of heart cavity by radial support power.
Skeleton 215 includes conveying connecting pin 211 and multiple support rods 218.The proximal end of each support rod 218 and conveying connect
End 211 connection, multiple support rods 218 from conveying connecting pin 211 (i.e. proximal hub) radiation stretch out form proximal side, bending after
To support circumferential surface is distally extended to form, the fixing piece 22 that is distally-oriented to of each support rod 218 extends to form end 217.The company
Fitting 23 passes through the space that the support rod 218 surrounds and connect with conveying connecting pin 211.
Anchor thorn 213 is also formed on support rod 218, anchor thorn 213 can be proximally facing.The anchor thorn 213 is used to be pierced into the left heart
In the cavity wall 3 of ear 2, to assist fixing seals 21.It is appreciated that due to fixing piece 22 using silk braiding structure already with the left heart
The cavity wall 3 of ear 2 forms firm fitting, therefore the anchor thorn 213 on support rod 218 can also save in some embodiments, keep away
Exempt to puncture any of cavity wall 3 of left auricle of heart 2.
End 217 is in open namely end 217 by forming the rod-shaped of each separation after cuts in metallic pipe.Other
In some embodiments, as shown in Figure 4, different shapes can also be presented in skeleton 2151.Compared with skeleton 215 shown in Fig. 3, bone
Frame 2151 also has conveying connecting pin 2111, support rod 2181, anchor thorn 2131, the difference is that, the end of support rod 2181
2171 be in closed, that is, the end 2171 of at least two support rods 2181 is joined together to form the loop of closure.It sets in this way
The end 2171 set, while keeping the relative independentability of support rod 2181, it is possible to reduce puncture the cavity wall 3 of left auricle of heart 2
Risk.
It is equipped with screw thread in the proximal lateral of conveying connecting pin 211, in order to connect with conveyer.It conveys on connecting pin 211
Screw thread can be formed by way of cutting or etching, can also be by welding a spiral shell in the proximal lateral of conveying connecting pin 211
Mother realizes.The distal side of conveying connecting pin 211 with connector 23 for connecting.
Overlay film 212 be polymeric membrane, with a thickness of 0.01~1mm, material is preferably PET, can also be used PET or PTFE or
Silica gel material or other biocompatibilities and physical property reach the thin-film material of requirement.Overlay film 212 passes through anchor thorn 213 and suture
The mode of cooperation is fixed on the outer surface of the skeleton 215 of flexible approximate sphericity.When occluder for left auricle is implanted into left auricle of heart
Afterwards, the cavity wall 3 of 213 insertion left auricle of heart 2 of anchor thorn, overlay film 212 constitute the outer surface that sealing element 21 is contacted with the cavity wall 3 of left auricle of heart 2.
Support with reference to Fig. 1, Fig. 2 and Fig. 3, when sealing element 21 is placed on the oral area of left auricle of heart 2, on skeleton 215
Bar 218 can adapt to the irregular shape of the inner cavity of left auricle of heart 2, preferably be bonded with the cavity wall 3 of left auricle of heart 2, and overlay film 212 combines solid
It is scheduled on the oral area for playing the role of sealing left auricle of heart 2 on skeleton 215, the blood 9 in atrium sinistrum 1 is prevented to flow into left auricle of heart 2, and
Anti- tampon flows into atrium sinistrum from left auricle of heart cavity.
As shown in Figure 5, fixing piece 22 forms knitted body by metal wire knitted.In some embodiments, fixing piece 22 by
16~144, preferably 36~72 pass through heat after wire (preferably niti material) braiding that string diameter is 0.01~0.8mm again
Processing molding.Fixing piece 22 after molding is column under natural unfolded state.Fixing piece 22 has elasticity, by outer
It can be deformed when power.
There are two end faces for the tool of fixing piece 22.Fixing piece 22 is in two settable end caps in endface, and fixing piece 22 is by wire
The knitted body being knitted to form is received and is fixed by end cap two endfaces, and the mode that welding specifically can be used is fixed.In Fig. 5
Proximal end cap 222 is only shown.This proximal end cap 222 is connect with connector 23.
The end face that fixing piece 22 is connect with connector 23 is formed about recess 223 in junction.End face setting recess 223,
It is beneficial to length deformation and angular distortion of the fixing piece 22 under the traction action of connector 23, while being ensured in deformation process
The overall profile pattern of fixing piece 22 is not influenced by the traction action.
In other some embodiments, as shown in fig. 6, it is convex also at least one can be arranged on the cylinder of fixing piece 22
It rises, such as can be annular protrusion 221.The quantity of annular protrusion 221 can be for one or more than one, can increase fixation
The contact area and support force of the cavity wall 3 of part 22 and left auricle of heart 2 increase frictional force between the two, promote occluder for left auricle
Firm performance.
As shown in Figure 7 and Figure 8, connector 23 includes proximal connecting end 231, Distal coupling end 235 and is connected to proximal end
Connecting rod 232 between connecting pin 231 and Distal coupling end 235.
The proximal connecting end 231 is connect with sealing element 21.Specifically, the conveying of proximal connecting end 231 and sealing element 21
The distal side of connecting pin 211 connects, and can be connected by welding or being interference fitted the modes such as crimping.
The connecting rod 232 extends from proximal connecting end 231, is pierced by the space surrounded by the support rod 218 of sealing element 21,
It is connect again with Distal coupling end 235.Connecting rod 232 is the lesser metal bar of outer diameter, and diameter is 0.1~5mm, with higher strong
Degree and elasticity can be bent with 0~180 ° of any angle.
The Distal coupling end 235 is connect with fixing piece 22, and the Distal coupling end 235 includes mutually matched bulb knot
Structure 233 and socket arrangement 234.Ball head structure 233 is connect with connecting rod 232, in some embodiments, ball head structure 233 with connect
Bar 232 is integrally formed, and ball head structure 233 is spherical in shape, and diameter is bigger than the diameter of connecting rod 232.Socket arrangement 234 and fixing piece 22
Proximal end cap 222 connect, such as can be connected by way of welding or being interference fitted crimping.
Ball head structure 233 and socket arrangement 234 can be with 360 ° of activities.When the occluder for left auricle is implanted in left auricle of heart 2
When, connector 23 can be bent with the shape of left auricle of heart 2, different in left auricle of heart 2 to adapt to sealing element 21 and fixing piece 22
The positioning requirements of axis, as shown in Figure 1.
Connecting rod 232 on connector 23 can be made the fried dough twist structure twisted by being no less than 1 one metal wire, for meeting
Left auricle of heart anatomical structure compensates the various angle requirements of occluder for left auricle.Connecting rod 232 also can be made spring structure, use
Compensation is required to the length and angle of occluder for left auricle in meeting bending biggish left auricle of heart anatomical structure.
The connection adjustable angle and fixing piece 22 of connecting rod 232 and fixing piece 22 are under the traction action of connecting rod 232
Energy length deformation and angular distortion, therefore the occluder for left auricle is applicable to the left auricle of heart cavity of different morphologies, it is especially curved
The biggish cavity of dog-ear degree, fixing piece 22 can be deep into cavity depths without generating damage to cavity at this time, also assure simultaneously
Sealing element 21 can effectively seal left auricle of heart in the opening portion of cavity.
Further, the radial deformation capabilities of the sealing element 21 of above-mentioned occluder for left auricle are greater than the radial of fixing piece 22 and become
Shape ability and/or the axial deformation ability of sealing element 21 are greater than the axial deformation ability of fixing piece 22.Specifically, in identical diameter
To under power effect, the path length variable quantity of sealing element 21 is greater than the path length variable quantity of fixing piece 22；Or it is acted in same radial power
Under, the path length change rate of sealing element 21 is greater than the path length change rate of fixing piece 22；Or under the effect of same axial power, sealing element
21 displacement along axial force direction is greater than fixing piece along the displacement in axial force direction.
The path length situation of change of flat band method difference test fixture and sealing element under the effect of same radial power can be used.Example
Such as, referring to Fig. 9 and 10, flat band method can be used and test above-mentioned occluder for left auricle.
Referring to Fig. 9, firstly, passing through two pieces of 61 Hes of parallel flat under the premise of sealing element 21 keeps free unfolded state
62 pairs of fixing pieces 22 apply radial forces F.Specifically, it is put respectively in the opposite sides of a diameter of fixing piece 22 parallel flat
Plate 61 and 62 applies the opposite radial forces F of the size same direction along the diameter respectively on plate 61 and 62；Above-mentioned fixation
The diameter of part 22 is through and perpendicular to central axes 140；Two pieces of parallel flats 61 and 62 keep putting down each other in entire test process
Row state, i.e., it is parallel with central axes 140 always in test process；Any plate at least covers the maximum radial wheel of fixing piece 22
At exterior feature, entire fixing piece 22 can be preferably covered on the direction for being parallel to central axes 140.If fixing piece 22 under natural unfolded state
Load plate at a length of R1 of diameter, then under the action of radial force F fixing piece 22 path length variable quantity be radial compression before and after
Path length difference can indicate that path length change rate is △ R1/R1 with △ R1.During applying in order to ensure radial force, plate itself is not
Deformation, so that radial force can apply in plate uniform throughout, the thickness of plate is at least 5mm.
Referring to Figure 10, sealing element 21 is tested using above-mentioned same plate test method, that is, uses identical diameter
It is identical respectively to directed force F, including directed force F size, direction, action time, before fixing piece 22 is in nature expansion
It puts, tests the path length variable quantity △ R2 or path length change rate △ R2/R2 of sealing element 21, at this time the maximum radial of sealing element 21
It is located at it at profile and supports circumferential surface.Based on above-mentioned test condition, under the effect of identical radial force, according to an embodiment of the present invention
The path length variable quantity △ R2 of the sealing element 21 of occluder for left auricle is greater than the path length variable quantity △ R1 of fixing piece 22；Alternatively, foundation
The path length that the path length change rate △ R2/R2 of the sealing element 21 of the occluder for left auricle of the embodiment of the present invention is greater than fixing piece 22 changes
Rate △ R1/R1.
After occluder for left auricle is implanted into human body, it is possible that implantation position selects inappropriate situation, such as fixed
Part may be because excessively going deep into left auricle of heart cavity, so that the natural expansion axial length of plugging device be caused to be less than the fixing piece after implantation
With the relative distance of sealing element so that mutual traction action occurs between fixing piece and sealing element；Alternatively, plugging device is after the implantation
It will be moved together with heart, because of the difference in motion amplitude or direction everywhere, it is also possible to so that being sent out between fixing piece and sealing element
Raw mutual traction action, in general, mutually being pulled between fixing piece and sealing element by connector.
When drawing of the fixing piece by sealing element, because fixing piece passes through the radial branch of the circumferential zones around central axes 140
Support force is fixed in left auricle of heart cavity, therefore mainly resists this lead for the circumferential zones of left auricle of heart cavity are close to by fixing piece
Active force is drawn, in this way, the axial drawing for fixing piece will cause its radial deformation, if traction action is sufficiently large, it would be possible to make
It is detached from fixing piece and left auricle of heart cavity wall, so that occluder for left auricle falls off, implantation is caused to fail.Sealing element and fixing piece
It is similar, be fixed in left auricle of heart cavity by the radial support power of the circumferential zones around central axes 140, therefore when sealing element by
When the drawing of fixing piece, the circumferential zones that sealing element is close to left auricle of heart cavity will resist this traction action power, cause its radial direction
Deformation.
As a result, when fixing piece and sealing element pull each other, a side of easily radial deformation will be dominated by another party in the two
Drawing, for example, the path length variable quantity of fixing piece according to an embodiment of the present invention is less than sealing element under identical radial forces
Path length variable quantity, or fixing piece according to an embodiment of the present invention path length change rate be less than sealing element path length change rate,
Then during mutual drawing, leading drawing sealing element is made sealing element towards fixing piece direction (or towards remote by fixing piece
End) deformation.Fixing piece dominates drawing and is not easy to be pulled by sealing element to be detached from left auricle of heart cavity wall, and plugging device is made preferably to be fixed on a left side
In auricle, plugging device is avoided to fall off from left auricle of heart.
Above-mentioned plate test method is only a kind of example test method, is not limitation of the present invention, this field
Any suitable method progress and the equivalent test of plate test method can be used in those of ordinary skill, for example, can also be to be measured
Uniformly apply radial forces in the circumferential direction of component to be tested.Specifically, referring to Figure 11, can the parts to be tested (fixing piece or
Sealing element) maximum radial profile at same circumferential direction on be evenly arranged three arc panels 63, in above-mentioned arc panel 63 in test
It is upper radially to apply radial forces F, and the variable quantity or change rate of the path length R of test component simultaneously.Similarly, in order to realize
The uniform application of radial force, the thickness of settable arc panel are at least 5mm.In addition, Machine Solution can also be used
The radial support force tester of Inc (MSI) company RX550-100 model tests occluder for left auricle.
In addition, can the parts to be tested (fixing piece or sealing element) it is a part of restrained under conditions of, by same axis
Axial direction (along 140 direction of the central axes) displacement of lower test component is acted on to power to characterize the axial deformation ability of the component.?
In the first axial deformation aptitude tests method, above-mentioned to be constrained to equidimension constraint, i.e., the parts to be tested is not sent out during constraint
Raw elastic deformation or amount of elastic deformation are very small, substantially negligible；In addition, selection the parts to be tested do not occur it is elastically-deformable
Apply axial force at position.For example, can identical axial direction be applied in the one end that the parts to be tested is connected with connector respectively
Active force, the axial displacement of test component characterize its respective deformability, and herein the axial displacement of component is and applies
Axial displacement at force, the axial displacement that occluder for left auricle meets fixing piece are less than the axial displacement of sealing element.
In test independent test is carried out to fixing piece and sealing element respectively, such as only tests single fixing piece or single sealing element every time.
Referring to Figure 12, test during fixed frame 22, using marmon clamp gripping member 71 fixed frame 22 maximum radial profile
Place circumferentially grips frame 22, and the marmon clamp gripping member 71 is around central axes 140 and perpendicular to central axes 140, in clamping process, Gu
The radial dimension for determining the holding position of frame 22 remains essentially as size under nature unfolded state, and elastic deformation can be ignored substantially；?
The proximal end cap 222 that fixed frame 22 is connected with connector applies axial action along central axes 140 and towards the direction of sealing element 21
Elastic deformation does not occur during applying axial force F1 for power F1, the proximal end cap 222, and measurement proximal end cap 222 exists
On central axes 140 projection O1 with F1 axial displacement △ O1, using the △ O1 characterization fixed frame 22 deflection (or deformation
Ability), in the entire loading procedure of axial force F1, the clamp position of clamping piece 71 itself is remained unchanged.
From the above, it can be seen that occluder for left auricle implantation human body after, fixed frame under conditions of a part is clamped,
Such as fixed frame 22 is clamped at largest contours, axial displacement quantitative response under the effect of the axial tension that measures this fix
Frame is after being implanted into left auricle of heart cavity, by the axial deformation ability of seal disc drawing under the constraint effect of left auricle of heart cavity.It is identical
Under axial tension, △ O1 is bigger, then shows that fixed frame is more easy to be pulled deformation.
Referring to Figure 13, test during sealing element 21, using marmon clamp gripping member 71 sealing element 21 maximum radial profile
Place's circumferentially grip seal part 21, the marmon clamp gripping member 71 are close in clamping process around central axes 140 and perpendicular to central axes 140
The radial dimension of the holding position of sealing 21 remains essentially as the size under nature unfolded state, and elastic deformation can be ignored substantially；?
The conveying connecting pin 211 that sealing element 21 is connected with connector applies axial make along central axes 140 and towards the direction of fixing piece 22
Elastic deformation, measurement conveying connecting pin do not occur during applying axial force F1 for firmly F1, the conveying connecting pin 211
The 211 projection O2 on central axes 140 characterizes the deflection of the sealing element 21 using the △ O2 with the axial displacement △ O2 of F1
(or deformability), in the entire loading procedure of axial force F1, the clamp position of clamping piece 71 itself is remained unchanged.
From the above, it can be seen that occluder for left auricle implantation human body after, sealing element under conditions of a part is clamped,
Such as sealing element 21 is clamped at largest contours, the sealing of axial displacement quantitative response under the effect of the axial tension that measures
Part is after being implanted into left auricle of heart cavity, the axial deformation ability of fixture drawing under the constraint effect of left auricle of heart cavity.It is identical
Under axial tension, △ O2 is bigger, then shows that sealing element is more easy to be pulled deformation.
It measures under the effect of same axial power, the axial displacement △ O1 of fixing piece is less than the axial displacement △ of sealing element
O2.It is appreciated that the biggish side of axial displacement will be by another party master in the two when fixing piece and sealing element pull each other
Drawing is led, for example, the axial displacement of fixing piece according to an embodiment of the present invention is greater than sealing under identical axial force
The axial displacement of part, then during mutual drawing, leading drawing sealing element is kept sealing element direction fixed by fixing piece
Part direction (or towards distally) deformation.Fixing piece dominates drawing and is not easy to be pulled by sealing element to be detached from left auricle of heart cavity wall, makes to block
Device is preferably fixed in left auricle of heart, and plugging device is avoided to fall off from left auricle of heart.
Second of axial deformation aptitude tests method also can be used, referring to Figure 14, during test fixture 22, using ring
Clevis gripping member 76 circumferentially grips part 22 at the maximum radial profile of fixing piece 22, and the marmon clamp gripping member is around central axes
140 and perpendicular to central axes 140, in clamping process, the radial dimension of the holding position of fixing piece 22 is less than under nature unfolded state
Size, fixing piece 22 is radially compressed in holding position, such as the maximum path length before a length of compression of compressed maximum diameter
80%, certainly, other compression factors can also be used, will not enumerate herein.For example, diameter can be applied in marmon clamp gripping member 76
To power F0, radial compression fixing piece 22.In the proximal end cap 222 that fixing piece 22 is connected with connector, along central axes 140 and direction
The direction of sealing element 21 applies axial force F2, which does not occur during applying axial force F2
Elastic deformation measures projection O3 of the proximal end cap 222 on central axes 140 with the axial displacement △ O3 of F2, using the △ O3
Characterize the deflection (or deformability) of fixing piece 22 in the test method.
From the above, it can be seen that fixing piece 22 is in a part of condition being clamped after occluder for left auricle implantation human body
Under, such as fixing piece 22 is clamped at largest contours, the lower axial displacement quantitative response of the axial tension effect measured this
Fixing piece 22 is after being implanted into left auricle of heart cavity, the deformability that is pulled by sealing element 21 under the constraint effect of left auricle of heart cavity.
Under same axial pulling force, △ O3 is bigger, then shows that fixing piece 22 is more easy to be pulled deformation.
Referring to Figure 15, test during sealing element 21, using marmon clamp gripping member 76 sealing element 21 maximum radial profile
Place's circumferentially grip seal part 21, the marmon clamp gripping member is around central axes 140 and perpendicular to central axes 140, in clamping process, sealing
The radial dimension of the holding position of part 21 is less than the size under nature unfolded state, and sealing element 21 is radially compressed in holding position, example
80% of maximum path length before such as a length of compression of compressed maximum diameter, certainly, can also be used other compression factors, herein
It will not enumerate.For example, radial force F0, radial compression sealing element 21 can be applied in marmon clamp gripping member 76.Sealing element 21 with
The connected conveying connecting pin 211 of connector applies axial force F2 along central axes 140 and towards the direction of fixing piece 22, should
Elastic deformation does not occur during applying axial force F2 for conveying connecting pin 211, and measurement conveying connecting pin 211 is in axis
Projection O4 on line 140 characterizes the deformation of sealing element 21 in the test method using the △ O4 with the axial displacement △ O4 of F2
It measures (or deformability).
From the above, it can be seen that sealing element 21 is in a part of condition being clamped after occluder for left auricle implantation human body
Under, such as sealing element 21 is clamped at largest contours, the lower axial displacement quantitative response of the axial tension effect measured this
Sealing element 21 is after being implanted into left auricle of heart cavity, the deformability that is pulled by sealing element 21 under the constraint effect of left auricle of heart cavity.
Under same axial pulling force, △ O4 is bigger, then shows that sealing element 21 is more easy to be pulled deformation.
It measures under the action of same axial power (F2), the axial displacement △ O3 of fixing piece is less than the axial position of sealing element
Shifting amount △ O4.It is appreciated that the biggish side of axial displacement will be another in the two when fixing piece and sealing element pull each other
The leading drawing of one side, for example, the axial displacement of fixing piece according to an embodiment of the present invention is small under identical axial force
In the axial displacement of sealing element, then during mutual drawing, fixing piece dominates drawing and is not easy to be pulled by sealing element
It is detached from left auricle of heart cavity wall, plugging device is fixed on preferably in left auricle of heart, plugging device is avoided to fall off from left auricle of heart.
Referring to Fig. 1-3, for above-mentioned occluder for left auricle under natural unfolded state, at least part of connector is extended
The space that support rod in sealing element is enclosed；At this point, the support rod that the remaining part of connector can be located in sealing element encloses
It closes within the space formed.In this way, a part of connector protrudes into the space that sealing element is enclosed, can reduce fixing piece with it is close
The distance between sealing (it is long to can be described as waist), while a part of connector is stretched out the space that sealing element is enclosed and be can avoid admittedly
Determine part and sealing element to influence each other because distance is too small, such as can avoid fixing piece and entwine with sealing element.
Fixing piece of the invention is braiding structure, and is had without salient point, smooth appearance, when fixing piece is placed on the left heart
Behind ear corresponding position, the irregular cavity wall shape of adaptive left auricle of heart cavity depths can not only be deformed, but also the change can be passed through
Shape adaptively enhances the frictional force of itself and cavity wall, to be set to what occluder for left auricle consolidated in left auricle of heart cavity, simultaneously
No setting is required for fixing the anchor thorn of plugging device, also it is avoided that anchor thorn is pierced into relatively thin left auricle of heart cavity wall, caused by avoiding thus
Hydropericardium or even pericardial tamponade.
Each technical characteristic of embodiment described above can be combined arbitrarily, for simplicity of description, not to above-mentioned reality
It applies all possible combination of each technical characteristic in example to be all described, as long as however, the combination of these technical characteristics is not deposited
In contradiction, all should be considered as described in this specification.
The embodiments described above only express several embodiments of the present invention, and the description thereof is more specific and detailed, but simultaneously
It cannot therefore be construed as limiting the scope of the patent.It should be pointed out that coming for those of ordinary skill in the art
It says, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to protection of the invention
Range.Therefore, the scope of protection of the patent of the invention shall be subject to the appended claims.
Claims (12)
1. a kind of occluder for left auricle, including described in sealing element, the fixing piece positioned at sealing element distal end side and connection
The connector of sealing element and the fixing piece；It is characterized in that, the sealing element includes skeleton and is arranged on the skeleton
Overlay film, the skeleton include proximal side and connect with the proximal side and to distal end extend support circumferential surface, it is described
Overlay film at least covers the proximal side；The fixing piece is cylindricality silk braiding structure, and the connector is flexible connector, institute
The radial deformation capabilities for stating sealing element are greater than the radial deformation capabilities of the fixing piece and/or the axial deformation energy of the sealing element
Power is greater than the axial deformation ability of the fixing piece.
2. occluder for left auricle according to claim 1, which is characterized in that under the effect of same radial power, the sealing
The path length variable quantity of part is greater than the path length variable quantity of the fixing piece；Or under the effect of same radial power, the sealing element
Path length change rate is greater than the path length change rate of the fixing piece；Or under the effect of same axial power, the sealing element is described in
The displacement in axial force direction is greater than the fixing piece along the displacement in the axial force direction.
3. occluder for left auricle according to claim 1 or 2, which is characterized in that the connector passes through the skeleton enclosure
At space, one end connect with the proximal side of the skeleton, near proximal ends and the fixation of the other end in the fixing piece
Part connection.
4. occluder for left auricle according to claim 1 or 2, which is characterized in that the skeleton includes multiple resilient support
Bar, the multiple support rod is stretched out from the radiation of the proximal hub of the sealing element forms Xiang Yuanduan after the proximal side, bending
Extend to form the support circumferential surface；Or the skeleton includes multiple grids surrounded by elastic supporting bar interconnection.
5. occluder for left auricle according to claim 1 or 2, which is characterized in that be additionally provided at least one on the skeleton
Proximally facing anchor thorn.
6. occluder for left auricle according to claim 1 or 2, which is characterized in that the fixing piece and the connector connect
The end face connect is formed about recess in junction.
7. occluder for left auricle according to claim 1 or 2, which is characterized in that have extremely on the cylinder of the fixing piece
Few braiding protrusion.
8. occluder for left auricle according to claim 1 or 2, which is characterized in that the connector and the fixing piece it
Between connection be adjustable angle flexible connection.
9. occluder for left auricle according to claim 8, which is characterized in that the connector includes proximal connecting end, remote
End connecting pin and the connector being connected between the proximal connecting end and the Distal coupling end；The proximal connecting end with
The sealing element connection, the Distal coupling end are connect with the fixing piece；The Distal coupling end includes distal end ball-and-socket, described
The distal end of connector includes the distal end bulb with distal end ball-and-socket cooperation.
10. occluder for left auricle according to claim 8, which is characterized in that between the connector and the sealing element
Connection be adjustable angle flexible connection.
11. occluder for left auricle according to claim 10, which is characterized in that the connector include proximal connecting end,
Distal coupling end and the connector being connected between the proximal connecting end and the Distal coupling end；The proximal connecting end
It is connect with the sealing element, the Distal coupling end is connect with the fixing piece；The Distal coupling end includes distal end ball-and-socket, institute
The distal end for stating connector includes the distal end bulb cooperated with the distal end ball-and-socket, and the proximal connecting end includes proximal end ball-and-socket, institute
The proximal end for stating connector includes the proximal end bulb cooperated with the proximal end ball-and-socket.
12. occluder for left auricle according to claim 1 or 2, which is characterized in that the connector is connecting rod, spring
The fried dough twist structure that structure or wire bundle twist into.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511033726.6A CN106923885B (en) | 2015-12-31 | 2015-12-31 | Occluder for left auricle |
| PCT/CN2016/086116 WO2017113632A1 (en) | 2015-12-31 | 2016-06-17 | Left atrial appendage occluder |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511033726.6A CN106923885B (en) | 2015-12-31 | 2015-12-31 | Occluder for left auricle |
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| Publication Number | Publication Date |
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| CN106923885A CN106923885A (en) | 2017-07-07 |
| CN106923885B true CN106923885B (en) | 2019-07-09 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201511033726.6A Active CN106923885B (en) | 2015-12-31 | 2015-12-31 | Occluder for left auricle |
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| Country | Link |
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| CN (1) | CN106923885B (en) |
| WO (1) | WO2017113632A1 (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20190183512A1 (en) * | 2017-11-17 | 2019-06-20 | Raj Subramaniam | System and method for left atrial appendage closure |
| CN108567461A (en) * | 2018-03-13 | 2018-09-25 | 刘金伟 | A kind of Asymmetric bidiscoidal left atrial appendage occlusion device |
| CN110974316B (en) * | 2019-11-19 | 2021-06-04 | 先健科技(深圳)有限公司 | Plugging device |
| CN112674829B (en) * | 2020-12-22 | 2022-03-18 | 南京吉米医疗科技有限公司 | Left auricle plugging device and plugging method thereof |
| EP4374796A1 (en) * | 2021-07-22 | 2024-05-29 | Lifetech Scientific (Shenzhen) Co., Ltd. | Medical device |
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| WO2000051500A9 (en) * | 1999-03-05 | 2002-03-14 | Univ Texas | Occlusion apparatus |
| CN102805654A (en) * | 2011-06-01 | 2012-12-05 | 先健科技(深圳)有限公司 | Occluder for left auricle |
| CN103607962A (en) * | 2011-06-17 | 2014-02-26 | Aga医药有限公司 | Occlusion device and associated deployment method |
| CN104958087A (en) * | 2015-07-28 | 2015-10-07 | 杭州德诺科技有限公司 | A left auricle occluding device |
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|---|---|---|---|---|
| US7044134B2 (en) * | 1999-11-08 | 2006-05-16 | Ev3 Sunnyvale, Inc | Method of implanting a device in the left atrial appendage |
| US8591543B2 (en) * | 2011-04-28 | 2013-11-26 | Cardiotulip Llc | Devices and methods for closure of a patent foramen ovale |
| US10675012B2 (en) * | 2012-11-16 | 2020-06-09 | W. L. Gore & Associates, Inc. | Joint assembly for medical devices |
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2015
- 2015-12-31 CN CN201511033726.6A patent/CN106923885B/en active Active
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2016
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000051500A9 (en) * | 1999-03-05 | 2002-03-14 | Univ Texas | Occlusion apparatus |
| CN102805654A (en) * | 2011-06-01 | 2012-12-05 | 先健科技(深圳)有限公司 | Occluder for left auricle |
| CN103607962A (en) * | 2011-06-17 | 2014-02-26 | Aga医药有限公司 | Occlusion device and associated deployment method |
| CN104958087A (en) * | 2015-07-28 | 2015-10-07 | 杭州德诺科技有限公司 | A left auricle occluding device |
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| CN106923885A (en) | 2017-07-07 |
| WO2017113632A1 (en) | 2017-07-06 |
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