Recyclable thrombus filter
Technical field
The present invention relates to one kind filtering thrombus effect is good, positioning is repeated, fixing-stable, can extend Implantation Time can
Reclaim thrombus filter.
Background technology
At present, Deep vain thrombosis (deep venous thrombosis, DVT) and pulmonary thromboembolism (pulmonary
Thromboembolism, PE) the incidence of disease increase day by day.As the complication of DVT most serious, PE has very high hair
Sick rate and fatal rate.Shown according to epidemiology survey in recent years, the only PE in U.S. year number of the infected is 750,000~900,000
People, year, lethal number was 120,000~150,000.Pulmonary thromboembolism does not only have the high incidence of disease and fatal rate, and onset is hurried,
Progress is rapid, and general pulmonary thromboembolism patient, which dies from, to fall ill in initial one hour, and pulmonary thromboembolism also results in chronic pulmonary
High pressure, has a strong impact on the quality of life of patient.
Lower limb DVT is to cause PE main reason, and document report shows that about 60%~70% lower limb DVT patient can send out
Raw pulmonary thromboembolism.Research is it is also shown that 90%~95% pulmonary thrombosis embolus derives from lower limb DVT.General small blood
Bolt embolus is difficult to cause pulmonary thromboembolism, only when Thromboembolus diameter is more than 7.5mm, can just Acute Pulmonary Embolism is endangered
Machine life.
Due to PE high incidence, high fatal rate and high disability rate, the concurrent PE of DVT how are prevented increasingly to be weighed by scholar
Depending on.Generally acknowledged effective precautionary measures include strict bed rest, the anticoagulant therapy of system and the placement vena cave filter of DVT acute stages at present
Device (vena cava filter, VCF).The anticoagulant therapy of system is considered as to treat the main side that DVT and prevention PE occur
Method, including treatment by Low molecule heparin and subsequent oral warfarin treatment.
But regular, system anticoagulant therapy is nor be perfectly safe and effectively.First, research shows, strict
Anticoagulant therapy under, PE can occur again for the patient for still having up to 33%.Secondly, many DVT and/or PE cases are controlled for anti-freezing
Treatment taboo (including:There are the wound or operation medical history person, have hemorrhagic apoplexy person, nervous centralis of height hemorrhage risk in the recent period
System tumor patient and have patient of hemorrhagic tendency and coagulation disorders etc.).Even if further, eliminating these high-risk bleedings
Patient, still have the incidence of 0.9%~7.9% severe haemorrhage complication during regular anticoagulant therapy.In addition, though
LMWHs can apply to the women of gestation, but during oral neodicoumarin anticoagulant therapy, medicine can by placenta shadow
Ring the development of fetus.In these cases, placing VCF in inferior caval vein by interventional method just turns into uniquely arranging for prevention PE
Apply.
External large case retrospective analysis shows that PE can effectively be prevented by placing VCF, make DVT patient PE incidence
Drop to 0.9%~6% by 60%~70%, and lethal PE incidence is reduced to 0.7%~4%.VCF prevents PE curative effects
Definitely, operation wound is small, simple to operate, complication is less, the method that the prevention PE of first choice is had been considered as at present.
VCF is a kind of with the apparatus of metal wire knitted or block of metal through laser engraving, is filled by special conveying
Put into inferior caval vein, form netted safeguard structure and stop thrombus larger in blood flow.These larger thrombus often also most hold
Easily cause mortality PE.VCF is in itself to lower limb DVT without any therapeutic action, and significance of which is the larger bolt for preventing to come off
Son blocks pulmonary artery and occurs PE.
VCF develops into today, experienced the first generation permanent VCF and second generation VCF.First generation VCF is permanent VCF.
Filter once insert cannot adjustment position, can not take out.Permanent VCF lay for a long time brought safety issue by
Gradually cause concern, focus of attention concentrates on the displacement of filter, recurrent PE and inferior vena cava obstruction etc..Decousus is ground at random
Study carefully discovery, filter is inserted rear PE in the recent period and reduced, but Deep vain thrombosis sends out PE situation showed increased again in 2 years,
Being long placed at filter has thrombotic danger;If can not melt thrombus at filter, recent filter reduction PE effect will gradually
It is cancelled.Obergassel etc. summarizes 26 documents totally 2646 permanent VCF of use patient, penetrates blood vessel up to 0~41%,
Displacement is up to 0~26%, and thrombus occlusion is up to 0~30%, and observing time is longer, and complication is higher.There is invention CN101147705 to adopt
Improve the performance on Nitinol surface with ceramic membrane, improve the biocompatibility of metal, promote endothelial cell quickly to climb attached, to drop
Low its lures the formation of thrombus into.But permanent filter may cause patient to take anticoagulant all the life and trigger other complication.
Therefore, the mid-80 has started recyclable VCF experimental study.
Second generation VCF includes recoverable version VCF and temporary VCF.The latter still lies in the conduit of percutaneous puncture after inserting
Or on seal wire, take out after a certain time, the taking-up of filter is more convenient, but it has the disadvantage the risk in the presence of infection, and increase is worn
Injury of vein, bleeding and thrombotic risk are pierced, makes troubles, has been rarely employed to patient's action.Recoverable version VCF can
Internal filter is reclaimed through jugular vein or femoral vein by the method for intervention using special recovery system.If the state of an illness needs
It is left in place putting as permanent VCF, without replacing.Tide over a critical period such as patient, can be reclaimed if stable disease, so as to keep away
A series of complication that Preserving time is brought are exempted from.Research shows that recoverable version VCF and permanent VCF prevent pulmonary artery bolt
The effect of plug is identical.Nadkami etc. is reported:Conventional recoverable version filter need to take out in 14 days, but Tempo filters have six
Still succeed the report taken out after week.Animal experiment proves that, filter can climb attached after inserting by vascular endothelial cell, occur endothelium
Change, this process was basically completed in 7~10 days, thus most scholars were advocated after recuperability VCF is inserted in 10 days at present
Taken out.
But in many cases, patient did not spent the critical days of DVT in 14 days.Need to place by VCF
2~3 months are extended in the blood vessels, reach that medium-long term prevents the effect of pulmonary embolism.At present, can only be permanent stagnant by filter
Stay in human body.There is invention CN103031523 and CN103007361A to point out cytotoxic copper metal being plated in VCF tables
Face, plays and delays filter surface to be climbed attached speed by vascular endothelial cell.But the heavy metal long term toxicity of metallic copper can be to people
Body produces serious adverse consequences, and lures that the secondary thrombus of filter surface is formed into, causes blood vessel blockage, and influence blood flow passes through.
It is another to there is invention CN103027763A to delay on thrombus filter surface using the polymeric coating layer of endothelial cell growth is unfavorable for
Endothelium is climbed attached.Equally, having cytotoxic polymeric coating layer, not only Human Umbilical Vein Endothelial Cells produce toxicity, while its toxicity can also be lured
The secondary thrombus of filter surface is formed, blood vessel blockage is caused, influence blood flow passes through.
In addition, the placement schematic diagram of the recyclable filter 1 largely used at present as shown in Figure 1 in the blood vessels.The filter 1 is put
Put in the inferior caval vein between renal vein and iliac vein, prevent lower limb embolus up.The lower section of the filter 1 is that grid is larger
Near-end net 2, is grid less distal end net 3 during top, and centre is connected by support bar 4.When being placed in inferior caval vein, anchor thorn 6
Blood vessel is pierced into, plays a part of grappling, support bar is close to blood vessel endothelium.There is a recovering hook below near-end net, be used for
Reclaim the filter placed temporarily.Generally in the lower section of recovering hook, a nut is welded, for being threadedly coupled push rod.The filter 1 can
As recyclable and permanent apparatus, clinically substantial amounts of case has confirmed that its is evident in efficacy simultaneously, substantially reduces the wind of pulmonary embolism
Danger.But, when making recyclable filter, it must be reclaimed being implanted into 14 days.If it exceeds 14 days, substantial amounts of endothelial tissue will
Large area covering support, resistance is big during recovery, easy injured blood vessel.The time window that filter is reclaimed is smaller, hinders recyclable filter
A large amount of reagent applications., in addition, the nut for being generally used for connecting push rod uses stainless steel material, it is welded on NiTi conjunction
In the filter tube of gold, in the presence of body fluid self-corrosion easily occurs for different materials.Corrosion product toxicity is big, is unfavorable for forever
Stay for a long time in implant.
Preferable vena cava filter must include including following characteristics:1. secondary thrombus will not be caused to be formed, had well
Biocompatibility;2. the thrombus come off can be effectively captured, but does not influence venous return;3. can be safe and reliable to be fixed on cavity of resorption quiet
Astillen, it is not easily shifted;4. filter induction system caliber is thin, and releasing mechanism is simple;5. without ferromagnetism, magnetic resonance imaging is not influenceed;
6. good mechanical stability, is unlikely to deform, is broken, falls apart;7. without severe complication;8. it can reclaim, or even can be in implantation 2~3
It is recyclable after month.With updating for filter, some filters have possessed the most of feature of the above, but to so far, it is any
It is preferable filter on a kind of filter is imponderable.These above-mentioned features can not be met simultaneously again.Therefore, comprehensive various chambers are quiet
The advantage and disadvantage of arteries and veins filter, develop a kind of filter and easily insert;Thrombus efficiency high is captured without influenceing Inferior Vena Cava Blood Flow;And filter
Device can be fixed on inferior caval vein wall safely, it is often more important that can extend the recyclable vena cava filter of Implantation Time.
The content of the invention
It is an object of the invention to provide one kind filtering thrombus effect is good, positioning is repeated, fixing-stable, implantation can be extended
The recyclable thrombus filter of time.
To achieve these goals, the technical scheme that provides of the present invention is:A kind of recyclable thrombus filter is provided, passed through
The method of intervention is positioned over the inferior caval vein position between renal vein and iliac vein, prevents from being advanced into lung on Lower Limb Thrombosis, draws
Play pulmonary embolism, it is characterised in that using two layers of screen pack design, including:Near-end net, distal end net and be connected to the near-end net and
Support bar between the net of distal end, the support bar is designed using inner concave shape, and the indent design includes female parts and is connected to
The proximal points and remote point of the upper and lower both sides of female parts, the proximal points and remote point play support close to blood vessel
Anchor thorn is provided with blood vessel function, the proximal points, fixation is played, prevents filter generation position under the washing away of blood
Move.
The recyclable thrombus filter is integrally cut by laser shaping using Nitinol pipe.
Also include recovering hook, push rod and snare, the recovering hook is connected with the recyclable thrombus filter, and set
There is the breach coordinated with the snare, the distal end of the push rod sets the snare, and the snare is sheathed on the breach,
The push rod and recovering hook are in hollow structure, and the push rod is built-in with latch lever, and the push rod penetrates described return
Hook is received, until the marginal position of the near-end net, and the snare is locked in recovering hook.
The recyclable thrombus filter surface parcel PTFE films.
Each support bar is branched into two, and is designed using inner concave shape.
Compared with prior art, in recyclable thrombus filter of the invention, support bar using inner concave shape design, by apparatus with
The face contact of blood vessel endothelium is converted into a contact, greatly reduces the contact area of apparatus and blood vessel.And then delay endothelium group
Knit the time of covering support bar.In addition, inner concave shape is designed most support bar surface, away from blood vessel surface, is further added
Big endothelial cell climbs attached difficulty.In addition, proximal points and the effect of the multi-point support of remote point, can play stable filter in blood vessel
The effect of interior form.At the same time, PTFE films can be wrapped up in metal surface, to reduce the thrombus originality of apparatus in itself, and subtracted
Slow endothelial cell climbs attached speed in equipment surfaces.Design more than, can extend the time of thrombus filter in the blood vessels
To 2~3 months, the need for meeting clinical treatment.At the same time, by the implementation of the present invention, using on recovering hook and push rod
Snare and latch lever design, it is to avoid different types of material is introduced on apparatus, it is to avoid filter occur self-corrosion and destroy
The mechanical performance and generation noxious material of apparatus so that filter of the present invention is more beneficial for extending the time window placed temporarily and use
In in Permanent implantation human body.
By following description and with reference to accompanying drawing, the present invention will become more fully apparent, and these accompanying drawings are used to explain the present invention
Embodiment.
Brief description of the drawings
Fig. 1 is the schematic diagram of one embodiment of the thrombus filter of prior art.
Fig. 2 is the schematic diagram of one embodiment of recyclable thrombus filter of the invention in the blood vessels.
Fig. 3 is the front view of recyclable thrombus filter as shown in Figure 2.
Fig. 4 is the upward view of recyclable thrombus filter as shown in Figure 2.
Fig. 5 is the top view of recyclable thrombus filter as shown in Figure 2.
The schematic diagram for first state that the recyclable thrombus filter of Fig. 6 a present invention is freed with push rod.
The schematic diagram for second state that the recyclable thrombus filter of Fig. 6 b present invention is freed with push rod.
The schematic diagram for the 3rd state that the recyclable thrombus filter of Fig. 6 c present invention is freed with push rod.
Fig. 7 is the front view of second embodiment of recyclable thrombus filter of the invention.
Fig. 8 is the upward view of recyclable thrombus filter as shown in Figure 7.
Fig. 9 is the top view of recyclable thrombus filter as shown in Figure 7.
Figure 10 is the front view of the 3rd embodiment of recyclable thrombus filter of the invention.
Figure 11 is the upward view of recyclable thrombus filter as shown in Figure 10.
Figure 12 is the top view of recyclable thrombus filter as shown in Figure 10.
Embodiment
Element numbers similar in embodiments of the invention, accompanying drawing, which are described, with reference now to accompanying drawing represents similar element.
Embodiment 1:
As shown in Fig. 2,3,4 and 5, in the present embodiment, filter 1 is integrally cut by laser shaping using Nitinol pipe, its
The Nitinol pipe used has diamagnetism, does not influence Magnetic resonance imaging.Filter is in integrally cage structure, and with pole
Good mechanical stability, is unlikely to deform, is broken and falls apart, keep its structural intergrity.As shown in Fig. 2 involved in the present invention
Recyclable thrombus filter can be positioned over the position of inferior caval vein 7 between renal vein 9 and iliac vein 8 by the method for intervention, prevent
Lung only is advanced on Lower Limb Thrombosis, causes pulmonary embolism.As shown in figure 3, using the design of two layers of screen pack, including near-end
Net 2 and distal end net 3.The support bar 4 for connecting near-end net 2 and distal end net 3 is designed using inner concave shape.Support bar 4 curves inwardly, and is formed
Female parts 11, and two contact points up and down, including proximal points 12 and remote point 10.Filter of the present invention is being placed in the blood vessels
When, the arc of proximal points 12 and remote point 10 plays a part of support blood vessels close to blood vessel.The near-end of a plurality of support bar 4
Point 12 and remote point 10 can play stable filter in the blood vessels in circumferencial direction formation multi-point support effect proximally and distally
The effect of form.Anchor thorn 6 is provided with the position of proximal points 12, anchor thorn 6 stabs blood vessel, can played fixed obliquely
Effect, prevents filter to be subjected to displacement under the washing away of blood.Inner concave shape design is thoroughly by between support bar 4 and blood vessel
Face contact is changed into a contact, greatly reduces the contact area of apparatus and blood vessel.Also endothelial tissue covering branch is delayed significantly
The time of strut 4.The most surface of support bar 4 is caused away from blood vessel surface, further to increase endothelium in addition, inner concave shape is designed
Cell climbs attached difficulty.At the same time, PTFE films can be wrapped up in metal surface, to reduce the thrombus originality of apparatus in itself, and
Slow down endothelial cell and climb attached speed in equipment surfaces.
As shown in Figure 6 a, recyclable thrombus filter recovering hook 5 of the invention is connected with push rod 15.In push rod 15
Distal end is set on the breach 51 on a snare 14,14 sets of recovering hooks 5 of snare, and push rod 15 and recovering hook 5 are hollow structure, and
The push rod 15 is built-in with latch lever 13, and latch lever 13 is penetrated in the recovering hook of filter 1 inside push rod 15 up to near-end
The marginal position of net 2, snare 14 is locked in recovering hook, causes snare to be fixed in recovering hook, be will not fall off.
As shown in Figure 6 b, when pushing, push rod 15 applies active force in the near-end of filter 1, through conduit by filter 1
It is pushed to inferior caval vein position.When reclaiming, the pulling force effect of snare 14 pulls filter 1 in conduit in recovering hook.Latch lever
13 are locked in snare 14 on the recovering hook 5 of the near-end of filter 1 so that thrombus filter and the secure connection of push rod 15, will not take off
Fall.Filter 1 can be withdrawn when the placement location of filter 1 is not good in conduit, release and place again, untill success.
As fig. 6 c, after thrombus filter is placed into correct position, latch lever 13 is dropped back, 13 pairs of circles of latch lever are released
The limitation of 14 pairs of set, snare flicks rapidly, is freed with recovering hook and depart from filter 1.
Embodiment 2:
As shown in Fig. 7, Fig. 8 and Fig. 9, the recyclable thrombus filter provided in the present embodiment in the same manner as in Example 1, is used
Nitinol pipe is integrally cut by laser shaping, and its Nitinol pipe used has diamagnetism, does not influence Magnetic resonance imaging.
Its cage structure has fabulous mechanical stability, is unlikely to deform, is broken and falls apart, and keeps its structural intergrity.This example is carried
The recyclable thrombus filter supplied can equally be positioned over the inferior caval vein 7 between renal vein 9 and iliac vein 8 by the method for intervention
Position, prevents from being advanced into lung on Lower Limb Thrombosis, causes pulmonary embolism.As shown in fig. 7, using the design of two layers of screen pack, wherein
Including near-end net 2 and distal end net 3.The support bar 4 for connecting near-end net 2 and distal end net 3 is designed using inner concave shape.The bifurcated of support bar 4
Into two, curved inwardly after opening, form female parts 11, and two contact points up and down, including proximal points 12 and remote point 10.
The angle of the bifurcated of support bar 4 and interior curved degree are different with the size of support bar branch and different according to actual material property.
When the recyclable thrombus filter that the present embodiment is provided is placed in the blood vessels, the arc of proximal points 12 and remote point 10 is close to blood vessel
Wall, plays a part of support blood vessels.The proximal points 12 and remote point 10 of a plurality of support bar 4 are in circumferencial direction shape proximally and distally
Into multi-point support effect, the form in the blood vessels of stable filter 1 can be played a part of.Anchor thorn is provided with the position of proximal points 12
6, anchor thorn 6 stabs blood vessel obliquely, can play fixed effect, prevent the generation position under the washing away of blood of filter 1
Move.Face between support bar 4 and blood vessel endothelium thoroughly is contacted to be changed into by inner concave shape design a little to be contacted, and greatly reduces apparatus and blood
The contact area of inside pipe wall.Also endothelial tissue is delayed to cover the time of support bar 4 significantly.In addition, inner concave shape, which is designed, causes big portion
The support bar surface divided is away from blood vessel surface, and further increase endothelial cell climbs attached difficulty.At the same time, can be in metal surface
PTFE films are wrapped up, attached speed is climbed in equipment surfaces to reduce the thrombus originality of apparatus in itself, and slow down endothelial cell.
Embodiment 3:
As shown in Figure 10, Figure 11 and Figure 12, on the basis of embodiment 1, a time similar with near-end is set in distal end
Hook 5 is received, two-way attachable characteristic is formed.During vena cava filter is implanted into, generally using through femoral vein or quiet through neck
Arteries and veins enters paths.In order to realize that a filter is applied to two approach requirements, in proximally and distally setting respectively for filter 1
Two recovering hooks 5, for being connected with push rod 15.Two paths of femoral vein and jugular vein can be used when also realizing and reclaiming.
Above disclosed is only the preferred embodiments of the present invention, can not limit the right of the present invention with this certainly
Scope, therefore the equivalent variations made according to scope of the present invention patent, still belong to the scope that the present invention is covered.