CN204293210U - Organize anchor system - Google Patents

Organize anchor system Download PDF

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Publication number
CN204293210U
CN204293210U CN201420385948.9U CN201420385948U CN204293210U CN 204293210 U CN204293210 U CN 204293210U CN 201420385948 U CN201420385948 U CN 201420385948U CN 204293210 U CN204293210 U CN 204293210U
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China
Prior art keywords
bobbin
component
stretch
anchor
draw
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CN201420385948.9U
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Chinese (zh)
Inventor
杰森·H·罗宾逊
史蒂文·D·卡哈拉尼
梅根·E·福尔摩斯
克里斯托弗·C·李
迈克尔·W·萨瑟兰
阿伦·M·考尔
詹姆斯·M·塞勒斯
迈克尔·R·科尔
格雷戈瑞·J·肯尼
马修·S·卡尔迪纳利
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Beijing Caditai Medical Device Technology Co ltd
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Mitralign Inc
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Priority to CN201420385948.9U priority Critical patent/CN204293210U/en
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Publication of CN204293210U publication Critical patent/CN204293210U/en
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Abstract

The utility model organizes anchor system about one, comprises tissue anchor component, and it is suitable for anchoring organizationally.This system also comprises stretch-draw component, and it may be operably coupled to anchor component, thus makes anchor component can stretch-draw member slide relatively, this stretch-draw component can be pulled to cause anchor component to move and seat by organizing.Manual operation launches conduit and can be operated to extend and therefrom launch anchor component.This expansion conduit comprises rotating parts and clutch component, and described stretch-draw component is advanced around rotating parts, and described clutch component for limiting the tension force in stretch-draw component, thus stops the anchor launched to be pulled by tissue.

Description

Organize anchor system
Technical field
The utility model relates to be organized fastening, and especially, relates to and uses manual operation apparatus fastening with organizing of carrying out of Wicresoft and transcutaneous modalities.
Background technology
Only for understanding heart 10 and the object of the specifically anatomical structure in the left side of heart 10, show atrium sinistrum (LA) 12 and left ventricle (LV) 14 with reference to Fig. 1-4.Sustainer 16 receives the oxygenated blood from left ventricle 14 by aorta petal 16, and aorta petal 16 is back to left ventricle 14 for stoping blood backflow.Bicuspid valve 20 is positioned between atrium sinistrum 12 and left ventricle 14, and makes oxygenated blood from the one-way flow of atrium sinistrum 12 to left ventricle 14.
Bicuspid valve 20, it will be described in more detail below, and comprises frontal lobe 22 and posterior lobe 24, and they are connected to valve chordae tendineae 26,28 (Fig. 4).Valve chordae tendineae 26,28 is used as " strain component ", and it stops the leaflet 22,24 of bicuspid valve 20 cross their closing point and prolapse and be back to atrium sinistrum 12.When during systole left ventricle 14 shrinks, valve chordae tendineae 26,28 limits frontal lobe and posterior lobe 22,24 crosses frontal lobe and posterior lobe 22,24 crosses and movable upward (towards the atrium sinistrum) of the point sealed, thus stops the backflow (" mitral regurgitation " or " mitral valve insufficiency ") of left ventricle 14 to atrium sinistrum 12.Valve chordae tendineae 26,28 from columnae carneae or more specifically columnae carneae muscle nipple (papillary muscle) rise.In each accompanying drawing here, be only in and know object, some anatomical features are deleted.
The frontal lobe 22 of bicuspid valve 20 and posterior lobe 24 normally thin, flexible membrane.When bicuspid valve 20 closes, frontal lobe 22 and posterior lobe 24 usually aligns along " closing line " of their free margins rollback numbers millimeter and contact with each other, thus produce and seal, and which prevent mitral regurgitation.Alternately, when bicuspid valve 20 is opened, blood flows into left ventricle 14 through the opening down of generation frontal lobe 22 and posterior lobe 24.
Relate to mitral many problems can occur and cause eurypalynous disease perhaps.These problems include but not limited to mitral regurgitation.Mitral regurgitation or leakage are not exclusively closing due to bicuspid valve 20, and blood is from left ventricle 14 adverse current to atrium sinistrum 12.That is, reveal and usually occur in frontal lobe and posterior lobe 22,24 not against time sealed against one another, which results in the gap between frontal lobe 22 and posterior lobe 24 when during systole each leaflet is considered to engage completely.
In general, be in multiple different reason, considerable constringency cleft can occur between frontal lobe 22 and posterior lobe 24.Such as, gap can due to congenital abnormality, be damaged and exist due to ischemic disease or due to heart 10 by previous heart attack.This gap also can produce when congestive heart failure, such as, and cardiomyopathy, or the illness of some other types causing heart 10 to expand.The expansion of heart 10 can cause mitral expansion (stretching).This expansion is confined to posterior annulus usually, and relates to posterior lobe 24, this is because front ring is the fibre structure of relative stiffness.When rear ring expands, it causes posterior lobe 24 to leave frontal lobe 22 to move, produce the gap during shrinking, this is because two leaflets no longer form suitable joint.Which results in blood through the leakage of valve 20 or backflow.
Blood causes heart 10 efficiency to run lower by the leakage of bicuspid valve 20 usually, this is because blood is pumped to external via sustainer 16 by heart 10, and returns (form with mitral regurgitation) to atrium sinistrum 12.By leakage or the usual mitral valve insufficiency of bicuspid valve 20, be therefore usually considered to the tendency of congestive heart failure (CHF), or the reason that heart failure runs down.Usually there is the symptom of relevant different brackets of decaying to heart.These grades are classified by New York Heart association (NYHA) Function Classification system.Even if this grade is from the class 4 substantially not having asymptomatic patient's grade 1 of being correlated with of muscle power restriction to be correlated with to the patient that cosily can not perform any physical exertion and have cardiac dysfunction symptom when rest.In general, the degree that rectification or minimizing bicuspid valve are revealed can successfully make the NYHA classification grade of patient reduce.And therefore such as, the patient with class 4 classification can make his classification be reduced to grade 3 or grade 2, in rest is or even relatively comfortable during slight physical exertion.By eliminating blood back flow to atrium sinistrum 12, the treatment reducing mitral valve insufficiency decreases the live load of heart 10, and the degeneration of common cardiac function and congestive heart failure when the mitral valve insufficiency significantly that can stop or slow down keeps not correcting.
For correct bicuspid valve reveal or more generally CHF treatment normally very invasive, open-heart surgery.In egregious cases, this can comprise the implantation of ventricular assist device, such as has the artificial heart of the patient of failure heart.The implantation of ventricular assist device is normally expensive, and the needs of patients with ventricular assist device is placed in long-term anticoagulation agent treatment.Anticoagulant treatment decreases the risk that in ventricular assist device, such as blood clotting is formed.The risk reducing the blood clotting relevant to ventricular assist device expects, but uncontrollable risk of bleeding when anticoagulant treatment can increase patient such as owing to falling down.
Do not adopt implantation ventricular assist device, the double-ventricle pacemaker device being similar to pacemaker can be implanted in some cases, such as, in the situation that heart is ineffectually beaten with special non-synchronized manner.Although the implantation of double-ventricle pacemaker device is effective, not all cardiac is suitable for receiving double-ventricle pacemaker device.In addition, the implantation of double-ventricle pacemaker device is expensive, and usually significantly effectively can not reduce or eliminate mitral regurgitation.
Be intended to the open-heart surgery correcting bicuspid valve leakage, specifically, the implantation of replacement valve can be comprised.Valve from the animal of such as pig can be used for replacing the bicuspid valve 20 in human body.Although pig valve relatively successfully can replace bicuspid valve, this replacement valve can be worn and torn usually, and then needs other open surgery in the future.Mechanical valve prosthesis, it unlikely grinds, and also may be used for replacing the bicuspid valve revealed.But, when implanting mechanical valve prosthesis, there is the thromboembolism increasing risk, and usually need the agent of patient experience long-term anticoagulation to treat.
Less invasive operation comprises and enters the relevant bypass surgery of art to port.Enter art for port, open the whole thoracic cavity of patient relative to segmentation breastbone, heart enters by the otch between rib or the part sometimes by removing one or more rib.
A kind of open-heart surgery being successfully used to correct bicuspid valve leakage and other mitral regurgitation is especially annuloplasty.During annuloplasty, the medical treatment device of such as valve forming ring surgically can be implanted in (that is, the link position of usual bicuspid valve substrate and heart) on side, mitral atrium sinistrum.The annulus of mitral valve of expansion is reduced to relatively normal size by this device, and specifically, is moved by posterior lobe and more engage with auxiliary frontal lobe-posterior lobe near frontal lobe, and therefore improves the closed quality of heart shrinkage period bicuspid valve.The shaping of the usual substantially similar letter " D " of valve forming ring, with the natural shape of the annulus of mitral valve observed by the upper figure of correspondence.Usually, these rings are formed by the bar of biocompatible material or pipe, and such as, plastics, it has the netted coating of DACRON.
In order to implant valve forming ring, valve forming ring is surgically connected in mitral atrial side by surgeon.Conventional method for installing ring needs open heart operation, and it comprises the breastbone of opening patient and patient is placed on heart pass machine.Valve forming ring is made on mitral top.When being sewn on bicuspid valve by valve forming ring, surgeon is usually by the fibr tissue of the joint of the straight flange latasuture system of " D " extremely between AoPW and ALMV substrate.Bending section along with ring divides the rear side made to valve annulus, relatively little the lunging that the fibre-coated ining contrast to valve forming ring adopts, surgeon alternately needs the relatively a large amount of tissue from annulus of mitral valve, such as, use the tissue of 1/8th inches of pin and line to lunge.Once valve forming ring is loosely connected to annulus of mitral valve tissue by line, valve forming ring slips into contact annulus of mitral valve.The rear side annulus of mitral valve previously stretched owing to expanding heart is organized in and circumferentially effectively reduces, and the pulling force applied by valve forming ring by suture or line is by forward towards ALMV tractive.Therefore, can to reduce and substantially closed even in some cases in ventricular contraction or the gap between heart shrinkage period frontal lobe 22 and posterior lobe 24, and then reduce significantly or even eliminate mitral valve insufficiency.When bicuspid valve 20 is by loop forming, frontal lobe and posterior lobe 22,24 usually will by carrying out shape again by posterior lobe 24 pulled forward with the frontal lobe 22 that crosses exactly, and produce and bicuspid valve 20 is presented completely and the new contact wire worked.
Although receive the patient of valve forming ring will bear anticoagulant treatment, this treatment is a large amount of, this is because patient only bears this treatment such as about several weeks until be organized on valve forming ring and grow.
Usually effectively reduce and the prolapse operation of another kind of type that relevant bicuspid valve reveals of leaflet of mitral valve comprises and is placed in bicuspid valve 20 by single edge butt joint suture, it is placed in the middle part of frontal lobe and posterior lobe 22,24.Such as, in Alfieri stitching or Bow-tie prosthesis, edge butt joint is sewed up in the middle of large gap between the frontal lobe 22 and posterior lobe 24 of bicuspid valve 20 and is made.Once this is sewn between frontal lobe and posterior lobe 22,24 in place, it is drawn into form stitching frontal lobe being held against posterior lobe 24.
The another kind of operation reducing bicuspid valve leakage comprises places suture along the annulus of mitral valve around posterior lobe 24.These sutures can be formed as double track by monofilament suture material, such as two " OK ".These sutures are tied a knot at about intermediate point (P2) place of posterior lobe 24.Wipe pad to be usually placed in selected suture bottom and to pass the suture through ring 40 tear to stop.At suture taught and knotting time, the circumference of ring 40 can be reduced to desired size effectively, thus the size in the heart contraction gap between posterior lobe 24 and frontal lobe 22 is reduced.
Although effectively verified in the treatment having wound operation to reveal at bicuspid valve, but have and create operation and usually there is significant deficiency.Whenever, during patient experience open heart operation, there is infection risk.Open breastbone and use cardiopulmonary bypass machine to demonstrate to cause the remarkable incidence of disease of short-term and long-lasting nerve functional defect.In addition, the complexity of open heart operation is considered, and a large amount of relevant recovering time, do not caused the people of greatly inconvenience by CHF symptom, such as, be in the people that grade 1 is classified, can select not carry out corrective procedure.In addition, need most the people of open heart operation, such as, be in the people of class 4 classification, can be very weak or very fragile so that this operation can not be born.Therefore, many mitral people benefiting from surgical repair can not bear operation.
In another approach, use conduit system to be placed in by hooping device in coronary sinus (CS), wherein distally, centre and nearside anchor are in the tube chamber of CS, are folded by CS to make ring 40.In force, these anchor bandings together, and distance between them by tractive such as cable or sutural, be intended to for shortening valve annulus 40 in the mode being similar to valvoplasty and tractive posterior lobe 24 shortens near the flexible strain component of frontal lobe 22 more.Unfortunately, because the tissue forming CS is relatively fragile, these anchors are easy to tear tissue during banding program.In addition, when the CS of particular patient does not directly align with bicuspid valve, mitral effect can reduce.Proposed other Minimally Invasive Surgery, but had various shortcoming, they relate to such as based on the validity of the embodiment of conduit and/or these factors of accuracy.
Utility model content
The utility model proposes one and organize anchor system, it comprises:
Tissue anchor component, it is configured to for anchoring organizationally;
Stretch-draw component, it may be operably coupled to anchor component, thus makes anchor component can stretch-draw member slide relatively, and described stretch-draw component can be pulled to cause anchor component to change its position; And
Manual operation launches conduit, and it can operate to extend and therefrom launch anchor component, and this expansion conduit has handle and comprises:
Rotating parts and clutch component, described stretch-draw component is advanced around rotating parts, and described clutch component is for limiting the tension force in stretch-draw component, and wherein said rotating parts holds in the enclosure;
Deployable push-rod assembly, it is for controllably launching a part for anchor component, and described push-rod assembly comprises slidably ram actuators, and it is connected to handle and can be close along handle, and movable between retracted position and expanded position, wherein push-rod assembly launches anchor component at least partially; And
Locking mechanism, it selectively engages rotating parts and stops the rotation of rotatable structure, wherein when slidably ram actuators is in retracted position, locking mechanism automatically engages rotating parts thus stops the rotation of rotating parts, and maintains the length of stretch-draw component in the existence of rotating parts outside.
The utility model also proposes one and organizes anchor system, and it comprises:
Anchor component, it can be inserted through tissue and be suitable for being anchored at least side of tissue;
Stretch-draw component, it may be operably coupled to anchorage element, thus make anchor component can relative to stretch-draw member slide, described stretch-draw component can be pulled to cause anchor component to move relative to described stretch-draw component, thus apply pulling force to stretch-draw component with seat by anchor component;
Launch conduit, it can operate to extend and therefrom launch anchor component, and described expansion conduit comprises:
Handle;
Catheter body, it is at one end securely connected to handle, and described anchor component and the stretch-draw component connected are included in the main tube cavity of catheter body;
Bobbin assemblies, it comprises the bobbin that stretch-draw component is advanced around it;
Slide engaging and disengaging assembly, it may be operably coupled to bobbin assemblies, and described slide engaging and disengaging arrangement of components is when applying pulling force to anchor component, is pulled and is wound around bobbin along with stretch-draw component, the pulling force in restriction stretch-draw component; And
Deployable push-rod assembly, it is for controllably launching a part for anchor component, and described push-rod assembly comprises slidably ram actuators, and it is connected to handle and can be close along handle, and movable between retracted position and expanded position, wherein push-rod assembly launches anchor component at least partially.
The utility model also proposes one and organizes anchor system, and it comprises:
Anchor component, it can be inserted through tissue and be suitable for being anchored at least side of tissue;
Stretch-draw component, it may be operably coupled to anchorage element, thus make anchor component can relative to stretch-draw member slide, described stretch-draw component can be pulled to cause anchor component to move relative to described stretch-draw component, thus apply pulling force to stretch-draw component with seat by anchor component;
Launch conduit, it can operate to extend and therefrom launch anchor component, and described expansion conduit comprises:
Handle;
Catheter body, it is at one end securely connected to handle, and described anchor component and the stretch-draw component connected can be included in the main tube cavity of catheter body;
Bobbin assemblies, it comprises the bobbin that stretch-draw component is advanced around it, and described bobbin has the first slide engaging and disengaging portion; And
Slide engaging and disengaging assembly, it comprises the first slide engaging and disengaging portion of bobbin and is formed as the second slide engaging and disengaging portion of bobbin ratchet part, described slide engaging and disengaging arrangement of components is when applying pulling force to anchor component, is pulled and is wound around bobbin along with stretch-draw component, the pulling force in restriction stretch-draw component; Wherein said bobbin and bobbin ratchet rotate around common axle.
In one embodiment, organize anchor system to comprise tissue anchor component, it is suitable for launching and being suitable for anchoring organizationally.This system also comprises stretch-draw component, and it may be operably coupled to anchor component, thus makes anchor component can stretch-draw member slide relatively, described stretch-draw component can be pulled to cause anchor component to move and seat by organizing.Manual operation launches conduit and can be operated to extend and therefrom launch anchor component.This expansion conduit comprises rotating parts and clutch component, and described stretch-draw component is advanced around rotating parts, and described clutch component is for limiting the tension force in stretch-draw component.
In another embodiment, comprise anchor component for the anchor system of organizing launching tissue anchor, it can be inserted through tissue and be suitable for being anchored at least side of tissue.This system also comprises stretch-draw component, and it may be operably coupled to anchor component, thus makes anchor component can stretch-draw member slide relatively, and stretch-draw component can be pulled to cause anchor component to move relative to stretch-draw component.As described herein, according to the tissue anchor that the utility model can use any amount dissimilar.
This system also comprises expansion conduit, can therefrom extend and launch tissue anchor.Launch conduit and comprise handle and catheter main body, described catheter main body is at one end securely connected to handle.Anchor component and be connected stretch-draw members contain are in the main tube cavity of catheter main body.Conduit comprises bobbin assemblies, and it comprises bobbin and slide engaging and disengaging assembly, and stretch-draw component roll is advanced, and is connected to bobbin assemblies slide engaging and disengaging component operable.Slide engaging and disengaging arrangement of components is when anchor component moved into place, is pulled and is wound around bobbin along with stretch-draw component, the tension force in restriction stretch-draw component, and specifically, slide engaging and disengaging arrangement of components is passed through for stoping draw tissue.In other words, slide engaging and disengaging arrangement of components is the power that restriction is applied to atrium anchor, thus stops draw tissue by (such as, stoping anchor to be pulled by organizing self).
There is provided a kind of extensible push-rod assembly, it is for controllably launching a part for anchor component.Push-rod assembly comprises slidably ram actuators, and it is connected to handle and can be close along handle, and can move between punctured position and extended position, and at described expanded position, wherein push-rod assembly at least launches a part for anchor component.
By accompanying drawing and the description of some embodiment of the utility model, these and other aspects, Characteristics and advantages will obtain further instruction.
Accompanying drawing explanation
Fig. 1 is the schematic diagram of a patient, and wherein cardiac anatomy represents with profile, in the sustainer that steerable catheter enters patient through vascular system and heart;
Fig. 2 is the profile of the heart from upper figure, it illustrates the introducing of various conduit;
Fig. 3 is the profile of the heart being similar to Fig. 2, and illustrates the further introducing of seal wire;
Fig. 4 is the partial longitudinal sectional view of heart, it illustrates the location of conduit in left ventricle and coronary sinus;
Fig. 5 is the profile of the heart being similar to Fig. 4, but illustrates the further introducing of seal wire through annulus of mitral valve;
Fig. 6 be bicuspid valve with the zoomed-in view of section, and show deployable three cavities conduit pipe and be introduced into left ventricle;
Fig. 7 is the mitral profile being similar to Fig. 6, and shows the further introducing of deployable three cavities conduit pipe;
Fig. 8 is the profile of the heart being similar to Fig. 7, but illustrates the initial deployment of three cavities conduit pipe;
Fig. 9 is the front view of the three cavities conduit pipe launched relative to annulus of mitral valve;
Figure 10 is the side perspective of anchor (the wiping pad) delivery conduit according to an embodiment;
Figure 11 is the decomposition diagram of the anchor delivery conduit of Figure 10;
Figure 12 is the side view of the lower body of the conduit shell of Figure 10;
Figure 13 is the first side view of the upper body of the conduit shell of Figure 10;
Figure 14 is the second side view of the upper body of the conduit shell of Figure 10;
Figure 15 is the side view of the bobbin cover of the conduit shell of Figure 10;
Figure 16 is the bottom side plan view of the bobbin ratchet of the conduit of Figure 10;
Figure 17 is the bottom side plan view of the bobbin of the conduit of Figure 10;
Figure 18 is the perspective view of the bobbin lock of the conduit of Figure 10;
Figure 19 is the side view of the button of the conduit of Figure 10;
Figure 20 is the bottom view of the button of Figure 19;
Figure 21 is the first side view of the intermediate body portion of the conduit shell of Figure 10;
Figure 22 is the second side view of the intermediate body portion of the conduit shell of Figure 10;
Figure 23 is the perspective view of the thumb push rod of the conduit shell of Figure 10;
Figure 24 is the bottom view of the thumb push rod of Figure 23;
Figure 25 is the side view of thumb pusher button;
Figure 26 is the side view of push rod;
Figure 27 is the profile of the push rod of Figure 26;
Figure 28 is the side view of pawling; And
Figure 29 A-29E is that signal is for being fastened to the respective side view of the series of steps of a layer tissue by tissue anchor.
Detailed description of the invention
Specifically describe the utility model for folded tissue now with reference to each accompanying drawing, especially fold the implementation method of the annular tissue relevant to patient's bicuspid valve, device and system.Although it should be understood that the detail of described methods, devices and systems will provide herein, those of ordinary skill in the art can make various change, replacement to these details and add.These change, replace and add still belong to herein more general set forth and within the scope of the utility model that can understand after integrally checking this explanation of those of ordinary skill in the art.It should be noted that, it is the same that term " nearside " and " distally " and this area are commonly used, and is used to indicate the spatial relationship relative to the individual using specific device or parts.That is, " nearside " refers to more near the position of user, and " distally " refers to more away from the position of user.
It should be understood that with reference to the apparatus described by Fig. 1-9 and technology be in fact only illustrative, and as described herein, other technologies also can be used in location and place seal wire, and in down-stream, use its seal wire that anchor is delivered to destination organization.Illustrate that guiding catheter 50 causes the vascular system of patient by the artery (Fig. 1) of such as patient's inguinal region with reference to Fig. 1-4.Guiding catheter 50 can be the 12mm conduit being directed across vascular system in any way as suitable.As best shown in figure 4, guiding catheter 50 guides and enters sustainer 16, through aorta petal 18 and the left ventricle entered a pair valve chordae tendineae 26,28.In the method for the ring 40 for folding bicuspid valve 20, guiding catheter 50 can be used as guiding sheath or pipe, enters in left ventricle 14 for being guided by all further conduit devices.It should be understood that other guidance method can substitute or supplement various method disclosed herein.After the initial insertion of guiding catheter 50, P2 conduit 52 is inserted into guiding catheter 50.Road as known in the art, " P2 " refer to the middle position of posterior lobe 24 substrate along ring 40.P2 conduit 52 can have and can deflect tip, to allow more accurately and to carry out catheter tip more easily relative to the manipulation of ring 40 and location.The radiopaque mark 52a that catheter tip is visual under can being included in fluorescence.The far away most advanced and sophisticated 52a of P2 conduit 52 is aligned on ring 40 as shown in Figure 4, thus makes it be directed upwards towards the inside of atrium sinistrum 12.
Except using guiding catheter 50 and P2 conduit 52, also single guiding sheath of handling can be positioned at desired locations place in annulus of mitral valve ventricular side, then launch seal wire.
With reference to Fig. 5, when using such as fluorescence to confirm the accurate location of P2 conduit 52, a RF seal wire can be introduced through P2 conduit.P2 seal wire can have the most advanced and sophisticated 60a of radio frequency (RF) Energy transfer, penetrates through for auxiliary the mitral valve tissue being usually located at ring 40 place.For this reason, suitable RF energy device (not shown) can be connected to seal wire 60, and other hereafter disclosed RF seal wires.Then the distal portion of P2 seal wire 60 extends into atrium sinistrum and curling with the tissue damage helped in prevention atrium sinistrum 12 on itself, as best seen in fig. 6.
Then the method also comprises making for introducing P1 seal wire 62 by the interior double channel catheter 70 comprised of sheath 72.Double channel catheter 70 and sheath 72 are directed into guiding catheter 50 after P2 conduit 52 is therefrom withdrawn from.Or guiding catheter 50 can be can handle guiding sheath and launch on the very near position of annulus of mitral valve, and in this case, sheath 72 can omit.Double channel catheter 70 more specifically comprises central authorities or the first catheter component 74, and it has the tube chamber 74a be through on P2 seal wire 60.Except this first or P2 catheter component 74, double channel catheter 70 also comprises the second catheter component 76, and it is usually corresponding generally along the P1 position of rear side annulus of mitral valve 40.Second and the 3rd catheter component 76 also comprise tube chamber 76a containing seal wire 62.It should be understood that except those positions except schematically describing herein or substitute those positions schematically described herein, other positions along ring 40 can also be selected.
As Fig. 7 illustrates further, double channel catheter 70 and the sheath 72 of combination are pushed through guiding catheter 50, and the deployable distal portion that catheter component 74,76 forms extends from sheath 72 in Left Ventricular 14.The initial alignment of P2 seal wire 60 ensure that centre or P2 catheter component 74 become the accurate reference point at P2 place.When sheath 72 arrives the distal position shown in Fig. 7-9, double channel catheter 70 is by extrapolated from the far-end of sheath 72, and as shown in FIG. 8 and 9 such launches.As best illustrated in figure 9, lateral sheathed component 76 (that is, P1 catheter component) due to they by connecting rod 80,84 with central authorities or P2 catheter component 74 be connected and automatically outwards launch.These connecting rods can by such as thin metal plate material, such as the combination of elastic material, stainless steel, other metals or these materials, formed.Nitinol (trade mark) (Ni-Ti) thin slice and stainless steel thin slice are close to stacking material and can be used for manufacturing connecting rod 80,84.The effective elastic characteristic that Nitinol can provide two outer conduit components 76 to extend away from inner or center conduit component 74, and the stainless steel substrates of each connecting rod provides the additional stiffness for supporting object.
As shown in Figure 9, each connecting rod 80,84 is connected to each catheter component 76,74 by the loose-joint butt near each connector 88,90,94,96 by each connector 88,90,94,96.Therefore the structure illustrated basically forms the four rod-type link structures formed by catheter component 74,76 and bar 80,84.Therefore this deployable structure causes outer conduit component 76 distad translation and be also laterally outwards expanded to the known location determined by the respective length of bar 80,84.In this example, the far-end of conduit 76 is finally approximately positioned at P1 place, position along bicuspid valve 40.It should be understood that these positions are only representative and schematic, and the method can be implemented in any other position along bicuspid valve 40 based on the demand of surgical requirement and patient.
Catheter component 76 comprises the tube chamber 76a that P1 seal wire 62 can therefrom guide.Be similar to P2 seal wire 60, P1 seal wire 62 and can comprise RF or RF energy delivery tip 62a, penetrate through ring tissue 40 for auxiliary.It should be understood that when to refer to " ring tissue " herein, it is often referred to the tissue of generation along ring 40, can be the suprabasil tissue of posterior lobe 24 self.Illustrate as Fig. 6 institute, RF seal wire 62 is inserted through ring tissue 40, extends into atrium sinistrum 12 to make its distal portion in the mode being similar to RF seal wire.Then, double channel catheter 70, comprises sheath 72, can remove from guiding catheter 50.
Other details about wire catheter and said procedure are illustrated in total U.S. Patent Application Serial Number 11/685,240 (U.S. Patent Publication No. 2008/0228265).This patent application is contained in this.
It should be understood that Fig. 1-9 pairs of the utility model do not impose any restrictions, only reflection is used for seal wire to insert and location in position that is predetermined, that expect.In another embodiment, pre-surgery assessment can be used for seal wire to locate, thus recovers leaflet combination.Therefore, other programs and technology also can be used to introduce and positioning guide wire.
Figure 10-28 illustrates hand-operating device and program for tissue anchor (wiping pad) 2000 being connected to tissue, such as ring tissue.Especially, anchor (wiping pad) delivery conduit 100 is illustrated as and is configured to controllably carry anchor 2000.Conduit 100 is configured to hand-held device and comprises flexible catheter body 110, and it stretches out from one end of modular catheter 200.Catheter main body 110 is also lateral sheathed simultaneously, can receive other workpieces of conduit 100, comprise the anchor as described herein of prestrain.
According to an illustrative embodiment, flexible catheter body (oversheath) 110 can with the form of rapid-exchange catheter, it comprises guidewire lumen, allows conduit 100 to enter to target location along seal wire (such as seal wire 2200 (Figure 10)).When the form of catheter main body 110 with rapid-exchange catheter, it not only comprises for the main tube cavity of receiving slot zygonema 1150, pusher catheter 1530 and anchor 2000, and also comprises the guidewire lumen for receiving seal wire 2200.Main tube cavity is at outlet port 113 opening, and it departs from (in a proximal direction) a little from the far-end 112 of catheter main body, and in handle 200 upper shed with receiving slot zygonema 1150 and other workpieces, comprises as herein described at inside propelling anchor 2000.Guidewire lumen can enter at two some places on the position along catheter main body 110 length separation far-end 112.More specifically, guidewire lumen can enter at the ingress port place at far-end (tip) 112 place and outlet port 115 place, and seal wire enters guidewire lumen by ingress port, and seal wire leaves through outlet port 115.
Outlet port 115 is located along the length of the quick exchange part of catheter main body 110, and relative to outlet port 113 closer to handle 200.In order to by conduit initially located in place, corresponding seal wire inserts in ingress port at far-end 112 place, and through guidewire lumen before leaving through outlet port 115.This makes conduit 100 enter along seal wire, thus far-end 112 and outlet port 113 are positioned at target location.Therefore it should be understood that the length (in quick exchange part) along catheter main body 110, guidewire lumen and main tube cavity exist with the form in the direction side by side at interval.
Modular catheter 200 comprises multiple workpiece, and they to be contained in shell 210 and can be handled by user initially launches anchor 2000 and under anchor is placed in pulling force, thus guarantees the expansion of anchor and be fastened to tissue.Shell 210 comprises the first shell body 220, and it has first end 222 (front end), the second relative end 224 (rear end), top 226 and relative bottom 228.First shell body 220 comprises diapire 223 and periphery wall 221, periphery wall 221 to extend and around the periphery of diapire 223 laterally from diapire 223, comprise end 222,224 and top and bottom 226,228, thus limit interior compartment or space 230 (limiting between periphery wall 221) for receiving miscellaneous part as mentioned below.The shape of the end 222,224 of housing 210 is different, and similar, and the shape of shell 210 top and bottom 226,228 is different.Especially, top 226 comprises segmental arc 227, and it is generally within the centre position of end 222,224.In segmental arc 227, periphery wall 221 comprises the slit 229 of the openings at one side of circumferentially wall 221.
The diapire 223 of the first shell body 220 comprises inner surface 232 and opposed outer surface 234, and inner surface 232 partly limits interior compartment 230, and outer surface 234 limits the outer surface of handle 200.Through hole 240, through the diapire 223 of the first shell body 220, is being located near segmental arc 227.Multiple connecting elements 250 is also formed along the bottom surface 223 of the first shell body 220, for being connected to form the different parts of shell 210.Such as, connecting elements 250 can exist with the form of the integrated axle sleeve formed along diverse location place, bottom surface 223.Such as, an axle sleeve 250 can formed near end 222 place, and another axle sleeve 250 can formed near end 224 place, and another axle sleeve 250 can formed along top 226 place.As mentioned below, axle sleeve 250 is for securely linking together all parts of shell 210.
First shell body 220 also comprises the protruding guide rail 260 formed along inner surface 232.Raised track 260 is slim-lined constructions, and has two opposed closing ends 262,264, and wherein one end 262 is near through hole 240, and the other end 264 is near the end 222 of the first shell body 220.In institute's exemplary embodiment, guide rail 260 has the elongated oval shape that limited by vertical wall and comprises rounded tip 262,264.The height of vertical wall is less than the height of the wall along the end 222,224 of the first shell body 220 and side 226,228.
The inner surface 232 of the first shell body 220 also comprises bobbin location and retaining member 290, and itself and inner surface 232 are integrally formed.In institute's exemplary embodiment, component 290 is with the form of the structure of similar sight or analog.Component 290 is placed in below slit 229.
Shell 210 comprises second housing body 300, the complementary and shape of itself and lower body 220 and being configured to and its pairing.Second housing body 300, therefore with the form of slim-lined construction, has first end 302 (front end), the second relative end 304 (rear end), top 306, relative bottom 308.Second housing body 300 comprises diapire 305 and periphery wall 311, and they to extend and along the periphery of diapire 305 laterally from diapire 305, comprise end 302,304, top 306 and bottom 308.
Each end 302,304 and top and bottom 306,308 comprise sidewall, thus make second housing body 300 have interior compartment or space 310 for receiving miscellaneous part as mentioned below.The shape of end 302,304 is different, and similar, and the shape of lateral surface 306,308 is different.Especially, top 306 comprises the segmental arc 307 in the centre position generally within end 302,304.In segmental arc 307, periphery wall 311 comprises the slit 309 of the top edge opening of circumferentially wall 311.
Second housing body 300 also comprises the inner surface 320 limiting interior compartment 310 bottom surface and the opposing outer face 322 limiting handle 200 outer surface.Second housing body 300 comprises the opening 330 extending through inner surface 320.In institute's exemplary embodiment, opening 330 has round-shaped.Opening 330 is placed in slit 309 nearside.Periphery wall 311 has the otch or notch 340 that extend along its length along bottom surface 308.In institute's exemplary embodiment, notch 340 normally rectangular shape.
The outer surface 322 of second housing body 300 is not planar structure, but has several recessed region.Especially, as described herein, second housing body 300 comprises the first recessed region 341 and the second recessed region 343, first recessed region 341 place forms otch 340, second recessed region 343 adjoins the first recessed region 341 and opening entering part first recessed region 341, and is intended to the thumb receiving user's hand.In addition, outer surface 322 also comprises the 3rd recessed region 370, and its top 306 along second housing body 300 is formed and comprises slit 309.3rd recessed region 370 extends to second end (rear end) 304 of second housing body 300.Protruding annular wall 380 limits central opening 330 and is formed as making it to extend into second and the 3rd recessed region 343 and 370.One column 385 extends outwardly from the annular wall 380 of projection and enters slit 309.This column 385 is spaced.Protruding annular wall 380 is not the surface of continuous print, non-interrupted, but comprises the interruption limiting slit, and this slit provides the entrance entering opening 330.
In the 3rd recessed region 370, there is connecting elements 381.In institute's exemplary embodiment, connecting elements 381 exists with the form locking axle sleeve, and comprises a pair locking plate.
Multiple connecting elements 350 is also formed along the inner surface of second housing body 300, for the first and second shell bodies 220,300 are joined together to form shell 210.Such as, connecting elements 350 can be formed in the form sentencing integrated axle sleeve along the diverse location of inner surface, and especially, connecting elements 350 is formed in diverse location place, the connecting elements 250 of itself and the first shell body 220 is complementary, thus when two shell bodies 220,300 are paired together, connecting elements 250,350 is axially aligned each other.Axle sleeve 250,350 is for securely linking together shell 210.Such as, securing member (screw) 291 can be received in aimed at connecting elements 250,350, connects the first and second shell bodies 220,300.
It should be understood that, first and second shell bodies 220,300 are the hollow components in the local that limited by inner space 230,310, and therefore, when housing 220,300 is paired together, between the first and second shell bodies 220,300, form interior compartment, this compartment is for receiving and holding each workpiece of this device.
The shell 210 comprising the first and second shell bodies 220,300 can be formed by the different materials of any amount, comprises plastic material.
As mentioned below, modular catheter 200 has bobbin assemblies, and comprises bobbin cover 400, and it covers some bobbin parts at least in part and is securely connected to second housing body 300.Bobbin axle 400 comprises first end 402 (front end) and the second end 404 (rear end), top 406 and bottom 408.Second end 404 of bobbin cover 400 is aimed at and is positioned at the second end 224,304 place of first and second shell 220,300.Bobbin cover 400 also comprises inner surface 411 (it is towards second housing body 300) and relative outer surface (outer surface) 420.The top 406 of bobbin cover 400 comprises slit 410, and itself and the slit 229,307 be respectively formed in the top 226,306 of the first and second shell bodies 220,300 axially align.Bottom 408 also comprises slit 415, and it is formed with along inner surface 411 and the arcwall 419 of portions defining slots 415 cooperates and forms the entrance entering the second recessed region 343.Slit 410 is also partly limited by arcwall 419.As mentioned below, arcwall 419 limits arc space or compartment 421, for receiving bobbin parts.
The inner surface 411 of bobbin cover 400 also comprises one or more connecting elements, for auxiliary bobbin cover 400 and second housing body 300 location and be connected.Such as, can form axle sleeve 430 along inner surface 411, it is configured to match with connecting elements 380 and comprise complementary locking plate, and described locking plate matches with a pair locking plate as connecting elements 380 parts.It should be understood that other connection features, such as locking plate etc., the parts of bobbin cover 400 can be set to, thus allow bobbin cover 400 securely but be connected to second housing body 300 removedly.
Bobbin cover 400 can be formed by the different materials of any amount, comprises plastic material.
As shown in figures 10 and 16, bobbin assemblies comprises bobbin ratchet 500.Ratchet 500 comprises downside gear 510, and it has the gear teeth 512 of the neighboring annular formation along wheel 510.Wheel 510 has central axle 520, and it has the spoke members 530 extended between wheel shaft 520 and the inner surface of wheel 510.Wheel shaft 520 is sized and shaped as and component 290 is received in the inner space of wheel shaft 520, thus the motion (such as, horizontal direction) of location and restriction bobbin ratchet 500, and allow bobbin ratchet 500 around the rotation of component 290.Therefore bobbin ratchet 500 is rotatably supported on component 290, thus makes the inner surface interval of bobbin ratchet and the first shell body 220.Wheel shaft 520 has the height being greater than wheel 510, and therefore, a part for wheel shaft 520 extends above wheel 510.
In institute's exemplary embodiment, there are three spoke members 530.Bobbin ratchet 500 also comprises the clutch part that same wheel shaft 520 is integrally formed.Clutch part comprises multiple flexible lock claw 540, and they extend outwardly from wheel shaft 520 and are interval in wheel shaft 520.Each flexible pawl 540 has arcuate shape, and it has first end 542 and the second contrary end 544.The first end 543 of pawl 540 is connected to wheel shaft 520, and the second end 544 is free ends.In institute's exemplary embodiment, have three flexible pawls 540, they are around wheel shaft 520 circumferentially interval.The first end 542 of each pawl 540 is connected to wheel shaft 520 in the position of location spoke members 530.Most of length of pawl 540 is positioned at more than the space be formed between two adjacent spoke components 530.
Free end 544 comprises ratchet 545.Ratchet 545 has the first hypotenuse 547 and and is in the Second Edge 549 at freely the second end 544 place.Time on force is to it to cause finger 540 inwardly to bend towards wheel shaft 520, pawl 540 has the flexibility on the direction towards wheel shaft 520.The bending of pawl 540 causes pawl 540 storage power.It should be understood that, when force removes, pawl 540 is back to its nature.
Along wheel shaft 520 inner surface circumferentially interval land formed multiple rib 525.Rib 525 does not extend the whole length of wheel shaft 520, but only extend its partial-length, thus make when bobbin ratchet 500 is inserted on component 290, wheel shaft 525 and component 290 interval, and therefore, ratchet 500 can freely rotate around component 290 and can not be interfered by rib 525.Therefore rib 525 is positioned at those parts that wheel shaft 520 exceedes wheel 510.
The height of ratchet 500 makes when the first and second shell bodies 220,300 are paired together, and ratchet 500 extends in the central opening being formed at second housing body 300, and wherein clutch part 530 is positioned between raised annular wall 380.When bobbin cover 400 is connected to second housing body 300, bobbin cover 400 partly covers bobbin assemblies.
Bobbin assemblies also comprises bobbin 600.Bobbin 600 is designed to match with bobbin ratchet 500.Bobbin 600 is the annular construction members with central opening or aperture 610.Bobbin 600 has first end 602 and the second contrary end 604.Bobbin 600 has the first flange 630, it stretches out from cylindrical main line axis body 620, and the second wheel rim 640, and it stretches out from main line axis body 620 and is interval in the first flange 630, thus limit a region, the component that this areas accept is wound around around main line axis body 620.
At first end 602 place and nearside, there is the annular space 660 be formed between main line axis body 620 and the first flange 630.
Second end 604 of bobbin 600 has clutch structure 670.Clutch structure 670 is formed by continuous print concave wall 672, and it extends around the second end 604 and comprises the surface towards aperture 610.Wall 672 is limited by recessed section 673 of alternate mode, and described recessed section 673 is positioned between platform 676, and platform 676 extends in the aperture 610 of bobbin 600.Each recessed section 674 is bonded to platform 676 by hypotenuse 678 and in fact substantially straight limit 680, and wherein limit 680 is at least basically perpendicular to platform 676 and recessed section 673.Aperture 610 does not have uniform diameter from first end to the second end, but has variable-diameter.Especially, form lug 690 between clutch structure 670 and cylindrical section 692, its mesoporous 610 has diameter less the diameter relative to clutch section.
Bobbin 600 is inserted on ratchet 500, wherein clutch structure 670 inwardly ratchet 500.The external diameter of the first flange 630 and the second flange 640 is slightly less than the diameter of raised annular wall 380.Therefore bobbin 600 is securely positioned at and is rotatably held in place in the annular space between raised annular wall 380.Second flange 640 is located on lug 690.
In normal operating position (resting position), the flexible pawl 540 of ratchet 500 is received in clutch structure 670.More specifically, in resting position, the ratchet 545 at pawl 540 second end 544 place is received in the recessed region 673 of clutch structure 670, and the remainder seat of pawl 540 is by platform 676.In resting position, the first hypotenuse 547 of ratchet 545 is towards hypotenuse 678, and Second Edge 549 is towards straight flange 680.The size of pawl 540 and the quantity of recessed region 673 and position make when bobbin 600 matches with ratchet 500, and the ratchet 545 of pawl 540 is received in each recessed region 673.In normal position, bobbin 600 and ratchet 500 rotate as single component synergism.As described in detail below, clutch component is as pulling force restraint device, and when pulling force is excessive, bobbin 600 and ratchet 500 relative to each other slide, and this causes the ratchet 545 of pawl 540 to be temporarily separated with corresponding recessed section 673.During sliding action, ratchet 545 gets on along hypotenuse 678, causes ratchet 545 to depart from correspondent section 673, and pawl 540 is along with they curve inwardly storage power.Before running into next adjacent recesses section 673 (the relative rotation due between bobbin 600 and ratchet 500), the ratchet 545 of displacement is advanced along adjacent platform 676, when running into next adjacent recesses section 673, ratchet 545 is driven into recessed section 673 wherein because pawl 540 discharges the energy stored by them.Clutch action will hereafter described in detail more.
Thumb wheel 700 is connected to bobbin ratchet 500, thus makes the rotation of thumb wheel 700 be converted to the rotation of bobbin ratchet 500.Thumb wheel 700 comprises wheel portion 710 and column 720, and column 720 is for being connected to bobbin ratchet 500 by thumb wheel 700.Wheel portion 710 has neighboring 712, and it can comprise grip element 714 (such as rib) and grasps with auxiliary user and rotate thumb wheel 700.Column 720 shape is allow with the pairing of bobbin ratchet 500 and be connected.Such as, column 720 comprises multiple rib 722, and it extends circlewise around column 720 and can exist with the form of the vertical ribs at interval.Rib 722 is received in the gap between rib 525 that the inner surface along wheel shaft 520 formed.Gap between rib 525 and the complementation of the width between rib 722, thus make to produce mechanical matching between thumb wheel 700 and bobbin ratchet 500.Rib 722 is received in the gap between rib 525 and effectively thumb wheel 700 is coupled to bobbin ratchet, and allows the rotation of thumb wheel 700 can be converted to the rotation of bobbin ratchet 500.The diameter in wheel portion 710 is greater than the diameter of annular wall 380, and therefore, wheel portion 710 extends (protrusion) and exceeds annular wall 380.
Device 100 also comprises bobbin lock 800.As shown in figure 18, bobbin lock 800 comprises and has cylindrical shape winner pivot body 810, and main pivot body 810 comprises the central opening or aperture 812 that extend therethrough.Central opening 812 receives pivot and locks 800 around its pivotable to allow bobbin.In institute's exemplary embodiment, pivot exists with axle sleeve 250,350 form of a part for the first and second shell bodies 220,330.
Bobbin lock (locking mechanism) 800 comprises the first arm 820 extended radially outwardly from main pivot body 810.First arm 820 can have slight bending and have free end 822.First arm 820 has first side (top margin) 824 and second side (base) 826, and its insole binding 826 is towards bobbin ratchet 500.The dentation section limited by multiple gear teeth 828 is comprised along base 826.First arm 820 also comprises projection (pin) 830, its free end 822 place or near stretch out from the first arm 820.Especially, pin 830 is from the outwardly extension of the first arm 820, and wherein this outer surface is towards second housing body 300.
Bobbin lock 800 comprises the second arm 840, and it extends radially outwardly from main pivot body 810.Second arm 840 has free end 842.Free end 842 place or near, protruding (pin) 850 stretches out from the inner surface of the second arm 840.Inner surface inwardly first shell body 220 of the second arm 840.The length of the second arm 840 is less than the length of the first arm 820.Protrude the difformity that 830,850 can have any amount, the protrusion 830,850 of anticipating shown in it has annular shape.The first axle and the angle extended through between main pivot body 810 and the second axle of pin 850 that extend through main pivot body 810 and pin 830 are about 114 degree.
First biasing member 860 comprises first end and the second end.First end is connected to pin 850, and the second contrary end is connected to the fixed lobe (pin) 870 be formed on second housing body 300 inner surface.In institute's exemplary embodiment, the first biasing member 860 exists with the form of spring (extension spring).
As shown in the drawing, tooth 828 is configured to mate the tooth 512 formed along downside gear 510 neighboring.
Button 900 is operationally set to a part for handle, for generation of the controlled operation of bobbin lock 800.Button 900 is general hollow units, and it comprises roof 910 and sidewall 920, and sidewall 920 is engaged to roof 910.Roof 910 has curved shape, and the segmental arc of itself and the first and second shell bodies 220,300 is complementary.Sidewall 920 has bending base 922.Button 900 comprises medial extremity, and it comprises connecting elements 930, for button 900 is movably connected to second housing body 300.More specifically, connecting elements 930 is recessed section that is spaced apart from each other for a pair.In institute's exemplary embodiment, recessed section 930 exists with the form of ring-shaped depression (recessed).
Column 385, by being placed on column 385 by a pair biasing member 950, being then inserted in ring-shaped depression 930 and being connected to second housing body 300 by button 900.Button 900 is inserted in the slit 309 formed with second housing body 300, and use again other means to be connected to slit 309, described other means comprise the guide rail 980 be formed in slit 309 sidewall limiting shell body 300 to be inserted into and are formed with the complementary slot 990 of button 900 end.Therefore button 900 advances slidably in the slit 309 of second housing body 300.
Button 900 is also formed along bottom opening and is positioned at reception space or the inside at the rear of connecting elements 930.The pin 830 formed along the first arm 820 is received in reception space.It should be understood that the sliding motion of button 900 causes the first arm 820 towards the pivotable of bobbin ratchet 500.More specifically, button 900 causes the first arm 820 inwardly bobbin ratchet 500 pivotable towards the motion of bobbin ratchet 500, and the gear teeth 512 that the continuous motion of button 900 causes the gear teeth 828 and the neighboring along downside gear 510 to be formed mate.The position of the gear teeth 512 is engaged at the gear teeth 828, first biasing member 860 is storage power due to the pivoting action of the second arm 840, and therefore, when user's release-push 900, stored fault offset, this causes the pivotable of bobbin lock 800 and button 900 to be back to normal, static (discharging) position.
It should be understood that bobbin lock 800 is for controllably limiting the rotation of bobbin ratchet 500.In other words, when user wishes stop the rotation of bobbin ratchet 500 and therefore stop the rotation of thumb wheel 700 and bobbin 600, user presses button 900 simply until the gear teeth 828 engage the gear teeth 512.
This device 100 also comprises and to be arranged in the middle of second housing body 300 and to provide the intermediate body portion 1000 to the supporting construction of miscellaneous part.As shown in figure 21, intermediate body portion 1000 uses securing member or analog to be fixedly connected to second housing body 300.More specifically, intermediate body portion 1000 comprises first end 1010 and the second end 1020, first end 1010 is connected to second housing body 300, second end 1020 in the first position closer to second housing body 300 base and is connected to second housing body 300 in the second position closer to second housing body 300 top margin.
Intermediate body portion 1000 comprises the main body 1030 extending to first end 1010.Main body 1030 comprises arc-shaped side 1031.Intermediate body portion 1000 also comprises from outward extending first and second arms 1040,1050 of main body 1030.First arm 1040 represents connecting plate and comprises the opening for receiving securing member intermediate body portion 1000 be connected with second housing body 300.Second arm 1050 is included in the vertical pillars 1060 of its edge.Column 1060 is perpendicular to the surface of the second arm 1050.It is a stayed surface 1070 receiving washer member 1100 between arm 1040,1050.Stayed surface 1070 comprises the pass through openings 1072 be formed in wherein.
Washer member 1100 is components hollow at least partly, and it has first end and the second contrary end, and extends through pass through openings or the hole 1110 of first end and the second end.Washer member 1100 has the cylinder extended between these sides usually.Between these sides, washer member 1100 comprises from main cylinder outward extending side protrusion or column 1120.Aperture is formed through column 1120 and is communicated with the pass through openings 1110 be formed in main cylinder.
Washer member 1100 is arranged on outer surface 1070 to make column 1120 to aim at the opening 1072 be formed in supporting construction 1070 and to extend through opening 1072.Washer member 1100 can use any conventional art comprising mechanical connection to be securely connected to main stayed surface 1070.When being connected to the main body 1030 of intermediate body portion 1000, the axle that washer member is arranged to extend through hole 1110 usually extends along the length of first end to the second end from main body 1030 of main body 1030.As mentioned below, hole 1110 is configured to receive the suture 1150 of certain length to make this suture extend through hole 1110 and to be wound around the bobbinet 620 of bobbin 600.Along with bobbin 600 rotates in a first direction under the effect of thumb wheel 700, suture 1150 is wound around along bobbin 600.As mentioned below, suture 1150 is controllably advanced from coil member 1100 to the outlet port/opening being formed in shell 210 front end in shell 210.
This device 100 also comprises the push-rod assembly that can cause the hole of the advance of anchor (wiping pad) as mentioned below, and this push-rod assembly indicates with 1200 usually in Figure 11 and 23.Push-rod assembly 1200 comprises the thumb push rod (slidably ram actuators) 1210 that can be actuated to the startup causing push-rod assembly 1200.Thumb push rod 1210 is advanced along a pair raised track 1230 be formed on the first shell body 220 inner surface.Thumb push rod 1210 comprises main body 1220, and it has first end 1222, contrary the second end 1224, inner surface 1231 and outer surface 1240, the outer surface of the thumb push rod 1210 that described outer surface 1240 is operated by user exactly.
Although inner surface 1231 is a plane substantially, and outer surface 1240 allows user to grasp and handles thumb push rod 1210.Such as, outer surface 1240 can have multiple recessed section of grasping 1245, to provide the grip surface for user.The recessed section of grasping 1245 illustrated is parallel to each other, and extends along the length of outer surface 1240.First end 1222 place or near, in outer surface 1240 formed latch recess 1250.In institute's exemplary embodiment, latch recess 1250 is along the first limit 1252 opening of outer surface 1240, and the recessed section of grasping 1245 is along contrary Second Edge 1254 opening.Guide channel or guide rail 1255 is had in latch recess 1250.
Thumb push rod 1210 comprises the elongated locking rail 1260 that has first end 1262 and the second end 1264.Locking rail 1260 is formed along inner surface 1230 and extends along main body 1220, and the second end 1264 of locking rail 1260 protrudes and exceeds the second end 1224.Locking rail 1260 is formed in the first edge 1252 place.The locking rail 1260 illustrated is narrow rectangle rails, and has the locking edge formed by multiple gear teeth 1272.The first end 1262 of guide rail 1260 comprises linkage section 1280, comprising the part that size (such as, increasing width) increases gradually.Linkage section 1280 can be network-like, comprising bending exposed limit, and comprises the pass through openings 1282 formed through it.
First limit 1252 comprises the guide channel 1280 that the length along main body 1220 is formed.Guide channel 1280 is opening and shape is receive the protruding guide rail 1230 being formed as the first shell body 220.This connection allows thumb push rod 1210 to advance in the enclosure to controllably.
Thumb push rod 1210 along housing 210 sole arrangement and especially, thumb push rod 1210 is advanced in first recessed section 341 of second housing body 300.It should be understood that main body 1220 has the slight bending shape along its length thus the protruding guide rail 1230 along first shell body 220 equally with slight curvature shape is advanced and carries out complementation to protruding guide rail 1230.Protruding guide rail 1230 can be touched by the notch 340 in be formed at second housing body 300 first recessed section 341.
Push-rod assembly 1200 also comprises movably to be arranged and the thumb pusher button 1300 be included in latch recess 1250.Thumb pusher button 1300 comprises main thumb section 1310, and it can have the curved surface comprising antelabium 1312, makes the thumb of itself and user complementary, thus allows user at the thumb pusher button 1300 that moves up towards the side of Second Edge 1254.The diameter of thumb section 1310 is only slightly less than the width of latch recess 1250, thus can advance smoothly in groove 1250.Thumb section 1310 is formed in one end place of thumb pusher button 1310, and at end opposite place, thumb pusher button 1310 comprises stop pin 1320.The stop pin 1320 illustrated is columniform pins.The width of pusher button 1310 diminishes gradually on the direction towards stop pin 1320.
Thumb pusher button 1310 is biased in latch recess 1250 by biasing member 1330.Biasing member 1330 can be Compress Spring.Thumb pusher button 1310 against protruding guide rail 1230.Protruding guide rail 1230 comprises the first locking slit 1257 be formed in guide rail 1255 and the second locking slit 1257 be formed in protruding guide rail 1230.First locking slit 1257 is located more near the first end of shell, and the second locking slit 1259 is more near the second end of shell.First and second locking slits 1257,1259 can be considered to be formed in the notch in protruding guide rail 1230.
As depicted in figs. 11-12, the size of locking slit 1257,1259 selects according to the size of stop pin 1320, and especially, the width of slit 1257,1259 is less times greater than the width (diameter) of stop pin 1320, thus when stop pin 1320 is axially aligned with slit 1257,1259, allow stop pin 1320 to be received in of slit 1247,1259.
The biasing force of biasing member 1330 causes thumb pusher button 1310 biased against protruding guide rail 1230.Therefore, along with thumb push rod 1210 is advanced along protruding guide rail 1230, stop pin 1320 against protruding guide rail 1230, and therefore, when thumb push rod 1210 to be in stop pin 1320 with an axially aligned position in slit 1257,1259 along protruding guide rail 1230, the biasing force of biasing member 1330 causes stop pin 1320 to be driven into respective slots 1257,1259, and then locks the position of thumb push rod 1210 and stop thumb push rod 1210 along the continuous lengthwise movement of protruding guide rail 1230.The importance of locking slit 1257,1259 will be discussed in detail below.
Controlled push-rod assembly 1200 also comprises propelling connecting rod 1400.Advance connecting rod 1400 to be bending curvilinear structures, it is S shape normally.Described propelling connecting rod 1400 has first end and the second contrary end.More specifically, connecting rod 1400 is advanced to have central portion 1410 and be at least basically perpendicular to a pair terminal part 1420,1430 of central portion 1410.Advance connecting rod 1400 can be formed by the different materials of any amount, comprise metal or plastic material.By being inserted into end 1420 in the opening 1282 that is formed in linkage section 1280, connecting rod 1400 is advanced to be coupled to guide rail 1260.
The other end 1430 is coupled with push rod 1500 (Figure 26 and 27).Push rod 1500 is parts of part hollow, and it has first end 1502 and the second contrary end 1504, and first end 1502 is towards the front end of shell, and the second end 1504 is towards bobbin 600.Push rod 1500 has the through hole or hole 1505 that extend through from first end 1502 to the second end 1504.Hole 1505 is formed in the main body 1510 of push rod 1500, and it is generally cylindric.Flange or the wing (thin slice) 1520 stretch out from main body 1510.Flange 1520 has the pass through openings 1521 be formed in wherein.Advance the terminal part 1430 of connecting rod 1400 to be inserted in the opening be formed in flange 1520, cause thumb push rod 1210 to be coupled with push rod 1500, thus make the lengthwise movement of thumb push rod 1210 be converted to the lengthwise movement of push rod 1500.Push rod 1500 also comprises the second flange 1525, and it has wing shape and stretches out from main body 1510.
At the first end 1502 of push rod 1500, pusher catheter 1530 is connected to this end and extends from this end radial direction.Conduit 1530 has tube chamber, and it receives the suture 1150 that roll 600 is wound around.More specifically, suture 1150 is through washer member 1100 and extend to the second end 1504 of push rod 1500, and here it enters push-rod hole 1505 and travels across push rod 1500 and the first end 1520 leaving push rod 1500 enters in the tube chamber of pusher catheter 1530.Pusher catheter 1530 can be formed by the different materials of any amount, comprises plastics and metal.In institute's exemplary embodiment, pusher catheter 1530 is formed by metal.It should be understood that because pusher catheter 1530 is connected to push rod 1500, the motion of push rod 1500 causes pusher catheter 1530 to be pushed into equally.As described herein, pusher catheter 1530 to be pushed in the tube chamber entering flexible outer catheter sheath 1590 and to advance on suture 1150.
As shown in the profile of Figure 27, hole 1505 does not have uniform-dimension, but hole 1505 has the taper configurations at the second end 1504 place.At the second end 1504 place, hole 1505 has taper inwardly to allow suture 1150 to locate more easily and through push rod 1500.The size of the central portion in hole 1505 is more even.
Operating in of push rod 1500 hereafter will be described in detail more.
Controlled push-rod assembly 1200 also comprises pawls 1600.Pawl and 1600 have cylinder-shaped body 1610, it limits pivoting point.Main body 1610 has the opening 1611 be formed at wherein, and it limits the pivotal axis of pawling.Pawl and 1600 have the first arm 1620 and the second arm 1630, first arm 1620 stretches out from main body 1610, the second arm 1630 stretches out from main body 1610.First arm 1620 ends at end 1622, and it comprises pawl or hook 1625.Second arm 1630 ends at end 1632, and it comprises ratchet 1636.As shown in FIG., the first arm 1620 has the length larger than the second arm 1630.
Pawl and 1600 pivotally to arrange in the enclosure, by using as in pin 1640 insertion opening 1611 of intermediate body portion 1000 global facility, pawling 1600 can rotate around pin 1640.Pawl 1600 location to make the first arm 1620 towards button 900 and the second arm 1630 towards locking guide rail 1260.
Biasing member 1650 is at one end connected to hook 1625 and is connected to vertical pillars 1060 at the other end, thus makes to pawl and 1600 bear biasing force.The gear teeth 1272 that the locking edge 1270 that the ratchet 1636 of pawling 1600 interlockingly engages edge locking guide rail 1260 is formed.Along with the protruding guide rail 1230 of thumb push rod 1210 along the first shell body 220 moves, ratchet 1636 one after the other engages the gear teeth 1272.As hereafter more described in detail, 1600 designs of pawling are the uncontrolled motions backward for stoping thumb push rod 1210, and and then stop sutural unexpected motion.
Controlled push-rod assembly 1200 also comprises bobbin ratchet (locking mechanism) 1700.Bobbin ratchet 1700 is coupled to intermediate body portion 1000 with bias fashion, and bobbin ratchet is moved slidably relative to fixing intermediate body portion 1000.Bobbin ratchet 1700 is arranged near opening 1072 along stayed surface 1070.Bobbin ratchet 1700 has bottom guide track structure 1720, and it mates with a pair location of parts and brace 1730 that are formed as intermediate body portion 1000, thus allows the controlled sliding motion of bobbin ratchet 1700.
By being arranged in the spring 1710 between bobbin ratchet 1700 and intermediate body portion 1000, bobbin ratchet 1700 is biased relative to intermediate body portion 1000.Bobbin ratchet 1700 also comprises ratchet section 1740, and it comprises surface, forms the gear teeth above.Ratchet section 1740 represents vertical section, and its main body away from bobbin ratchet 1700 is protruded.The gear teeth of ratchet section 1740 are complementary with the gear teeth 512 that the neighboring hoop of the wheel 510 along bobbin ratchet 500 is formed and be configured to engage with the gear teeth 512.Bobbin ratchet 1700 is designed to make when normal resting position, and spring 1710 bias voltage bobbin ratchet 1700 away from bobbin ratchet 500, thus makes the gear teeth of bobbin ratchet 1700 not engage the gear teeth 512.
When bobbin ratchet 1700 is matched to intermediate body portion 1000, vertical ratchet section 1740 be arranged in pawl 1600 the first arm 1620 and the wheel 510 of bobbin ratchet 500 between.Along with thumb push rod 1210 moves backward along protruding guide rail 1230, push rod 1500 is in the enclosure similarly backward towards axle motions.The flange 1525 of push rod 1500 contacts the end of bobbin ratchet 1700 and moving backward continuously of push rod 1500 causes bobbin ratchet 1700 to move along intermediate body portion 1000.The continuous motion of push rod 1500 and the motion of push rod 1500 cause spring 1710 storage power.Thumb push rod 1210 and moving backward continuously of push rod 1500 cause the gear teeth meshing gear teeth 512 of bobbin ratchet 1700.Once the gear teeth 512 of the gear teeth meshing bobbin ratchet 500 of bobbin ratchet 1700, bobbin ratchet 500 no longer can freely rotate, and therefore, bobbin 600 no longer can rotate.On the contrary, when thumb push rod 1210 moves upward in the side away from bobbin, push rod 1500 moves similarly, and flange 1525 departs from and the engaging of bobbin ratchet 1700, and stored by spring 1700, energy is discharged.
According to the utility model, anchor delivery conduit 100 comprises with the pulling force restraint device of bobbin clutch form as above.As mentioned below, bobbin clutch can guarantee that suture 1150 can not tension during the expansion of suture 1150.
As elucidated before, conduit 100 is configured to controllably carry anchor (wiping pad) 2000.Anchor 2000 can have the difference structure of any amount, and be included in those structures described in total U.S. Patent Application Serial Number 12/273,670 (open as US 2009/0076547), its overall content is contained in this by introducing.
As shown in Figure 29 A-29E, tissue anchor 2000 comprises stretch-draw component (suture 1150), and it has the elongated flat band 2100 of flexibility of close end and distal portion 2100a, 2100b for activity.The tip 2106 being formed or be fastened on distal portion 2100b is comprised with 2100.It should be understood, however, that tissue anchor 2000 is only according to a kind of tissue anchor in apparatus of the present utility model.Tissue anchor 2000 has fan-shaped fold design; But tissue anchor is not limited to have the design of this folded form.Especially, the tissue anchor of other types can be used, and especially, the tissue anchor of another kind of type can to have enough surface areas and/or to have the form of aid in tissue anchoring part by the tissue anchor of the hook of tissue in its atrial side.Described hook is hindered through pull-out by also finally engaging tissue by seat.In the type of anchor design, tissue anchor can not have ventricle parts.In another other embodiment, anchor can be two-piece type, a slide engaging and disengaging mechanism side be in atrial side after ventricle anchor, another part be atrial tissue anchor produce organize on both sides be blocked in these embodiments each in, slide engaging and disengaging mechanism is configured to stop anchor to be pulled through tissue.
In the design of fan-shaped fold type anchor, stretch-draw component 1150 and most advanced and sophisticated 2106 is arranged so that stretch-draw component 1150 slides relative to most advanced and sophisticated 2106.More particularly, stretch-draw component 1150 can through most advanced and sophisticated 2106.In contrast to other flexible parts of band 2100, most advanced and sophisticated 2106 relative stiffnesses, and there is the diameter less than the width of band 2100.
Band 2100 can be that about 40mm is long, about 3mm is wide.Certainly, based on the demand of embody rule, any other suitable size and dimension can be used.Dispose and fastening after have may be more satisfactory compared with the device of low profile, add folding less, can bring be suitable for extensively, cause that thrombus is few, simple etc. the advantage of usage.In addition, fastening near the close end of band 2100 on suture 1150, the distally radiopaque band 2122 of nearside radiopaque band 2120 is in the inside of most advanced and sophisticated 2106 far away or outside fastening.Under fluorescence, these bands or other marks 2120,2122 will indicate anchor 2000 to dispose as required during placement program for surgeon, start and to compress completely and/or fastening.
Most advanced and sophisticated 2106 self also can be formed by radiopaque material.The knot 2150 be formed in suture 1150 or in other stretch-draw components is Slipped Clove Hitch, and another part of suture 1150 slides through this Slipped Clove Hitch between the starting period of tissue anchor 2100.It should be understood that this Slipped Clove Hitch 2150 can be substituted by the element that another object is substantially identical, but adopt such as little tube element or be functionally similar to the form of other features of Slipped Clove Hitch.
Stretch-draw component or suture 1150 advantageously can extend through the respective folded portion 2100c of elongate strips 2100 substantially with hourglass configuration.The fold line of described portion 2100c represents at 2100d place.Specifically, sutural adjacent part interval in the pars intermedia of band 2100 is compared near the adjacent part of the suture 1150 of the near-end of band 2100 and distal portion 2100a, 2100b location farther.
Stretch-draw component or suture 1150 can pass or pads in any number of manners along band 2100, such as comprise x-pattern or other cross-mode, zigzag pattern, etc., they by anchor folding or to shorten or shape after compression becomes various useful shape, such as spend shape, annular or other circle, spherical or other configure.The change of the mode that stretch-draw component or suture 1150 pass along band 2100 length or connect can produce the higher or lower pulling force compressed needed for anchor, and/or helps higher or lower friction anchor being remained on compression or shortening configuration.
' 670 application ' has more detailed description to other details of anchor 2000.
When band 2100 is in extended position (uncompressed) state, anchor 2000 is loaded on the far-end 112 of catheter body 110.This loading position in catheter body 110, along with pusher catheter 1530 advances as described herein in catheter body 110, pusher catheter 1530 (it advances on suture 1150) engages and contacts loaded band 2100.The continuous advance of pusher catheter 1530 causes the distal ports of anchor 2000 discharge from the tip 112 of catheter body 110 and launch.
Figure 29 A-29E illustrates for launching and the series of steps of securely fixing organization anchor 2000 to organized layer 101.In general, as shown in figure 29 a, the combination of elongate strips 2100 and stretch-draw component or suture 1150 launches through organized layer 101.Then tractive suture 1150 extends through one end of Slipped Clove Hitch 2150 or a part of 1150a.This makes the distal portion 2100b of elongate strips 2100 fold and compress the distal face against organized layer 101.As shown in fig. 29b, the further tractive of tractive component 1150 causes Slipped Clove Hitch 2150 upwards or distad to advance along suture 1150, and against the proximal portion 2100a of elongate strips 2100, and then folding and compression proximal portion 2100a the proximal side made it against organized layer 1011, as shown in Figure 29 C.As shown in Figure 29 D, suitable suppression or locking member 103 can be used in Slipped Clove Hitch 2150 relative to the suture extended therethrough or stretch-draw segment securely locks in place.This is by whole anchor 2000 locks in place, and wherein organized layer or multilayer tissue's layer securely keep between which by corresponding nearside and enveloped portion, distally 2100a, 2100b.Figure 29 D shows top 2106 as the fixator on distal portion 2100b top, in place for auxiliary maintenance distal portion 2100b.Figure 29 E shows alternative, and wherein stretch-draw component is through at least one hole 2112a being positioned tip at deflection center.Another alternative is by the hole of stretch-draw component through two centralized positionings, instead of through the near-end on top 2106 and the center positioning hole 2112a of shown in Figure 29 E.These alternative make top 2106 more as "T"-shaped bar, and wherein exert a force mode effect that is more vertical with the distal portion 2100b relative to band 2100 or standard.
In normal, static (beginning) position, thumb push rod 1210 is in complete punctured position, and its middle finger pusher button 1300 is in the latched position along guide rail 1230.More specifically, the lock of button 1300 is received in notch 1259 surely, and then by thumb push rod 1210 locks in place.In order to launch anchor 2000, pusher button 1300, moving upward towards the side on limit 1254, overcomes biasing force, and is therefore retracted from notch 1259 by pin 1320.This effect release thumb push rod 1210 also allows the nose motion of thumb push rod 1210 along protruding guide rail 1230 towards handle casing 210.Along with thumb push rod 1210 moves, pawl 1600 because thumb push rod 1210 is pushed into the ratcheting fashion engagement gear teeth 1272 (not inadvertently moving backward for stoping thumb push rod 1210).
Because push rod 1500 is connected to thumb push rod 1210, the motion of thumb push rod 1210 causes push rod 1500 to be driven similarly in the same direction, and because pusher catheter 1530 is securely connected to push rod 1500, the advance of thumb push rod 1210 causes pusher catheter 1530 to be driven in the main tube cavity of also pushing guidance body 110.Anchor 2000 is arranged in pusher catheter 1530 (with initial contraction state) at least in part, and therefore, pusher catheter 1530 causes at least local expansion of anchor 2000 as described herein towards the advance of catheter body 110 far-end 112.
In addition, because anchor 2000 is connected to suture 1150, suture 1150 is caused to launch from bobbin 600 by the expansion of pusher catheter 1530 pairs of anchors 2000.
Thumb push rod 1210 is advanced forward until pin 320 axially aligned notches 1257, and now, the biasing force of spring 1330 causes pin 1320 locks in place in notch 1257.In this full extended position, thumb push rod 1210 is advanced completely in catheter body 110.Distance between two locking notches 1259,1257 is chosen as and makes to allow pusher catheter 1530 to advance in the main tube cavity of catheter body sufficient distance, thus not only contacts prestrain anchor 2000, but also at least launches or discharge a part for anchor 2000.
Far away most advanced and sophisticated 112 of catheter body 110 can have sharp point (hypotenuse), thus promotes and make far away most advanced and sophisticated 112 can puncturing tissue, such as mitral ring tissue.When conduit 100 is used as annuloplasty on bicuspid valve, catheter body 110 launches on seal wire 2200 until far away most advanced and sophisticated 112 puncture and pass through ring, to make outlet port 113 and far away most advanced and sophisticated 112 in the same side of ring.Once outlet port 113 is positioned in the atrial side of ring, a part for anchor 2000 is deployed in the atrial side of ring by thumb push rod 1210.Stretch-draw component (suture) 1150 has close end and distal portion 2100a, the flexibility of 2100b, elongated flat band 2100 for activating again.Along with catheter body 110 and elongate strips 2100 extend through ring tissue, the hypotenuse far away most advanced and sophisticated 112 and in some cases most advanced and sophisticated 2106 of catheter body 110 helps puncture ring tissue.Along with catheter body is recalled from ring tissue, in order to prevent the distal portion 2100b of elongate strip to be pulled through ring tissue, far away most advanced and sophisticated 112 from left ventricle puncture through ring tissue and after entering atrium sinistrum, the free end of tractive stretch-draw component 1150.This makes distal portion 2100b be formed as folding or shorten configuration.Then catheter body 110 can be withdrawn, and elongate flexible strip 2100 can not be made to recall together with catheter body.
As described herein, the distal portion of elongate strips 2100 is advanced by the driving of push rod 1500 and pusher catheter 1530 and launches with engaging of anchor 2000 in catheter body 110.This action causes the distal portion of band 2100 to discharge from far away most advanced and sophisticated 112.During the expansion of band 2100 distal portion and after launching, first by pressing button 900, these gear teeth 828 causing bobbin to lock 800 pivotables and bobbin lock 800 engage the gear teeth 512 of bobbin ratchet 500, and suture 1150 is tightened up thus.Along with suture 1150 is tightened up, the gear teeth 828 stop bobbin ratchet 500 freely to reverse with engaging of the gear teeth 512.More specifically, by Rotating thumbwheel 700, this causes the rotation of bobbin 600 and bobbin ratchet 500, and suture 1150 is tightened up.
Bobbin lock 800 is used to allow the one-handed performance of this device.Thumb wheel 700 can be rotated, and the thumb of doctor can lift and to be repositioned at wheel upper for further rotation, and locks 800 and with when taking turns and contact do not allow to reverse at thumb.
Along with thumb wheel 700 rotates, under suture 1150 is little by little placed in pulling force; But as discussed earlier, conduit 100 of the present utility model comprises pulling force limiting mechanism, such as slide engaging and disengaging assembly, this assembly stops tissue anchor to be pulled by tissue due to excessive tension.Be wound around gradually under larger pulling force along with suture 1150 and arrange, clutch component is used as pulling force restraint device, and when overtighten event occurs, bobbin 600 and ratchet 500 slide relative to each other, the ratchet 545 of pawl 540 is caused temporarily to be separated from corresponding recessed section 673.During sliding action, ratchet 545 gets on along hypotenuse 678, causes ratchet 545 to depart from corresponding section 673, and pawl 540 is along with they curve inwardly and storage power.Before running into next adjacent recesses section 673 (the relative rotation due between bobbin 600 and ratchet 500), now ratchet 545 is driven into wherein because pawl 540 discharges the energy stored by them, and the ratchet 545 of displacement is advanced along adjacent platform 676.This sliding action repeatedly can occur based on operation of this device etc.
It should be understood that slide engaging and disengaging arrangement of components is passed through for stoping draw tissue.In other words, slide engaging and disengaging arrangement of components is the force that restriction is applied to atrium anchor, thus stops draw tissue by (such as, stoping anchor to be pulled by organizing self).
Along with ratchet 500 slides relative to bobbin 600, receiving slot zygonema 1150 is fully tensioned and the sense of hearing that should not be placed under further pulling force and/or tactile feedback by user, thus stops draw tissue to pass through.When slide engaging and disengaging component slippage, the distal portion of band 2100 should be compressed on the side of tissue (ring tissue) completely, as shown.Once the distal portion of band 2100 is fully compressed, by further tractive catheter body 110 in a proximal direction, far away most advanced and sophisticated 112 of flex conduit body 110, and and then whole length of exposed band 2100, launch the proximal portion 2100a of elongate strips 2100.In other words, tractive catheter body 110 is being organized on opposite side relative to by the ring of compression distal portion to make it.By catheter body 110 of retracting in a proximal direction, thus make far most advanced and sophisticated 112 spacer rings organize certain distance, the proximal portion of the anchor 2100a of elongate strips 2100 is exposed and be positioned at the outside of catheter body 110, thus allows its tension in ring ventricular side.Bobbin lock 800 is separated during shrinking, thus is pulled along with the far-end of catheter body 110 relative to band 2100, allows the uncoiling of suture 1150.
Then, stretch-draw component 1150 is pulled or strains to make to draw or the proximal portion 2100a of compression elongate strips 2100 enters folding, shortening state and is resisted against ring and organizes bottom side.
This process repeatedly many times, thus can produce the tissue fold of requirement by tissue anchor is placed in diverse location.
After tissue anchor is fastened to tissue site, those the other steps such as existed described in the application of ' 240 can be taked.
It should be understood that the utility model provides hand-held and manually operated device, make tissue anchor (wiping pad) controllably launch and be anchored to tissue.This hand-operating device comprises multiple safety component, to guarantee that described anchor is carried exactly and guarantees to occur the overtighten of stretch-draw component (suture).
Although describe the utility model in conjunction with some embodiment, the utility model can be implemented with other forms and use other materials and structure.Therefore, the utility model is limited by the description in appended claims and equivalent thereof.

Claims (22)

1. organize an anchor system, it is characterized in that, it comprises:
Tissue anchor component, it is configured to for anchoring organizationally;
Stretch-draw component, it may be operably coupled to anchor component, thus makes anchor component can stretch-draw member slide relatively, and described stretch-draw component can be pulled to cause anchor component to change its position; And
Manual operation launches conduit, and it can operate to extend and therefrom launch anchor component, and this expansion conduit has handle and comprises:
Rotating parts and clutch component, described stretch-draw component is advanced around rotating parts, and described clutch component is for limiting the tension force in stretch-draw component, and wherein said rotating parts holds in the enclosure;
Deployable push-rod assembly, it is for controllably launching a part for anchor component, and described push-rod assembly comprises slidably ram actuators, and it is connected to handle and can be close along handle, and movable between retracted position and expanded position, wherein push-rod assembly launches anchor component at least partially; And
Locking mechanism, it selectively engages rotating parts and stops the rotation of rotatable structure, wherein when slidably ram actuators is in retracted position, locking mechanism automatically engages rotating parts thus stops the rotation of rotating parts, and maintains the length of stretch-draw component in the existence of rotating parts outside.
2. organize an anchor system, it is characterized in that, it comprises:
Anchor component, it can be inserted through tissue and be suitable for being anchored at least side of tissue;
Stretch-draw component, it may be operably coupled to anchorage element, thus make anchor component can relative to stretch-draw member slide, described stretch-draw component can be pulled to cause anchor component to move relative to described stretch-draw component, thus apply pulling force to stretch-draw component with seat by anchor component;
Launch conduit, it can operate to extend and therefrom launch anchor component, and described expansion conduit comprises:
Handle;
Catheter body, it is at one end securely connected to handle, and described anchor component and the stretch-draw component connected are included in the main tube cavity of catheter body;
Bobbin assemblies, it comprises the bobbin that stretch-draw component is advanced around it;
Slide engaging and disengaging assembly, it may be operably coupled to bobbin assemblies, and described slide engaging and disengaging arrangement of components is when applying pulling force to anchor component, is pulled and is wound around bobbin along with stretch-draw component, the pulling force in restriction stretch-draw component; And
Deployable push-rod assembly, it is for controllably launching a part for anchor component, and described push-rod assembly comprises slidably ram actuators, and it is connected to handle and can be close along handle, and movable between retracted position and expanded position, wherein push-rod assembly launches anchor component at least partially.
3. system according to claim 2, wherein said anchor component is flexible anchor component, and it is in prolongation configuration and shorten between configuration movable; Described anchor component has close end, distal portion and compressible pars intermedia, wherein shorten configuration and comprise zigzag folding mode, and tractive stretch-draw component causes anchor component to move to from prolongation configuration and shortens configuration, and wherein compressible mid portion can compress also and then be adjusted to the thickness of organized layer between close end and distal portion.
4. system according to claim 2, wherein said anchor component is formed by the material being selected from least one in natural fiber, synthetic fibers, polymer and metal.
5. system according to claim 2, wherein said stretch-draw component comprises suture.
6. system according to claim 2, wherein said stretch-draw component comprises the stop member engaged with described anchor component.
7. system according to claim 6, wherein said stop member also comprises the knot in stretch-draw component.
8. system according to claim 2, wherein said catheter body is rapid-exchange catheter body, and it comprises the guidewire lumen for receiving seal wire and the main tube cavity for receiving anchor component and stretch-draw component.
9. system according to claim 8, wherein said guidewire lumen is at the tip far away place opening of catheter body, and wherein the main tube cavity of catheter body is being interval in far away most advanced and sophisticated and is being positioned at the position opening of most advanced and sophisticated nearside far away.
10. system according to claim 8, wherein said push-rod assembly comprises can pivotable pawl, and it is connected to the shell of handle and interlockingly engages slidably ram actuators, thus stops the freedom of push-rod assembly to be moved backward.
11. systems according to claim 10, wherein said pawling is connected to biasing member, and described biasing member is securely connected to shell, and described in pawl there is arm, described arm has the gear teeth, and the described gear teeth interlockingly engage the gear teeth along the slidably locking guide rail formation of ram actuators.
12. systems according to claim 10, wherein said slidably push rod is along guide rail movement, described guide rail is formed along the inner surface of handle casing, wherein said guide rail comprises the first locking notch and the second locking notch, described first locking notch is used for slidably to fix on extended position by push-rod lock, and described second locking notch is used for slidably to fix on punctured position by push-rod lock.
13. systems according to claim 2, wherein said bobbin assemblies also comprises bobbin ratchet, it comprises lower gear, described lower gear has the gear teeth circumferentially formed along the neighboring of taking turns, described bobbin ratchet has the first clutch component, and it is the parts of clutch component and matches, when the pulling force wherein in stretch-draw component exceedes threshold value with the second clutch component as bobbin parts, described bobbin ratchet and bobbin relative to each other slide, and then stop stretch-draw component to be excessively stretched.
14. systems according to claim 13, wherein said bobbin assemblies also comprises rotatable thumb wheel, its along handle can close to and be connected to bobbin ratchet, thus make the rotation of thumb wheel be converted to the rotation of bobbin ratchet.
15. systems according to claim 13, wherein said first clutch component comprises at least one flexible pawl, it comprises the locking pawl being positioned at its free end, and described second clutch component comprises annular protrusion wall, it is formed as the parts of bobbin and comprises multiple recessed section, the platform section of they and concave wall alternately, wherein at normal operating position, locking pawl bias voltage enters and remains in one recessed section until the pulling force in stretch-draw component exceedes threshold value, and then locking pawl skids off and recessed section engage, and advance until bias voltage enters next recessed section along adjacent platforms section.
16. systems according to claim 13, wherein said bobbin assemblies also comprise along the come-at-able button of handle and be pivotally connected to handle casing and be connected to button and biasing member bobbin lock, described bobbin lock comprises arm, it has lock-in edge, described lock-in edge comprises multiple gear teeth, wherein button cause bobbin to lock towards the motion of bobbin arm towards bobbin ratchet pivotable until the gear teeth of bobbin lock interlockingly engage the gear teeth of bobbin ratchet, and then stop rotating freely of ratchet and bobbin.
17. systems according to claim 2, wherein said push-rod assembly comprises push rod, described push rod is connected to slidably ram actuators and also can therewith moves, and have and be fastenedly connected and the pusher catheter extended laterally from its one end, described pusher catheter has the tube chamber receiving stretch-draw component, and wherein said push-rod assembly comprises bobbin ratchet, movable in its guide channel formed in the parts of formation handle casing, and comprise the part with the gear teeth, wherein described slidably ram actuators is in punctured position time, a part for push rod engages and drives bobbin ratchet towards bobbin assemblies, thus make the gear teeth meshing of bobbin ratchet be formed as the complementary gear teeth of bobbin assemblies parts, and stop bobbin assemblies to rotate.
Organize anchor system, it is characterized in that for 18. 1 kinds, it comprises:
Anchor component, it can be inserted through tissue and be suitable for being anchored at least side of tissue;
Stretch-draw component, it may be operably coupled to anchorage element, thus make anchor component can relative to stretch-draw member slide, described stretch-draw component can be pulled to cause anchor component to move relative to described stretch-draw component, thus apply pulling force to stretch-draw component with seat by anchor component;
Launch conduit, it can operate to extend and therefrom launch anchor component, and described expansion conduit comprises:
Handle;
Catheter body, it is at one end securely connected to handle, and described anchor component and the stretch-draw component connected can be included in the main tube cavity of catheter body;
Bobbin assemblies, it comprises the bobbin that stretch-draw component is advanced around it, and described bobbin has the first slide engaging and disengaging portion; And
Slide engaging and disengaging assembly, it comprises the first slide engaging and disengaging portion of bobbin and is formed as the second slide engaging and disengaging portion of bobbin ratchet part, described slide engaging and disengaging arrangement of components is when applying pulling force to anchor component, is pulled and is wound around bobbin along with stretch-draw component, the pulling force in restriction stretch-draw component; Wherein said bobbin and bobbin ratchet rotate around common axle.
19. systems according to claim 18, be arranged in the centre bore be formed in bobbin, and then described first and second slide engaging and disengaging portions are operationally connected to each other comprising the center-wheel arbor in the second slide engaging and disengaging portion.
20. systems according to claim 18, wherein said first slide engaging and disengaging portion comprises concave wall, it comprises the multiple spacing convave troughs be formed at wherein, described groove inwardly and opening to the centre bore of bobbin, and described second slide engaging and disengaging portion comprises multiple flexible pawl, each grippers has the ratchet being formed in its free end, so that bobbin is coupled to bobbin ratchet in the corresponding recesses that the ratchet of described flexible pawl is received in bobbin.
21. systems according to claim 18, wherein said bobbin ratchet comprises multiple first gear teeth formed around its periphery, and this system this comprise bobbin lock, it comprises second gear teeth mate with first gear teeth, thus prevention bobbin ratchet freely reverses when stretch-draw component is tightened up.
22. systems according to claim 18, wherein said bobbin and bobbin ratchet coupled to each other and as one man rotate.
CN201420385948.9U 2014-07-11 2014-07-11 Organize anchor system Expired - Lifetime CN204293210U (en)

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US11964145B2 (en) 2019-07-12 2024-04-23 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use
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Patentee after: Beijing Tide Pharmaceutical Co.,Ltd.

Address before: Massachusetts

Patentee before: MITRALIGN, Inc.

TR01 Transfer of patent right
TR01 Transfer of patent right

Effective date of registration: 20200812

Address after: 7 / F, block B, building 8, No. 8, Rongjing East Street, Beijing Economic and Technological Development Zone, Daxing District, Beijing 100176

Patentee after: Beijing caditai Medical Device Technology Co.,Ltd.

Address before: 100176 No.8, rongjingdong street, Beijing Economic and Technological Development Zone, Beijing

Patentee before: Beijing Tide Pharmaceutical Co.,Ltd.

CX01 Expiry of patent term
CX01 Expiry of patent term

Granted publication date: 20150429