CN106572910A - Mitral valve implants for the treatment of valvular regurgitation - Google Patents

Abstract

The invention relates in some aspects to a device for use in the transcatheter treatment of mitral valve regurgitation, including steerable guidewires, implantable coaptation assistance devices, anchoring systems for attaching a ventricular projection of an implantable coaptation device, a kit, and methods of using an implantable coaptation assistance device among other methods.

Description

For treating the mitral valve implant of valvular regurgitation

This application claims entitled " for treating the mitral valve implant of valvular regurgitation " submitted on June 18th, 2014 U.S. Provisional Patent Application No. 62/014060 priority.The complete disclosure of priority application before is by quoting It is expressly incorporated herein for all purposes.

Background

Field

Present invention generally provides be typically used in treatment heart valve disease and/or for change body one or more The improved medical apparatus of the feature of valve, system and method.Embodiment of the present invention is included for treating mitral reflux Implant.

Human heart receives blood via vein from organ and tissue, pumps the blood by lung, and blood becomes in lung Must be rich in oxygen, and promote the blood of oxygenation to leave heart to artery so that the tract of body can extract oxygen for Appropriate function.The blood of deoxidation flows back to heart, and it is pumped to again lung in heart.

Heart includes four chambers：Atrium dextrum (RA), right ventricle (RV), atrium sinistrum (LA) and left ventricle (LV).Heart is left The general synchronous generation during total cardiac cycle of the pump action on right side.

Heart has four valves, and the valve is commonly configured to during cardiac cycle optionally in correct side It is delivered up blood flow.The valve that atrium and ventricle separate is referred to as into atrial ventricle (or AV) valve.Atrium sinistrum and left ventricle it Between AV valves be bicuspid valve.AV valves between atrium dextrum and right ventricle are tricuspid valves.Pulmonary valve guides blood flow to lung Artery and thus to lung；Blood returns to atrium sinistrum via pulmonary vein.Aorta petal guiding blood flow by sustainer and by This is to periphery.It is not directly connected to generally between ventricle or between atrium.

Mechanical heart is beaten by the electric pulse triggering propagated in whole heart tissue.The opening and closing of heart valve can be with Mainly due to occurring caused by the pressure reduction between chamber, these pressure are produced by passive fill or chamber contraction.For example, it is mitral Opening and closing can occur due to the pressure reduction between atrium sinistrum and left ventricle.

When ventricle filling (diastole) starts, aorta petal and pulmonary valve close to prevent driven arteries and veins to be back to ventricle In.Thereafter at once, AV valves are opened with the uncrossed flowing in allowing from atrium to corresponding ventricle.In ventricular contraction (that is, ventricle emptying) start after at once, tricuspid valve and bicuspid valve are normally closed, and so as to form sealing, the sealing is prevented from the heart Room is flow back in corresponding atrium.

Unfortunately, AV valves may be damaged or may not suitably function, so as to cause improper closure.AV Valve is complicated structure, generally includes annulus (annulus), leaflet (leaflet), rope (chordae) and support structures.Respectively Individual atrium is connected via atrium vestibular with its valve.Bicuspid valve has two leaflets；Tricuspid similar structures have three lobes Leaf, and the relative or engagement toward each other of corresponding leaflet surface helps provide the closure of valve or sealing so as to anti-Hemostatic Oral Liquid Flow in the wrong direction.Leaflet can not be sealed and be referred to as bad pairing during ventricular systole, and may allow blood (backflowed) by valve regurgitation.Heart valve backflows may cause serious consequence to patient, typically result in heart failure, and blood flow subtracts It is few, low blood pressure, and/or to the oxygen flow reduction of bodily tissue.Mitral reflux is likely to cause blood to be back to from atrium sinistrum Pulmonary vein, causes hyperemia.Serious valvular regurgitation, if being not added with treatment, may cause permanent disabled or dead.

Description of Related Art

Various therapies are applied to treat mitral reflux, and other therapies are still suggested but are not also actually used In treatment patient.Although it have been found that some known therapies provide benefit at least some of patient, but still need further Selection.For example, medicament (such as diuretics and vasodilator) can be used for the patient with slight mitral reflux to help Reduction is back to the amount of the blood in atrium sinistrum.However, medication may lack the compliance of patient.Many patients may be once in a while (or even regularly) medication could not be carried out, despite the presence of the potential of mitral reflux that is chronic and/or going from bad to worse Seriousness.The pharmacological treatment of mitral reflux is also likely to be inconvenient, and often invalid (dislikes especially with situation Change), and may be related to serious side effect (such as low blood pressure).

Various procedure options have also been suggested and/or for treating mitral reflux.For example, open heart operations (open-heart surgery) can replace or repair function obstacle bicuspid valve.At valvoplasty (annuloplasty) During annulus are repaired, rear annulus of mitral valve can be reduced along the size of its girth, optionally pass through mechanical operation valve using suture Plasty sutures annulus to provide pairing (coaptation).Open surgery is likely to try to carry out leaflet shaping and/or right Support structures are transformed.Anyway, open mitral valve surgery (open mitral valve surgery) is all generally one Very invasive treatment is planted, it is carried out in general anesthesia and in the case that thoracic cavity is cut open in patient on heart-lung machine. Complication can be common, and in view of the incidence of disease (and potential death rate) of open heart operations, arrangement of time Becoming the heavier patient of a difficult problem-disease may be highly desirable to operation, but but less be amenable to the art that must stop.Successfully open two is sharp Lobe surgical outcome is likely to be highly dependent on operation skill and experience.

In view of the M ＆ M of open heart operations, innovator has sought less invasive operation and has treated Method.The method carried out using robot or by endoscope generally remains quite invasive, and be also likely to be it is time-consuming, Expensive, and at least some of situation, it is highly dependent on surgical technology.To these sometimes weak patients in addition Even less wound would be desirable, and equally will preferably be to provide such therapy, and the therapy can be by substantial amounts of doctor It is raw successfully to be implemented using the technology for differing greatly.For this reason it has already been proposed that various it is said that the less technology of invasive and method.This It is a little to include trying to carry out the device of shaping to annulus of mitral valve from coronary sinus；Attempt by fastening natural annulus from top to bottom to lobe Ring carries out the device of shaping；The device (imitating Alfieri sutures) of fusion leaflet；Device of shaping etc. is carried out to left ventricle.

Have been developed for may is that most known various mitral valve replacement implants, these implants are generally replaced (or replace) native leaflets and control the blood flow paths between heart chamber by the structure of operation implantation.Although this A little various Method and kit fors meet the affirmative of varying level, be also widely recognized as great majority without one kind or The preferable therapy of all patients for being subjected to mitral reflux.

It is still also alternative due to known minimally-invasive mitral reflux therapy and the difficult problem and shortcoming of implant Treatment is suggested.Some are alternatively proposed to require that the structure of implantation is maintained in annulus within the whole cardiac cycle.During these are proposed One group of holding on the rope or rigid rod extended between atrium and ventricle by valve orifice such as including cylindrical balloon Implantation.Another group, by arch ring structure etc., generally combines the arch wall (buttress) or structure cross member for extending through valve, With fixation implant.Unfortunately, the sealing between native leaflets and balloon or other whole girths with axis body may certify that and be There is challenge, if bent while allowing arch wall or fixator to interconnect cross member, during each heartbeat around natural annulus Significantly shrink significant fatigue failure tissue during may causing to be chronically implanted.Additionally, the notable movement of valvular tissue may make Being accurately positioned of implant becomes difficult, and is rigid or flexible unrelated with implant.

In view of more than, it is generally desirable to improved medical apparatus, system and method are provided.Particularly desirable is to provide new technology For treating mitral reflux and other heart valve diseases, and/or for one or more in other valves for changing body Feature.There is still a need for such device, it can directly strengthen leaflet pairing (rather than indirectly via fusion or other modes Ground is via annulus or ventricle shaping) and leaflet anatomy is not destroyed, but can be simply and reliably to configure, and without the need for mistake Many cost or operating time.If will be particularly advantageous these new technologies can be implemented using less intrusion method, and not Need to stop heart or dependence heart-lung machine to configure, and be not need to rely on surgical professional technique, so as to provide The valve and/or cardiac function of raising.

General introduction

In some embodiments, disclosed herein is a kind of implant for treating heart valve insufficiency.The plant Entering thing can include one of the following or various：Shape memory structure, couples to the bio-compatible film of the structure, is placed on On the nearside of the implant and couple to the maincenter of the film (hub), one of the edge of the film on the nearside, Two or more holes or perforation, and couple to the ventricle protrusion of anchor.The implant can be folded up for leading to Cross percutaneous catheter delivering.Shape memory structure can include shape memory ridge (spine), such as Nitinol or such as PEEK.The heart A part for room protrusion, such as distal tip, can be radiopaque.Anchor can be active, or passive. The ridge can include the minute aperture and the part of miniature hook for being such as used to be connected to the film and tissue.

There is disclosed herein a kind of controllable conduit, it includes one or more in controllable axle, rotatable handle, institute State rotatable handle to couple to the draught line being placed in the axle with according to the torque capacity adjustment for putting on the shank The bending radius of the distal tip of axle.In some embodiments, the diameter of the shank of the conduit is equal to described behaviour The diameter of control axle, or the diameter of no more than described controllable axle.There is disclosed herein a kind of delivery catheter, the delivery catheter bag Include one of the following or various：Coupling to being placed on can reverse the draught line in (torqueable) axle to adjust the conduit The axle distal tip bending radius rotatable handle, be designed to be accommodated when the implant is folded described The sheath of implant, and distal tip, the distal tip further includes the maincenter that delivery catheter can be made to be connected to implant (hub) or it is connected to the locking member of anchoring piece.In some embodiments, the conduit can also include it is peelable once Property funnel is aiding in the folding of the implant.In some embodiments, the distal tip further includes locking tongue, The locking tongue is arranged in unlocked position naturally.The delivery catheter can be coupled into the annulus of the implant Pivot (annular hub), the annulus maincenter has the part of the locking tongue for receiving the delivery catheter.In some embodiment party In case, guide wire or other conduits can be inserted into matching somebody with somebody to push locking tongue to the implant supercentral in the axle To part so that the conduit and the maincenter are locked.The conduit can also include ring, and such as proximally shank is marched to The wire of distal tip allows the tension force in ring to control via the control piece on shank.Delivery catheter can couple to The annulus maincenter of implant, the annulus maincenter has cross pin.Guide wire or other conduits can be inserted in the axle, And wire rings are tensed against cross pin and guide wire, till the tension force on ring is maintained so that the delivering Conduit locks onto the maincenter of the implant.

Implant can be coupled and anchoring piece and the second of implant maincenter via the first of anchoring piece and delivery catheter Couple (wherein apply moment of torsion so as to anchoring piece is inserted in maincenter and tissue to delivery catheter) and operationally couple to tissue, Such as heart tissue.First couples and can be coupled to withdraw the conduit by solution.

In some embodiments, Colaesce (commissure) anchoring piece can through the following steps in one or more To be delivered：Anchoring piece is coupled to into the axle of conduit, the anchoring piece and the conduit are advanced into into anchoring position, delivering is described Anchoring piece causes it to engage with implant and tissue, and the anchoring piece is coupled from the axle solution.The axle can be can Apply torque, and engaging mechanism can apply moment of torsion and the anchoring piece is engaged with implant and tissue to the axle. The anchoring piece can be made up of shape-memory material and can be compressed in the axle of conduit for delivery to anchoring position, The distal tip of wherein conduit is formed as so that it pierces through tissue.Anchoring can be advanced after delivery catheter pierces through tissue first Part, and conduit is subsequently withdrawn, leave anchoring piece in place.

In some embodiments, a kind of implant for treating heart valve insufficiency is disclosed.The implant Can include it is following in one or more：Removable shape memory structure, couples to the bio-compatible film of the structure, puts Put on the nearside of the implant and couple to the maincenter of the film, one of the edge of the film on the nearside, Two or more holes or perforation, and couple to the ventricle protrusion of anchor.The implant can also include at least one Path, such as places and/or along the path of ventricle protrusion around annulus edge.In some embodiments, deliver multiple, it is all If 2,3,4,5 or more anchoring pieces by implant so that be coupled to heart tissue.Delivery apparatus can have remote Side section, the distal section includes rotatably being coupled to 1,2 or multiple anchoring pieces of central rotary shaft.Spring loaded mechanism Thrust can be applied to cause anchoring piece to leave distal end.In some embodiments, anchoring piece can be contained in internal diameter upper band In reeded shell so that when central rotary shaft rotates, anchoring piece may exit off distal end.Described device can include following One or more, for example：Hollow shaft, in the tip of the end of the hollow shaft, be placed in hollow shaft by metal wire One, the two or more hollow barrels for passing through, and in the push rod of proximal end so that when to push rod applying power, one, the bucket Connect a ground and leave hollow shaft.

In some embodiments, disclosed herein is a kind of controllable guide wire, including elongated flexible body portion, it has The longitudinal axis, near-end and distally deflecting region；Control piece on the near-end, it is used for the controllable deflection of the deflecting region；With from institute State the removable deflecting element that control piece extends to the deflecting region.In some embodiments, the guide wire is not any Partial external diameter is greater than about 10 French, 8 French, 6 French or 4 French.The control piece can have no more than institute State the external diameter of the external diameter in body portion.The control piece can cause the transverse shifting of the deflecting region around the rotation of the axle.Institute Stating control piece can cause the proximal retraction of the deflecting element around axle rotation in a first direction.

There is disclosed herein a kind of implantable pairing servicing unit, including flexible body portion；The first recessed table in the body portion Face, first concave surface is configured to limit posterior valve leaflet；The second concave surface in the body portion, second concave surface is by structure Cause to contact front leaflet；Arc-shaped circumference upper limb in the body portion, the arc-shaped circumference upper limb is limited and faces away from described first The opening on surface；With ventricle protrusion, the ventricle protrusion extends and is configured to be anchored at ventricle away from the body portion In.Described device can also include the anchoring piece on ventricle protrusion.The anchoring piece can be active or passive.It is described Device can also include the flexible ridge for supporting the arc-shaped circumference edge.In some cases the ridge can be removable 's.

There is disclosed herein a kind of anchor system for being attached the ventricle protrusion of implantable pairing device.The system Can include：Shoulder, the shoulder has the hole for extending through the shoulder；Helical tissue anchoring piece, the helical form group Knit anchoring piece distally extending from maincenter；The first connected structure on the anchoring piece, first connected structure is used to release Engage torque axis with putting；The second connected structure on the torque axis, second connected structure is used to engage the anchoring piece； And implant, the implant has a maincenter, and being dimensioned to of the maincenter receives the helical form anchoring piece and pass through；Its Described in torque axis be configured for rotating driving the helical form anchoring piece to enter in tissue and by the implant It is fixed to tissue.First connected structure can be hole, and second connected structure can be protrusion.The protrusion Thing can laterally be moved into and out the hole, all as in response to the axial movement of the elongated member in the torque axis.

In some embodiments, there is provided controllable guide wire.The controllable guide wire can include elongated scratching Gonosome portion, it has the longitudinal axis, near-end and distally deflecting region.The controllable guide wire can be included in the control on the near-end Part, it is used for the controllable deflection of the deflecting region.The controllable guide wire can be included from the control piece to the deflection The removable deflecting element that area extends.In some embodiments, the guide wire does not have any portion of external diameter to be greater than about 10 French.In some embodiments, the guide wire does not have any portion of external diameter to be greater than about 6 French.In some enforcements In scheme, the guide wire does not have any portion of external diameter to be greater than about 4 French.In some embodiments, the control piece External diameter be not more than the external diameter in the body portion.In some embodiments, the control piece causes institute around the rotation of the axle State the transverse shifting of deflecting region.In some embodiments, the control piece is led around axle rotation in a first direction Cause the proximal retraction of the deflecting element.

In some embodiments, there is provided implantable pairing servicing unit.The implantable pairing servicing unit can be with Including flexible body portion.The implantable pairing servicing unit can include the first concave surface in the body portion, and described first is recessed Surface is configured to limit posterior valve leaflet.The implantable pairing servicing unit can include the second concave surface in the body portion, Second concave surface is configured to contact front leaflet.The implantable pairing servicing unit can include the arc in the body portion Shape periphery upper limb, the arc-shaped circumference upper limb limits the opening for facing away from the first surface.The implantable pairing auxiliary Device can include ventricle protrusion, and the ventricle protrusion extends away from the body portion and is configured to be anchored at the heart In room.

In some embodiments, the implantable pairing servicing unit can include the anchoring on the ventricle protrusion Part.In some embodiments, the implantable pairing servicing unit can include active anchoring piece.In some embodiments In, the implantable pairing servicing unit can include passive anchoring piece.In some embodiments, the implantable pairing is auxiliary Device is helped to include for supporting the flexible ridge at the arc-shaped circumference edge.In some embodiments, the ridge is removable Remove.

In some embodiments, there is provided for being attached the anchor system of the ventricle protrusion of implantable pairing device. The anchor system can include shoulder, and the shoulder has the hole for extending through the shoulder.The anchor system can be wrapped Helical tissue anchoring piece is included, the helical tissue anchoring piece is distally extending from maincenter.The anchor system can include The first connected structure on the anchoring piece, first connected structure is used to be releasably engaged torque axis.The anchoring system System can include the second connected structure on the torque axis, and second connected structure is used to engage the anchoring piece.It is described Anchor system can include implant, and the implant has a maincenter, and being dimensioned to of the maincenter receives the spiral Shape anchoring piece is passed through.In some embodiments, the torque axis is configured for rotating to drive the helical form to anchor Part to be entered and be fixed to tissue in tissue and by the implant.In some embodiments, first connected structure is Hole, and second connected structure is protrusion.In some embodiments, the protrusion can laterally be moved into and out described Hole.In some embodiments, the protrusion may be in response to the axial movement of the elongated member in the torque axis and horizontal Be moved into and out the hole.

In some embodiments, there is provided implantable pairing servicing unit.The implantable pairing servicing unit can be with Including pairing auxiliary body portion, the pairing auxiliary body portion includes the first pairing surface, the second contrary pairing surface, each surface By the first lateral margin, the second lateral margin, lower edge and upper limb limited boundary.The implantable pairing servicing unit can be included under described The ventricle protrusion that edge extends.The implantable pairing servicing unit can include the first supporter, and first supporter exists At least a portion of the pairing servicing unit is extended through between the upper limb and the ventricle protrusion.It is described implantable right Closing servicing unit can include the second supporter, and second supporter prolongs between first lateral margin and second lateral margin Extend through at least a portion in the pairing auxiliary body portion.The implantable pairing servicing unit can include path, described logical Road extends through at least a portion of the pairing servicing unit, and being dimensioned to of the path receives controllable conduit to wear Cross wherein.In some embodiments, first supporter has that wherein described first supporter is generally straight line One configuration and wherein described first supporter are the second configurations of bending.In some embodiments, described first and second Support body is configured to allow for being percutaneously inserted for the implantable pairing servicing unit.

In some embodiments, the path extends through described right between the upper limb and the ventricle protrusion Close at least a portion of servicing unit.In some embodiments, the controllable conduit includes being adapted to the remote of bending Side tip.In some embodiments, rotating the shank of the controllable conduit causes the distal tip to bend.In some realities In applying scheme, first supporter includes shape-memory material.In some embodiments, first supporter is attached to The pairing auxiliary body portion.In some embodiments, the pairing auxiliary body portion includes inner chamber, and the size of the inner chamber is made Become at least a portion for receiving first supporter.In some embodiments, first supporter is removable. In some embodiments, first supporter extends to the ventricle protrusion from the upper limb.In some embodiments In, the path extends through at least of the pairing auxiliary body portion between first lateral margin and second lateral margin Point.In some embodiments, second supporter includes shape-memory material.In some embodiments, described second Supporter is attached to the pairing auxiliary body portion.In some embodiments, the pairing auxiliary body portion includes inner chamber, described interior Being dimensioned to of chamber receives at least a portion of second supporter.In some embodiments, described second support Body is removable.In some embodiments, second supporter extends to second lateral margin from first lateral margin. In some embodiments, first supporter is coupled to second supporter.In some embodiments, described first Supporter and second supporter are coupled to removable maincenter, and the removable maincenter is from the pairing auxiliary body portion Surface projects.

In some embodiments, there is provided kit utility.The kit utility can include implantable pairing auxiliary dress Put.The implantable pairing servicing unit can include pairing auxiliary body portion, and the pairing auxiliary body portion includes the first pairing table Face, the second contrary pairing surface, each surface is by the first lateral margin, the second lateral margin, lower edge and upper limb limited boundary.It is described to plant Enter the ventricle protrusion that pairing servicing unit can include extending from the lower edge.The implantable pairing servicing unit can be wrapped Include path, the path extends through at least a portion of the pairing servicing unit, being dimensioned to of the path connects Controllable conduit of receiving passes through the path.The kit utility can include controllable conduit.In some embodiments, it is described Controllable conduit is configured to by bicuspid valve and towards ventricular organization's bending, wherein the implantable pairing servicing unit quilt It is configured to be passed through the controllable conduit towards the ventricular organization.

In some embodiments, the path extends through described right between the upper limb and the ventricle protrusion Close at least a portion of servicing unit.In some embodiments, the controllable conduit includes being adapted to the remote of bending Side tip.In some embodiments, rotating the shank of controllable conduit causes the distal tip to bend.In some embodiment party In case, the path extends through at least the one of the pairing auxiliary body portion between first lateral margin and second lateral margin Part.

In some embodiments, there is provided using the method for implantable pairing servicing unit.Methods described can include By pairing auxiliary body portion towards heart valve insert the step of.In some embodiments, the pairing auxiliary body portion includes first Pairing surface, the second contrary pairing surface, each surface by the first lateral margin, the second lateral margin, lower edge and upper limb limited boundary, from The ventricle protrusion that the lower edge extends.Methods described can include that manipulating the first supporter causes the pairing auxiliary body portion to be in The step of existing curved configuration.In some embodiments, first supporter the upper limb and the ventricle protrusion it Between extend through at least a portion of the pairing servicing unit.Described in methods described can include that manipulating the second supporter causes The step of pairing auxiliary body portion is presented curved configuration.In some embodiments, second supporter is in first lateral margin At least a portion in the pairing auxiliary body portion is extended through and second lateral margin between.

In some embodiments, manipulating the first supporter includes discharging the pairing auxiliary body portion from delivery catheter. In some embodiments, manipulating the second supporter includes discharging the pairing auxiliary body portion from delivery catheter.Methods described can be with Including guiding the pairing auxiliary body portion through the controllable conduit the step of.Methods described can be included in pairing auxiliary Body portion towards heart valve insertion before by controllable conduit from the ventricle protrusion towards the upper limb transmit the step of.It is described The step of method can include making the distal part movement of the controllable conduit so as to bend around posterior valve leaflet.Methods described can With the step of the bending that the pairing servicing unit is passed through the controllable conduit.In some embodiments, in institute State and the controllable conduit is removed after ventricle protrusion is engaged with ventricular organization.In some embodiments, when by the ventricle Protrusion towards the ventricular organization advance when the controllable conduit be held in place.Methods described can be included from the pairing The step of auxiliary body portion removes first supporter.Methods described can include removing described from the pairing auxiliary body portion The step of two supporters.Methods described can include the step of engaging the ventricle protrusion with ventricular organization.In some realities In applying scheme, methods described is percutaneously carried out.

Brief description

Figure 1A -1F schematically illustrate heart and mitral some tissues, such as background section and hereinafter described, and They can be with implant as herein described and system interaction.

Fig. 2A illustrates the simplified cross section of heart, the mitral valve function during schematically illustrating diastole.

Fig. 2 B illustrate the simplified cross section of heart, the mitral valve function during schematically illustrating paradoxical expansion.

Fig. 3 A-3B illustrate the simplified cross section of heart, schematically illustrate the situation in mitral leaflet incompetence Mitral reflux during lower paradoxical expansion.

Fig. 4 A illustrate the stylized cross section of heart, it is shown that the bicuspid valve in the case of Functional mitral regurgitation Incompetence.

Fig. 4 B illustrate the stylized cross section of heart, it is shown that the bicuspid valve in the case of degeneration mitral reflux Incompetence.

The embodiment that Fig. 5 A illustrate pairing servicing unit.

Fig. 5 B illustrate each cross section that can have along the cross section A-A supporting construction of Fig. 5 A.

Fig. 5 C illustrate ventricle protrusion far-end anchoring piece it is variously-shaped.

Fig. 5 D illustrate the non-limiting example of the size range of pairing servicing unit.

Fig. 5 E illustrate the table of the non-limiting example of the various modifications (material, size range) of supporting construction.

The embodiment that Fig. 5 F illustrate the distal end of ventricle protrusion.

Fig. 5 G illustrate the position of pairing servicing unit can clamp by using the shape of pairing servicing unit it is natural Posterior valve leaflet is keeping.

Fig. 5 H illustrate the pairing servicing unit how embodiment that can be fixed by posterior valve leaflet from ventricular side.

Fig. 6 A illustrate controllable conduit.

Fig. 6 B illustrate position of the controllable conduit of Fig. 6 A in heart.

Fig. 7 A illustrate delivery catheter.

Delivery catheter is locked onto annulus maincenter by the embodiment that Fig. 7 B illustrate locking mechanism, the locking mechanism.

Fig. 7 C illustrate the another embodiment of locking mechanism, and the locking mechanism locks onto delivery catheter in annulus Pivot.

Fig. 7 D illustrate coupling for pairing servicing unit, delivery catheter and guide wire or controllable conduit.

Fig. 8 A-8D illustrate how pairing servicing unit is folded and drawn in implant sheath and be delivered to by stock approach Heart.

Fig. 8 E-8G illustrate delivery catheter and implant sheath and how to place and cause the ventricle protrusion of pairing servicing unit can be with Anchored.

Fig. 8 H illustrate full opening of pairing servicing unit and be positioned above annulus maincenter for by annulus Pivot anchors to the delivery catheter of annulus.

The embodiment that Fig. 8 I illustrate the anchoring piece that can be used to anchor the annulus maincenter.

Fig. 9 A illustrate the hole in the framework via pairing servicing unit and come what neighbouring Colaesce anchored pairing servicing unit Method.

Fig. 9 B illustrate the anchoring piece of Fig. 9 A and the top view of cross bar.

Figure 10 A illustrate the another embodiment of delivery catheter, and the delivery catheter has multiple inner chambers and and implant Connection.

Figure 10 B illustrate the cross section of the delivery catheter shown in Figure 10 A.

Figure 11 A-B illustrate each alternative embodiment of anchoring piece.

Figure 11 C illustrate delivery tube, and anchoring piece 11A and 11B can be delivered by the delivery tube.

Figure 11 D illustrate the anchoring piece of Figure 11 B after anchoring procedure terminates and how can look.

Figure 12 is illustrated and (shown with structure 1220 in figure, withdraw from from implant after it) without the design of ridge implant.

Figure 13 A-B were illustrated for the starting stage of the delivery program without ridge implant.

Figure 14 A-B are illustrated for the various types of anchoring process without ridge implant.

The embodiment that Figure 15 A illustrate anchoring catheter, the embodiment can be realized delivering multiple anchoring pieces.This figure is also Illustrate multiple anchor designs.

Figure 15 B illustrate the another embodiment of anchoring catheter, and the embodiment can be realized delivering multiple anchoring pieces.

How the anchoring piece that Figure 15 C-D are illustrated in 15B can be coupled to tissue.

Figure 16 A illustrate the another embodiment of anchoring catheter, and the embodiment can be realized delivering multiple anchoring pieces.

Figure 16 B-C illustrate how the instrument in Figure 16 A can be used to deliver multiple anchoring pieces.

Figure 17 A illustrate the another embodiment without ridge implant.

Figure 17 B-E illustrate how the embodiment of Figure 17 A can be anchored.

Describe in detail

Described devices, systems and methods are generally used for treating mitral reflux (MR) in the disclosure.When in the systole phase Period bicuspid valve can not prevent blood that mitral reflux occurs when being back to atrium sinistrum from left ventricle.Bicuspid valve by two leaflets, Front leaflet and posterior valve leaflet are constituted, and two leaflet pairings or join to prevent backflow during the systole phase.Generally have two kinds of Mitral reflux, feature is backflowed and is backflowed with degeneration.Feature MR is by including abnormal or impaired left ventricle (LV) wall What motion, left ventricle dilatation and papillary muscle disorder caused in interior number of mechanisms.Degeneration MR be by including chordae tendineae stretching or Rupture causes in the textural anomaly of interior valve leaflets and valve undertissue.Impaired chordae tendineae can cause the prolapsus of leaflet, This means that leaflet projects (normally entering in atrium), or, if chordae tendineae tear, leaflet becomes flail, causes blood Backflow.As described below, the devices, systems and methods in the disclosure make above natural posterior valve leaflet there is provided new pairing surface The Modelling of Flow with Recirculation of blood must be minimized or eliminated.

Referring to Figure 1A -1D, four chambers of heart, atrium sinistrum 10, atrium dextrum 20, left ventricle 30, and right ventricle 40 are shown. Bicuspid valve 60 is disposed between atrium sinistrum 10 and left ventricle 30.(it is by atrium dextrum 20 and right ventricle to also show tricuspid valve 50 40 separate), aorta petal 80 and pulmonary valve 70.Bicuspid valve 60 is made up of two leaflets (front leaflet 12 and posterior valve leaflet 14). In the heart of health, the edge of two leaflets is relative at pairing area 16 during the systole phase.

It is to be referred to as mitral two of front leaflet 12 and posterior valve leaflet 14 as the fiber annulus 120 of the part of ardiac skeleton Leaflet provides attachment.Leaflet is axially supported by being attached to chordae tendineae 32.The rope be attached to again left ventricle papillary muscle 34, One or both in 36.In the heart of health, the rope support structures fasten mitral leaflet, it is allowed to which leaflet is in diastole Period readily opens, but the high pressure developed during tolerance ventricular systole.Except support structures fasten effect in addition to, lobe The shape and tissue consistency of leaf helps lend some impetus to effectively sealing or pairing.The forward position of front leaflet and posterior valve leaflet is along the meeting of pairing area 16 Close, wherein the cross section 160 of three-dimensional pairing area (CZ) is schematically illustrated in Fig. 1 E.

Front mitral leaflet and rear mitral leaflet have different shapes.Front leaflet more firmly attaches to covering center The annulus of corpus fibrosum (ardiac skeleton), and the posterior valve leaflet of the rear annulus of mitral valve bigger than attaching to mobility is slightly hard.About 80% Enclosed region is front leaflet.Merge in the base portion of non-coronary point (non-coronary cusp) of annulus of mitral valve and sustainer In the case of the left side (outside (lateral)) 124 that formed and right (interval (septal)) 126 fiber Rhizoma Sparganiis be positioned adjacent to Colaesce 110th, 114, on annulus 120 or before (Fig. 1 F).Fiber Rhizoma Sparganii 124,126 forms the interval of central fibrous body 128 and extends Extend with outside.In some embodiments, fiber Rhizoma Sparganii 124,126 can have the advantage that such as providing firm region is used for With the stable engagement of one or more annulus anchoring pieces (archor) or atrium anchoring piece.Pairing area CL between leaflet 12,14 It is not a simple line, but the funnel-shaped surface interface of bending.One 110 (outside or left side) and the 2nd 114 (interval Or right side) Colaesce is where front leaflet 12 is met at annulus 120 with posterior valve leaflet 14.Such as in the atrium of Fig. 1 C, 1D and 1F Axial view in it is most clearly visible, the axial cross section in pairing area generally shows the line CL of bending, the line CL and annulus CA The centre of form separate, and during diastole CO with separated by the opening of valve.Additionally, leaflet edge has knuckle-tooth, compare In front leaflet, posterior valve leaflet is even more so.Incompetence be likely to occur in these A-P (anterior-posterior) sections to A1/P1, A2/P2 and Between one or more in A3/P3 so that incompetence characteristic may change along the curve of pairing area CL.

Referring now to Fig. 2A, the bicuspid valve 60 of the correct function of heart is opened to allow blood during diastole Thus liquid edge fills to the flow path FP of left ventricle 30 flowings and left ventricle from atrium sinistrum.It is as shown in fig. 2B, by increasing Ventricular pressure, before this passively followed by one's own initiative, the bicuspid valve 60 of function is closed and effectively during the systole phase Left ventricle 30 and atrium sinistrum 10 are separated, thus allows the heart tissue around left ventricle to shrink so as to promote blood to pass through blood Guard system.

Referring to Fig. 3 A-3B and 4A-4B, there is some illnesss or morbid state, wherein mitral leaflet edge can not fill Split-phase pair and thus allow blood regurgitate in atrium from ventricle in the systole phase.No matter the concrete cause of disease of particular patient is such as What, leaflet can not seal during ventricular systole and be referred to as incompetence and cause mitral reflux.

Generally, incompetence can be caused by excessively fastening for the support structures of one or two leaflet, or can by The excessive tensile or tear for holding structure is caused.The reason for other are less common includes heart valve infection, birth defect, Yi Jichuan Wound.Valve kakergasia can be caused by following：Chordae tendineae is stretched (be referred to as mitral valve prolapse), and tendon in some cases The tear (being referred to as flail leaflet 220) of rope 215 or papillary muscle, as shown in figure 3 a.Or, if leaflet is organized itself being Unnecessary, then valve may prolapse so that atrium 230 of the higher level that occurs of pairing in atrium, during ventricular systole In higher open valve.Any one in leaflet may occur prolapsus or become flail.This illness is sometimes referred to as degeneration Mitral reflux.

Shown in figure 3B excessively to fasten, the leaflet of the normal valve of structure increases or shape because of annulus Change (so-called annulus expand 240) and can not suitably function.This kind of function mitral reflux is generally declined by cardiac muscle Exhaust and cause with associated chamber enlargement.And may be increased by the excessive volume load itself that Functional mitral regurgitation causes The expansion of heart failure, ventricle and annulus, and thus deteriorate mitral reflux.

Fig. 4 A-4B (scheme during being shown in the systole phase in Functional mitral regurgitation (Fig. 4 A) and degeneration mitral reflux The backflow BF of blood in 4B).The size of the increase of annulus in Fig. 4 A, adds the hypertrophy due to ventricle 320 and papillary muscle 330 Increase fasten, prevent front leaflet 312 and posterior valve leaflet 314 relative, thus prevent pairing.In figure 4b, the tear of chordae tendineae 215 Cause the prolapsus of posterior valve leaflet 344 to be upwardly in atrium sinistrum, which prevent relative with front leaflet 342.In either case, tie Fruit is all that blood is back in atrium, and this reduces the validity of left ventricle compression.

The embodiment that Fig. 5 A illustrate pairing servicing unit 500.Pairing servicing unit 500 can include pairing auxiliary body Portion 515.Pairing auxiliary body portion 515 can include the first pairing surface 535.First pairing surface 535 can be towards incompetence Native leaflets arrangement, in the case of mitral, when implanted towards posterior valve leaflet arrange.Pairing auxiliary body portion 515 can wrap Include the second pairing surface 540.Second pairing surface 540 can be with the first pairing surface 535 conversely, as shown in Figure 5 A.Second Pairing surface 540 can be arranged towards the native leaflets of incompetence, in the case of mitral, when implanted towards front leaflet Arrangement.First pairing surface 535 and the second pairing surface 540 can be by the first lateral margin and the second lateral margin limited boundaries.First pair Closing the pairing surface 540 of surface 535 and second can be by lower edge and the limited boundary of upper limb 545.

First pairing surface 535 and the second pairing surface 540 are the same implant structures to form pairing auxiliary body portion 515 Two sides.In some embodiments, the shape in pairing auxiliary body portion 515 can generally by the shape of upper limb 545, first The shape on the pairing surface 540 of pairing surface 535 and second is characterizing.

Pairing servicing unit 500 can include ventricle protrusion 525, as shown in Figure 5 A.Ventricle protrusion 525 can be from The lower edge in pairing auxiliary body portion 515 extends.Ventricle protrusion 525 can be placed on when implanted in left ventricle.Ventricle protrusion 525 can provide anchoring mechanism.The commonly provided anchoring mechanism in distal end 530 of ventricle protrusion 525.

The distal end 530 of ventricle protrusion 525 can have different shapes, as shown in Figure 5 C.Fig. 5 C show distal end 530 five embodiments.It is noted that more modifications have been possible to, and these modifications are not limited to five realities shown in Fig. 5 C Apply scheme.Generally, and in other embodiments, there is two kinds of anchoring piece.The example of passive anchoring piece is displayed in figure Embodiment 555.1 to 555.4 in 5C.Passive anchoring piece depend on chordae tendineae rear capture (entrapment) and/or With the interference of chordae tendineae.With regard to passive anchoring piece, in some embodiments, the size of full-size or responsible winding chordae tendineae is (logical It is often width) can be 10mm-40mm, such as 25mm.

Distal end 555.1 includes one or more tips.Tip can be elongated bar, it is as illustrated its from central authorities Pivot extends.In the embodiment shown in the drawing, four tips extend from central hub.In other embodiments, one or more Tip extends from central hub.Tip can angularly extend with central hub, so as to increased the surface of distal end 530 Product.Distal end 555.2 can be general rectangular, substantially rectangle, square, substantially square, rhombus or rhombus.Distal end 555.2 can With including one or more otch (cut out otch).Otch can increase the ability promptly organized.In embodiment illustrated In, four otch are formed in distal end.In other embodiments, one or more otch are set.

Distal end 555.3 includes one or more tips.Tip can be elongated bar, it is as illustrated its from central authorities Pivot extends.In the embodiment shown in the drawing, two tips extend from central hub.In other embodiments, one or more Tip extends from central hub.Tip can at a right angle extend with central hub, so as to increased the surface area of distal end 530.

Distal end 555.4 includes one or more barbs.Barb can be extended with as illustrated from central hub.Barb can To refund to central hub.In the embodiment shown in the drawing, three or more barbs extend from central hub.In other enforcements In scheme, one or more barbs are set in one or more directions.

Distal end 555.5 includes one or more tips, and similar to the configuration as shown in distal end 555.1.Distal end 555.5 It is the example of active anchoring piece.Active anchoring piece can have such as cusp, barb or the screw that can be coupled to ventricular organization Part.Active anchoring piece can need driving force, such as moment of torsion, so as in embedded tissue.Being passively or actively anchoring piece can be with By the biocompatible material such as organosilicon, PEEK, Pai Baikesi (pebax) of implant rank, polyurethane into.

The size of pairing servicing unit 500 is described in detail in Fig. 5 D.The figure illustrates the pairing of pairing servicing unit 500 The top view and front view in auxiliary body portion 515.Three parameters " x ", " y " and " z " shown in figure characterize pairing servicing unit 500.The scope of these variables x, y and z and the non-limiting examples of size are displayed in " the size table " in figure.

Pairing servicing unit 500 can include supporting construction 505.Supporting construction 505 can be referred to as ridge.Supporting construction 505 The shape of pairing servicing unit 500 can be at least partially defined.

Fig. 5 A are back to, supporting construction 505 is shown by dotted line.In some embodiments, supporting construction 505 is remembered by shape Recall material such as, but not limited to Nitinol (NiTi), polyether-ether-ketone (PEEK) or other rigid polymers or endurance metal system Into.The use of shape-memory material can realize advantage as herein described.For example, an advantage of shape-memory material is that it surpasses Pairing servicing unit 500 keeps it when elastic characteristic contributes to when heart contraction and expands and pairing servicing unit 500 is pressed Shape and the feature as pairing servicing unit.Another example of advantage is that shape-memory material is suitable for will be herein The dermal delivery method of description.

Supporting construction 505 can include one or more sections.In some embodiments, supporting construction 505 includes one Individual sections.In some embodiments, supporting construction 505 includes two sections.In some embodiments, supporting construction 505 Including three or more sections.In some embodiments, one or more sections of supporting construction 505 can include one Or it is multiple segmented.In fig. 5 in shown embodiment, supporting construction 505 includes two sections：The He of first segment 505.2 Second section 505.1.

First segment 505.2 can extend past pairing servicing unit 500 between upper limb 545 and ventricle protrusion 525 At least a portion.In some embodiments, first segment 505.2 can be prolonged between upper limb 545 and ventricle protrusion 525 Extend through the whole length of pairing servicing unit 500.In some embodiments, first segment 505.2 is from pairing auxiliary body portion Position between 515 upper limb 545 and lower edge extends.In some embodiments, first segment 505.2 is from pairing auxiliary body portion Position between 515 lower edge and ventricle protrusion 525 extends.In some embodiments, first segment 505.2 is auxiliary along pairing Body aid portion 515 extends and continues to support ventricle protrusion 525.

Second section 505.1 can extend past pairing auxiliary body portion 515 extremely between the first lateral margin and the second lateral margin A few part.In some embodiments, second section 505.1 can extend past whole between the first lateral margin and the second lateral margin Individual length.In some embodiments, second section 505.1 is from the position between the upper limb 545 and lower edge in pairing auxiliary body portion 515 Put extension.In some embodiments, second section 505.1 from compared with the lower edge in pairing auxiliary body portion 515 closer to upper limb 545 position extends.In some embodiments, second section 505.1 extends from the first lateral margin towards the second lateral margin.At some In embodiment, second section 505.1 extends from the second lateral margin towards the first lateral margin.In some embodiments, second section 505.1 sections between the first lateral margin and the second lateral margin extend.In some embodiments, second section 505.1 is along pairing The edge of servicing unit 500 extends.

In some embodiments, the first segment 505.2 and second section 505.1 of supporting construction 505 can be one Single piece or integral structure.In some embodiments, the first segment 505.2 and second section 505.1 of supporting construction 505 It is single component.In some embodiments, first segment 505.2 and second section 505.1 can be two individually sections Section, both are linked together by the method for such as, but not limited to crimping and laser welding.

In some embodiments, first segment 505.2 is incorporated in pairing auxiliary body portion 515 as described herein. In some embodiments, first segment 505.2 is incorporated in ventricle protrusion 525 as described herein.In some embodiments In, first segment 505.2 can be removed from pairing auxiliary body portion 515 as described herein.In some embodiments, first Sections 505.2 can be removed from ventricle protrusion 525 as described herein.In some embodiments, second section 505.1 It is incorporated in pairing auxiliary body portion 515 as described herein.In some embodiments, second section 505.1 be can from such as this What the pairing auxiliary body portion 515 described in text removed.In some embodiments, first segment 505.2 can have the firstth area and Secondth area, firstth area is generally arranged essentially parallel to the longitudinal axis orientation in body portion 515, and secondth area generally substantially hangs down The straight longitudinal axis in body portion 515 is oriented, as illustrated.

The supporting construction 505 of the shape of support ventricle protrusion 525 can have each as shown in the section AA in Fig. 5 A Plant cross section and be illustrated in detail in Fig. 5 B.In figure 5b, it is shown that five embodiments of cross section；However, to note The embodiment of the cross section of meaning supporting construction 505 is not limited to this five kinds.Cross section 550.1 is circular or substantial circular. Cross section 505.2 is circular or substantial circular.Cross section 550.1 can have the cross section bigger than cross section 550.2 Product.Cross section 550.3 includes the cross section of multiple circular or substantial circulars.In the embodiment shown in the drawing, seven circles or The cross section of substantial circular is collectively form cross section 550.3.In other embodiments, it is two or more circular or substantially Circular cross section is collectively form cross section 550.3.Cross section 550.3 can be the form of cable.Cross section 550.4 is square Shape or general rectangular.Cross section 550,5 is rectangle or general rectangular.Cross section 550.4 can have bigger than cross section 550.5 Cross-sectional area.

It is also noted that first segment 505.2 and second section 505.1 there can also be different cross sections.Shown in Fig. 5 B Each cross section or embodiment can have some advantages, such as some cross sections can be easily bent in one direction And then do not allow in the other directions flexible.Some other cross sections can have the reliable spy higher than other cross sections Property.The material Nitinol and PEEK different for two kinds is described in the feature and Fig. 5 E of each type of cross section in table 2 Cross section scope and non-limiting possible size.Although presenting various configurations in table 2, in some embodiments In, for bi-material cross section 550.4 and 550.5 may be by.

When pairing servicing unit 500 is placed in heart, in some embodiments, pairing servicing unit 500 is caused Ventricle protrusion 525 will be generally placed in left ventricle, as shown in figure 5g.Ventricle protrusion 525 is provided and uses the heart The mechanism of the structure anchor pairing servicing unit 500 of room.Example diagram pairing servicing unit 500 being positioned above posterior valve leaflet In Fig. 5 G.

Remember, other examples of positioning are possible and discussing elsewhere in the disclosure, here is special In different embodiment, it is illustrated that the pairing servicing unit 500 of the ventricle protrusion 525 with curve shape.Ventricle protrusion 525 and/ Or first supporter 505.2 can be made up of shape-memory material, keep curve shape after the implantation in the case.Shaped form Shape can enable pairing servicing unit 500 to be held in place after engaging with natural posterior valve leaflet 14.

The embodiment that Fig. 5 F show the passive anchoring piece for ventricle protrusion 525.In this embodiment, along the heart The pipe 560 that the length of room protrusion 525 is advanced pairing servicing unit 500 terminating at distal ends in two Hes of pipe 565.1 565.2.Pairing servicing unit 500 can be delivered to into the left side of heart so that two Hes of pipe 565.1 with the wire for stretching 565.2 near linears, as shown in dotted line 565.1 and 565.2 (position A), show state of the wire for stretching in propulsion. In some embodiments, two pipes 565.1 and 565.2 can be made up of shape-memory material, and the shape-memory material includes But it is not limited to polyurethane, organosilicon, polyethylene, Pai Baikesi (pebax) and nylon.In the situation wiry do not stretched Under, two pipes 565.1 and 565.2 can have the shape of acquiescence, and the shape of the acquiescence can be crimped or coiling, such as Shown in solid line 565.1 and 565.2 in Fig. 5 F (position B).

After implant is suitably delivered and is placed in heart, the wire for stretching can be withdrawn, so as to allow Two pipes 565.1 and 565.2 take the shape (position B) of their acquiescences.Two pipes 565.1 and 565.2 because with chordae tendineae winding and Anchorage support can be provided.The advantage of such anchoring is, if due to placing dissatisfied and cause to become must be by Pairing servicing unit 500 is repositioned, and can be advanced the wire for stretching and be returned in two pipes 565.1 and 565.2, Make two pipes 565.1 and 565.2 be in line and cause two pipes 565.1 and 565.2 to depart from chordae tendineae structure.Although above-mentioned reality Apply example and describe two pipes 565.1 and 565.2, it will be appreciated that there may be one, two or more pipes.

Another embodiment again of anchoring pairing servicing unit 500 is illustrated in fig. 5h.Active anchoring piece can be even It is connected to the distal end of ventricle protrusion 525.After delivering implant, active anchoring piece can be driven to pass through posterior valve leaflet so as in such as institute Pairing servicing unit 500 is coupled at annulus (atrium) sections for showing.Will be discussed herein by anchoring piece position and drive Method.

In another embodiment, the tip of ventricle protrusion 525 can be radiopaque or echo, so as to work as The placement and anchoring of pairing servicing unit 500 are aided in during transcutaneous placement pairing servicing unit 500.In such program, fluorescence Or ultrasound imaging modality can be used to visualize heart and pairing servicing unit 500.

Fig. 5 A are back to, in another embodiment, pairing servicing unit 500 can include maincenter (hub) 510.In Pivot 510 can have one or more purposes.One purpose can act as anchor as discussed herein.Another mesh Can be to provide the mechanism of dermal delivery pairing servicing unit 500 as discussed herein.In some embodiment party In case, maincenter (not shown) can exist in the far-end of pairing servicing unit 500.Maincenter may be located at ventricle protrusion 525 End.Ventricle maincenter may be located at the farthest side tip of the distal end 530 of ventricle protrusion 525.In order to distinguish two maincenters, Maincenter 510 on nearside will be referred to simply as " maincenter ", " annulus maincenter " or " nearside maincenter ".The distally point of ventricle protrusion Maincenter at end will be particularly referred to as " ventricle maincenter ".

Referring also to Fig. 5 A, the pairing auxiliary body portion 515 of pairing servicing unit 500 can be by various biocompatible material systems Into the biocompatible material such as expanded PTFE (ePTFE).Pairing surface is this material offers, front leaflet will Abut against the closing of pairing surface.The pairing auxiliary body portion 515 of pairing servicing unit 500 can be coupled to supporting construction 505 and cause The shape of supporting construction 505 gives the general shape of pairing servicing unit 500.

The shape of pairing servicing unit 500 can further obtain the support of one or more (not shown)s of rib 546. There may be one, two or more ribs 546.Rib 546 can be made of a variety of materials, and the multiple material is such as But it is not limited to suture, polypropylene, nylon, NiTi cables, NiTi silks and PEEK.This document describes by pairing servicing unit 500 Pairing auxiliary body portion 515 be coupled to the mistake of supporting construction 505 and/or rib 546 (if there is rib 546) Journey.

In some manufacture methods, the process can by supporting construction 505 and/or rib 546 (if there is Rib 546) on slip polyethylene (PE) pipe start.The combination is placed between two sheet of ePTFE, after-applied heat and Pressure.Because the aperture in ePTFE material, ePTFE are bonded with PE pipes, the polythene material of the pipe can be molten to ePTFE In aperture in material, mechanical adhesion is formed.Similarly, when heat and compression is applied, PE tube materials can be molten to support In minute aperture in structure 505 and/or rib 546.During supporting construction 505 and/or rib 546 can modestly be laid Minute aperture is so as to improving bonding.

In the modification of said process, PE pieces can be placed, at this moment can not there is PE pipes.In this modification, as upper Described in face, using heating and the simple procedure for compressing, and more homogeneous composite construction can be produced.In further embodiment party In case, supporting construction 505 and/or rib 546 can have the part of such as minute aperture, and the minute aperture couples ePTFE membrane. Fine bore dia can be such as 0.005 " -0.030 " scope.

In the modification with regard to the material type that can be used to prepare the pairing auxiliary body portion 515 of pairing servicing unit 500, Other materials such as, but not limited to sponge material, polyurethane, organosilicon, ox or Pigs Hearts bag can be utilized.Adhesion process can be wrapped Include but be not limited to heat bonding, suture and gluing.

With continued reference to Fig. 5 A, in some embodiments, pairing servicing unit 500 has perforation or groove 520.There may be One or more such perforation or groove 520.These perforation 520 can serve the mesh for providing the position that can place anchoring piece , as discussed herein.

One advantage of pairing servicing unit 500 is that pairing servicing unit 500 can be folded into less structure.Pairing Servicing unit 500 can pass through delivery catheter dermal delivery.In some embodiments, supporting construction 505 is by shape memory material Material is made.When pairing servicing unit 500 launches in heart, the required form of pairing servicing unit 500 is regained.Now Many embodiment descriptions are used for the various methods, devices and systems being delivered to pairing servicing unit 500 in heart.

In some usings method, the first supporter has the first structure that wherein the first supporter 505.2 is substantially straight line Type, and wherein the first supporter 505.2 is the second configuration of bending.In some usings method, the first supporter 505.2 and Two supporters 505.1 are configured to allow for being percutaneously inserted pairing servicing unit 500.

Before in delivery operations several steps can similar to it is as known in the art those.For example lower torso/ The body of patient is punctured in upper femoral region (groin) so as to obtain entering femoral venous approach.Generally, will be across interval sheath (trans-spetal sheath) and pin are inserted into inferior caval vein and boost to atrial septum, carry out at this point across between room Every puncture, and will be advanced in atrium sinistrum across interval sheath.The pin is removed, sheath there is presently provided entering to atrium sinistrum across interval Road.Can find in public medical document with regard to the more details of above-mentioned steps.

Methods described can include that various steps include those that will now be described.The ventricle of pairing servicing unit 500 is projected Thing 525 can be generally placed in left ventricle.Advantageously pairing servicing unit 500 can be led using various guidance technologies Cause this position.For example, can by simple guide wire be placed on across interval intrathecal and by initially enter atrium sinistrum and It is directed in left ventricle through bicuspid valve.However, simple guide wire may not be carried in the placement of ventricle protrusion 525 For the sufficient degree of accuracy.

In some embodiments, it is possible to use in the method that controllable intrathecal places guide wire.With guide wire can Manipulation sheath can be by being advanced in left ventricle across interval sheath propulsion and subsequently by bicuspid valve, the controllable sheath in left ventricle Manipulation ability will provide extra support to being properly located guide wire.After guide wire is placed, controllable sheath needs passing Send and be removed before pairing servicing unit.Although this method is there is provided being more accurately positioned to guide wire, relate to remove One additional step of controllable sheath.In order to improve this process in terms of the number for reducing the step needed for performing implantation, herein Disclose multiple embodiments of controllable sheath.

The controllable conduit of minor diameter

Reference picture 6A, it is illustrated that the controllable conduit 600 of minor diameter.In some embodiments, the handle of controllable conduit 600 The diameter 615 in portion 610 can be equal or substantially equal to the diameter 620 in the body portion 605 of controllable conduit 600.Controllable conduit There can be draught line 625 in 600.When rotational handle 610, such as on the direction of arrow 632, controllable conduit 600 Distal part is moved to bending position 640 along arrow 635 from linear position 630.Bending position 640 can be beneficial to position ventricle Protrusion 625, as discussed herein.When rotational handle 610, such as on the rightabout of arrow 632, controllable conduit 600 distal part is moved to linear position 630 along bending position 640.The linear position 630 of controllable conduit 600 is by dotted line Show, should not obscure with the draught line 625 being also shown in phantom.Linear position 630 can be beneficial to according to anatomy insertion or Recall controllable conduit 600.

In some embodiments, the diameter of shank 610 can be equal to the diameter in body portion 605.This can be it is favourable, because It is that after controllable conduit 600 is placed in ventricle, pairing servicing unit 500 can slide past shank 610 and/or body portion 605.In some embodiments, controllable conduit 600 can include the ennation 612 in proximal end extended from shank 610. Ennation 612 can be wire or other slim-lined constructions.The purpose of ennation 612 is other conduits of secondary load or device, Clinician or other operators are allowed to keep the control to controllable conduit 600 simultaneously.Other conduits or device are being loaded After on ennation 612, other conduits or device are guided using controllable conduit 600.The length of ennation 612 can be matched Or cause during loading and delivering other conduits or device beyond the length of the conduit or device that are loaded, keeping pair can The control of manipulation conduit 600.

In some embodiments, only to shank 610 ennation 612 can be coupled when necessary.For example, if in operation Period, medical team determines that longer conduit is required, then can couple ennation 612 to shank 610.Coupling mechanism can be with Including but not limited to threaded connection, press-fit or other mechanisms.

The unrestricted reality of the size of each sub-components (body portion 605, shank 615, ennation 612) in some embodiments Example can be as follows：The diameter 620 in body portion 605 may range from 2-10Fr, such as 4Fr, about 2Fr- about 6Fr, and about 3Fr- is about 5Fr, or less than 10Fr, 9Fr, 8Fr, 7Fr, 6Fr, 5Fr, 4Fr, 3Fr or 2Fr.In some cases the length of shank 610 can be About 1/2 "-about 2 ", such as about 1 ", the scope of the shank rectilinear path (for starting draught line) can be in some cases About 1/8 "-about 3 ", such as about 1/4 ".

During implantation process, certain methods are related to guide wire or guide wire and controllable sheath.In certain methods, can grasp Control conduit 600 can be advanced by stock approach.Because shank 610 is in the outside of patient body, thus it can rotate so that this The distal part of controllable conduit 600 is placed at the correct position below posterior valve leaflet.Can be to the proximal attachment of shank 610 Ennation 612, so as to allow subsequent load pairing servicing unit 500 and delivery catheter 700, is inserted into afterwards across interval sheath 650 In, it is as described herein.This delivery catheter 700 may then serve as the guide member for introducing pairing servicing unit 500, such as herein As explaining.

Fig. 6 B illustrate placement of the controllable conduit 600 in heart.Show the embodiment across interval sheath 650.Also Show atrium sinistrum 655, left ventricle 660, mitral posterior valve leaflet 665 and mitral front leaflet 670.Controllable conduit 600 Show by bicuspid valve and be positioned in the lower section of posterior valve leaflet 665.It should now be appreciated that how to have making controllable conduit 600 The ability of distal part deflection can be the favourable suitable location for allowing to acquisition pairing servicing unit 500.It is controllable to lead The distal part of pipe 600 as illustrated can bend below posterior valve leaflet 665.It is controllable placing in certain methods Next general step after conduit 600 is that pairing servicing unit 500 is delivered to into heart.Now concerning realize delivering method and Device describes further embodiment.

Delivery catheter

Reference picture 7A, will now be described delivery catheter 700.The function of delivery catheter 700 is to carry pairing servicing unit 500 To heart.The axis body 710 of delivery catheter 700 can apply torque and deflectable.Axis body 710 is shown by cross-hauling Show.Delivery catheter 700 can include shank 730.Shank 730 can have rotating mechanism, such as drag wire etc..Rotating mechanism can So that axis body 710 is deflected and manipulated.It is implant sheath 725 in the distally of shank 730, as will be explained herein, it can be carried Pairing servicing unit 500 is to heart.In some embodiments, and the even farther side of implant sheath 725 is to remove funnel (tear away funnel)720.Remove the folding that funnel 720 can aid in pairing servicing unit 500.In some embodiment party In case, the distalmost end of axis body 710 has and axis body 710 can be locked onto into the part of pairing servicing unit 500 so that pairing auxiliary Device 500 can be transported to heart and be properly positioned.Locking process and part are described now concerning Fig. 7 B, 7C and 7D.

Reference picture 7D, delivery catheter 700 and pairing servicing unit 500 can have matching block (matching Feature), the matching block can make their temporary transient lockings.In some embodiments, delivery catheter 700 includes one Or multiple distally locking tongues 705.Pairing servicing unit 500 can include annulus maincenter 510 as described herein.Delivery catheter 700 distally locking tongue 705 can be coupled with the part in the annulus maincenter 510 of pairing servicing unit 500, such as be solved herein As releasing.

In certain methods, controllable conduit 600 or other guide wires or conduit can by ventricle protrusion 525 and/ Or anchoring mechanism 530 is advanced.In some embodiments, anchoring mechanism 530 can have hole or path to allow in central authorities Controllable conduit 600 is passed through, as shown in Figure 7 D.Controllable conduit 600 can lead to annulus maincenter 510 from anchoring mechanism 530. It is expected by other paths of pairing servicing unit 500.Controllable conduit 600 can lead to annulus from anchoring mechanism 530 Maincenter 510 and further open into delivery catheter 700.

Reference picture 7B, the tip of delivery catheter 700 is shown with the view for amplifying.Also show pairing servicing unit 500 Annulus maincenter 510.Distally locking tongue 705 can be made up of some shape-memory materials such as Nitinol.Locking tongue 705 Natural place is configured such that they are inside and bend toward each other, as shown in Figure 7A.In certain methods, guide wire or The such as controllable conduit 600 of conduit is inserted in annulus maincenter 510 and between distally locking tongue 705, and can be with Distally locking tongue 705 may abut into annulus maincenter 510 to release.There is the design of annulus maincenter 510 matching slot 740 to cause Distally locking tongue 705 is just put in these slots 740.Simply by the presence of controllable conduit 600 forcing distally locking tongue 705 are outwardly in slot 740, then the tip of delivery catheter 700 still locks onto annulus maincenter 510.Other locking mechanisms Such alternative be possible to and a kind of will now be described in fig. 7 c.

Reference picture 7C, annulus maincenter 510 can include latch 745.Latch 745 can be the reality through annulus maincenter 510 Central member, the solid member is in position by method as known in the art.Delivery catheter 700 can include wire or suture 750 ring.The guide wire or controllable conduit 600 that suture 750 can be surrounded in object such as annulus maincenter 510 is cyclic.Seam Zygonema 750 can extend into the shank 730 of delivery catheter 700.Shank 730 can have the tension force of control suture 750 Mechanism.By controlling tension force, pairing servicing unit 500 can be drawn against the distal end of delivery catheter 700 and can be firm Ground is fixed on the distal end.When controllable conduit 600 is withdrawn through the level of latch 745, the ring 755 of suture 750 can be with In the upper slip of latch 745, so as to discharge latch 745 and pairing servicing unit 500.

Delivery program

Fig. 8 A-8D show delivering method.In certain methods, implant sheath 725 and funnel 720 are pushed into covering pairing Servicing unit 500.Implant sheath 725 and funnel 720 can be pushed away after delivery catheter 700 and the locking of pairing servicing unit 500 Enter to cover pairing servicing unit 500.The shape auxiliary pairing servicing unit 500 of funnel 720 is closed or itself is folded up.Implantation The advance of thing sheath 725 and funnel 720 is displayed in Fig. 8 A and 8B.How arrow 760 in Fig. 8 A indicates pairing servicing unit 500 In being drawn into funnel 720.Once pairing servicing unit 500 just removes funnel 720 in implant sheath 725.In some realities In applying scheme, by pullling tongue piece 715, so that funnel 720 splits to remove funnel 720, in being displayed in Fig. 8 C.Then may be used With discarded funnel 720 and tongue piece 715.In certain methods, the implant sheath 725 for accommodating pairing servicing unit 500 can be pushed away Enter through guide wire or controllable conduit 600.To be reaffirmed, when pairing servicing unit 500 can flow on controllable conduit It is controllable when freely sliding and there is no the hell and high water caused by the various sizes of diameter due to shank 610 and body portion 605 The advantage of the design of conduit 600 becomes apparent from.Implant sheath 725 is inserted in the sheath 650 of interval, as in fig. 8d.

The system of pairing servicing unit 500 and implant sheath 725 is pushed into until it is left across interval sheath 650, such as Fig. 8 E Shown in.Delivery catheter 700 is deflected to cause implant sheath 725 to be positioned between mitral leaflet, and this is displayed in Fig. 8 E In.Implant sheath 725 is placed between chordae tendineae 765 (" P2 " position).Once implant sheath 725 reaches the position, delivering is led Pipe 700 is held in place and lentamente recalls implant sheath 725, causes pairing servicing unit 500 to start to exit implant sheath 725, As seen in fig. 8f.Should be noted that controllable conduit 600 or equivalent guide wire are still located in posterior valve leaflet lower section, and still may be used To be adjusted on one's own initiative or be deflected using control piece shank 610.In certain methods, when delivery catheter 700 is advanced, pairing Servicing unit 500 is pushed out, along the path of controllable conduit 600 until the distal end 530 of ventricle protrusion 525 is coupled to ventricle group Knit.This is shown in Fig. 8 G.While pairing servicing unit 500 is pushed out, implant sheath 725 can be withdrawn.At some In method, can delivery catheter 700 be carried out rotating and be adjusted to ensure that suitable placement.

Anchoring

Once pairing servicing unit 500 is opened, methods described can include for pairing servicing unit 500 being anchored at two sharp In the atrium orientation of lobe, i.e. on annulus of mitral valve.The method and system of anchoring is realized in several embodiment descriptions now.

The supporting construction 505 by made by shape-memory material can be favourable.When pairing servicing unit 500 is opened, The shape that pairing servicing unit 500 is taken is intended to by produced by the effect of shape-memory material.It is as described herein, pairing auxiliary The shape of device 500 can be intended to provide new pairing surface so that reducing or eliminating flowing of backflowing.Return to delivering and anchor Gu the explanation of process, delivery catheter 700 (can still be coupled to the annulus maincenter 510 of pairing servicing unit 500) now can be with (rotationally and axially) is manipulated so as to pairing servicing unit 500 to be appropriately positioned at the posterior valve leaflet top of native leaflets. In embodiments, the supporting construction 505 of pairing servicing unit 500 can have the part that can be attached to tissue.At some In embodiment, these parts are passive hooks.In certain methods, these part engagement annulus cause pairing servicing unit 500 Can be held in place while anchoring is started.Fig. 8 H show the state of delivery catheter 700, the wherein quilt of implant sheath 725 Withdraw from and axis body 710 is still coupled to annulus maincenter 510.

The embodiment of anchoring piece 800 is illustrated in detail in Fig. 8 I.Anchoring piece 800 can be coupled in many ways pass Send conduit 700 and/or pairing servicing unit 500.Annulus maincenter 510 can have latch 512.Latch 512 can be provided so Position, the helical structure 815 of anchoring piece 800 can be wound around the position, as illustrated.Anchoring piece 800 There can be shoulder 805.Shoulder 805 can be brought into close contact the axis body 710 of delivery catheter 700.Shoulder 805 can have such as window 810 part, it can lock the distally locking tongue 705 of delivery catheter 700.The distally locking tongue 705 of delivery catheter 700 Can lock when the such as controllable conduit 600 of pin, guide wire or conduit is present in the axis body 710 of delivery catheter 700.One In a little methods, anchoring piece 800 can be loaded previously on pairing servicing unit 500 and install pairing servicing unit 500 Lock with delivery catheter 700 during process on delivery catheter 700 in place.This can be pulled in pairing servicing unit 500 Occur in implant sheath 725 and before being ready for insertion in femoral vein.Fig. 8 H are returned to, axis body 710 can be applied to turn round Square causes anchoring piece 800 to be driven in tissue.In order to provide the feedback whether anchoring piece 800 is suitably fixed, fluorescence mark Note may reside on anchoring piece 800.The mark may be located at proximal end.These marks can notify medical team's anchoring piece 800 can advance towards annulus maincenter 510 about how far and can notify about when anchoring piece 800 is firmly fixed just Position.In some embodiments, in order to ensure applying suitable moment of torsion, when anchoring piece 800 on annulus maincenter 510 on earth when, Torque level at shank 730 can culminate (spike).The torque level of this increase can at shank 730 quilt Feel, so as to provide the feedback of the moment of torsion for being applied with suitable.Central guide wire or controllable conduit 600 can be removed Go out.This causes window 810 rollback of the distally locking tongue 705 from anchoring piece 800, thus solves delivery catheter 700 and anchoring piece 800 Lock.This can cause the release of pairing servicing unit 500.Delivery catheter 700 and controllable conduit 600 can be removed completely now Go out.

Colaesce is anchored

Several embodiments illustrate Colaesce anchoring.One such embodiment shows in figure 9 a.Delivery catheter 700 (not shown) has been withdrawn from, and anchoring catheter 900 is advanced by stock approach.Anchoring catheter 900 can apply torque. One or more anchoring catheters 900 can be provided.The distal tip of anchoring catheter 900 can have one or more parts with It is during delivering anchoring piece that anchoring piece locking is in place.In figure 9 a, distal tip has otch 905, and it can receive spiral shell A part for rotation anchoring piece 915.Anchoring catheter 900 can also have central pin 920.Central pin 920 can be in distal tip With tip.In some embodiments, central pin 920 can have the ability being withdrawn by.

Fig. 9 A show ring 910.The end (not shown) of ring 910 can advance to the shank of anchoring catheter 910 or therebetween Partial-length the tension force of ring 910 is controlled.Ring 910 is coiled through cross bar 917 or forms Screw Anchor firmware 915 The other parts of proximal portion.The top view of the Screw Anchor firmware 915 with cross bar 917 shows in figures 9 b and 9.When outside body, Entering before the sheath (not shown) of interval, Screw Anchor firmware 915 can be placed with adjacent central pin 920.Ring 910 can be below Mode arranges, i.e., when pulling force is applied to ring 910, ring 910 keeps Screw Anchor firmware 915, and central pin 920 lock it is in place. In Fig. 9 A, this arrangement is packed up so that otch 905 receives the portions of proximal of Screw Anchor firmware 915.Retaining ring 910 is in stretching State, total is advanced in the sheath of interval.

Once the desired location in body, adjusts anchoring catheter 900 and causes the remotely located even of anchoring catheter 900 Close the top in hole 520.Central pin 920 and Screw Anchor firmware 915 are pushed into so that central pin 920 is first after by Colaesce hole 520 First pierce through tissue.Apply moment of torsion to anchoring catheter 900, Screw Anchor firmware 915 pierces through tissue.Screw Anchor firmware 915 will support knot The framework of structure 505 or pairing servicing unit 500 anchors to tissue.After Screw Anchor firmware 915 is in place, central pin 920 is withdrawn from.In Withdrawing from for centre pin 920 can allow ring 910 to slide in the top of cross bar 917 of Screw Anchor firmware 915, thus discharge anchoring piece 915. This process can be repeatedly used for other Colaesce positions so as to anchor two end projections of pairing servicing unit 500.

Alternative anchorage technology

Figure 10 A show the optional anchorage technology in another embodiment.In this embodiment, delivery catheter 1000 can With with multiple inner chambers 1040.Delivery catheter 1000 can have cross section as shown in Figure 10 B.Inner chamber 1040 can be carried The single different drive shaft reversed.Each drive shaft can be locked onto on anchoring piece (during for axle 1020 and 1030) or Lock onto on annulus maincenter 510 (as to shown in axle 1010).Each can torsional axis 1010,1020,1030 can have Fig. 9 A in The design of illustrated anchoring catheter 900.Delivery catheter 1000 can have central lumen 1050, guide wire or controllable conduit 600 can pass through central lumen 1050.It is multiple to reverse drive shaft 1010,1020,1030, guide wire or controllable conduit 600 And pairing servicing unit 500 can be fully loaded in the implant sheath of delivery catheter 1000 entering into before the sheath of interval With withdraw from from the implant sheath of delivery catheter 1000.So whole arrangement can be pushed into and can follow as herein The identical program explained is placing pairing servicing unit 500.Being advantageous in that for this arrangement can be need not be more It is secondary withdraw from anchoring catheter, reload anchoring piece and reenter body in the case of complete anchoring procedure.

For the alternative design of anchoring piece

Although some anchoring pieces already described herein, it is anticipated that there is other optional embodiments.Figure 11 A show Anchoring piece with claw hook.Figure 11 B show the anchoring piece of similar umbrella.In two embodiments, anchoring piece can be by shape Shape memory material is made.In two embodiments, anchoring piece can be loaded into delivery catheter, and (what is illustrated in such as Figure 11 C passs Send conduit) in.

Locking mechanism (all as those described herein) can be used to for anchoring piece to lock onto delivery catheter.Delivery catheter can To allow delivery catheter to be guided to suitable position and preliminarily pierce through tissue with tip.Put in delivery catheter After putting in suitable position and completing preliminary puncture, one or more anchoring pieces can be pushed into and install in place.This step It is to unlock and withdraw from delivery catheter after rapid.

Figure 11 D are that the umbrella anchoring piece of Figure 11 B has been fitted into afterwards should to anchor pairing servicing unit 500 in tissue Umbrella anchoring piece outward appearance diagram how.Due to the natural unstressed shape of anchoring piece, when in the tissue in pairing servicing unit When launching on 500, the shape of deformation will have effective spring force to the face of pairing servicing unit 500, it is ensured that good is vertical Foot point.

Without ridge implant

Pairing servicing unit 500 described in Fig. 5 A-F can include supporting construction 505.Supporting construction 506 can be by As described herein shape-memory material is made.In some embodiments of pairing servicing unit, it is contemplated that have another construction.This Construction can be referred to as without ridge pairing servicing unit, remove supporting construction after pairing servicing unit to indicate be placed in heart.Two The pairing servicing unit of type can have some advantages.Can be because of less component and material without ridge pairing servicing unit Expect and there is no metal fatigue but favourable.

Figure 12 shows the embodiment without ridge pairing servicing unit 1200.Can include without ridge pairing servicing unit 1200 Pipe or path 1210.Path 1210 can be placed around annulus edge.This path 1210 can be referred to as annulus pipe.It is auxiliary without ridge pairing Device 1200 is helped to include pipe or path 1212 along ventricle protrusion.This path 1212 can be referred to as ventricle pipe.

The section of path 1210 can be shown towards the end of annulus pipe.Although illustrating circular section, manage or path 1210th, 1212 can have other sections include but is not limited to it is avette and flat.

Supporting construction 1210.1,1210.2,1210.3 is shown that exception is, in annulus edge, to support in this place by dotted line Structure 1210.1 and 1210.3 is projected.Supporting construction 1210.1,1210.2,1210.3 can have three different sections, its In 1210.1 and 1210.3 be placed in annulus pipe, and 1210.2 are placed in ventricle pipe.Supporting construction 1210.1,1210.2, 1210.3 can have in chi chung pivot 1220 coupling.In some embodiments, supporting construction 1210.1,1210.2, 1210.3 can be different and single sections.In some embodiments, supporting construction 1210.1,1210.2,1210.3 Can be linked together by using one of various methods, methods described such as, but is not limited to, be crimped and laser welding.Support This arrangement permission supporting construction 1210.1 of structure 1210.1,1210.2,1210.3 and pairing servicing unit 1200, 1210.2nd, 1210.3 extract out from pairing servicing unit 1200.In certain methods, by there is chi chung pivot 1220 to apply pulling force To extract supporting construction 1210.1,1210.2,1210.3.To provide herein with regard to pairing servicing unit 1200 and delivering With the more details of the program of anchoring pairing servicing unit 1200.

Delivery program without ridge implant

The delivery program of Figure 13 A and 13B diagram pairing servicing unit 1200.Figure 13 A show the pairing servicing unit of Figure 12 1200.Figure 13 A show additional component, anchor position 1300.This anchoring position 1300 will be described in greater detail herein.

Controllable conduit 600 is inserted in pairing servicing unit 1200.Controllable conduit 600 can be projected from ventricle The distal tip insertion of thing 1212.Controllable conduit 600 can leave from outlet opening 1335.Delivery catheter 1320 can be provided. Delivery catheter 1320 can include can torsional axis 1310.During delivery catheter 1320 can include being coupled with maincenter anchoring piece 1300 Pivot locking member 1330.In figure 13a, maincenter locking member 1330 is shown as screw.Explained herein its can be utilized His locking mechanism.

Figure 13 B illustrate the more details with regard to delivery catheter 1320.The distal tip of delivery catheter 1320 can include Funnel 1360.In the nearside of funnel 1360, there may be implant inducting device 1340.At most proximal end, delivery catheter 1320 can With with shank 1370.

Controllable conduit 600 can pass through pairing servicing unit 1200 as described herein.Funnel 1360 is inserted into In the distal tip of delivery catheter 1320.Pairing servicing unit 1200 can be locked using locking member 1330 in place so that Maincenter anchoring piece 1300 is connected to can torsional axis 1310.

Controllable conduit 600 can pass through the angled side ports 1350 on implant introducer 1340.Pairing is aided in Device 1200 and controllable conduit 600 can be drawn through funnel 1360 by withdrawing from delivery catheter 1320.With continuing to remove Go out, pairing servicing unit 1200 oneself is folded in the inside of implant introducer 1340.Once implant is in introducer 1340, Just remove funnel 1360 and abandon.Funnel 1360 is designed such that it can be easily removed.For the design of funnel Including but not limited to tear design (being above displayed in Fig. 8 A-8C) or clamshell designs (Figure 13 B).

Delivery catheter 1320 can be advanced together with implant introducer 1340 on controllable conduit 600, until implantation Thing introducer 1340 is coupled with the maincenter across interval sheath 650.At this point, implant introducer 1340 can be pushed away further Enter, and pairing servicing unit 1200 may be advanced in itself in the sheath of interval.Below several steps are similar in Fig. 8 E to Fig. 8 G Those shown, difference is in this embodiment, not use implant sheath.Pairing servicing unit 1200 is placed in posterior valve leaflet Top, ventricle protrusion 1212 is placed in left ventricle.Controllable conduit 600 can be withdrawn by so that ventricle protrusion 1212 exists The curling of P2 lower sections is coiled.Once ventricle protrusion 1212 is anchored, maincenter anchoring piece 1300 can be rotated or with others Mode is activated.The nearside of pairing servicing unit 1200 can be anchored to annulus by maincenter anchoring piece 1300.Can torsional axis 1310 can To be withdrawn by.(will be explained herein) after extra anchoring, maincenter locking member 1330 is withdrawn by, by supporting construction 1210.1st, 1210.2,1210.3 therewith pull.Pairing servicing unit 1200 can not support knot in the minds of a left side now Operate under conditions of structure 1210.1,1210.2,1210.3.

For the anchoring program without ridge implant

Figure 14 A show the embodiment for anchoring pairing servicing unit 1200.Due to existing after the implantation just Property structure such as supporting construction 1210.1,1210.2,1210.3, pairing servicing unit 1200 may need extra anchoring piece. In some embodiments, pairing servicing unit 1200 can utilize the anchoring piece of solid matter.In some embodiments, pairing is auxiliary Device 1200 is helped to utilize extra close beyond the similar pairing servicing unit with supporting construction 505 as herein described The anchoring piece of row.The embodiment that Figure 14 A show anchoring piece 1400, the embodiment can be used to pairing servicing unit 1200 and tissue couple.Figure 14 B show another embodiment.In Figure 14 B, suture or belt 1410 are used for pairing Servicing unit 1200 " suture " is to tissue.Suture or belt 1410 can be made up of one of different materials, the different materials Including but not limited to, polypropylene or nylon.Explain how description places several embodiments of multiple anchoring pieces now herein.

The embodiment that Figure 15 A show the anchoring catheter 1500 of the multiple anchoring pieces of delivering.Several anchoring pieces 1510 are (including anchor Firmware 1510.1 and anchoring piece 1510.2) it is stacked in anchoring catheter 1500.Although Figure 15 A show is stacked on anchoring catheter 1500 Interior two anchoring pieces 1510.1 and 1510.2, but more or less of anchoring piece can be stacked.Each anchoring piece 1510 can be with Including coiling section 1550.Coiling section 1550 can include tip 1570.Anchoring piece 1510 can include anchoring piece head 1560.Anchor Fastener heads 1560 can have in the several cross sections by shown in 1545.1 in Figure 15 A, 1545.2,1545.3 and 1545.4 One.Other cross sections are possible.

In order to tentatively load anchoring catheter 1500, anchoring piece 1510 is loaded into the axis of centres 1520 of anchoring catheter 1500 On.During the axis of centres 1520 and anchoring piece 1510 can have the cross section of matching that anchoring piece 1510 is rotatably coupled to Centre axle 1520.In the proximal end of anchoring catheter 1500, spring 1540 can be included.This spring 1540 causes central authorities there is provided thrust Axle 1520 rotates, and anchoring piece 1510 is in the distal end of the upward out anchoring catheter 1500 in side of arrow 1550.When anchoring piece 1510 from When opening, anchoring piece 1510 can engage pairing servicing unit 1200 and tissue so as to pairing servicing unit 1200 is coupled to into group Knit.The rotation of the axis of centres 1520 can be by operator's such as doctor's control.In some embodiments, the axis of centres 1520 is coupled to The wire (not shown) of torque can be applied, the wire for applying torque can be coupled to shank and (not show in proximal end Show).In some embodiments, can apply the wire of torque can control manually.In some embodiments, can applying power The wire of square can be via Motor Control.Method for applying from rotary motion to the axis of centres 1520 is expected.In figure Features not shown is the distal end manipulation to anchoring catheter 1500 and the ability for positioning in 15A.When one anchoring piece 1510 of delivering When, distal tip can need to reposition to deliver next anchoring piece 1510.Operating-controlling mechanism such as drag wire can be included So as to manipulate to the distal tip of anchoring catheter 1500.

Figure 15 B show another embodiment for the anchoring catheter 1600 for delivering multiple anchoring pieces.Figure 15 B only show anchor Gu the distal tip of conduit 1600.Anchoring catheter 1600 can include multiple anchoring pieces 1610 such as 1610.1 and 1610.2.To the greatest extent Pipe anchoring catheter 1600 shows five anchoring pieces.But can once load more or less of anchoring piece 1610 any.Anchor Gu conduit 1600 can have the axis of centres 1630.Anchoring catheter 1600 can include screw thread, such as on the inside of housing 1605 1620.It is shown that these screw threads 1620 can accommodate the coil of anchoring piece 1610.Lead to preliminarily load anchoring Pipe 1600, anchoring piece 1610 is inserted into housing 1605.Anchoring piece 1610 is inserted on the axis of centres 1630.As it was previously stated, the axis of centres 1630 cross section can match the cross section of anchoring piece 1610 and anchoring piece 1610 is installed on the axis of centres 1630.In The rotation of centre axle 1630 can be controlled by the cable (not shown) that can apply torque, and the cable for applying torque can be by Centre axle 1630 is coupled to the shank (not shown) of anchoring catheter 1600.Operator such as doctor can control rotation.In some realities In applying scheme, can apply the wire of torque can control manually.

In some embodiments, the wire that can apply torque can be via Motor Control.When the axis of centres 1630 revolves When turning, screw thread will force anchoring piece 1610 to leave anchoring catheter 1600 and engage pairing servicing unit 1200 and tissue so as to will be right Together with conjunction servicing unit 1200 is coupled with tissue.Anchoring catheter 1600 can also have drag wire so as to anchoring catheter 1600 Distal tip manipulate cause when deliver an anchoring piece 1610 when, anchoring catheter 1600 can be positioned to deliver next anchor Firmware 1610.

Figure 15 B illustrate central suture 1635.Central suture 1635 can include ball 1640, during ball 1640 is coupled to The end of centre suture 1635.How Figure 15 C and 15D diagram is can be using central suture 1635 and ball 1640.Ball 1640 can To be placed in the slot in the first anchoring piece 1610.1.Central suture 1635 can be connected to the first anchoring piece 1610.1 Second anchoring piece 1610.2 and other anchoring pieces 1610 (not shown in figure).This arrangement can be provided using central suture 1635 abilities as guide wire after anchoring piece 1610 has been screwed in tissue 1645 return anchoring piece 1610.Operator May desire to return anchoring piece 1610 so as to reposition or adjust anchoring piece 1610.In addition, if one or more anchoring pieces 1610 fluff, then central suture 1635 can provide the tether of the anchoring piece 1610 for the loosening, therefore prevent bolt Plug event.

Figure 16 A-C show the another embodiment of the anchoring catheter 1700 for delivering multiple anchoring pieces.Anchoring catheter 1700 There can be hollow shaft.Hollow shaft can come to a point in far-end, and the distal end can be used to pierce through the He of pairing servicing unit 1200 Tissue.Multiple anchoring pieces 1710 such as 1710.1,1710.2 can be arranged in the hollow shaft of anchoring catheter 1700.Anchoring piece 1710 can be hollow barrel.

Suture 1720 can be with as directed through anchoring piece 1710.Can be by the way that suture 1720 be positioned away from into Two anchoring pieces 1710.2 and suture 1720 is fixed to into the first anchor into the first anchoring piece 1710.1 through side opening 1740 Firmware 1710.1.Then suture 1720 can be fixed on into the first anchoring piece 1710.1 by means of knot (as dotted line is painted) It is interior.In addition to the first anchoring piece 1710.1, the suture 1720 in other anchoring pieces 1710 can seem such as anchoring Shown in part 1710.2.A part of wall of the anchoring piece 1710 in addition to the first anchoring piece 1710.1 is excavated becomes otch. The otch can aid in that preferably anchoring piece is embedded in tissue, similar to toggle bolt.In the near of anchoring catheter 1700 At end, there may be the part of such as pusher tube 1750 so that anchoring piece 1710 such as 1710.1 and 1710.2 far-end from Open anchoring catheter 1700.Push rod 1750 can be attached to shank (not shown) so as to make operator such as doctor in due course Dispose one or more anchoring pieces 1710.Arrow 1760 indicates the direction for promoting.

Figure 16 B-C illustrate how the anchoring catheter 1700 of Figure 16 A can operate.In fig. 16b, anchoring catheter 1700 leads to Cross the groove such as by described in 520 in Fig. 5 A and be advanced through pairing servicing unit 1200.Then anchoring catheter 1700 pierces through tissue 1645.First anchoring piece 1710.1 is released anchoring catheter 1700 by operator, and anchoring piece 1710.1 is placed in tissue.Once The first anchoring piece 1710.1 is disposed, the remainder of anchoring piece 1710 has been disposed as shown in fig. 16 c.In placement in Figure 16 C Anchoring catheter 1700 is pulled out into tissue to enter the second place after first anchoring piece 1710.1.In second position, anchoring is led Pipe 1700 can dispose the second anchoring piece 1710.2.Continue this process until needing for pairing servicing unit 1200 to be fixed on group Knit.After last anchoring piece 1710 is delivered, cutter (not shown) can advance to cut seam in anchoring catheter 1700 Zygonema 1720, leaves anchoring piece 1710.

In some embodiments, anchoring piece 1710 can be radiopaque or they can be by radiopaque mark Cover.During the process of delivering anchoring piece 1710, if radiopaque mark can be seen using fluorescope.This can have Help separate anchoring piece 1710 around the annulus of pairing servicing unit 1200.

In some embodiments, MR is assessed while fixed pairing servicing unit 1200, according to the presence or absence of MR It is determined that the needle gage (pitch) of suture action and/or position.

With sleeve pipe without ridge implant

Figure 17 A illustrate the another embodiment without ridge pairing servicing unit 1800.In this embodiment, supporting construction 1810 only can move down along ventricle protrusion 1820.Pipe or path 1830 can surround the annulus of pairing servicing unit 1800 Marginal existence.Replacement keeps the shape of pairing servicing unit 1800, anchoring catheter 1850 to insert using supporting construction 1810 Enter in pipe 1830, as shown in Figure 17 B.In Figure 17 B, anchoring catheter 1850 can be deflectable anchoring catheter.

Figure 17 B also show first position 1860.1, and the anchor such as by described in 1560 in Figure 15 A can be delivered in this place Firmware.At this position 1860.1 and all anchoring positions 1860, the tip of anchoring catheter 1850 is by by positioned at external control Part is deflected.Anchoring piece (not shown) can be delivered, pairing servicing unit 1800 is fixed to into tissue.The tip of anchoring catheter 1850 Can be radiopaque, then it can be visualized during anchoring piece delivery process.Can utilize to the visual of tip Change the annulus by anchoring piece around pairing servicing unit 1800 to position.Figure 17 B illustrate the first anchorage point 1860.1, figure 17C illustrates the second anchorage point 1860.2.After the anchoring piece of delivering suitable number, anchoring catheter 1850 is recalled completely, As shown in Figure 17 D.Finally, supporting construction 1810 can be removed, as shown in Figure 17 E.

In the modification of the embodiment shown in Figure 17 A-17E, supporting construction 1810 can be not limited only to ventricle protrusion Thing；It can also pass through the insertion of sleeve pipe 1830 and allow to keep required shape.Supporting construction can be shape-memory material. Can produce such anchoring catheter using the supporting construction around sleeve pipe 1830, the anchoring catheter with for institute in Figure 17 A The anchoring catheter 1850 of the pairing servicing unit 1800 stated is compared with relatively simple controlling organization.

Being contemplated that can make multiple combinations of the specific features of embodiments disclosed above and aspect or sub-portfolio And the combination or sub-portfolio are still fallen within one or more inventions in the present invention.Additionally, any specific feature, side The disclosure herein of face, method, property, characteristic, quality, attribute, key element etc. can be used for together with embodiment The every other embodiment being presented herein.It is to be understood, therefore, that the various features and aspect of disclosed embodiment With combination with one another or can replace so as to form the different modes of disclosed invention.It is, therefore, intended that this disclosed herein Bright scope should not be limited by above-mentioned specific embodiments disclosed.Although additionally, the present invention can receive it is various modification and Alterative version, its instantiation has been illustrated in the accompanying drawings and describes in detail herein.It is to be understood, however, that this Invention should not necessarily be limited by disclosed concrete form or method, and but, on the contrary, it is intended to cover to fall in described various realities Apply all modifications in scheme and spirit and scope of the appended claims, equivalent and replacement scheme.Herein disclosed Any method need not carry out by the order for being described.Method herein disclosed includes certain taken by practitioner A little action；However, they expressly or impliedly can also be indicated including any third party of those behaviors.For example, take action such as " pairing auxiliary body portion is inserted near bicuspid valve " includes " indicating to insert pairing auxiliary body portion near bicuspid valve ".Herein Disclosed scope also includes any one or all overlap, subrange and combinations thereof.Language as " up to ", " at least ", " being more than ", " being less than ", " between " etc. including the numeral for being described.Term is above added as used in this article as " greatly About ", " about " and the numeral of " substantially " includes described numeral, and it is also represented by and still plays required function or realization The amount being close to the amount of results needed.For example, term " about ", " about " and " substantially " can refer to less than described Amount less than 10% in the range of, less than the amount less than 5% in the range of, less than the amount less than 1% in the range of, no More than the amount less than 0.1% in the range of, less than the amount less than 0.01% in the range of amount.

Claims (51)

1. a kind of controllable guide wire, including：

Elongated flexible body portion, it has the longitudinal axis, near-end and distally deflecting region；

Control piece on the near-end, it is used for the controllable deflection of the deflecting region；With

From the removable deflecting element that the control piece extends to the deflecting region；

Wherein described guide wire does not have any portion of external diameter to be greater than about 10 French.

2. as described in claim 1 controllable guide wire, wherein the guide wire does not have any portion of external diameter to be greater than about 6 French.

3. as described in claim 1 controllable guide wire, wherein the guide wire does not have any portion of external diameter to be greater than about 4 French.

4. as described in claim 1 controllable guide wire, wherein the external diameter of the control piece is not more than the outer of the body portion Footpath.

5. as described in claim 1 controllable guide wire, wherein the control piece cause around the rotation of the axle it is described The transverse shifting of deflecting region.

6. as described in claim 3 controllable guide wire, wherein the control piece around the axle in a first direction Rotation causes the proximal retraction of the deflecting element.

7. a kind of implantable pairing servicing unit, including：

Flexible body portion；

The first concave surface in the body portion, first concave surface is configured to limit posterior valve leaflet；

The second concave surface in the body portion, second concave surface is configured to contact front leaflet；

Arc-shaped circumference upper limb in the body portion, the arc-shaped circumference upper limb limits the opening for facing away from the first surface； With

Ventricle protrusion, the ventricle protrusion extends and is configured to be anchored in ventricle away from the body portion.

8. implantable pairing servicing unit as described in claim 7, further includes the anchor on the ventricle protrusion Firmware.

9. implantable pairing servicing unit as described in claim 8, including active anchoring piece.

10. implantable pairing servicing unit as described in claim 8, including passive anchoring piece.

11. implantable pairing servicing units as described in claim 7, further include for supporting the arc-shaped circumference side The flexible ridge of edge.

12. implantable pairing servicing units as described in claim 11, wherein the ridge is removable.

A kind of 13. anchor systems for being attached the ventricle protrusion of implantable pairing device, including：

Shoulder, the shoulder has the hole for extending through the shoulder；

Helical tissue anchoring piece, the helical tissue anchoring piece is distally extending from maincenter；

The first connected structure on the anchoring piece, first connected structure is used to be releasably engaged torque axis；

The second connected structure on the torque axis, second connected structure is used to engage the anchoring piece；With

Implant, the implant has a maincenter, and being dimensioned to of the maincenter receives the helical form anchoring piece and pass through；

Wherein described torque axis is configured for rotating driving the helical form anchoring piece to enter in tissue and will be described Implant is fixed to tissue.

14. anchor systems as described in claim 13, wherein first connected structure is hole, and the second engagement knot Structure is protrusion.

15. anchor systems as described in claim 14, wherein the protrusion can laterally be moved into and out the hole.

16. anchor systems as described in claim 15, wherein the protrusion may be in response to it is elongated in the torque axis The axial movement of element and be laterally moved into and out the hole.

A kind of 17. implantable pairing servicing units, including：

Pairing auxiliary body portion, the pairing auxiliary body portion includes the first pairing surface, the second contrary pairing surface, each surface By the first lateral margin, the second lateral margin, lower edge and upper limb limited boundary；

From the ventricle protrusion that the lower edge extends；

First supporter, it is auxiliary that first supporter extends through the pairing between the upper limb and the ventricle protrusion Help at least a portion of device；

Second supporter, second supporter extends through the pairing between first lateral margin and second lateral margin At least a portion in auxiliary body portion；With

Path, the path extends through at least a portion of the pairing servicing unit, and the path is dimensioned to Controllable conduit is received to pass through the path；

It is generally the first configuration of straight line and wherein described that wherein described first supporter has wherein described first supporter First supporter is the second configuration of bending；

Wherein described first and second supporter is configured to allow for being percutaneously inserted for the implantable pairing servicing unit.

Device described in 18. claims 17, wherein the path is extended through between the upper limb and the ventricle protrusion Cross at least a portion of the pairing servicing unit.

Device described in 19. claims 17, wherein the controllable conduit includes the distal tip for being adapted to bend.

Device described in 20. claims 19, wherein the shank for rotating the controllable conduit causes the distal tip to bend.

Device described in 21. claims 17, wherein first supporter includes shape-memory material.

Device described in 22. claims 17, wherein first supporter is attached to the pairing auxiliary body portion.

Device described in 23. claims 17, wherein the pairing auxiliary body portion includes inner chamber, the inner chamber is sized so as to To receive at least a portion of first supporter.

Device described in 24. claims 17, wherein first supporter is removable.

Device described in 25. claims 17, wherein first supporter extends to the ventricle protrusion from the upper limb.

Device described in 26. claims 17, wherein the path extends between first lateral margin and second lateral margin Through at least a portion in the pairing auxiliary body portion.

Device described in 27. claims 17, wherein second supporter includes shape-memory material.

Device described in 28. claims 17, wherein second supporter is attached to the pairing auxiliary body portion.

Device described in 29. claims 17, wherein the pairing auxiliary body portion includes inner chamber, the inner chamber is sized so as to To receive at least a portion of second supporter.

Device described in 30. claims 17, wherein second supporter is removable.

Device described in 31. claims 17, wherein second supporter extends to second side from first lateral margin Edge.

Device described in 32. claims 17, wherein first supporter is coupled to second supporter.

Device described in 33. claims 17, wherein first supporter and second supporter are coupled to removable Maincenter, the removable maincenter is projected from the surface in the pairing auxiliary body portion.

A kind of 34. kit utilitys, including：

Implantable pairing servicing unit, including：

Pairing auxiliary body portion, the pairing auxiliary body portion includes the first pairing surface, the second contrary pairing surface, each surface By the first lateral margin, the second lateral margin, lower edge and upper limb limited boundary；

From the ventricle protrusion that the lower edge extends；

Path, the path extends through at least a portion of the pairing servicing unit, and the path is dimensioned to Controllable conduit is received to pass through the path；

Controllable conduit, wherein the controllable conduit is configured to by bicuspid valve and towards ventricular organization's bending, wherein The implantable pairing servicing unit is configured to be passed through the controllable conduit towards the ventricular organization.

Device described in 35. claims 34, wherein the path is extended through between the upper limb and the ventricle protrusion Cross at least a portion of the pairing servicing unit.

Device described in 36. claims 34, wherein the controllable conduit includes the distal tip for being adapted to bend.

37. the device described in claim 34, causes the distal tip to bend wherein making the shank rotation of controllable conduit.

Device described in 38. claims 34, wherein the path extends between first lateral margin and second lateral margin Through at least a portion in the pairing auxiliary body portion.

A kind of 39. methods using implantable pairing servicing unit, including：

Pairing auxiliary body portion is inserted towards heart valve, the pairing auxiliary body portion includes：First pairing surface, contrary second Pairing surface, each surface by the first lateral margin, the second lateral margin, lower edge and upper limb limited boundary, from the ventricle that the lower edge extends Protrusion；

Manipulating the first supporter causes the pairing auxiliary body portion to be presented curved configuration, first supporter in the upper limb and At least a portion of the pairing servicing unit is extended through between the ventricle protrusion；

Manipulating the second supporter causes the pairing auxiliary body portion that curved configuration is presented, and second supporter is in first side At least a portion in the pairing auxiliary body portion is extended through between edge and second lateral margin.

Method described in 40. claims 39, wherein manipulate the first supporter to include discharging the pairing auxiliary from delivery catheter Body portion.

Method described in 41. claims 39, wherein manipulate the second supporter to include discharging the pairing auxiliary from delivery catheter Body portion.

Method described in 42. claims 39, further includes to guide the pairing auxiliary body portion through controllable conduit.

Method described in 43. claims 39, further included before the pairing auxiliary body portion is inserted towards heart valve Controllable conduit is transmitted from the ventricle protrusion towards the upper limb.

Method described in 44. claims 43, further includes the distal part movement for making the controllable conduit so as to surround Posterior valve leaflet bends.

Method described in 45. claims 44, further includes for the pairing servicing unit to pass through described controllable lead The bending of pipe.

Method described in 46. claims 43, wherein can grasp described in removing after the ventricle protrusion is engaged with ventricular organization Control conduit.

Method described in 47. claims 43, wherein described in when the ventricle protrusion is advanced towards the ventricular organization Controllable conduit is held in place.

Method described in 48. claims 39, further includes to remove first supporter from the pairing auxiliary body portion.

Method described in 49. claims 39, further includes to remove second supporter from the pairing auxiliary body portion.

Method described in 50. claims 39, further includes to engage the ventricle protrusion with ventricular organization.

Method described in 51. claims 39, wherein methods described are percutaneously carried out.