Source: https://patents.google.com/patent/CN103237523A/en
Timestamp: 2020-02-22 20:42:21
Document Index: 502193859

Matched Legal Cases: ['Application No.61', 'art 18', 'art 35', 'art 35', 'art 35', 'art 35', 'art 35', 'art 61']

CN103237523A - Cardiac valve support structure - Google Patents
CN103237523A
CN103237523A CN2011800523742A CN201180052374A CN103237523A CN 103237523 A CN103237523 A CN 103237523A CN 2011800523742 A CN2011800523742 A CN 2011800523742A CN 201180052374 A CN201180052374 A CN 201180052374A CN 103237523 A CN103237523 A CN 103237523A
CN2011800523742A
M.布克宾德
J.A.洛根
2011-09-01 Application filed by M阀门技术有限公司 filed Critical M阀门技术有限公司
2013-08-07 Publication of CN103237523A publication Critical patent/CN103237523A/en
Cardiac valve supports and their methods of use are provided.
The cardiac valve supporting construction
The application requires the U.S. Provisional Application No.61/379 that submitted in 1st in JIUYUE in 2010, and 235 rights and interests, this application are herein incorporated with its full content by reference.
The cardiac valve adverse current does not take place when heart valve leaflet is fully closed when heart contraction.When heart contraction, blood refluxes by incorrect closed lobe leaf.For example, when ventricular systole, at blood the Bicuspid valve adverse current takes place by mitral incompetence and when entering left atrium.
Under the certain situation, adverse current is owing to (for example main or " organic " adverse current) takes place lobe leaf disease.Adverse current also can be caused that by the expansion of left ventricle this can cause the reexpansion of Bicuspid valve zona.The expansion of endless belt makes mitral lobe leaf expansion separately and forms very poor tip by-election (tip cooptation) and secondary leakage, or so-called " functional regurgitation ".
At present, main adverse current is revised by transforming primary lobe leaf, and is for example by clip, stitching, hook etc., fully closed when the heart contraction to allow them.Too late during the phase, whole lobe need be by machinery or biological prosthetic replacement at disease progression.Example comprises the actual valve replacement that always valve forming ring is sewn onto band lobe leaf, and wherein suture ring is stitched into annulus of mitral valve.Valve forming ring also is sewn valve annulus, and valve forming ring also is used for transforming endless belt, makes primary lobe leaf be close together, and is correctly closed to allow them.
Because based on the success of aortic valve replacement, what constantly receive publicity is to assess similar technology and come noinvasive ground to use the replacement valve displacement Bicuspid valve of similar type.
But, being different from aortic valve, annulus of mitral valve is not provided for locating the mitral good labelling of displacement.In the patient of needs displacements aortic valve, the height of aortic valvular ring and width form the existence of relevant degenerative disease and increase being present in calcium usually.Because aortic valve zona cross-sectional area reduces, these in the tissue change the feasible easier aortic valve of fixed permutation correctly.But the degenerative change of finding in aortic valve is not present in the adverse current of mitral valve experience usually, and annulus of mitral valve is therefore thinner than the valve annulus of the aortic valve of catching an illness usually.Thinner annulus of mitral valve makes it relatively be difficult to correctly location displacement Bicuspid valve in primary annulus of mitral valve.It is fixing in place that the general anatomical structure of annulus of mitral valve also makes it be difficult to correctly will replace Bicuspid valve.With the transitional face ratio from the aorta to the left ventricle that the aortic valve zona provides, annulus of mitral valve is used for transition more level and smooth from the left atrium to the left ventricle.The aortic valve zona is structurally more remarkable, and bigger " projection " is provided, and the displacement aortic valve is more easily fixed thereunto in place.
Usually, aortic valve chain rate annulus of mitral valve is littler.Annulus of mitral valve estimates at about 2.4cm to the diameter of about 3.2cm, and the aortic valve zona estimates at about 1.6cm to the diameter of about 2.5cm.
Bigger annulus of mitral valve makes it be difficult to implant securely at primary mitral valve position the valve of current endovascular delivery.Current displacement aortic valve is can be during launching and implanting restricted aspect the amount of radial expansion of experience at them.Thereby to have expanded configuration and can be securely fixed in displacement aortic valve in the annulus of mitral valve in order to provide, profile is sent in the contraction that requires to replace aortic valve be increased.But, increase to shrink and to send profile and will make endovascular delivery more dangerous and be difficult to advance in vascular system by bigger diameter delivery system concerning the patient.
Made some and attempted sending and implant the unitary replacement Bicuspid valve, but being difficult to provide can accept and have and enough little send profile and still can expand in Bicuspid valve and fix device in place via the vascular intervention position.
Need a kind of valve supporting construction or fixture, it can be positioned in the primary Bicuspid valve or is neighbouring and be suitable for fixing displacement Bicuspid valve in place.
One aspect of the present invention is the cardiac valve support member, and it is suitable for endovascular delivery to cardiac valve, comprising: first support component has to shrink and sends structure and deployment configuration; Second support component has to shrink and sends structure and deployment configuration; First bridge member extends to second support component from first support component, wherein first bridge member have send the structure and deployment configuration; With second bridge member, extend to second support component from first support component, wherein first bridge member have send the structure and deployment configuration, wherein first and second support components of first and second bridge members in deployment configuration extend radially inwardly.
In certain embodiments, first and second bridge members extend from first and second discrete locations around first and second support components, and can extend symmetrically from first and second support components.First and second bridge members can relative to each other extend from first and second support components approximately in 180 degree.
In first and second support components at least one has annular shape in certain embodiments.
In certain embodiments first and second bridge members each have the replacement valve bonding part, it is suitable for engaging securely replacement heart valve.Each can have anchoring piece/locking member the bonding part, locks securely with the part of replacement heart valve being suitable for.
In certain embodiments, first and second support components are suitable at least one position priority bending.
In certain embodiments, each has sweep in its deployment configuration first and second support components, and wherein sweep is suitable for sending in contraction and presents tighter curved configuration in the structure.
In certain embodiments, first and second bridge members C shape normally under its deployment configuration.
In certain embodiments, first support component has at least one connection element, and it is suitable for reversibly being connected to delivery system.At least one connection element can be threaded hole.
In certain embodiments, second support component has the bigger size of size than first support component under the deployment configuration under deployment configuration, and it is attached and radially be bonded in the heart tissue when needed that it has or do not have one or more retaining elements.
One aspect of the present invention is a kind of system, and it is suitable for endovascular delivery to Bicuspid valve, comprising: the cardiac valve support member, and this cardiac valve support member comprises first support component, has to shrink to send structure and deployment configuration; Second support component has to shrink and sends structure and deployment configuration; First bridge member extends to second support component from first support component, wherein first bridge member have send the structure and deployment configuration; With second bridge member, extend to second support component from first support component, wherein first bridge member have send the structure and deployment configuration; Wherein first and second bridge members extend radially inwardly from first and second support components in deployment configuration; And replacement heart valve, a plurality of lobe leaves that it comprises expansible anchoring piece and is suitable for being fixed to the cardiac valve support member.
In certain embodiments, bridge member is suitable for engaging securely replacement heart valve.
One aspect of the present invention is the mitral method of a kind of displacement patient, comprise: the endovascular delivery valve support is near the position the main body Bicuspid valve, valve support comprises first support component, second support component and first and second bridge members that extend from first and second support components; Expand first support component to the deployment configuration of below the annulus of mitral valve plane, fixing against heart tissue from contracted configurations; From sending structure bridge member is expanded to deployment configuration, orientates as roughly and aim at the abutment of primary mitral valve leaflet; With from contracted configurations second support component is expanded to deployment configuration, above the annulus of mitral valve plane, fix against left atrial tissue.
In certain embodiments, expand first support component and comprise that permission first support component is against the heart tissue self expandable.
In certain embodiments, each comprises that the permission bridge member presents deployment configuration the expansion bridge member, and they extend radially inwardly from first and second support components in deployment configuration.
In certain embodiments, the expansion of second support component is comprised the permission second support component self expandable against left atrial tissue.
In certain embodiments, expanding first support component comprises the structure expansion of first support component towards roughly ring-type expansion.
In certain embodiments, expand first support component and comprise expansion against the first fixing support component of Papillary muscle, and be attached to primary mitral tendon, and can not allow them be shifted.
In certain embodiments, primary lobe leaf continues the performance function after expansion second support component.
In certain embodiments, expanding first support component took place before expansion second support component.
In certain embodiments, the expansion bridge member comprises that the permission bridge member extends to second support component from the first support component symmetry.
In certain embodiments, the expansion bridge member comprises that the permission bridge member is from each other approximately first and second support components extension of 180 degree.
In certain embodiments, expand second support component and comprise and allow second support component be expanded to deployment configuration that second support component has the bigger size of size than first support component under the deployment configuration in described deployment configuration.Second support component can have one or more retaining elements that are suitable for penetrating heart tissue.
In certain embodiments, method further comprises the displacement Bicuspid valve is fixed to valve support.To replace Bicuspid valve is fixed to valve support and can comprises that allowing the displacement Bicuspid valve send structure from contraction is expanded to expanded configuration.The expansion of displacement Bicuspid valve can be comprised by air bag to be made the expansion of displacement Bicuspid valve and/or allows displacement Bicuspid valve self expandable.To replace Bicuspid valve is fixed to valve support and can comprises the displacement Bicuspid valve radially is fixed in the valve support.The fixed permutation Bicuspid valve can comprise displacement Bicuspid valve element and the locking of valve support component to valve support, lock onto valve support will replace Bicuspid valve.Each can comprise the bridge joint locking member bridge member, and the displacement Bicuspid valve can comprise a plurality of locking members, thereby lock step comprise with one in a plurality of locking members with the bridge joint locking member in locking and with second in a plurality of locking members with the bridge joint locking member in another locking.
If each discloses or patent application is described to merge by reference particularly or individually, then the patent disclosure of mentioning in this description and patent application all are herein incorporated by reference.
Novel feature of the present invention is specifically described in the appended claims.Can better understanding be arranged to the features and advantages of the present invention by the detailed description with reference to following illustrative embodiment, utilized principle of the present invention in the described illustrative embodiment, and appended accompanying drawing be:
Figure 1A-1C shows the exemplary displacement Bicuspid valve supporting construction in the expanded configuration;
Fig. 2 A-2C shows be used to the exemplary delivery system of sending displacement Bicuspid valve supporting construction;
Fig. 3 A-3E shows the illustrative methods of sending and launching exemplary displacement Bicuspid valve supporting construction;
Fig. 4 A-4D shows the illustrative methods of launching the displacement Bicuspid valve and being fixed to displacement Bicuspid valve supporting construction;
Fig. 5 A-5D shows be used to the exemplary delivery system of sending displacement Bicuspid valve supporting construction;
Fig. 6 shows the profile of exemplary displacement Bicuspid valve support member;
Fig. 7 shows the expansion valve support, and wherein the supported underneath element has the diameter littler than the diameter of top support component;
Fig. 8 A and 8B show and comprise that sealing member is to reduce the embodiment that leaks.
The present invention relates generally to the cardiac valve supporting construction, its be suitable for being implanted in primary cardiac valve or the native valve ring or near, and be suitable for replacement heart valve and provide support.Supporting construction is suitable for interacting with replacement heart valve, to be fixed in native valve or the native valve ring or near implantation position.In certain embodiments, supporting construction be suitable for being positioned in the annulus of mitral valve or near, and be suitable for and the displacement Bicuspid valve sent afterwards interacts, with will replace Bicuspid valve fix in place, to replace primary mitral function.
The present invention also provides the blood vessel in two steps to be implanted into process, is used for displacement patient's primary Bicuspid valve.Usually, supporting construction at first be positioned in the annulus of mitral valve or near, and it is in place to be fixed.The displacement Bicuspid valve is fixed to supporting construction subsequently, make replacement valve in valve annulus or near fixing in place.By implant supporting construction and displacement Bicuspid valve with two steps, the displacement Bicuspid valve can have the littler profile of sending, because because the existence of supporting construction, it needn't be expanded too much with contact primary structure.This has eliminated the needs with big replacement valve of sending profile, this big profile replacement valve of sending can be required when attempting that aortic valve is positioned at primary Bicuspid valve, or single-piece Bicuspid valve implant (namely not the implant of assembling) in vivo can be required when being positioned in the primary Bicuspid valve attempting.
Figure 1A-1C has shown the exemplary embodiment of valve support in the expanded configuration.Valve support 10 comprises first support component 12, second support component 14 and extends to first and second bridge members 16 of second support 14 from first support 12.Figure 1A shows the perspective view of valve support 10, and Figure 1B and 1C show side view and the vertical view of valve support 10 respectively.As shown in Figure 1B, each bridge member 16 comprises valve bonding part 18.
In certain embodiments, first support component and second support component in its expanded configuration normally the annular (for example shown in Figure 1A).But in the cardioanatomy structure aspects, the patient can require support component to have different sizes and structure with patient's difference.Therefore support component can have any structure to be fixed to any anatomical structure as required.For example, support component can have roughly oval structure.In addition, support component does not need to have identical essential structure.For example, the top support component can have the shape of general toroidal and the supported underneath element can have the shape of common ellipse.Bridge member operatively connects first and second support components, and roughly radially inwardly and axially extends away from first support component before radially stretching out towards second support component.For example, in the embodiment of Figure 1A-1C, before radially stretching out towards support member 14, bridge member 16 extends from the radially inside direction of support member 12, and axially extends away from support component 12 with towards support component 14.The valve bonding part of bridge member radially inwardly arranges with respect to support component.Bridge member is biased into the structure shown in Figure 1A-1C by the valve bonding part, and described valve bonding part radially inwardly arranges with respect to support component.Because they are by towards this structure bias voltage, so they are suitable for applying radially inner power, with the displacement mitral valve location that will be expanded to expanded configuration subsequently in bridge member (as described below).Therefore bridge member is suitable for engaging replacement heart valve, is fixed to valve support will replace Bicuspid valve.
In the embodiment shown in Figure 1A-1C, extend from support component at the discrete location place of bridge member around support component.That is, in this embodiment, bridge member does not extend around support component fully from support component.If so, then valve support will have the roughly shape of water leakage.Therefore, bridge member is not the extension fully of support component.Although the embodiment among Figure 1A-1C has shown two bridge members that extend from support component at discrete location, valve support can comprise the bridge member that extends from support component at discrete location along support component more than two.
In the embodiment of Figure 1A-1C, bridge member also extends from first and second support components symmetry.That is, at least one view of valve support, have at least one line or the plane that extend through valve, it forms the part of the symmetry of valve support.For example, with reference to figure 1C, the line that extends through bridge member and cross structure connection member forms the symmetric part of valve support.Or for example with reference to Figure 1B, the vertical line that extends through the valve support center forms the symmetric part of valve support.
In certain embodiments, the resilient material manufacturing of first and second support components and bridge member, the resilient material deformable has the optional extra expansion of one or more parts for sending structure and still being suitable for self expandable to expanded configuration by air bag.For example, according to the superplastic character of Nitinol, support member can be made with Nitinol.The valve support apparatus has the material manufacture of shape-memory properties in certain embodiments, Nitinol for example, and be suitable for after being heated to its transition temperature, turning back to its expansion memory structure.In certain embodiments, wherein valve support is utilized shape-memory properties and superplasticity property with for example such material manufacture of Nitinol.In the embodiment of Figure 1A-1C, valve support 10 is suitable for by self expandable (superplasticity that depends on material) or by the expanded configuration shown in being heated to it (for example by being exposed to body temp) turning back to more than transition temperature.
In case supporting construction expansion and fix in placely in primary Bicuspid valve is then shunk the displacement Bicuspid valve of sending in the structure and is pushed into and is positioned in the bridge member by first supporting construction.Replace mitral expansion (for example air bag expansion, self expandable etc.) and not only allow the expansion of displacement Bicuspid valve, and apply expansionary force at bridge member, make them further radially outwards towards the native valve ring extension.Replace mitral expansion and make replacement valve engage bridge member, and will replace Bicuspid valve and be fixed to valve support.Because the structure bias voltage that bridge member is roughly radially extended internally towards them, so bridge member applies radially inner power at the displacement Bicuspid valve, it is fixing in place that help will be replaced Bicuspid valve.The further details of exemplary expansion process is described later.
In the embodiment shown in Figure 1A-1C, bridge member and support component are to be fixed to each other the different elements that separates by any suitable technique (for example soldering).In the embodiment of some replacements, it is individual unit that support component and bridge member are manufactured to, and does not need parts fixed to one another (for example exemplary embodiment of Fig. 3 A-7 hereinafter).For example, in certain embodiments, the manufacturing of valve support is simplified, because it is made with single tubular form memory material, this material preform has predetermined divergence ratio, and needs power will replace Bicuspid valve to be held in place.
In certain embodiments, height valve support, that measure to the second support member top from the bottom of first support member be about 1cm to about 50cm, can adapt to the height of replacement heart valve, the cardiac valve of belt supporting frame for example.Height is greater than 50cm in certain embodiments.The height of valve support is that about 10cm is to about 25cm in certain embodiments.For example, the cardiac valve of the belt supporting frame in the expanded configuration has the height of about 17.5mm.But the height of valve support is less than the height of replacement heart valve in certain embodiments.These numbers only are exemplary rather than restrictive.In addition, two annular brace elements can have different size.For example, two support components (if general toroidal) can have different-diameter.The first support member element has than the bigger diameter of the second support member element in certain embodiments, because its anatomical position that is placed is bigger than the anatomical position that the second support member element is placed.In the embodiment shown in Figure 1A-1C because compare in the bigger left atrium with less left ventricle, in mastoid process tendon and the muscle, the expansion in the left ventricle in other supporting constructions, support component 12 can have the diameter bigger than support component 14.The possible difference of above and below support component size is described in detail hereinafter.
Support component does not have cladding element in embodiment as herein described.But in certain embodiments, one or more support components can have cladding element, for example seal the shirt rim, to improve around replacement heart valve and supporting construction and the sealing of blood flow wherein.Cladding element can be the material of any kind, the sealing function that it centers on support component and reinforcement is provided.
In certain embodiments, one or more supporting constructions are coated in the material of polyester textile (for example terylene) for example.Alternatively or in addition, one or more bridge members can be coated in the polyester textile of terylene for example.
Fig. 2 A shows the exemplary delivery device and shrinks the mitral valve support member of sending in the structure.Delivery apparatus 30 comprise have an actuator 34 actuate part 35.Delivery apparatus 30 also comprises slender body 32, and described slender body is fixed to actuates part 35.Delivery apparatus 30 also comprises the guidewire lumen 42 that connects female Luer 38, and wherein tube chamber 42 is suitable for (seeing Fig. 2 B) outside seal wire 40 and is pushed into to far-end, to allow delivery apparatus 30 be advanced to target location in the main body.The part of dotted line left side delivery apparatus 30 can be considered to the proximal section of delivery apparatus 30, and its at least a portion remains in the patient outside in operation process, provides actuating user's operation of part 35.The part on dotted line the right of device can be considered to distal section, and is considered to be in the part that is suitable in the operation process being pushed into by patient's delivery apparatus usually.Actuator part 35 comprises actuator 34, and described actuator is suitable for being actuated to control the motion of slender body 32.Specifically, actuator 34 actuates control slender body 32 with respect to the motion of interior tube chamber 42 and valve support 44.In Fig. 2 A and 2B, the displacement to axial of the Spin Control slender body 32 of actuator 34, but the actuator of any other adequate types can be used and be incorporated in the system, with the axial displacement of control slender body 32.Tube chamber 42 can be axially displaced with respect to slender body 32 by the axially-movable of tube chamber 42 near-ends.Delivery apparatus 30 also comprises device coupling member 36, and it extends the near-end of the proximal section of device 30, and also in slender body 32 and beyond guiding tube chamber 42 radially towards remote extension.Remote area at device coupling member 36 in the expansion process is fixed to valve support 44(releasedly shown in Fig. 2 A and 2B), but also be suitable for controllably discharging from valve support 44, so that valve support is discharged from delivery apparatus.Coupling member 36 can be actuated by actuating its patient proximal section in addition, with the motion of control valve support 44.Valve support 44 is in to shrink in the slender body 32 and sends in the structure in Fig. 2 A, and is arranged on the outside of guiding tube chamber 42.In sending structure, the annular section 45 of valve support 44 shrinks (only having shown a bridge member) downwards on bridge member 47.When shrinking, basic each semi-circular support member 45 all shrinks downwards and has a C shape structure, and this C shape structure has curved configuration (having the part than small curvature radius) tighter than in expanded configuration (valve support shown in Fig. 2 C send structure) time.In sending structure, bridge member 47 presents than structure more straight in expanded configuration.As describing in detail later, the annular brace element can be biased with at some location bendings so that in loading process and the contraction in any contraction process again that may need easy.Shrink the axial location of valve support by coupling member 36 controls.Fig. 2 B shows for a part (its details is described later) that discharges the process of valve support 44 from delivery apparatus 30.Actuating of actuator 34, the rotation of as directed actuator 34 makes slender body 32 return along proximal direction.Guiding tube chamber 42 can be held in place or be pushed into and slender body 32 is return to far-end.Slender body 32 and coupling member 36(valve support 44 are attached to this coupling member 36) between relative motion expand when allowing valve support 44 to move on slender body 32 near-end ground.In Fig. 2 B, the first valve support element (with the sub-fraction of bridge member 47) expansion.The lasting withdrawal of slender body allows valve support 44 fully to expand, and still is connected to coupling member 36.
Fig. 2 C shows the replacement perspective view of delivery apparatus 30, has shown two bridge members 47.But in Fig. 2 C, when shrinking in slender body 32 in sending structure, support component 45 is suitable for roughly axially being out of shape away from the end of bridge member.
In the embodiment of Fig. 2 A-2C, slender body 32 for example can be but be not limited to is conduit, and its example is known.Actuate part 35 such as but not limited to being runner (touhy borst), allow actuator 34 to rotate to control the axially-movable of slender body 32.Guiding tube chamber 42 for example can be but be not limited to the tube chamber that corrugated steel is strengthened, to allow to have enough flexibilities when being pushed into by vascular system.Guiding tube chamber 42 can also be the suitable guiding tube chamber of any other type.
Get involved in Bicuspid valve or other chamber valves and will preferably realize (getting involved by skin) by the patient's vascular system percutaneous.Percutaneous is got involved at a distance, and the vascular system position is well known in the art.According to the point that vascular is got involved, the Bicuspid valve method can be direct motion and need enter left atrium by passing septum interatriale cordis.Alternatively, can drive in the wrong direction to mitral method, wherein enter left ventricle by aortic valve.Alternatively, Bicuspid valve can be got involved through the apex of the heart (transapically), is being known in the art.Antegrade approach by septum interatriale cordis and the details of other suitable interventional methods can be in U.S. Patent No.s 7,753, find in 923, and this patent was submitted on August 25th, 2004, and its content is incorporated herein by reference.
Although the supporting construction of this paper be described to usually be for the displacement mitral valve support member, it can be delivered to desired locations, to support other replacement heart valve, for example replaces tricuspid valve, the displacement lung valve and the displacement aortic valve.
Fig. 3 A-3E shows the profile of heart H, has shown the illustrative methods of launching valve support in primary Bicuspid valve MV.Can realize using known method by femoral vein, IVC, right atrium, passed septum interatriale cordis S and entered left atrium LA and got involved Bicuspid valve.The exemplary details of this method can be for example but be not limited to US Patent No 7,753, find in 923.As shown in Figure 3A, guide catheter 50(is the 18F guide catheter for example) outside seal wire 52, be pushed into by in every S, to provide mitral intervention.Seal wire 52 has been pushed into by primary Bicuspid valve and has entered left ventricle, is pushed into and enters position in the primary Bicuspid valve to allow delivery apparatus outside seal wire 52.Alternatively, guide catheter 50 can be pushed into outside seal wire 52 and put in place, and seal wire 52 can be removed subsequently.Delivery apparatus can be pushed into simply subsequently and not use seal wire 52 by guide catheter 50.But seal wire 52 can preferably be left in place, is pushed into outside seal wire 52 with the displacement Bicuspid valve that allows to be sent subsequently.
In Fig. 3 B, delivery apparatus 54(valve support is shunk therein) outside seal wire 52, be pushed into and by guide catheter 50, and be advanced to beyond the far-end of guide catheter 50.Delivery apparatus 54 is pushed into by primary mitral lobe leaf L, thereby the far-end of slender body 55 is arranged in the left ventricular LV, shown in Fig. 3 B.
Shown in Fig. 3 C, slender body 55 is return to near-end with respect to valve support subsequently, and valve support is discharged (for example using the such actuator of actuator 34, shown in Fig. 2 A-2C) from slender body 55.In this embodiment, valve support resilient material manufacturing, Nitinol for example, and when slender body 55 is return, begin self expandable.In Fig. 3 C, first support component, 58 self expandables are to the circular structure of expansion, and are as directed.When support component 58 expansion, it engages the heart tissue of ventricle below the annulus of mitral valve plane, with itself against this fixation of tissue.Support component 58 preferentially is positioned at subring shape space, with minimum damage or do not damage ground and fix against the mastoid process tendon, thereby does not interfere its performance function.Support component 58 is preferably sufficiently expanded to far-end, thereby primary mitral valve leaflet also can be brought into play function after support component 58 expansions.As mentioned above, in certain embodiments, below or secondary support component have than top or the littler diameter of senior support component, with coupling from the internipple distance of the measurement of the object considered from.Less relative diameter does not make the ability of their displacements for the supported underneath element provides opposing mastoid process tendon.The mastoid process tendon is attached at an end of Papillary muscle and is attached at the other end of primary lobe leaf, and allows mastoid process tendon or Papillary muscle displacement can stop primary lobe leaf correctly closed, makes and causes adverse current in valve support between expansionary phase.The supported underneath element is therefore fixing in place and do not interfere the function of primary lobe leaf.With reference to Fig. 7, it is in place that the exemplary valve support member is shown as expansion tout court.Supported underneath element 130 is shown as has the diameter littler than top support component 126.Support component 130 antagonism mastoid process tendons 124 still do not allow their be shifted, and do not disturb with the function of Papillary muscle 122 and mastoid process tendon 124 thus.Support component 130 is expanded in subring shape space, and support component 126 is expanded in left atrium LA.Although the embodiment that this paper shows has shown the supported underneath element by mastoid process tendon and/or Papillary muscle displacement, thereby purpose is the supported underneath part correctly to be set size it is expanded in mode shown in Figure 7.
Later referring to Fig. 3 C, slender body 55 is return to near-end with respect to the part of bridge member 60, allows the part expansion of bridge member 60.If necessary, this some place support component 58 in this process can shrink in slender body 55 again.Known visualization technique (fluorescent technique for example can be used in the location of valve support, or other imaging techniques of any necessity) and visual, if and definite support component 58 is correctly located, then slender body 55 can be pushed into to far-end with respect to valve support, coupling member 64 can be return with respect to slender body 55, or the combination of the two can be implemented as and allows at least a portion of support component 58 shrink in slender body 55 again.Valve support can be relocated subsequently, and support component 58 further expansion subsequently is correctly fixing in place with anatomical position or space in expectation.
Shown in Fig. 3 D, slender body 55 continues to return permission second support component 62 self expandables to near-end (not shown among Fig. 3 D), and itself is fixed against the sidewall in the atrium of annulus of mitral valve top.In certain embodiments, second support component comprises one or more retaining elements, and for example anchoring piece, agnail, clip etc. help second support component is fixed against heart tissue, or be suitable for piercing through and enter heart tissue, so that support component is fixed to heart tissue.One or more retaining elements (if being used) then can arrange around support component periphery.They can present contraction or send structure, are used for sending of system, but are being deployed to expansion or anchoring structure when delivery system discharges.For example, retaining element can be resilient material, and its self expandable is to anchoring structure.Alternatively, retaining element can be actuated, so that they are reconfigured to fixture construction.But in certain embodiments, one or more retaining elements are unsuitable for changing structure.For clear, mitral valve leaflet is not shown at Fig. 3 D.Only one as seen in Fig. 3 D for coupling member 64() still controllably be fixed to second support component 62.Support component 62 can be regained in slender body 55 at this point in this process again.This can take place as described above with respect to support component 58.In certain embodiments, support component 62 can be suitable near the point that coupling member 64 is fixed or some place priority bending (sending structure towards it shrinks).Should shrink again in slender body 52 if determine support component 62, then the power towards near-end can be applied to coupling member 64, applies power at support component 62 thus.If support component 62 is suitable at the fixing position priority bending of coupling member, then power will be applied in the position that support member is suitable for priority bending.This will allow support component 62 more easily and more effectively be out of shape towards its contracted configurations.In case support component 62 shrinks in slender body 55, the continuing to return of coupling member 64 can make support component 58 also shrink.Support component 58 can be suitable at some position priority bendings as support component 62, and it is easy towards its distortion of sending structure to make.
Support component 62(and support component 58) on position (bridge member 60 from this position extend) be separated from each other and be 180 degree roughly, roughly 180 degree that are similar to primary lobe leaf abutment separate.In the expanded configuration shown in Fig. 3 D, the position on that bridge member extends from it, the support component roughly preferably is positioned at the end of closing line between two native valve lobe leaves.Be that the connecting line of the point that extends from it of the bridge member on the support component preferential (though be not must) is aimed at primary lobe leaf closing line.One or two support component can have radiopaque labelling in these positions, in place with the correct orientation that helps valve support.By allowing bridge member be positioned at these positions with respect to primary lobe leaf, even after valve support is deployed into fully expanded configuration, shown in Fig. 3 D, bridge member does not disturb (or minimally disturbs at least) mutually yet with the function of primary lobe leaf in implantation process.Because primary lobe leaf can be brought into play function during this part of this process, so the key factor that the time is not valve support during launching.
Although supporting construction is described as comprising two bridging elements usually herein, supporting construction can have than two more bridging elements of bridging element that are arranged in supporting construction any structure on every side.
Next, guiding elements 56 is return from the patient, and it is in place to stay seal wire 52, guide catheter 50 and slender body 55, shown in Fig. 3 E.Guide catheter 50 and seal wire 52 can provide mitral intervention, are fixed to valve support to allow replacing Bicuspid valve, and described valve support is expanded and is fixed in the native valve.
Fig. 4 A-4D shows exemplary displacement Bicuspid valve sending and expand subsequently.In Fig. 4 A, have the balloon catheter of air bag 70 and replacement valve thereon 72 and outside seal wire 52 and in guide catheter 50, be advanced to the position shown in radially in the expansion valve support.Usually, replacement valve 72(comprises expandable stent and is fixed to its displacement lobe leaf in this example) be pushed into, radially be positioned in the valve bonding part 61 of bridge member up to it.Be in the optimum position (for example using visualization technique, for example echocardiogram) of passing atrium-ventricle line in case replacement valve is determined, then replacement valve can be expanded.
Shown in Fig. 4 B, air bag 70 is by filling it with expansion fluid and being expanded, and this process is well known in the art.The expansion of air bag 70 makes the expandable stent of replacement valve partly expand.The expansion of support applies radially outside power at the bridge member of valve support, makes their expand (or the edge is outward direction distortion radially roughly).When support was expanded, support outwards promoted primary lobe leaf towards valve annulus.When support was expanded, the hole in the support that limits by timbering material was suitable for engaging with protuberance or other surface character of the valve bonding part of bridge member, so that expandable stent is fixed to bridge member.The radially inside bias voltage of bridge member also helps by applying radially inner bed knife at support replacement valve to be fixed in the valve support.Support applies radially outside power at bridge member, and the two-way interaction stops the axially displaced and contraction of replacement valve to allow replacement valve fixing in place.In addition, bridge member can be suitable for presenting preferential expanded configuration (for example shown in Fig. 4 B) in the replacement valve process of expansion of expansion.For example, bridge member can be suitable for having inflection point 75, at place, this inflection point, bridge member will be when expansion priority bending, this stops the axially migration away from each other in the replacement valve process of expansion of two supporting members.But inflection point 75 also auxiliary phase for supporting construction fixed permutation valve.
Replacement valve expanded and fixing in place after, air bag 70 venting and recalled from the patient with seal wire are shown in Fig. 4 C.In case air bag deflation is replaced mitral lobe leaf L and is begun to bring into play function.Shown three lobe leaves, can in this example process, use to replace primary Bicuspid valve so that known displacement aortic valve (only be US Patent No 7,585, the example of describing in 321, this patent was submitted on May 27th, 2005) to be described.
Although shown the expansible replacement heart valve of gasbag-type, but also self expandable of replacement heart valve.
In case it is in place that replacement valve is fixed in valve support, then coupling member 64 is thrown off from support component 62.In this exemplary embodiment, the far-end of coupling member 64 has screw thread, its be suitable for support component 62 in engage threaded.The rotation of coupling member 64 makes coupling member 64 untie spiral from support component 62, thus coupling member 64 is broken away from from supporting 62.Guide catheter 50 is removed from the patient subsequently, and it is in place to stay implant, shown in Fig. 4 D.
As mentioned above, Bicuspid valve can be via getting involved through the method for the apex of the heart, or via the summit of heart.In such method, coupling member 64 will be fixed to supported underneath element 58 rather than top support component 62, shown in this paper embodiment.Coupling member 64 still can by as actuate in same mode as herein described.
Fig. 5 A-5D illustrate the exemplary delivery device and therein, be in the mitral valve support member of sending structure.Delivery apparatus and mitral valve support member are similar to shown in the embodiment of Fig. 2 A-2C.Delivery apparatus 80 comprises haemostatic valve 82, and described haemostatic valve comprises the protruding Luer lock 81 of rotation and recessed Rule side ports 83.Delivery apparatus 80 also comprises the slender body 84 that is fixed to actuator 85, and wherein actuator 85 is suitable for rotating to control the axially-movable of slender body 84.Device 100 shrinks in slender body 84 and arranges radially outwardly with respect to tube chamber 86.Delivery apparatus 80 also comprises guidewire lumen 86, and it is suitable for seal wire 90 is received in wherein, and it is connected to female Luer 88, and described female Luer is suitable for respect to slender body 84 axially-movables.Coupling member 92 reversibly is fixed to valve support 100, as described in the above-described embodiments.Other details of delivery apparatus 80 can be with described in above-described embodiment identical.
In Fig. 5 B, the actuating of actuator 85 makes slender body 84 return to near-end with respect to valve support 100.This makes the far-end support component 101 of valve support 100 begin self expandables to the expanded configuration against tissue (not shown in order to know anatomical structure), for example embodiment of Fig. 3 A-3E.Haemostatic valve 82 replacedly or is in addition spurred (shown in arrow among Fig. 5 B) to near-end, so that slender body 84 is return with respect to valve support 100.In addition or alternatively, guiding tube chamber 86 can be pushed into (shown in Fig. 5 B arrow) to far-end with respect to slender body 84.The motion of these types can impel or help the expansion of valve support.
Shown in Fig. 5 C, the bridge member 102 of valve support 100 continues to expand by the motion of the relative near-end of slender body 84.This can get near-end motion (as shown by arrows) by slender body and be performed, and by advancing tube chamber 86 to be performed to far-end, or is performed by this dual mode.The relative motion that slender body 84 continues makes second support component 103 be expanded to deployment configuration at last, shown in Fig. 5 D.When second support component, 103 self expandables, coupling member 92 can radially stretch out with support component 103.
In case it is in place that valve support is confirmed as locating, then guide tube chamber 92 can be removed to allow replacement heart valve to be positioned in the valve support, its example shows at Fig. 4 A-4D.
Fig. 6 shows the profile of the valve support 110 of single-piece, comprise first support component 114, second support component 116, bridge member 118, with connection element 112, they are shown as is screwed hole and is suitable for securely in conjunction with the threaded section of coupling member, and its example as mentioned above.
Fig. 8 A and 8B show the alternative embodiment of valve support.Valve support 200 comprises the parts that alleviate valve leaks.Except support component 202 and 204 and bridge member 206 and 208, valve support 200 comprises one or more fins 210 and 212.Fin has been expanded the coverage of valve support system, and helps to reduce valve leaks, is similar to the function of the dashboard on the automobile.During launching, exemplary fin 210 and 212 around or be adjacent to against top support component 202, shown in Fig. 8 B, when launching from conduit, fin is expanded or is extended to the structure shown in Fig. 8 A (for clear, native valve is not shown).Fin can be with flexible biocompatible material manufacturing, for example various polymers compositionss.Fin can be fixed to valve support by any suitable mechanism, for example by fin is sewn onto support component, or is sewn onto capped material and uses bridge member to stop the suture material displacement.
Upon deployment, in certain embodiments, fin is arranged on valve annulus top and up on the side of support component, it can not extend to atrial walls always.This can reduce valve leaks with some millimeters of coverage extension of valve support system.Alternatively, in certain embodiments, wherein support component is bigger, and fin is prompted to against atrial tissue.In this used, fin was as extra sealing member when in place in the valve support system.Therefore one or more fins can be the parts of valve support system, and it reduces valve leaks and/or is used as extra sealing member.
Although this paper has described some embodiment, it will be understood by those skilled in the art that such embodiment only provides by the mode of example.Those skilled in the art can understand, and can make many variations example, change and replace and do not break away from the present invention.The various replacements that should understand embodiment as herein described can be used for implementing the present invention.
1. a cardiac valve support member is suitable for arriving cardiac valve at endovascular delivery, comprising:
First support component has to shrink and sends structure and deployment configuration;
Second support component has to shrink and sends structure and deployment configuration;
First bridge member extends to second support component from first support component, wherein first bridge member have send the structure and deployment configuration; With
Second bridge member extends to second support component from first support component, wherein second bridge member have send the structure and deployment configuration;
Wherein first and second bridge members extend radially inwardly from first and second support components in deployment configuration.
2. cardiac valve support member as claimed in claim 1, wherein first and second bridge members extend from first and second discrete locations around first and second support components.
3. cardiac valve support member as claimed in claim 2, wherein first and second bridge members extend from first and second support components symmetry.
4. cardiac valve support member as claimed in claim 2, wherein first and second bridge members extend from first and second support components, each other approximately are 180 degree.
5. cardiac valve support member as claimed in claim 1, wherein at least one in first and second support components has annular shape.
6. cardiac valve support member as claimed in claim 1, wherein first and second bridge members each have the replacement valve bonding part, this replacement valve bonding part is suitable for engaging securely replacement heart valve.
7. cardiac valve support member as claimed in claim 6, each has locking member wherein said bonding part, and this locking member is suitable for locking securely with the part of replacement heart valve.
8. cardiac valve support member as claimed in claim 1, wherein first and second support components are suitable at least one position priority bending.
9. cardiac valve support member as claimed in claim 1, wherein first and second support components each have sweep in its deployment configuration, wherein this sweep is sent in contraction and is suitable for presenting tighter curved configuration in the structure.
10. cardiac valve support member as claimed in claim 1, wherein first and second bridge members are generally C shape under its deployment configuration.
11. cardiac valve support member as claimed in claim 1, wherein first support component has at least one connection element, and this connection element is suitable for reversibly being connected to delivery system.
12. cardiac valve support member as claimed in claim 10, wherein this at least one connection element is threaded hole.
13. cardiac valve support member as claimed in claim 1, wherein the size that has under deployment configuration of second support component is bigger in the size under the deployment configuration than first support component.
14. one kind is suitable for endovascular delivery to replace mitral system, comprises:
The cardiac valve support member comprises
Second bridge member extends to second support component from first support component, wherein first bridge member have send the structure and deployment configuration;
Wherein first and second bridge members extend radially inwardly from first and second support components in deployment configuration; With
Replacement heart valve comprises distensible anchoring piece and a plurality of lobe leaves that are suitable for being fixed to the cardiac valve support member.
15. system as claimed in claim 14, wherein bridge member is suitable for engaging securely replacement heart valve.
16. the mitral method of displacement patient comprises:
With near the position of valve support endovascular delivery arrives the Bicuspid valve of object, valve support comprises first support component, second support component and first and second bridge members that extend from first and second support components;
First support component is expanded to below the plane of annulus of mitral valve against the fixing deployment configuration of heart tissue from contracted configurations;
Make bridge member orientate the deployment configuration of roughly aiming at the abutment of primary mitral valve leaflet as from sending to construct to be expanded to; With
Second support component is expanded to above the plane of annulus of mitral valve against the fixing deployment configuration of left atrial tissue from contracted configurations.
17. method as claimed in claim 16 wherein makes the expansion of first support component comprise and allows first support component against the heart tissue self expandable.
18. method as claimed in claim 16 is wherein expanded each bridge member and comprised that the permission bridge member presents deployment configuration, they extend radially inwardly from first and second support components in described deployment configuration.
19. method as claimed in claim 16 wherein makes second support component comprise against the left atrial tissue expansion and allows the second support component self expandable.
20. method as claimed in claim 16 wherein makes the expansion of first support component comprise and makes first support component to the structure expansion that roughly launches annularly.
21. method as claimed in claim 16 wherein makes the expansion of first support component comprise and makes against fixing first support component expansion of mastoid process tendon.
22. method as claimed in claim 21 wherein makes the expansion of first support component comprise and makes against fixing first support component expansion of mastoid process tendon, and do not make their displacements.
23. method as claimed in claim 16, wherein primary lobe leaf performance function after making the expansion of second support component.
24. method as claimed in claim 16 wherein makes the expansion of first support component take place before making the expansion of second support component.
25. method as claimed in claim 16 is wherein expanded bridge member and is comprised that the permission bridge member extends to second support component from the first support component symmetry.
26. method as claimed in claim 16 is wherein expanded bridge member and is comprised that the permission bridge member relative to each other extends from first and second support components approximately in 180 degree.
27. method as claimed in claim 16 is wherein expanded second support component and is comprised and allow second support component be expanded to deployment configuration that second support component has the bigger size of size than first support component under the deployment configuration in this deployment configuration.
28. method as claimed in claim 16 further comprises the displacement Bicuspid valve is fixed to valve support.
29. method as claimed in claim 28 wherein will be replaced Bicuspid valve and is fixed to valve support and comprise that making the displacement Bicuspid valve send structure from contraction is expanded to expanded configuration.
30. method as claimed in claim 29 wherein makes the expansion of displacement Bicuspid valve comprise by air bag and makes the expansion of displacement Bicuspid valve.
31. method as claimed in claim 29 wherein makes the expansion of displacement Bicuspid valve comprise and allows displacement Bicuspid valve self expandable.
32. method as claimed in claim 28 wherein will be replaced Bicuspid valve and is fixed to valve support and comprise the displacement Bicuspid valve radially is fixed in the valve support.
33. method as claimed in claim 28, wherein the fixed permutation Bicuspid valve comprises displacement Bicuspid valve element and the locking of valve support component to valve support, locks onto valve support will replace Bicuspid valve.
34. method as claimed in claim 33, wherein bridge member each comprise the bridge joint locking member, and the displacement Bicuspid valve comprises a plurality of locking members, lock step comprise with one in a plurality of locking members with the bridge joint locking member in locking and with second in a plurality of locking members with the bridge joint locking member in another locking.
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