Source: https://patents.google.com/patent/CN106572905B/en
Timestamp: 2020-01-25 02:55:55
Document Index: 276702738

Matched Legal Cases: ['art 14', 'art 6', 'art 6', 'art 72', 'art 72', 'art.\n2']

CN106572905B - It is used to support the anchoring piece curled up, heart valve prosthesis and deployment device of heart valve prosthesis - Google Patents
It is used to support the anchoring piece curled up, heart valve prosthesis and deployment device of heart valve prosthesis Download PDF
CN106572905B
CN106572905B CN201580009731.5A CN201580009731A CN106572905B CN 106572905 B CN106572905 B CN 106572905B CN 201580009731 A CN201580009731 A CN 201580009731A CN 106572905 B CN106572905 B CN 106572905B
anchoring piece
CN201580009731.5A
CN106572905A (en
M·朝
A·J·西格尔
2014-02-20 Priority to US201461942300P priority Critical
2014-02-20 Priority to US61/942,300 priority
2015-02-20 Priority to PCT/US2015/016898 priority patent/WO2015127264A1/en
2017-04-19 Publication of CN106572905A publication Critical patent/CN106572905A/en
2019-11-05 Publication of CN106572905B publication Critical patent/CN106572905B/en
238000004873 anchoring Methods 0 abstract claims description title 222
210000004115 Mitral Valve Anatomy 0 abstract claims description 105
210000002216 Heart Anatomy 0 abstract claims description 44
210000003709 Heart Valves Anatomy 0 description title 11
210000001308 Heart Ventricles Anatomy 0 claims description 26
229910001092 metal group alloys Inorganic materials 0 abstract description 5
210000003698 Chordae Tendineae Anatomy 0 description 36
238000002513 implantation Methods 0 description 23
REDXJYDRNCIFBQ-UHFFFAOYSA-N aluminium(3+) Chemical group data:image/svg+xml;base64,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 data:image/svg+xml;base64,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 [Al+3] REDXJYDRNCIFBQ-UHFFFAOYSA-N 0 description 4
210000003157 Atrial Septum Anatomy 0 description 3
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OYPRJOBELJOOCE-UHFFFAOYSA-N calcium Chemical compound data:image/svg+xml;base64,PD94bWwgdmVyc2lvbj0nMS4wJyBlbmNvZGluZz0naXNvLTg4NTktMSc/Pgo8c3ZnIHZlcnNpb249JzEuMScgYmFzZVByb2ZpbGU9J2Z1bGwnCiAgICAgICAgICAgICAgeG1sbnM9J2h0dHA6Ly93d3cudzMub3JnLzIwMDAvc3ZnJwogICAgICAgICAgICAgICAgICAgICAgeG1sbnM6cmRraXQ9J2h0dHA6Ly93d3cucmRraXQub3JnL3htbCcKICAgICAgICAgICAgICAgICAgICAgIHhtbG5zOnhsaW5rPSdodHRwOi8vd3d3LnczLm9yZy8xOTk5L3hsaW5rJwogICAgICAgICAgICAgICAgICB4bWw6c3BhY2U9J3ByZXNlcnZlJwp3aWR0aD0nMzAwcHgnIGhlaWdodD0nMzAwcHgnID4KPCEtLSBFTkQgT0YgSEVBREVSIC0tPgo8cmVjdCBzdHlsZT0nb3BhY2l0eToxLjA7ZmlsbDojRkZGRkZGO3N0cm9rZTpub25lJyB3aWR0aD0nMzAwJyBoZWlnaHQ9JzMwMCcgeD0nMCcgeT0nMCc+IDwvcmVjdD4KPHRleHQgeD0nMTM4LjQ5MycgeT0nMTU3LjUnIHN0eWxlPSdmb250LXNpemU6MTVweDtmb250LXN0eWxlOm5vcm1hbDtmb250LXdlaWdodDpub3JtYWw7ZmlsbC1vcGFjaXR5OjE7c3Ryb2tlOm5vbmU7Zm9udC1mYW1pbHk6c2Fucy1zZXJpZjt0ZXh0LWFuY2hvcjpzdGFydDtmaWxsOiMzQjQxNDMnID48dHNwYW4+Q2E8L3RzcGFuPjwvdGV4dD4KPC9zdmc+Cg== data:image/svg+xml;base64,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 [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0 description 1
It is a kind of for mitral to be docked at the anchoring piece curled up at the primary bicuspid valve of heart with first end, second end and the central axis that extends between the first and second ends, and limit the inner space with central axis coaxial.The anchoring piece curled up includes the core curled up and the coating around core, the core curled up includes biocompatibility metal or metal alloy, and there are the multiple rotating parts extended in first position around central axis, coating includes the biocompatible materials less more rigid than the metal or metal alloy of the core curled up.
It is used to support the anchoring piece curled up, heart valve prosthesis and the portion of heart valve prosthesis Affix one's name to device
The present invention relates generally to the medical devices and program about heart valve prosthesis.More particularly it relates to can There can be the valvular displacement of deformity and/or dysfunction.The embodiment of the present invention is related to for replacing two in heart The heart valve prosthesis of cusp, promotion and maintain the anchoring piece of positioning of the heart valve prosthesis in native valve, Yi Jiyu The relevant deployment device of the implantation of heart valve prosthesis and program.
It is referring generally to Fig. 1 and Fig. 2 first, bicuspid valve controls stream of the blood between the atrium sinistrum and left ventricle of human heart It is dynamic.After atrium sinistrum receives oxygenated blood fluid from lung via pulmonary vein, bicuspid valve allows oxygenated blood fluid to flow into the left heart from atrium sinistrum Room.When left ventricular contraction, the oxygenated blood fluid accommodated in left ventricle is delivered through aortic valve and aorta reaches body Rest part.Meanwhile bicuspid valve is closed during ventricular contraction, is flow back into atrium sinistrum to prevent Hemostatic Oral Liquid.
When left ventricular contraction, the blood pressure in left ventricle sufficiently increases, and bicuspid valve is forced to be closed.Due in the heart Big pressure difference between left ventricle and atrium sinistrum during room is shunk, mitral leaflet prolapsus or turns back intra-auricular possibility outside Property occur.In order to prevent this situation, a series of chordae tendineaes (chordae tendineae) are sharp by two along the opposite wall of left ventricle Valve is connected to papillary muscle.Tendon is schematically illustrated in both mitral top views in the heart cross section of Fig. 1 and Fig. 2 Rope.Just before and during ventricular contraction, papillary muscle also shrinks and maintains the tension in chordae tendineae, by mitral leaflet It is maintained in closed position, and prevents their inside-outs from overturning and return in atrium, thus also prevent oxygenated blood fluid from arriving Intra-auricular adverse current.
The overall shape for bicuspid valve and its leaflet such as seen from atrium sinistrum is illustrated in Fig. 2.Mitral complication Potentially cause fatal heart failure.A kind of form of valvular heart disease is bicuspid valve leakage, also referred to as bicuspid valve Reflux, it is characterized in that blood passes through bicuspid valve exceptional leakage from left ventricle and backflows into atrium sinistrum.In these cases, may Wish to repair bicuspid valve or the manually mitral function of valvular replacement of function.
At this point, mitral valve repair is more popular than valve replacement, wherein previous research and development has been subjected to To limitation.It is set in the presence of seldom or there is no effective commercial methods by conduit implantation and/or other minimally invasive or noninvasive programs Change bicuspid valve.In contrast, the field through conduit aortic valve replacement has been developed, and has obtained universal success. This species diversity is more difficult than aortic valve replacement in many aspects derived from mitral displacement, for example, due to the physics knot of valve Structure and more difficult entrance to valve.
Since valve is subjected to large period load, the obstacle most outstanding of mitral valve replacement is to anchor valve or be maintained at suitable When in position.Especially during ventricular contraction, the load in the movement and valve of heart can be combined, and artificial valve is made to drift about Or displacement.Moreover, movement and rhythmicity load can make fatigue of materials, lead to the rupture of the valve of implantation.If bicuspid valve is false The orientation of body is inadvertently drifted about, then the blood flow between atrium sinistrum and left ventricle can be obstructed or otherwise by negatively It influences.Although puncturing in annulus of mitral valve or the tissue of surrounding with the valve for preferably anchoring implantation being for keeping putting for implantation material A kind of selection set, but this can potentially result in the unexpected perforation and patient's injury of heart.
Referring back to Fig. 2, mitral valve replacement another problem is that primary mitral size and shape.Aortic valve exists Vpg connection is more more round than bicuspid valve.In addition, in many cases, when aortic valve is due to the calcium of such as aortic valve leaflet Change and/or hardening the reason of and the when of narrowing, occur to the needs of aortic valve replacement since such as aortic valve is narrow. Therefore, compared to quite big and non-circular annulus of mitral valve, aortic valvular ring itself is generally formed for artificial valve more Stable anchoring position.Therefore, if good sealing is not established in valve periphery, too small round mitral valve implant It can cause the leakage (that is, leakage by valve) of the valve periphery of implantation.Meanwhile too big circular valve implantation material can tensible And damage annulus.The outer shape of valve implant also can be potentially manipulated to preferably for example by the outer of implantation material Fabric sleeve additive on surface cooperates annulus of mitral valve.However, these additives will limit through conduit and/or minimally invasive procedure Valve delivery, because additional fabric is likely difficult to compress and delivered by conduit.
Since many valves for being used for aortic position have been developed, so will wish to attempt to use these existing Valve technology, and same or similar valve is used in mitral valve replacement.It therefore will be usefully for such previous Existing artificial valve generates bicuspid valve anchoring piece or Docking station (docking station).Then, it is sent out for aortic position The perhaps existing valve with some changes of exhibition can be implanted in such anchoring piece or Docking station.Some previous development Valve can have seldom change or without change in the case where be well matched with, such as Edwards Lifesciences SapienTMValve.
Therefore the docking or anchoring that can be used to promote such valve in various method for implantation be would be desirable to provide Device and method.The embodiment of the present invention provides the stabilization Docking station for keeping mitral valve replacement prosthese.Provide improvement example Other devices of the positioning wherein of such Docking station and/or replacement prosthesis and deployment such as during various noninvasive or minimally invasive procedure And method.Described device and method can be also used for preventing or greatly reducing the adverse current or infiltration of the blood around replacement prosthesis Leakage, such as passes through the leakage in primary mitral comissure outside prosthese.
Feature of the invention is related to the docking being more effectively anchored at replacement valve prosthese in annulus of mitral valve or anchoring dress It sets.Other features of the invention be related to the anchor of embodiment according to the present invention and with primary mitral periphery Point and heart the replacement valve prosthese that more effectively interacts of other parts.Other features of the invention are related to for inciting somebody to action The different piece of anchor is more effectively deployed in above and below primary annulus of mitral valve (that is, respectively by anchor Unitary part is deployed in atrium sinistrum and left ventricle) docking or anchor and method.Other features of the invention are related to Chordae tendineae is assembled or kept together during docking or the deployment of anchor, more easily by docking or anchor positioning Around native valve leaflets and chordae tendineae.
In an embodiment of the present invention, a kind of for mitral to be docked at curling up at the primary bicuspid valve of heart Anchoring piece (coiled anchor) have first end, second end, the central axis extended between the first and second ends, And limit the inner space with central axis coaxial.The anchoring piece curled up includes the core curled up and the covering around core Layer, the core curled up includes biocompatibility metal or metal alloy, and has and prolong in first position around central axis The multiple rotating parts stretched, coating include the biocompatibility material less more rigid than the metal or metal alloy of the core curled up Material.The anchoring piece curled up is adjustable to the second position from first position, in the second position at least one of multiple rotating parts It is straightened the anchoring piece to curl up and primary bicuspid valve is delivered to by conduit, and return to first from the second position is adjustable Position.The anchoring piece curled up is implanted at primary bicuspid valve, wherein at least part on primary mitral side is in the heart In dirty atrium sinistrum and primary mitral at least part on opposite sides is in the left ventricle of heart, when the anchor curled up When firmware is implanted at primary bicuspid valve, mitral is supported or is kept in the interior space.
In another embodiment, the anchoring piece curled up can be included in the system for being implanted at bicuspid valve, In the system can further comprise mitral, mitral includes that extensible framework and accommodating passes through for controlling Multiple leaflets of blood flow therein, wherein frame extends to the second position of extension from the first position of shrinkage, is wrinkling Frame has the first overall diameter for mitral delivering to be passed through to conduit in the first position of contracting, in the second of extension Middle frame is set with second overall diameter bigger than the first overall diameter.When the anchoring piece and mitral that curl up are not biased When, the minimum interior diameter of the inner space limited by coil anchoring piece can be less than the second overall diameter of mitral.
In another embodiment, a kind of anchor curled up for mitral to be docked at the primary bicuspid valve of heart Firmware has first end, second end, the central axis extended between the first and second ends, and limits same with central axis The inner space of axis.The anchoring piece curled up includes: first coil, has multiple rotating parts along the first circumferencial direction, and Second end is extended to from first end；Second coil has along the multiple of second circumferential direction opposite with the first circumferential direction Rotating part, and second end is extended to from first end；Connector is configured as the first end of first coil and the second coil First end keeps together, so that first coil and the second coil are far from connector and along central axis from extending each other. The anchoring piece curled up has first position, during the respective rotating part of first coil and the second coil surrounds in first position Mandrel line extends.The anchoring piece curled up is adjustable to the second position from first position, in the second position first coil or second At least one of multiple rotating parts of coil are straightened the anchoring piece to curl up and are delivered to primary bicuspid valve by conduit, And first position is returned to from the second position is adjustable.The anchoring piece curled up is implanted at primary bicuspid valve, wherein primary two At least part of first coil on the side of cusp is in the atrium sinistrum of heart and primary mitral on opposite sides At least part of second coil is in the left ventricle of heart, with when the anchoring piece curled up is implanted at primary bicuspid valve, Mitral is supported or is kept in the interior space.
In another embodiment, a kind of for delivering the primary bicuspid valve for being configured as that mitral is docked to heart The method of the anchoring piece curled up at place includes: that the conduit for being used to deliver the anchoring piece curled up is located at primary bicuspid valve；It will Ring is located in around chordae tendineae；Ring is closed to draw together chordae tendineae；The anchoring piece curled up is released simultaneously from conduit And it is promoted around chordae tendineae；And remove ring and conduit.
According to an embodiment of the invention, mitral valve replacement can be realized by a variety of different method for implantation.Therefore originally The embodiment of invention provides the flexibility with different modes and replaces mitral selection for being implanted into.
Using attached drawing description according to the embodiment, further characteristic of the invention and advantage will be obvious.In In attached drawing:
Fig. 1 shows the schematic sectional view of human heart；
Fig. 2 shows the diagrammatic top views of the annulus of mitral valve of heart；
Fig. 3 A to Fig. 3 E shows the various views of the coil anchoring piece of embodiment according to the present invention；
Fig. 4 A and Fig. 4 B are the respective images of the unlapped coil of embodiment according to the present invention and the coil of covering；
Fig. 5 A to Fig. 5 F show embodiment according to the present invention via through apex of the heart program division affix one's name to spiral winding anchoring piece Process；
Fig. 6 A to Fig. 6 D show according to another embodiment of the present invention via transseptal program dispose spiral winding anchor The process of firmware；
Fig. 7 A and Fig. 7 B show embodiment according to the present invention respectively in the feelings of the valve prosthesis with and without implantation The sectional view of the spiral winding anchoring piece in mitral valve position is deployed under condition；
The exemplary signal through conduit valve prosthesis that Fig. 8 A and Fig. 8 B respectively illustrate embodiment according to the present invention is saturating The cross section of a part of view and valve prosthesis；
Fig. 9 A and Fig. 9 B respectively illustrate the valve prosthesis of embodiment according to the present invention being maintained in spiral winding The opening occurred with the frame of the valve prosthesis of embodiment according to the present invention；
Figure 10 A and Figure 10 B are the respective images for illustrating the splaying effect of valve prosthesis of embodiment according to the present invention；
Figure 11 A and Figure 11 B are to show the set for being added to valve prosthesis according to other embodiments of the invention or protection The schematic images of layer；
Figure 12 shows the perspective view of spiral winding anchoring piece according to another embodiment of the present invention；
Figure 13 A and Figure 13 B respectively illustrate the spiral winding anchoring piece for the Figure 12 being deployed at mitral valve position With the spiral winding anchoring piece of Figure 12 in its final deployed position；And
Figure 14 shows the deployment system of change according to another embodiment of the present invention.
The Screw Anchor firmware of embodiment according to the present invention is built as seen in Fig. 3 A to Fig. 3 E.Fig. 3 A is shown The perspective view of Screw Anchor firmware 72, Fig. 3 B shows the side view of anchoring piece 72, and Fig. 3 C shows bowing for anchoring piece 72 View.Screw Anchor firmware 72 includes the coil of the multiple rotating parts (turn) extended with the central axis along anchoring piece.Anchor Firmware 72 has a series of lower part rotating parts or coil 82 and a series of top rotating parts or coil 84.Lower coil 82 it is each Rotating part is spaced apart each other with small―gap suture.Meanwhile each rotating part of upper coil 84 is wound closer to each other.Under in addition, The rotating part of portion's coil 82 has the radius of curvature bigger than the rotating part of upper coil 84, and therefore forms bigger inside Annular space.These features will discuss in more detail below in relation to implantation of the anchoring piece 72 at primary bicuspid valve.At it In his embodiment, characteristic and difference between the lower coil 82 and upper coil 84 of anchoring piece 72 can be based on such as patient'ss Anatomical structure is arranged differently.
As it can most clearly see in Fig. 3 C, anchoring piece 72 winds or curls up the central axis of anchoring piece 72, with Roughly circular or cylindrical space is provided wherein, and the roughly circular or cylindrical space is than in primary two point seen in fig. 2 The non-circular shape of annulus is easier to maintain and anchors circular valve prosthese.Therefore, as that can see in fig. 3d, work as spiral When anchoring piece 72 is positioned in 44 surrounding of bicuspid valve, Screw Anchor firmware 72 provides stronger and more stable in structure docking It stands or position, to dock or be couple to primary annulus of mitral valve for valve prosthesis.A part of anchoring piece 72 is in bicuspid valve 44 The process (as seen in fig. 3d, process will be discussed more fully below) in comissure 80 allows anchoring piece 72 two Placement above and below cusp ring, more firmly to anchor wherein valve prosthesis.In addition, by the coil of anchoring piece 72 The minimal internal space of restriction can relative to valve prosthesis extension diameter dimension it is too small so that being extended wherein when prosthese When radial pressure be generated between anchoring piece 72 and valve prosthesis.
In one embodiment, the core 180 of spiral winding 72 is constituted or is wrapped by shape-memory material (such as Nitinol) Include shape-memory material (such as Nitinol).However, in other embodiments, the core 180 of spiral winding 72 can be by other Biocompatible material (for example, other alloys, or for example, such as titanium or stainless steel metal) be made or simultaneous including other biological Capacitive material (for example, other alloys, or for example, such as titanium or stainless steel metal).In some embodiments, coil can have Have widened and/or rounding end, for example, the tip of the end to prevent coil 72 damaged during deployment around group It knits.As can be most preferably seen in Fig. 3 A, Fig. 3 B and Fig. 3 E, Fig. 3 E illustrates the transversal of a part of spiral winding 72 The core 180 in face, coil 72 is covered or is surrounded by froth bed 182 and cloth covering 184.In the embodiment illustrated, it steeps Foam layer 182 is Biomerix froth bed (for example, polyurethane plate material layer of 2 millimeters thicks), and cloth covering 184 is by gathering Object material is closed to be made or including polymer material.In the illustrated embodiment, froth bed 182 and cloth covering 184 is corresponding It meets at the position being substantially the same circumferentially about coil core 180 end.However, in other embodiments, froth bed 182 Coil core 180 is wrapped up with cloth covering 184, and is attached at the different circumferential points around coil core 180.Layer 182,184 it can be attached to coil core 180 together, or coil core 180 can be individually attached to.
In more detail, in some embodiments, the fabric or cloth covering 184 for covering spiral winding are, for example, poly- to benzene Naphthalate (PET) polymer material.Fabric can have 0.008 ± 0.002 inch of thickness, and can have Such as 2.12 ± 0.18oz/yd2(every square yard of ounce), 40 ± 5 stringer numbers/inch and 90 ± 10 course counts/inch density Characteristic.Tissue layer can be further cut into the length or width with about 13+1/-0.5 inches, so as to substantially over The whole length of spiral winding 72.
In some embodiments, froth bed 182 can be cut into 19mm × 5mm, and cloth covering 184 can be by It is cut into 19mm × 6mm.However, being intended for covering depending on the size of such as spiral winding, the thickness of equivalent layer and every layer The cutting of the amount of core 180, other sizes of each layer 182,184 can also be used.In some embodiments, froth bed 182 can sew on (straight by polytetrafluoroethylene (PTFE) (PTFE) suture using such as 22mm with straight on a small quantity Stitch) it is attached to cloth covering 184.Froth bed 182 and/or cloth covering 184 can be folded in coil core Around 180, and is intersected using the fiber suture of such as 45mm and be sewn onto core 180.However, the present invention should not be limited It is formed on these attachment properties, and other suture sizes and/or type or for by froth bed 182 and/or cloth covering 184 are become effectively attached to any one of various other attachment means of coil core 180 or method also can be used and It is carried out.For example, in some embodiments, core can with through-hole, recess or can be cut by laser or otherwise edge The core of the changes of other features that is formed of core.This category feature in core can be used for and suture phase interaction With, increase friction or otherwise help against core keep coating or multiple coatings, and prevent or limit coating and Sliding or other relative motions between core.In some embodiments, core can also be formed with non-circular cross-section Face, to increase the contact area between core and coating.For example, flat filament coil can be used for forming core.In addition, various Biocompatible adhesive or other materials can be used between core and coating, more firmly to keep coating Position relative to core.In some embodiments, hydrogel or being capable of conduct with the other materials extended after contacting blood Gap fillers are used between core and coating, are matched with generating stronger sealing or interference between core and coating It closes.
Fig. 4 A shows one embodiment of the Screw Anchor firmware before being applied thereon foam and/or fabric cover Core, and Fig. 4 B show it is capped with the froth bed and tissue layer similar with the description as described in Fig. 3 A to Fig. 3 E Screw Anchor firmware.Foam and/or tissue layer are biocompatible, and be generally used for promote surrounding tissue around anchoring piece simultaneously And to the ingrowing in anchoring piece, anchoring piece is further secured to two points after anchoring piece and valve have been implanted Around the annulus.Although in the above-described embodiment, both froth bed and tissue layer are applied to the alloy core of Screw Anchor firmware Body it is upper, but in other embodiments, only froth bed is applied to the upper of the core of anchoring piece, and in other embodiments, only Tissue layer is applied on anchoring piece core.
According to an embodiment of the invention, mitral valve replacement can be performed in a variety of ways.It is led in a kind of utilization In the program of pipe, (it is initial for anchoring or Docking station and/or the artificial valve that be positioned in anchoring piece as described above Can be radially compressed or shrinkage) implant site can be delivered to by blood vessel.This can be for example by being connected to heart Each chamber artery or vein realize.In one exemplary embodiment (as that will be seen in Fig. 6 A to Fig. 6 D), Conduit can be delivered in atrium dextrum by inferior caval vein, and then by puncturing the left side reached above bicuspid valve through interval Atrium.
In some cases, mitral valve replacement can percutaneously be executed with the excessively remote artery of impure Triton and/or vein, And the program that can need more to open.In these cases, for example, doctor can cut small thoracic incision (opening chest) with into Enter heart, and then delivery apparatus catheter-based and/or implantation material are placed directly into heart.
Referring now to the embodiment in Fig. 5 A to Fig. 5 F, shows and be located in patient for will curl up or Screw Anchor firmware Heart mitral valve position in through apex of the heart program.In this example, anchoring piece is delivered from the apex of the heart and by left ventricle To mitral valve position.Fig. 5 A shows drawing in the left ventricle 10 for being inserted into the heart 14 of patient by the notch at the apex of the heart 6 Enter device 2.Blood leakage can be tightened by the apex of the heart 6, purse string suture around introducer 2 in order to prevent, or in other selections Among, closure device can be used.Seal wire 30 is pushed through left ventricle 10 from introducer 2, by papillary muscle 56,60 and Chordae tendineae 48, and between the anterior leaflet 38 and posterior leaflet 42 of primary bicuspid valve 44, so that a part of seal wire 30 is positioned in In atrium sinistrum 46.
As shown in figure 5B, then delivery catheter 64 is introduced in atrium sinistrum 46 on seal wire 30.Delivery catheter 64 have preformed curved shape, the bending convenient for the introduced later of coil guiding catheter 68, the coil guiding catheter 68 Shape is designed the introducing to help anchoring piece 72 curl up or spiral.Coil guiding catheter 68 is straightened to introduce and pass through Delivery catheter 64, in contrast, the delivery catheter 64 can be generally straight, and the delivery catheter 64 can be by The material harder than coil guiding catheter 68 is made.Therefore, after leaving delivery catheter 64, the distal end of coil guiding catheter can Its original preformed curved shape is deflected or is restored to, to help the introducing and positioning appropriate of Screw Anchor firmware 72.It leads Silk 30 can be contracted simultaneously during disposing the process with set winding guiding catheter 68, before the delivering of Screw Anchor firmware 72 And it is removed.
In other embodiments, coil guiding catheter 68 can be introduced in heart as relatively straight element, and And it then can be manipulated to that desired curved shape is presented.
As shown in figure 5 c, in initial coil delivery location, delivery catheter 64 is removed, and coil The distal end of guiding catheter 68 is positioned in atrium sinistrum 46, a comissure in the bicuspid valve comissure 80, wherein the first two The leaflet of mitral valve 42 after the periphery of bicuspid valve 44 encounters of cusp leaflet 38.In other embodiments, coil guiding catheter Distal end can be alternatively positioned in left ventricle 10, close to bicuspid valve.In figure 5 c, it can be seen that under Screw Anchor firmware 72 The distal tip of portion's coil 82 extends out from the distal end of coil guiding catheter 68 and is returned in left ventricle 10 by bicuspid valve. The tip of anchoring piece 72 can have rotating part or turning part slightly downwards, in order to which tip is in the comissure of bicuspid valve 44 80 The insertion and propulsion of place backward.
Then Screw Anchor firmware 72 is further promoted and being pushed through coil guiding catheter 68.Fig. 5 D is shown Just below the leaflet of bicuspid valve 44 38,42 or around the Screw Anchor firmware 72 that is pushed into and winds.72 quilt of Screw Anchor firmware It is directed to advance all around the leaflet 38,42 and chordae tendineae 48 of bicuspid valve 44.The lower coil 82 of anchoring piece 72 therefore can It is made slightly larger, in order to which anchoring piece 72 is easier around leaflet 38,42 and chordae tendineae 48 during anchoring piece is disposed Aggregation or guiding.In addition, the rotating part of lower coil 82 can slightly be spaced apart to be easier at comissure 80 each other Ground, which promotes coil 82, passes through native valve 44.Meanwhile smaller coil (such as those of upper coil 84) can help more Valve prosthesis is kept securely or more tightly.
After the lower coil 82 of anchoring piece 72 has been placed below annulus of mitral valve, as seen in Fig. 5 E, Then the upper coil 84 of anchoring piece 72 is disposed from coil guiding catheter 68.In some embodiments, lower coil 82 It is advanced to below annulus of mitral valve after desired position, it may be undesirable to further promotion or propulsion coil 72, to protect Hold or maintain orientation and positioning of the lower coil 82 in left ventricle 10.Therefore, the upper coil 84 of anchoring piece 72 can pass through Back rotation coil guiding catheter 68 (such as arrow diagramming at the bottom by Fig. 5 E) is deployed in atrium sinistrum 46, so as to Expose and dispose more coil anchoring pieces 72 out of conduit 68.Other embodiments are disposed and are positioned in a variety of ways The upper coil 82 of anchoring piece 72.
After Screw Anchor firmware 72 is now fully implanted, coil guiding catheter 68 is removed, and can such as be seen in Fig. 5 F 's.Although the anchoring piece disposed in Fig. 5 F has about three coils for being positioned in 44 top of bicuspid valve and is positioned in Two coils of 44 lower section of bicuspid valve, but other embodiments can have other different arrangements and line based on concrete application Draw a circle to approve position.
Once shall also be noted that the such and implantation in artificial valve wherein as be described above of Screw Anchor firmware 72 It is inserted into and is positioned before, primary bicuspid valve 44 just can continue to generally normally operate, and patient is able to maintain Stablize.Therefore, which can execute without heart-lung machine beating heart.In addition, this allows doctor in time more Neatly valve prosthesis is implanted in anchoring piece 72, is spent too between anchoring piece implantation and valve implantation if may be not present More times, then patient was in the impaired risk of Hemodynamics.
Fig. 6 A to Fig. 6 D shows the alternative of the mitral valve position of the heart for Screw Anchor firmware to be located in patient Program.In this example, anchoring piece 330 is delivered to mitral valve position by the atrial septum of heart.In an example procedure, Conduit 332 is introduced in the quiet of patient by percutaneous puncture or for example, by the small surgical incision at the groin of patient In vein system system.Alternative inlet location can also be used.
As shown in fig. 6, conduit 332 is pushed upwardly along inferior caval vein 212, into atrium dextrum 210, across the heart Atrial septum 304, and enter atrium sinistrum 46.Then, in fig. 6b, coil guiding catheter 340 is from the distal end of conduit 332 by portion Administration, and with the joint in atrium sinistrum 46 close to bicuspid valve 44 is similarly extended seen in the embodiment in Fig. 5 A- Fig. 5 F At the position at place 80.Anchoring piece 330 leaves the tip of coil guiding catheter 340, and under the bicuspid valve 44 at comissure 80 Side is pushed into.
After the lower coil of anchoring piece 330 is positioned to desired orientation below bicuspid valve 44, anchoring piece 330 upper coil then can be for example and opposite direction rotating coil guiding catheter 340 of the propulsion along anchoring piece 330 It is disposed from coil guiding catheter 340, as shown in figure 6 c.It is implanted in Screw Anchor firmware 330 and is placed on the phase After in the position of prestige, coil guiding catheter 340 is removed, as seen in figure 6d.
Fig. 7 A shows the side section view for the Screw Anchor firmware 72 being implanted in the mitral valve position of the heart of patient Figure, and Fig. 7 B shows the sectional view that Screw Anchor firmware 72 therein is retained in valve prosthesis 120.Except being illustrated Those of except anchoring piece 72 different coils between orientation, shape and size difference can also due to various reasons and by Using, for example, end backup ventricle wall and/or atrial wall to cause anchoring piece 72, to preferably keep Screw Anchor firmware 72 position.
In figure 7b, valve prosthesis 120 is retained in mitral valve position by Screw Anchor firmware 72.Valve prosthesis 120 is preferred To be change or not changing through catheter heart valves, such as, such as Edwards Lifesciences SapienTMValve.One As for, valve prosthesis 120 accommodates the extensible framework structure 126 of multiple valve leaflets 122,124 by will include.Expansible frame Frame 126 can be from extending, or can be for example can balloon expandable, and the phase for introducing anchoring piece 72 can be passed through It is introduced into, or can be introduced by individual conduit with introducer and/or conduit.
In an embodiment of the present invention, the valve prosthesis 120 of shrinkage is first positioned under central passage or by anchoring piece 72 In the inner space of restriction, and then it is extended to against and is parked in anchoring piece 72.In these embodiments, two point At least part of the leaflet tissue 38,42 of valve 44 is fixed or is sandwiched between anchoring piece 72 and valve prosthesis 120, by anchor Firmware 72 and valve prosthesis 120 lock in place, and prevent them from drifting about or shifting.The tissue of leaflet 38,42 Nature sealing is generated, to prevent the blood flow between valve prosthesis 120 and Screw Anchor firmware 72.As discussed above, In In some embodiments, having been extended at it for valve prosthesis 120 is less than by the minimum interior diameter of the coil definition of anchoring piece 72 Diameter later, so that Radial resistant force is formed between anchoring piece 72 and valve prosthesis 120, part is further fixed on by this Together.Pressure between anchoring piece 72 and valve prosthesis 120 can occur above or below bicuspid valve 44, or above under Fang Fasheng.Due to the pressure being formed between anchoring piece 72, valve prosthesis 120 and leaflet 38,42 between it, valve prosthesis Additional suture or attachment are not needed between 120 and anchoring piece 72 or adjacent heart tissue generally.Due to being used for anchoring piece 72 With the different materials of prosthese 120, circumferential frictional force is also generated between the part and prosthese 120 for the anchoring piece 72 being in contact with each other, Thus the expansion and extension of anchoring piece 72 are limited.This interaction will beg in more detail below in reference to Fig. 9 A and Fig. 9 B By.
Fig. 8 A- Fig. 8 B shows the reality of the heart valve prosthesis for being used together with Screw Anchor firmware as previously discussed Apply example.Preferably, the valve prosthesis being used together with Screw Anchor firmware is such as change or not changing through conduit heart valve Film, such as, Edwards Lifesciences SapienTMValve.Fig. 8 A is shown with extensible framework structure 220 and more The valve of a valve leaflet 222.The frame 220 of artificial valve can be extension certainly, and can be for example by such as Nitinol Shape-memory material be made, or alternatively, can be made of non-shape-memory material.In some embodiments, valve prosthesis Can balloon expandable, and be intended for extending in the Screw Anchor firmware previously positioned.Leaflet 222 can be for example by soft Tough animal tissue's (such as ox, pig or horse pericardium or valvular tissue) is made of any other suitable material.
Valve prosthesis further comprise along the distal end of frame 220 or lower end be attached or integrally formed annular ring-shaped article or Set 224, the annular ring-shaped article or set 224 are made or are generally comprised by the less rigid material of the material than frame 220 and compare frame The less rigid material of the material of frame 220.For simplicity, Fig. 8 A shown schematically only show annular sleeve 224 shape and nothing Additional attachment features, and what Fig. 8 B showed valve prosthesis includes that set (is such as maintained on frame by additional attachment features Appropriate location in sleeve 246) low portion cross section.In the embodiment shown in the fig. 8b, annular sleeve 224 is at least Generally around the bottom comers 226 of the expansible Support frame 220 of valve prosthesis.Annular sleeve 224 includes surrounding frame 220 The froth beds 242 of bottom comers 226, the tissue layer 244 for covering froth bed 242 and for by froth bed 242 and tissue layer 244 The additional set retention sleeve or layer 246 being held in place.In one or more portions of sleeve layers 246 and frame 220 / carry out it is one or more sew on or suture 248, the various pieces for covering 224 are maintained at appropriate on frame 220 In position.In the embodiment of Fig. 8 A and Fig. 8 B, carry out sewing on 248 at two different axial regions of frame 220.So And in other embodiments, more or fewer to sew on 248 and can according to need and be used cover 224 and be retained in frame On 220 or any other suitable reservation means can be used to replace sleeve layers 246 and sew on 248 for froth bed 242 and knit Nitride layer 244 is maintained in the appropriate location on frame 220.In addition, in other embodiments, only froth bed 242 is used with no Tissue layer 244, or only tissue layer 244 be used with no froth bed 242 or any other cricoid suitable material can be by For forming annular sleeve 224.One or more layers of annular sleeve 224 generally will be by one or more of biocompatible materials systems At, and generally will be as less rigid a kind of material more soft than the material used in Support frame 220 or alloy or more Kind material is made.
Fig. 9 A shows the valve prosthesis for the extension of embodiment according to the present invention being anchored in Screw Anchor firmware 72 120.The top and bottom end that Fig. 9 B schematically illustrates valve prosthesis 120 are after prosthese 120 is deployed in Screw Anchor firmware 72 Advantageously radially outward due to the frictional force and resistance between the multiple portions and anchoring piece 72 of the prosthese 120 being in contact with each other The trend that (for example, along direction of arrow) is opened.As discussed above with regard to the anchoring piece 72 in Fig. 3 A to Fig. 3 E, according to this The core of the coil anchoring piece of the embodiment of invention is coated with froth bed and/or tissue layer, the froth bed and/or tissue layer It is used to promote the ingrowing after anchoring piece is implanted in mitral valve position.In addition, the foam or cloth of anchoring piece 72 Covering can be used in preventing or reducing the damage to around anchoring piece 72 and the tissue contacted with anchoring piece 72.
In addition, froth bed and/or tissue layer are further used in anchoring piece 72 and are anchored at valve prosthesis 120 therein Frame between contact after generate additional friction.It is not further comprising the base of froth bed on it and/or tissue layer In the case where the anchoring of metal or Docking station, a kind of material or multiple material of anchoring or Docking station can be false with production valve A kind of material or multiple material of the Support frame of body are similar or identical.In these cases, when valve prosthesis is anchored in coil It is extended in part and when the Support frame of prosthese starts to contact coil anchoring piece, it can be between Support frame and coil anchoring piece There are the smallest or low frictional resistance.Since the interior diameter of coil anchoring piece not biased is generally less than the valve prosthesis extended Overall diameter, and due to the general winding arrangement of spiral winding, the extension of valve prosthesis against spiral winding will at least be compeled The minimum diameter rotating part of coil anchoring piece is set radially outward to stretch and partly be unfolded.This can result in anchoring piece in turn The undesirable slightly displacement of possibility or drift in annulus of mitral valve, and lead to the function of the valve prosthesis of implantation being less effective Can property, or in the worst case, can cause weaker anchoring of the valve prosthesis in coil anchoring piece and valve prosthesis from The potential embolism of atrium sinistrum or left ventricle is come out and entered in annulus of mitral valve.
The coil anchoring piece 72 of foam and/or cloth or the fabric covering of embodiment according to the present invention is used for corresponding zero Increase the friction between coil anchoring piece 72 and valve prosthesis 120 after contact between part.Initially, when valve prosthesis 120 is being set When being extended in coil anchoring piece 72 during changing the implantation of valve, the metal or metal alloy frame 220 of valve 120 will be with The froth bed 182 or tissue layer 184 of coil anchoring piece 72 contact, and the circumferential frictional force between contact surface prevents coil anchor Firmware 72 slides or is unfolded under the action of the radially outer power applied by the frame 220 extended.Such frictional force can Such as due to the fact that being generated: due to the metal of the outer surface of cloth or the coil of foam coverage 72 and valve prosthesis 120 Or the material between alloy framework 220 difference, since the texture of cloth or the coil of foam coverage 72 is relative to prosthese 120 The coil of interference or cloth or foam coverage between the metal or alloy surface or various edges of expansible Support frame 220 72 and prosthese 120 frame 220 outer surface on edge, changeover portion or hinged, and/or interference between sewing on or " catch It obtains ".In other embodiments, it rubs or locks for the circumferential direction between coil anchoring piece 72 and the surface of valve prosthesis 120 Other means or reason can be used or are used, to apply radially outer in the valve prosthesis 120 due to extension The circumferential migration or extension of spiral winding 72 are prevented or reduced after pressure.
According to an embodiment of the invention, with prodefined opening size spiral winding 72 can more accurately be selected and It is implanted in annulus of mitral valve, to keep or to be supported wherein by valve prosthesis.Surgeon or doctor can be more accurately Coil size and shape and desired valve types and size are selected, the interaction between component will be more after the implants It is predictable and stronger.Valve prosthesis can be more firmly retained in coil anchoring piece 72, because in anchoring piece and vacation Will there are tighter retentivity or retention between body, and exist because there will be anchoring piece after prosthese extends wherein Less extension, drift or migration in primary annulus of mitral valve.
In addition, the characteristic of the coil anchoring piece 72 of the cloth or foam coverage of embodiment according to the present invention can also be in valve Easier implantation and positioning of the coil anchoring piece 72 itself in annulus of mitral valve are helped before the delivering of film prosthese.Firstly, by In additional frictional force help to help later the valve prosthesis against extended maintain coil anchoring piece 72 structural intergrity and/ Or overall dimension and shape, the core of coil can be made thinner and/or more flexible, this makes coil anchoring piece 72 pass through line The initial delivering of circle guiding catheter and the position entered in annulus of mitral valve is easier.In addition, when the inside with smaller diameter When the coil of opening generally more firmly keeps valve prosthesis, since coil anchoring piece 72 passes through the undesirable expansion of valve prosthesis Exhibition is prevented from or is reduced, and coil anchoring piece 72 can be also made less times greater than for what is compared to be covered without foam/cloth The coil anchoring piece of cover material layer, and during the deployment of anchoring piece 72 anchoring piece 72 around primary leaflet of mitral valve and chordae tendineae Propulsion can more easily promote.
Referring now to Fig. 9 B, another favorable characteristics of the coil anchoring piece of foam and/or cloth covering are schematically illustrated. In figures 9 b and 9, only the part of valve prosthesis 120 extended in coil anchoring piece has been illustrated, wherein in order to simple For the sake of, coil anchoring piece 72 is removed, to protrude influence of the coil anchoring piece to valve prosthesis 120 therein is implanted in.Such as It can see in figures 9 b and 9, the frame 220 of valve prosthesis 120 has the end radially outward opened.According to the present invention The frame 220 of valve implant 120 that uses of embodiment generally along the length of implantation material have constant extension width or Diameter.As described above, coil anchoring piece will generally be chosen to have such inner opening, the inner opening With the extension diameter smaller diameter than valve prosthesis 120.Due to the friction between coil anchoring piece 72 and valve prosthesis 120 The expansion of coil anchoring piece is prevented or reduced, and therefore also prevents broadening for the opening limited by coil anchoring piece, interference is matched Conjunction is formed between coil anchoring piece and the part for becoming the valve prosthesis 120 contacted with coil anchoring piece.In general, valve Film prosthese 120 will be placed in the middle on coil anchoring piece 72 or generally placed in the middle, against valve prosthesis 120 of coil anchoring piece 72 Central part guiding internal force or resistance, as in figures 9 b and 9 by the arrow diagramming at the center of direction prosthese.Valve prosthesis Therefore 120 central part will be expanded to its size extended completely by limitation.It should be noted that prosthetic valve size, coil Size of anchoring piece, or both can be selected, so as to consider it is this be slightly less than complete extension, to avoid damaging after the implantation The haemodynamics that evil passes through artificial valve.Meanwhile the top and bottom end of valve prosthesis 120 not contacted with coil anchoring piece 72 It continues to attempt to extend to the outside towards its complete propagation size, such as in figures 9 b and 9 by the arrow close to the end of prosthese into one Step diagram, to generate the opening in the end of implantation material.
Figure 10 A shows the coil anchoring piece for not being implanted in foam or cloth covering also of embodiment according to the present invention In valve prosthesis, and Figure 10 B shows and has been extended in the coil anchoring piece that foam or cloth cover in valve prosthesis Later and anchoring piece is removed the valve for showing the opening of the end as discussed above in prosthese or broadening Prosthese.
The opening shown in valve prosthesis 120 provides many benefits.Contact of the coil anchoring piece with valve prosthesis The locking dynamics and the frame geometry of the opening of prosthese 120 generated between surface is combined, and is existed with increasing anchoring piece Reservation in coil anchoring piece and annulus of mitral valve.The opening of the end of valve prosthesis 120 and broaden to the end of prosthese add ruler Very little, the size hinders displacement and valve of the valve from coil anchoring piece in raised pressure for generating additional engagement Potential embolism under power in heart.In preliminary test, when being against anchored at unlapped metal in independent test The up to static pressure of the fluctuation pressure of 70mmHG (millimetres of mercury) and up to 150mmHg that valve prosthesis in coil applies is not When shifting artificial valve from coil anchoring piece, artificial valve is in higher static pressure (for example, the pressure on 290mmHg Power) under from unlapped anchoring piece shift.Meanwhile in the coil anchoring piece for being anchored at covering of embodiment according to the present invention Artificial valve be all successfully reserved in test more than all.Therefore, artificial valve can be more effectively remained in bubble In foam and/or the coil anchoring piece of cloth covering.In addition, the sub- annular section of artificial valve is (that is, valve is located in left ventricle Part) open also will the sub- annular section of against coil anchoring piece more firmly clamp or keep mitral primary small Leaf, to further improve the reservation of implantation material.
The opening of the end of valve prosthesis 120 will will increase prosthese 120, and (such as primary bicuspid valve is small with surrounding heart tissue Leaf and chordae tendineae) between contact.This will potentially result in surrounding tissue by sharp edges on the frame 220 of valve or corner Damage.Referring back to the valve prosthesis illustrated in Fig. 8 A- Fig. 9 B, therefore annular sleeve 224 is added to the son of valve prosthesis 120 Ring-shaped end, with the surrounding tissue of cardioprotection from the injury of the end of the opening of frame 220, the end of the opening will be potential Ground stab into, cutting or otherwise injury tissue.
It sees as claimed in the embodiment described before, annular sleeve 224 is implemented as at least covering the bracket of valve prosthesis The continuous annular ring-shaped article of the corner of one end of frame 220.Meanwhile Figure 11 A and Figure 11 B illustrate two alternative guarantors Sheath arrangement.In Figure 11 A, alternative jacket layer 264 along the Support frame 220 of valve prosthesis 120 bottom (that is, subring shape) Edge track, in order to provide the increased protection to surrounding tissue from the entire bottom margin profile injury of Support frame 220. In Figure 11 B, another alternative protective layer 284 is by being attached to the spheroidal for most descending corner of Support frame 220 or spherical Protector is realized.Protective layer 284 in Figure 11 B or other similar low profile arrangement can be in some applications it is desirable, Because such as the Support frame of the protective layer with more low profile will be easier to shrinkage and by conduit or delivering sheath into Row delivering.In addition, although a variety of different protective layers are illustrated as being only added to valve prosthesis 120 in the described embodiment Sub- ring-shaped end, it should also be appreciated that, similar jacket layer or other protective layers can be added to other of valve prosthesis 120 Part, to prevent or reduce the extension of Support frame 220 and/or to open the damage of the caused other parts to surrounding tissue Wound.
Coil anchoring piece 72 described in embodiment is made by a spiral winding or including a helix previous Circle.Figure 12 shows the perspective view of coil anchoring piece according to another embodiment of the present invention.In Figure 12, coil anchoring piece 400 include twining along the first coil 402 of the first circumferential direction winding and along second circumferential direction opposite with the first circumferential direction Around the second coil 404.Therefore, first coil 402 and the second coil 404 can along coil longitudinal axis close to each other It is aligned, and the length at least near each of mutual coil 402,404 can be aligned or backup each other.In In this construction, the adjacent end of coil 402,404 is joined together at connector 406, described in one example to connect First 406 be pressure joint.In another example, the adjacent end of coil 402,404 is combined or is welded together, or with It is held together in one of various other biocompatibility means, various other biocompatibility means are being with or without Coil 402,404 is integrated into an individual anchoring piece or Docking station in the case where other biological compatibility material.Coil 402, it 404 extends in opposite directions and winds from connector 406, and first or the end in upper distal end 408 of upper coil 402 Only, and second or lower coil 404 terminated in distal lower end 410.Upper coil anchoring piece 402 (or atrium anchoring piece) is by such as This name, because once being disposed, upper coil 402 will be just positioned in above annulus of mitral valve in atrium sinistrum.Similarly, Lower coil anchoring piece 404 (or ventricle anchoring piece) is named in this way, because once being disposed, most of lower coil 404 is just Bicuspid valve will be pushed into or be fed through in comissure, and will circlewise be located in bicuspid valve by quilt in left ventricle Below ring.In some embodiments, coil anchoring piece 400 can have one or more coatings, and above with regard to coil The coating that anchoring piece 72 discusses is similar.In these embodiments, the core of coil anchoring piece 400 can for example by tissue layer, The combined covering of froth bed or other biological compatibility material or such layer.
Coil anchoring piece 400 can be initially with the coil anchoring piece 72 in previously described embodiment similarly by portion Administration.As seen in figure 13a, coil guiding catheter 68 is positioned in atrium sinistrum 46, near bicuspid valve comissure 80.Line Circle anchoring piece 400 is pushed into and starts to extend out from the distal openings of coil guiding catheter 68, and lower coil 404 Distal end 410 comissure 80 be directed through valve reach left ventricle in subring shaped position.Coil anchoring piece 400 can be through Be pushed into, can be pushed out by launch force or load, sheath can be withdrawn or anchoring piece 400 can using it is various other One of dispositions method known is delivered from coil guiding catheter 68.Lower coil 404 is hereafter and in embodiment previous Coil anchoring piece 72 similarly positioned.However, upper coil 402 is simultaneously from coil during the deployment of lower coil 404 It is released in the distal end of guiding catheter 68, and starts to be unfolded in opposite direction, and be deployed into atrium sinistrum upwards.Due to upper The central axis of the opposite winding direction of portion's coil 402 and lower coil 404, two coils can be in the portion of anchoring piece 400 It keeps generally being aligned during and after administration.Further, since opposite winding direction, when they leave from coil guiding catheter 68 When, upper coil 402 and lower coil 404 will be crimped naturally or be wound in opposite direction, and will be during deployment It is promoted away from each other along 400 central axis of coil anchoring piece.By this method, once lower coil 404 is led in comissure 80 To valve is passed through, since upper coil 402 will be disposed upward rather than the direction of propulsion for following lower coil 404, upper coil 402 Comissure 80 will be moved away from naturally, and will not be in comissure 80 and valve is passed through by unintentionally guidance.
Coil anchoring piece 400 is pushed into until connector 406 leaves the distal end of coil guiding catheter 68.In coil anchoring piece After 400 have been moved off conduit 68, the additional adjustment of anchoring piece to final desired locations can be further as needed by doctor It carries out.As that can see in Figure 13 B, coil anchoring piece 400 is deployed as anchoring with the coil in embodiment previous Part 72 is similarly arranged.Further, since upper coil 402 and lower coil 404 are disposed and are positioned simultaneously, and due to Coil guiding catheter can be maintained in substantially the same position during the deployment of coil anchoring piece 400, rotating coil Guiding catheter 68 no longer needs so that the upper part of anchoring piece is discharged into the step later in atrium sinistrum, to simplify anchoring Part is implanted into program.
In some embodiments, the upper coil 402 of coil anchoring piece 400 and lower coil 404 can interlock, wherein under Portion's coil 404 is slightly longer than upper coil 402.By this method, the distal end 410 of lower coil 404 is configured as being first away from line The distal end of guiding catheter 68 is enclosed, to be easier to be positioned as distal end 410 to pass through valve in comissure 80.In lower coil 404 Distal end 410 be positioned as through valve in comissure 80 after, anchoring piece 400 can be in the case where no adjustment or only The position of coil guiding catheter 68 is fully advanced and is positioned in the case where having minor adjustment.In other embodiments, Upper coil 402 and lower coil 404 are that substantially the same length or upper coil 402 can be longer than lower coil 404. The relative length of two coils of coil anchoring piece 400 be capable of preference and the other factors of needs and doctor based on patient come Adjustment.
As seen in embodiment previous, different coil anchoring pieces can be deployed in different ways In mitral valve position.In each example, it is important that sub- loop coil (enters left ventricle by bicuspid valve that is, promoting The part of coil anchoring piece) front end and/or distal end be directed to entirely around mitral primary leaflet and around chordae tendineae, with Just anchoring piece holding closely navigates to annulus of mitral valve.For example, and being replaced if the distal end of coil is advanced halfway around chordae tendineae Generation ground is pushed between two chordae tendineaes, and coil may be entangled in chordae tendineae and/or the sub- annular section of coil anchoring piece may It is maintained at the beneath tissue that two chordae tendineaes meet, and is therefore deflected than desired further from annulus.Such situation May have negative effect, such as damage to coil anchoring piece and/or chordae tendineae or primary leaflet of mitral valve or unstable anchor Gu or the False orientation for the valve prosthesis being maintained in coil anchoring piece.
Figure 14 shows the coil anchoring piece deployment system of embodiment according to the present invention.In some embodiments, it disposes System has the arrangement similar with the arrangement of previously described embodiment, has introducer 2, delivery catheter 64 and helical anchor Part 72 passes through the manipulation conduit or coil guiding catheter 68 wherein delivered.In the embodiment illustrated in Figure 14, introducer 2 is determined For by left ventricle 10, but in other embodiments, introducer 2 and/or other delivery catheters can be positioned as passing through for position Atrial septum or be suitable for Screw Anchor firmware delivering any other inlet location.
In addition to conduit associated with the delivering of Screw Anchor firmware, individual conduit 18 can also be included in deployment system In system, and it can also be supplied to and be pushed through other sheaths or casing in introducer 2 or deployment system.In conduit 18 far-end, provides provisional ring-shaped article or ring 22, and the provisional ring-shaped article or ring 22 are used in Screw Anchor The deployment of firmware 72 by the aggregation of chordae tendineae 48, binding, " set is caught " or otherwise is drawn together before.Chordae tendineae 48 is then in left ventricle Smaller cross-sectional area is occupied in 10, this promote Screw Anchor firmware 72 distal tip around chordae tendineae it is easier later Placement in desired or optimal position of deployment and Screw Anchor firmware 72 and snarled without any chordae tendineae.
Provisional ring-shaped article or ring 22 can be such as suture or seal wire or any other suitable line or silk.In In some embodiments, ring 22 utilizes the crawl work for for example passing through introducer 2 or being introduced by other delivering sheaths or casing Tool or other one or more tools are led or are guided around chordae tendineae 48.In other embodiments, ring 22 is pushed into Pass through the guiding catheter of one or more segmentations around chordae tendineae 48.In these embodiments, ring 22 for example passes through utilization Clamping device or gripping tool are closed via constraint or by one of various other attachment methods, and are then drawn The segment of conduit or conduit is contracted, and ring 22 is stayed in the final position around chordae tendineae.In other embodiments, ring 22 (such as Screw Anchor firmwares 72) are pre-formed into curvature, so that ring 22 is around chordae tendineae when ring 22 is disposed.One In a little embodiments, after ring 22 has been closed, the opening limited by ring 22 further can be tightened or be narrowed, with Further chordae tendineae 48 is more closely bundled or flocked together.Meanwhile although Figure 14 is shown and delivery catheter 64 and coil The conduit 18 and ring 22 that guiding catheter 68 is disposed together, but in other embodiments, when ring 22 is deployed in chordae tendineae When 48 surrounding, any combination of conduit can exist.For example, delivery catheter 64 is in coil in previously described embodiment Anchoring piece 72 is contracted before deployment, and similar process can be followed herein.In addition, being positioned in introducer 2 In the embodiment of apex of the heart inlet location, ring 22 also can be in introducer and/or delivery catheter or coil guiding catheter It is one or more.If alternatively transseptal program is performed, the distal end of ring conduit 18 can be alternatively from the left heart Room is pushed through bicuspid valve and enters left ventricle, and ring 22 can be deployed in around chordae tendineae 48, without bundling wherein Or aggregation any additional delivery catheter or pipe.
After ring 22 is deployed in around chordae tendineae 48 and is bundled chordae tendineae or is otherwise drawn together, and in spiral shell Spin line circle anchoring piece 72 is fully deployed around chordae tendineae and after being satisfactorily docked in mitral valve position, 22 quilt of ring It removes.This can be for example by the release of gripping tool (if gripping tool is by use), and/or by unlocking or cutting off Other tools in ring and deployment system are removed for the suture of ring 22, line or seal wire and then from inlet location It is realized with conduit.
In the embodiment for using ring as described above in coil anchoring piece deployment system, due to coil anchoring piece During deployment snarled in chordae tendineae or due to coil anchoring piece be stuck in it is between two or more chordae tendineaes and incorrect The problems caused by ground positions can be mitigated or be prevented from.By this method, anchoring piece can be positioned more firmly, and valve Film prosthese also can be disposed more firmly and is implanted into wherein.
Various other changes or alternative constructions can be made as helical anchor according to the abovementioned embodiments of the present invention Part, valve prosthesis and/or delivery system.For example, in the illustrated embodiment, the coil of Screw Anchor firmware is tightly wound around two Near cusp ring.In other embodiments, some in the coil of anchoring piece can broaden or open outward, with for example left heart The atrial wall in room contacts.In addition, the quantity of the coil above and below annulus can be based on for example primary mitral property And/or the expected location of valve prosthesis is changed.It is attached at together in upper coil and lower coil to form helical anchor In the embodiment of part, two coils can anatomical structure based on patient or various other factors and individually prepared, changed, And/or selection.In addition, other changes to deployment system can be used, so as in the deployment of Screw Anchor firmware and positioning phase Between more efficiently or more effectively bundle chordae tendineae.Also various other coil shapes, length can be made based on various consideration Degree and arrangement and change.
The purpose of specification thus, some aspects, advantage and novelty for being described herein the embodiment of present disclosure are special Sign.Disclosed methods, devices and systems not should be any mode be interpreted it is restrictive.Instead, this disclosure relates to All novel and non-obvious feature and aspect of disclosed various embodiments, can be individually and that This various combinations and sub-portfolio.This method, device and system are not limited to its any particular aspects or feature or combination, disclosed Embodiment also there are problems that or be solved without requiring the specific advantages of any one or more.
Although describing the operation of certain disclosed embodiments with specific, in-order sequence for convenience of expressing, answering Understand that this describing mode includes to rearrange, requires specific sequence unless there are specific sentence.For example, describe in order Operation can be rearranged in some cases or execute parallel.Moreover, for the sake of simplicity, attached drawing may be not shown disclosed The various methods that can be used in combination with other methods of method.In addition, description uses " offer " or " realization " etc sometimes Term describes disclosed method.These terms are the high abstraction concepts for the practical operation being performed.Corresponding to these arts The practical operation of language can change according to specific embodiment, and can easily be differentiated by those skilled in the art.
The many possible embodiments that can be applied in view of the principle of disclosure, it should be appreciated that the reality of diagram Applying example is only preferable example, should not be considered as limiting scope of the disclosure.Exactly, disclosure Range is defined by the claims.
1. a kind of system for being implanted at bicuspid valve, it includes:
The anchoring piece curled up, the anchoring piece curled up are used to for mitral being docked at the primary bicuspid valve of heart, and And there is first end, second end, the central axis extended between the first end and second end, and limit and the center The inner space of axis coaxle, the anchoring piece curled up includes:
The core curled up, it includes biocompatibility metals, and have and extend in first position around the central axis Multiple rotating parts；And
Around the coating of the core, the coating includes the life less more rigid than the metal of the core curled up Object compatibility material；
Wherein the anchoring piece curled up is adjustable to the second position from the first position, more described in the second position At least one of a rotating part is straightened so that the anchoring piece curled up is delivered to the primary bicuspid valve by conduit, And the first position is returned to from the second position is adjustable；And
Wherein the anchoring piece curled up is implanted at the primary bicuspid valve, wherein on primary mitral side At least part is in the atrium sinistrum of the heart and described primary mitral at least part on opposite sides is described It is with when the anchoring piece curled up is implanted at the primary bicuspid valve, the bicuspid valve is false in the left ventricle of heart Body is supported in the inner space；
Mitral, it includes extensible frameworks, and accommodate for controlling multiple leaflets by blood flow therein, Wherein the frame extends to the second position of extension from the first position of shrinkage, described in the first position of the shrinkage Frame has the first overall diameter for mitral delivering to be passed through to conduit, the institute in the second position of the extension Frame is stated with second overall diameter bigger than first overall diameter；
Wherein when the anchoring piece curled up and the mitral are not biased, limited by the anchoring piece curled up The minimum interior diameter of the inner space is less than second overall diameter of the mitral；And
Wherein the anchoring piece curled up is configured such that when the mitral is expanded in the anchoring piece curled up The expansion of the anchoring piece curled up and broadening for the inner space are prevented or reduced when exhibition, so that being limited in the rotation Around anchoring piece in the mitral end extended of the central part relative to the mitral so that described End is flared out from the central part.
2. system according to claim 1, wherein the coating includes tissue layer.
3. system according to claim 1 or 2, wherein the coating includes froth bed.
4. system according to claim 1, wherein the coating includes the tissue layer around froth bed.
5. system according to claim 1, wherein the core curled up includes shape-memory material.
6. according to claim 1, system described in one in 2,4 or 5, wherein when the mitral be maintained at it is described When in the inner space of the anchoring piece curled up, the anchoring piece curled up and the frame and the corresponding portion being in contact with each other Second overall diameter is expanded to by limitation.
7. system according to claim 6, wherein in the coating and the bicuspid valve of the anchoring piece curled up Frictional force is generated between contact between the frame of prosthese, with the anchoring piece curled up described in limitation and the mitral Between circumferential movement so that the inner space of the circumferentially deploying of the anchoring piece curled up and the anchoring piece curled up Radial expansion limited.
8. system according to claim 6, wherein not with the anchoring piece curled up with the minimum interior diameter The frame part of part contact is configured as expanding to such diameter radially outward, i.e., the diameter is greater than the anchor curled up Second overall diameter of the minimum interior diameter of firmware and the frame for being less than the mitral.
9. system according to claim 6, wherein the frame of the mitral has a first end and a second end, And at least part of protective layer for covering the second end of the frame is further included, described the second of the frame At least part at end is positioned as farthest from the first end of the frame.
10. system according to claim 9, wherein the protective layer includes the frame around the mitral The second end extend annular ring-shaped article.
11. system according to claim 9, wherein the protective layer includes at least one of froth bed or tissue layer.
12. a kind of system for being implanted at bicuspid valve, it includes:
First coil has multiple rotating parts along the first circumferential direction, and extends to second end from first end；
Second coil, with multiple rotating parts along second circumferential direction opposite with first circumferential direction, and from First end extends to second end；And
Connector is configured as the first end of the first end of the first coil and second coil being maintained at Together, so that the first coil and the second coil extend far from the connector and along the central axis from prolonging each other It stretches；
Wherein the anchoring piece curled up has first position, the first coil described in the first position and second line The respective rotating part of circle surrounds the central axis and extends；And
Wherein the anchoring piece curled up is adjustable to the second position from the first position, the described in the second position At least one of one coil or the multiple rotating part of second coil are straightened so that the anchoring piece curled up is logical It crosses conduit and is delivered to the primary bicuspid valve, and return to the first position from the second position is adjustable；And
Wherein the anchoring piece curled up is implanted at the primary bicuspid valve, wherein on primary mitral side At least part of the first coil is in the atrium sinistrum of the heart and primary mitral institute on opposite sides At least part of the second coil is stated in the left ventricle of the heart, to be implanted in the original when the anchoring piece curled up When at raw bicuspid valve, the mitral is supported in the inner space；And
Wherein when the anchoring piece curled up and the mitral are not biased, limited by the anchoring piece curled up The minimum interior diameter of the inner space is less than second overall diameter of the mitral.
13. system according to claim 12, wherein when the anchoring piece curled up is delivered to institute by the conduit When stating primary bicuspid valve, the respective second end of the first coil and the second coil by being distally positioned at the conduit with Be first delivered to the primary bicuspid valve, and the connector by proximally-oriented in the conduit.
14. system according to claim 12 or 13, wherein second coil is longer than the first coil.
15. system according to claim 12 or 13, further includes coating, the coating includes bio-compatible Property material.
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CN106572905A CN106572905A (en) 2017-04-19
CN106572905B true CN106572905B (en) 2019-11-05
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CN201580009731.5A CN106572905B (en) 2014-02-20 2015-02-20 It is used to support the anchoring piece curled up, heart valve prosthesis and deployment device of heart valve prosthesis
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2015-02-20 EP EP15751851.5A patent/EP3107499A4/en active Pending
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2015-02-20 WO PCT/US2015/016898 patent/WO2015127264A1/en active Application Filing
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2018-03-06 US US15/912,971 patent/US20180193139A1/en active Pending
MX2016010460A (en) 2017-02-27
WO2015127264A1 (en) 2015-08-27
CA2938468A1 (en) 2015-08-27
US10052198B2 (en) 2018-08-21
EP3107499A1 (en) 2016-12-28
CN106572905A (en) 2017-04-19
CR20160365A (en) 2016-11-03
US20150230921A1 (en) 2015-08-20
EP3107499A4 (en) 2018-03-14
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