CN101636128B - Stent-valves for valve replacement and associated methods and systems for surgery - Google Patents

Stent-valves for valve replacement and associated methods and systems for surgery Download PDF

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Publication number
CN101636128B
CN101636128B CN2007800412847A CN200780041284A CN101636128B CN 101636128 B CN101636128 B CN 101636128B CN 2007800412847 A CN2007800412847 A CN 2007800412847A CN 200780041284 A CN200780041284 A CN 200780041284A CN 101636128 B CN101636128 B CN 101636128B
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Prior art keywords
valve
support
attachment element
replacement valve
support element
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CN101636128A (en
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S·德拉罗耶
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Symetis SA
Jenavalve Technology Inc
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Symetis SA
Jenavalve Technology Inc
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Abstract

Stent-valves (e.g., single-stent-valves and double-stent-valves) and associated methods and systems for their delivery via minimally-invasive surgery are provided.

Description

Be used for the stent valve of valve replacement and correlation technique and the system that is used to perform the operation
The cross reference of related application
The application requires the U.S. Provisional Patent Application No.61/843 that submits on JIUYUE 7th, 2006, and 181 and the U.S. Patent application No.11/700 that submitted in 21st in December in 2006,922 priority, it combines in this article separately by reference and integrally.
Technical field
Embodiments of the invention relate to stent valve and the correlation technique and the system that are used for carrying through Minimally Invasive Surgery them.
Background technology
The traditional method that is used for cardiac valve replacement need be cut relatively large opening at patient's breastbone (" sternotomy ") or thoracic cavity (" thoracotomy "), so that allow the heart of surgeon near the patient.In addition, these methods need stop patient's heart, and need cardiopulmonary bypass (even use the cardiopulmonary bypass machine to come as patient's blood oxygenation and make its circulation).Although have invasion property, these operation methods can be quite safe for intervening for the first time.Yet the tissue that is caused by operation for the first time adheres to the relevant risk (like death) of valve replacement surgery that can increase with subsequently.Referring to people's such as Akins " Risk of Reoperative ValveReplacement for Failed Mitral and Aortic Bioprostheses (risk of the Bicuspid valve of inefficacy and the valve replacement once more of active valvular bioprostheses) ", Ann Thorac Surg1998; 65:1545-52 (thoracic surgery annual report, 1998 the 65th volume 1545-1552 pages or leaves); People's such as Weerasinghe " First Redo Heart Valve Replacement-A 10-YearAnalysis (cardiac valve replacement-10 year analysis of reforming for the first time) ", Circulation1999; 99:655-658 (circulation magazine, 1999 the 99th volume 655-658 pages or leaves), it combines in this article separately by reference and integrally.
Artificial valve and biovalve have been used for the various cardiac valve replacement of result.The artificial valve was seldom lost efficacy, but needed lifelong anticoagulant treatment, and (thrombosis) in replacement valve or on every side in case hemostasis liquid condenses.Patient's activity that this anticoagulant has been treated big limitations, and can cause various other complication.Biovalve does not need this anticoagulant treatment, but in 10-15, will lose efficacy usually.Therefore, in order to limit needs that the biovalve that lost efficacy is performed the operation once more and relevant risk thereof, have only remaining patient to accept the biovalve displacement traditionally less than the 10-15 life-span.Patient with more long-life expection has accepted artificial valve and anticoagulant treatment.
Carried out the trial that exploitation is used for the littler operation method of the invasion property of cardiac valve replacement.These operation methods (being called percutaneous cardiac valve replacement treatment (PHVT)) use conduit that replacement valve is transported to implant site through utilizing patient's vascular system.These PHVT attempt having various shortcomings, comprise it and can't guarantee that replacement valve is in intravital suitable location of patient and stability.
Consider aforementioned content, need be provided for the improved mthods, systems and devices of cardiac valve replacement.
Summary of the invention
Some embodiment of the present invention relates to system, the method and apparatus that is used for cardiac valve replacement.For example, these mthods, systems and devices can be applicable to all scopes of cardiac valve treatment, comprise the displacement of aortic valve, Bicuspid valve, Tricuspid valve and the valve of pulmonary trunk of inefficacy.In certain embodiments, the present invention can help the operation method of performing the operation and need not out thoracic cavity body and cardiopulmonary bypass on the dancing heart through being imposed in.This Minimally Invasive Surgery method can reduce with displacement originally lost efficacy from the relevant risk of body valve, and with the second time or the relevant risk of subsequent procedures of artificial (as the biological or artificial) valve that lost efficacy in order to displacement.
Stent valve according to some embodiment of the present invention can comprise valve member and at least one support element.Valve member can comprise biology or manual work (like mechanical type) valve and/or any other suitable material.Support element can comprise first's (like portions of proximal), be configured to so that hold the second portion of valve member, and third part (like distal part).Support and valve part can be at least two kinds of structures: contracted configurations (as in course of conveying) and deployment configuration (after implanting).
In certain embodiments, the first of stent valve can comprise retaining element.This retaining element can comprise that (for example) is used to make the annular groove of stent valve at implant site place fix in position.When stent valve comprised single support (" single-side stand valve "), annular groove can be configured to so that reception needs the anchor ring of metathetical valve.When stent valve comprised two supports (" double bracket valve "), the annular groove of first support element can be configured to so that can be attached on additional (complimentary) annular protrusion of second support element (being locating support) with mating.And second support element can anchor on metathetical valve of needs and/or the proximal structure implant site place (for example).
Perhaps or in addition, in certain embodiments, the third part of support element can comprise at least one attachment element.Each attachment element of stent valve can comprise that (for example) is configured to so that be attached to geometric form opening (as circular or avette), hook or the band on the supplementing structure (complimentary structure) of conveyer device removedly.In addition, each attachment element can be corresponding to all or part of of engaging lever, and the abutment between two valve leaflets can be attached on it.Attachment element can allow stent valve in patient's body, partly to launch, and stent valve keeps being attached on the conveyer device.When confirming that fully the stent valve will cause stent valve to be installed by error, this can allow stent valve to be returned to contracted configurations and in patient's body, reorientate.Perhaps or in addition, when definite stent valve does not correctly move (as not allowing competent flow), this can allow stent valve to be returned to contracted configurations and it is removed in patient's body.In certain embodiments, stent valve can comprise an attachment element.In other embodiments, stent valve can comprise the attachment element of at least two, three, six or any other right quantity.In certain embodiments, the complete unfolded stent diameter in the zone of attachment element can be less than the diameter in the zone that holds relevant valve.This can reduce the risk of the injury (like aortal perforation) of the patient body that attachment element causes, with and/or can be more prone to so that attachment element is fixed on the supplementing structure of conveyer device.
In certain embodiments, the support element of stent valve can comprise having a plurality of unitary networks.Network can be formed by (for example) marmem, for example Nitinol (nitinol) or any other suitable material.Unit in the network can be the most thick in the part that comprises retaining element of support element.This can be for retaining element provides more how other supporting, and improves the stability of stent valve.In certain embodiments, network can form at least one the elongated mast (like engaging lever) that distad extends along support element towards at least one attachment element.This at least one mast can be connected directly to this at least one attachment element.Perhaps, network can be formed for this at least one mast is connected at least one supporting member of at least one attachment element.In certain embodiments, all unit in the network can be closed cells, and it can help stent valve and be recovered to contracted configurations from the part deployment configuration.
Other embodiment in addition of the present invention relates to the method that is used for replacement valve.A kind of stent valve is provided, and it comprises that support element and this stent valve with annular groove axially are fixed on the anchor ring of the metathetical valve of needs.In certain embodiments, providing stent valve to comprise is sewn onto valve member on the support element.Perhaps or in addition, provide stent valve to be included in and launch valve member in the support element, so that form frictional fit.In certain embodiments, providing stent valve can comprise with shackle (like VELCRO
Figure G2007800412847D00041
) fastening system is fixed to valve member on the support element.
In other embodiments of the invention, a kind of method that is used for replacement valve is provided, has implanted first support element that comprises ring-type element, thereby at least a portion of this first support element is contained in the metathetical valve of needs through this method.The stent valve that comprises second support element can be attached to through the additional ring-type element with second support element on the ring-type element of first support element with mating and be positioned in first support element.
In other embodiment in addition of the present invention, a kind of stent valve induction system is provided.First assembly that comprises oversheath and guiding spool is provided.Induction system also comprises second assembly, and this second assembly comprises the support holder at least one attachment element that is configured for being attached to removedly stent valve.Stent valve can be positioned on the guide wire of first assembly.First assembly and second assembly can be configured for relative to each other relative motion, so that be transformed into open position from the make position position.In make position, oversheath can center on the stent valve that still is attached to the support holder, and the expansion of limit bracket valve thus.In open position, oversheath is the expansion of limit bracket valve not, and stent valve can separate from the support holder thus, and is extended to complete deployment configuration.
In certain embodiments, first assembly and second assembly can be configured to so that be transformed into the position of partly opening, be transformed into open position from make position.In the position of partly opening, stent valve can partly launch, but can not separate from the support holder, because oversheath can still center at least one attachment element and the support holder of stent valve.When stent valve is in the part deployment configuration, can confirm if stent valve is extended to complete deployment configuration, whether stent valve will correctly locate.Perhaps or in addition, when stent valve is in the part deployment configuration, functional (for example so that confirm whether stent valve will allow adequate blood flow) that can the test bracket valve.
In certain embodiments, the stent valve induction system can comprise at least one sacculus (like proximal stent valve or other support to be carried), and it is configured to so that when at least one inflation, cause stent valve to launch or locating support.
In certain embodiments, the stent valve induction system can comprise the handle that pushes away of the relative motion that causes first assembly and second assembly.Perhaps, the stent valve induction system can comprise the screw mechanism that is used for rotatablely moving of handle converted to the relative motion of first assembly and second assembly.
In certain embodiments, the stent valve induction system can comprise the integrated form introducer, is transported at stent valve that first assembly and second assembly are positioned in this integrated form introducer in the process of implant site.Still remain in patient's body after first assembly and second assembly are removed even this integrated form introducer can be configured to, allow to introduce light limiter with (for example).
In certain embodiments, after stent valve was extended to complete deployment configuration, induction system can be configured to so that be returned to make position through second assembly is sent towards the far-end of first assembly through stent valve.
Other embodiment in addition of the present invention relates to the method that is used for stent valve is transported to implant site, and stent valve is attached on the conveyer device through this method removedly, and stent valve is transported to implant site with contracted configurations.When making stent valve keep being attached on the conveyer device, this stent valve can partly launch.When stent valve is in the part deployment configuration, can make judgement about stent valve.When this judged that obtaining the front responds, stent valve can be extended to its complete deployment configuration through stent valve is separated from conveyer device.
In a particular embodiment, can confirm whether stent valve correctly is positioned at the implant site place.When stent valve correctly was not positioned at the implant site place, this stent valve can be returned to contracted configurations.
Perhaps or in addition, for example, whether will allow adequate blood flow can confirm whether the valve member of stent valve is correctly moved through the test valve member.When stent valve did not correctly move, stent valve can be returned to contracted configurations and in patient's body, remove.
In certain embodiments, stent valve is transported to implant site can comprises stent valve is transported to heart, so that replacement heart valve.This conveying can comprise through intercostal gap (like the 5th intercostal gap) entering patient's body, and on the summit of heart, thrust left ventricle.
Accompanying drawing is briefly described
In order to understand the present invention better, with reference to following explanation, wherein, same reference numerals refers to identical member from start to finish in conjunction with accompanying drawing, and wherein:
Figure 1A has shown the valve member that is in deployment configuration according to some embodiment of the present invention;
Figure 1B has shown the valve member that is in contracted configurations according to some embodiment of the present invention;
Fig. 2 A has shown the support element that is in deployment configuration according to some embodiment of the present invention;
Fig. 2 B has shown being in deployment configuration, comprising the single-side stand valve of support element and valve member according to some embodiment of the present invention;
Fig. 2 C has shown the single-side stand valve that is in contracted configurations according to some embodiment of the present invention;
Fig. 3 A has shown the support element that is in deployment configuration according to some embodiment of the present invention;
Fig. 3 B has shown the support element that is in contracted configurations according to some embodiment of the present invention;
Fig. 4 has shown being in deployment configuration, comprising the double bracket valve of two support elements and a valve member according to some embodiment of the present invention;
Fig. 5 A-7B has explained the use according to the single-side stand valve of biology (artificial) valve some embodiment of the present invention, that lost efficacy in order to displacement;
Fig. 8 A and 8B shown according to some embodiment of the present invention, comprise and be used for support is fixed to the attachment element on the conveyer device and is used for support is fixed on the support element of the retaining element at implant site place;
Fig. 8 C has shown the support element according to the littler diameter of the diameter of stent area some embodiment of the present invention, that in the zone of attachment element, have than hold relevant valve;
Fig. 8 D shown according to some embodiment of the present invention, comprise the support element of crooked element independently on the geometry/topological structure that is used for support being located/be fixed to the implant site place;
Fig. 8 E shown according to some embodiment of the present invention, comprise the locking member that is in crown structure and be used for support is fixed on the support element of the retaining element at implant site place;
Fig. 8 F has shown and has comprised the support element that is used for valve member is sent to a plurality of poles in the zone of more approaching support element that it comprises and is used for support element is attached to the attachment element on the conveyer device;
Fig. 9 A-16 shown according to of the present invention, comprise and be used for support is fixed to the attachment element on the conveyer device and/or is used for support is fixed on the additional embodiments of support element of the retaining element at implant site place;
Figure 17/18,19 and 20 have shown the other instance according to the double bracket valve of some embodiment of the present invention;
Figure 21 A has shown the two coronal stent valve relative according to being shaped as of some embodiment of the present invention;
Figure 21 B-E has shown the view according to the double cone shape support of some embodiment of the present invention;
Figure 22 A-22D shown according to some embodiment of the present invention be used for will self-deploy the induction system that stent valve is transported to implant site;
Figure 23 A-23D has shown the induction system with balloon-expandable according to some embodiment of the present invention;
Figure 24 A-24D has shown the induction system that has increased the nearside outer shaft of diameter according to having of some embodiment of the present invention;
Figure 25 A-25C has shown the induction system with balloon-expandable according to some embodiment of the present invention;
Figure 26 A-26C has shown the induction system with integrated form introducer according to some embodiment of the present invention;
Figure 27 is the flow chart from schematic stage of body or artificial valve that relates to that displacement lost efficacy according to some embodiment of the present invention; And
Figure 28 A-C has explained the valve that the use induction system is replaced inefficacy that passes through according to some embodiment of the present invention.
The specific embodiment
Figure 1A-3B has shown the member 100,200 and 300 according to (like what the degenerate) aortic valve, Bicuspid valve and the valve of pulmonary trunk (as in pediatric patients) that are used for displacement (for example) inefficacy of some embodiment of the present invention.More specifically, Figure 1A and 1B have shown valve member 100.Fig. 2 A-2C has shown the support element 200 that is used to hold valve member 100.Fig. 3 A and 3B have shown the support element 300 that is used for containment bracket member 200 and valve member 100.The device that comprises member 100 and 200 can be described as the single-side stand valve.The device that comprises member 300 in addition can be described as the double bracket valve.
Fig. 4 has shown the double bracket valve 400 that comprises valve member 100, support element 200 and support element 300 according to some embodiment of the present invention.The 400 replaceable inefficacies of double bracket valve from body or artificial valve.As used herein, " from the body valve " refers to and is present in the intravital valve of patient natively.What lost efficacy can be (for example) stenosed valve from the body valve." artificial valve " refers to through operation and introduces intravital biology of patient or manual work (like mechanical type) valve.The implant site that is used for device 400 (or other replacement valve) generally includes in the valve of inefficacy and/or along at least a portion in the zone of at least a portion of proximal structure.For example, in order to replace the aortic valve of inefficacy, device 400 can be implanted in patient's body, thereby the part 402 of device all is positioned in the aortic valve of inefficacy basically.The part 404 of device 400 can be extended along aortal at least a portion.Device 400 part 406 can extend at least a portion of left ventricle of patient's heart.
Double bracket valve 400 can use any suitable delivery to implant site.In certain embodiments of the present invention, before device 400 was transported to implant site, device 400 can basically intactly be assembled by member 100,200 and 300 in that the patient is external.In other embodiments of the invention, the member 100,200 and 300 of device 400 can be transported to implant site individually by a plurality of steps.For example, the implant site place can carried and be installed in to support element 300, then carries and mounting bracket member 200 and valve member 100 by one or more independent steps.In one embodiment, member 100 and 200 can be in patient's assembled in vitro, then it is carried simultaneously and is installed in the member 300.In another embodiment, support element 200 can be carried and be installed in the support element 300, then carries and install valve member 100 with independent step.The additional embodiments of double bracket valve has been described in conjunction with Figure 17-20.
In certain embodiments of the present invention, the single-side stand valve (Fig. 2 B) that comprises valve member 100 and support element 200 (but not comprising support element 300) can be used for replacing inefficacy from body or artificial valve.For example, in a particular instance, the process displace of the valve replacement surgery that the single-side stand valve can be is formerly introduced the biovalve of the intravital inefficacy of patient.Therefore, the operation that relates to the single-side stand valve shown in Fig. 2 B can be for the second time or follow-up valve replacement surgery.Though do not have new support element 300 can introduce patient's body in this embodiment, comprise that the single-side stand valve of member 100 and 200 can be held by the support and/or the valve that remain on from the implant site place of previous valve replacement surgery.In certain embodiments, before the single-side stand valve is installed in the implant site place, can remove at least a portion from the support and/or the valve of previous operation.In conjunction with Fig. 5 A-7B the other details about the biovalve that lost efficacy with the single-side stand valve replacement has been described.
In certain embodiments of the present invention, valve member 100 can be flexible and contractile, makes it in (for example) is transported to the process of implant site through conduit, can shrink.Below in conjunction with Figure 22 A-26C the induction system that is used for Minimally Invasive Surgery and the various embodiment of operation method have been described.When carrying, valve member can be launched at least in part.Figure 1A is the perspective view that is in the valve member 100 of deployment configuration.Figure 1B is the perspective view that is in the valve member 100 of contracted configurations.As used herein, " contracted configurations " and " deployment configuration " refers to diameter of (for example) member and/or the relative different of any other physical features (like length, width).For example, the valve member of the contraction shown in Figure 1B has the diameter that reduces, and can have or can not have than the longer length of unfolded valve member shown in Figure 1A.
Valve member 100 can comprise biomaterial (as tanning, not tanning, heterogeneous or from body), non-biological material, artificial material (as such as polymer such as polyurethane and/or silicon) or its combination.In certain embodiments, valve member 100 can comprise the biological tissue of preservation, for example, and such as human tissue (like alloplast, the autograft of valvular tissue) or animal tissue's (xenotransplantation or heteroplastic transplantation valvular tissue).In certain embodiments, valve member 100 can be the mechanical type valve.For example, when valve member 100 was biovalve, the expansion of valve member 100 from the contracted configurations to the deployment configuration possibly need self-deploying of fixed support element 200.On the contrary, artificial valve's member 100 can self-deploy.Valve member 100 can have the corresponding shape/form of shape/form (like length, width, diameter etc.) of using (like Tricuspid valve, valve of pulmonary trunk, Bicuspid valve or aortic valve) with the valve of expectation.In Figure 1A and 1B, valve member 100 is the Tricuspid valvies with three tablets.This particular configuration can be specially adapted to the aortic valve that (for example) displacement was lost efficacy.In other embodiments, valve member 100 can have tablet and/or other physical features (like diameter, length, width etc.) of any other right quantity.
Fig. 2 A is the perspective view of support element 200 according to an embodiment of the invention.Shown in Fig. 2 B, support element 200 has held valve member 100.In certain embodiments, at least a portion of support element 200 can be cylindrical in shape basically.Perhaps or in addition, support element 200 can have (for example) and be used to make breach (like annular groove) or other retaining element 202 of support at implant site place fix in position.For example, when support element 200 was double bracket valve 400 (Fig. 4) a part of, retaining element 202 can be attached on the additional retaining element 302 (like the inside annular protrusion of Fig. 3 A) of support element 300 with mating.When support element 200 was single-side stand valve (Fig. 2 B) a part of, retaining element 202 can be fixed at least a portion of valve of inefficacy.In conjunction with Fig. 6 A and 8A-16 the additional embodiments that can comprise the support element of retaining element has been described.
In certain embodiments of the present invention, support element 200, similar valve member 100 can be at least two kinds of structures: the first, and contracted configurations (as in course of conveying) and the second, deployment configuration (after installing).Fig. 2 A has shown the support element 200 that is in illustrative deployment configuration.Fig. 2 C has shown the support element 200 that is in illustrative contracted configurations, and the valve member 100 of wherein shrinking is contained in the support element 200, and (for example) is so that be transported to implant site with two members simultaneously.In certain embodiments, support element 200 can be processed by wire rod, or can be formed by cut such as pipe, sheaths.Support element 200 can comprise shape memory alloy material, for example Nitinol.Marmem can allow support element 200 (and/or valve member 100) is compressed into first structure, so that (for example) passed through the little opening transfer gantry member 200 in the patient body, and in installation process, makes support element 200 be extended to second structure.For example, member 100 and/or 200 can be held in contracted configurations with for example sheath or shade.Can remove sheath/shade, so that allow member 100 and/or 200 to be configured to second structure again.
Valve member 100 can be fixed on the support element 200 through any suitable fixed mechanism or the combination of fixed mechanism.For example, in one embodiment, valve member 100 can be sewn onto on the support element 200 with one or more stitch.In another embodiment, valve member 100 can be fixed on the support element 200 through the mode of frictional fit.For example, valve member 100 can have the complete deployed diameter less times greater than the deployed diameter of support element 200, thereby when member 100 launched in member 200, member 100 and 200 was combined together securely.In yet another embodiment, shackle-type (for example VELCRO ) fastening system can be used for valve member 100 is fixed on the support element 200.For example, support element 200 can comprise micro-hook, and valve member 100 can comprise corresponding micro-ring (or vice versa).This hook and loop fastening system can comprise the microfilament down material, and it had been used to the tissue that surgical application is improved growth in the past.After for example in member 100 and 200 has been implanted patient's body, this hook and loop fastening system can allow the position with respect to the fine position valve member 100 of support element 200.Hook/ring also can help the formation of the sealing of the joint between blood coagulation and valve member 100 and the support element 200.Condense (condensing) for fear of too early formation, can anticoagulant monitoring and/or treatment be provided for the patient as exceedingly forming before the installation.Shackle connects still and can under the situation that has the too early formation of condensing, realize reliably, but possibly need higher activation pressure (in following description).Entry evaluation shows that shackle connects and can under the situation that has water, colloidal quality, liquid soap and/or bind protein, form reliably.In certain embodiments; This hook and loop fastening system can be alternatively or additionally is used for support element 200 is fixed to support element 300 (for example with the corresponding micro-ring on the micro-hook and the inner surface that is attached to support element 300 that are attached on the outer surface of support element 200, or vice versa).
The combination (like directly or indirectly applying of mechanical compress) of any suitable mechanism or these mechanisms can be used for providing makes micro-hook be attached to activation pressure required on the micro-ring.For example, in certain embodiments, one or more sacculus can be arranged to adjacent valves member 100 and/or support element 200 (as in valve member 100), and it can temporarily expand, and contact so that micro-hook is given birth to micro-environment-development.After support and/or valve were transported to implant site, this sacculus can place in valve member 100 and/or the support element 200.Perhaps, in certain embodiments, before support and/or valve are transported to implant site (as before being written into support and/or valve in the conveyer device), sacculus can be installed (as installing removedly) in valve member 100 and/or support element 200.The use of this sacculus is not limited to valve and the support embodiment fixed to one another through the mode of hook/ring therein.On the contrary, need or expectation use sacculus assist support and/or valve to launch at the implant site place and/or engage whenever (for example when valve is sewn onto on the support) can be used this sacculus.In certain embodiments, can be provided in self-deploy in the support element 200 self-deploy valve member 100 so that make micro-clasp joint touch micro-ring.
Fig. 3 A is the perspective view of support element 300 according to an embodiment of the invention.As previously mentioned, support element 300 can have the retaining element 302 (like inside annular protrusion) on the additional retaining element 202 (Fig. 2 A) that can be attached to support element 200 with mating.Fig. 4 has shown a this attached embodiment who matees, wherein, member 300 held member 100 and 200 both, to form double bracket valve 400.The geometry of support element 300 (like length, width, diameter etc.) can be specially adapted to (for example) aortic valve replacement.Other geometry and the structure of support element 300 can be provided in other embodiments.
Through using any suitable fixed mechanism or the combination of fixed mechanism, support element 300 can be at the implant site place fix in position.For example, in certain embodiments, retaining element 302 can be formed for receiving the groove (like external annular groove) of at least a portion of the valve of inefficacy.In certain embodiments, support element 300 can have less times greater than the diameter of the diameter of implant site, thus make support element 300 in the conveying at implant site place and the mode through frictional fit launched with support element 300 fix in position.In certain embodiments, support element 300 can comprise and is used for support element 300 is anchored to the valve of inefficacy and/or one or more convexities (like spike) or clasp on the proximal structure at the implant site place.
Fig. 5 A-7B has explained that the operation process that is used for replacing formerly of the present invention introduces the embodiment of artificial (like biology) valve (like stent valve) of the inefficacy of patient body.Fig. 5 A is the perspective view of the biovalve 500 of inefficacy, and wherein the lobule 502 of valve can't be closed.Fig. 5 B is a perspective view of implanting the biovalve 500 of the inefficacy afterwards of the stent valve shown in Fig. 2 B.As shown in the figure, the biovalve 500 of inefficacy (for example: and/or it follows support) make new stent valve at the implant site place fix in position.More specifically, the retaining element 202 of stent valve (Fig. 2 A and 2B) (it can be the annular groove that forms the narrow of stent valve) can receive the anchor ring of the biovalve 500 of inefficacy, thereby makes the stent valve fix in position.In other embodiments of the invention, at least a portion of the biovalve 500 of inefficacy (valve self that for example lost efficacy) can remove in patient's body, and other part (like supporting bracket) of the valve that lost efficacy can be stayed the implant site place.In other other embodiment, before new stent valve is installed, can the biovalve 500 of the inefficacy that comprises all its associated components be removed from implant site basically fully.
Fig. 6 A is the perspective view of another instance of stent valve 600 according to an embodiment of the invention.Fig. 6 B has shown to use stent valve 600 to replace the perspective view of artificial (like biology) valve of inefficacy.Stent valve 600 comprises one or more (as three) locking or the holding element 602 along the outer surface of support element.Each locking member 602 can comprise directivity, makes it just shrink (as become flush with the outer surface of support element) in this locking member and another surface (like the inside of conduit) when engaging.When locking member 602 is outstanding from the outer surface of support element, the outer surface that first end 604 of locking member can the near bracket member, and second end 606 of locking component can be spaced apart with the outer surface of support element.When a plurality of locking member 602 is provided; First end 604 of all locking components can be positioned on essentially identical vertical height/position (though disperseing equably like the periphery around support element) along the central axis of support element, and second end 606 can be positioned on the vertical height/position different with first end 604.First end 604 can be flexible (moving with the mode of hinge-like along two dimensions as allowing), thereby second end can not hinder locking mechanism with respect to the motion of the outer surface of support element.
In certain embodiments of the present invention, stent valve 600 can insert the inside of inefficacy valve along the direction of the arrow among Fig. 6 B 608.When first end 604 of each locking member 602 ran into the internal diameter of the valve of inefficacy/anchor ring, second end 606 of locking member can shrink towards the outer surface of support element.When second end 606 of locking member arrived the open area of the valve that lost efficacy, second end can outwards be given prominence to, thereby makes stent valve 600 locks in place.Therefore; As the alternative or other scheme that is used for stent valve 600 is fixed to the retaining element 610 (like annular groove) of the support element on the anchor ring of the valve that (for example) lost efficacy, locking member 602 can be provided for making the mechanism of new stent valve fix in position.
Fig. 7 A and 7B have shown another embodiment that has the support element 700 of locking member according to of the present invention.Fig. 7 A has shown that this support element can be processed by (for example) suitable material (like Nitinol) sheet.Referring to Fig. 7 B; Support element 700 comprises one or more locking members 702; Its outer surface from support element radially extends, thereby makes to have essentially identical vertical position/highly for first end 704 of each locking member, this locking member and second end 706 along the central axis of support element.In other embodiments, this locking member can be angled a little, makes end 704 and 706 central axis along support element of same locking member have different relative vertical position/highly.In certain embodiments, the support element that comprises a plurality of locking members can be provided, wherein each locking member has with the directed end 704 and 706 of different angles.Different locking members 702 can have identical or different vertical position/highly along the central axis of support element.
Fig. 8 A-16 has shown the other instance according to the suitable support element that is used for valve replacement of some embodiment of the present invention.These support elements can (for example) use as the part of single-side stand valve and double bracket valve.These support elements all comprise the one or more attachment element that are used for support element (for example together with the integrated form valve member) is attached to removedly conveyer device (Figure 22-26) separately.In certain embodiments, these support elements also can comprise and are used to make the retaining element (as be similar to retaining element 202 (Fig. 2 A)) of support element at implant site place fix in position.
Fig. 8 A has shown the perspective view of the support element 800 that is in contracted configurations, and the explanation of support element 800 about the view of the similar cutting of the details of its structure.Fig. 8 B has shown the support element 800 that is in deployment configuration.Support element 800 comprises: first (like nearside) part 802, and it comprises retaining element (like annular groove); The profile that can follow valve member is to be contained in second portion 804 wherein; And the 3rd (like the distally) part 806 that comprises one or more (as three) attachment element 808.In certain embodiments, support element 800 can comprise (for example) network (as being processed by Nitinol), and for example, part 802 has than part 804 and/or part 806 more thick grid cells.This can provide other supporting for the retaining element in the part 802, and improves the stability of device 800 at the implant site place thus.In certain embodiments, support element 800 can only comprise closed grid cell, so that help when support element 800 is in the part deployment configuration, recaptures support element 800 (like the following stated) by conveyer device.
In certain embodiments, attachment element 808 can comprise the opening (as circular or avette) that is used for support element 800 is attached to removedly the addition item (like wire rod, band or hook) of conveyer device separately.Attachment element 808 can allow support element (as together with integrated form valve member and/or another support element) in patient's body, partly to launch when making support element keep being attached on the induction system; For example; When support element 800 partly discharges from axle in course of conveying; The part 802 and 804 of support element 800 (as and the part of part 806) deployable, and do not observe still variation (like " part discharges ") referring to Figure 28 by the relative position of the attachment element 808 of axle constraint.This can allow the surgeon in patient's body, to reorientate stent valve (or double bracket valve) before confirming the deployment of stent valve at the implant site place and/or test that it is functional final.This test that valvular function property is carried out can comprise peripheral monitoring of pulse, if valve correctly moves, then pulse wave is measurable by this method.The available TEE (TEE) of assessment more reliably, intravascular ultrasonic imaging (IVUS) and/or the ICE (ICE) of stent valve function carry out.If stent valve is out of order in test process (for example, if valve does not allow adequate blood flow), stent valve can fully be recaptured and in patient's body, fetched by conveyer device.In other embodiments; Support element 800 can have the different grid structure; The length of attachment element 808 and/or other size can be dwindled or amplify, with and/or attachment element 808 can be included in other position with respect to support element 800 (in part 804).
Fig. 8 C has shown another embodiment of the support element with integrated form attachment element 814, and this integrated form attachment element 814 is configured such that complete unfolded diameter in the zone of attachment element is less than the diameter in the zone that holds relevant valve.So shown in the instance, attachment element towards the central axis of support element partly to projecting inward.This can reduce attachment element damages (for example aortal puncture) to patient body risk.Perhaps or in addition, this can make attachment element is fixed on the supplementing structure of conveyer device and be more prone to.For example, when installing contraction so that being attached on the conveyer device, the diameter that dwindles in the zone of attachment element can make attachment element earlier engage with the support holder.
Fig. 8 D has shown another embodiment according to support element of the present invention.In this embodiment, first (nearside) of support part comprises 27 independently bendable 816, its can comprise separately can open and/or closed connection/with or the unit that breaks off.In this embodiment, each bendable comprises single closed cell.The bendable of other quantity and/or structure can be provided in other embodiments.Bendable 816 allows the proximal stent part accurately to locate/be fixed on the geometry/topological structure of biovalve of anchor ring/inefficacy of (for example) calcification.Each element 816 is the topological structure of the proximate portion of the biovalve of the anchor ring/inefficacy of bending/adaptation calcification independently.The common annular grooves that form of bendable 816, in this annular groove, the position that is used for the flexural deformation (reeded part) of each bendable is controlled through the length of dwindling or prolongs the stent strut (818,820) of the pair of attachment that is used as joint.The length of single stent strut is illustrated by label 822.At first, in the support manufacture process, the radial force/resistance of each bendable 816 receives the influence of the selection of angle 824.Other design parameter such as strut thickness/width also can influence radial force.The advantage of this design is: the support portions of proximal can make support in place in the grappling of implant site place more fully, and not influenced by the support mid portion.Therefore, the support mid portion can be designed to so that hold (for example) aortic valve, and does not exceed size, thereby reduces because the risk of the valve failure that secular mechanical stress causes.The support of Fig. 8 D also comprises and is used for regulating the compensating element, 826 (as comprising triangle wave part and two slender arms) of the prolongation mismatch (if any) in the support in manufacturing and/or BENDING PROCESS.Embodiment shown in Fig. 8 D and Fig. 8 C is opposite, and wherein, lacking of a special-purpose pole pair prevented that the support portions of proximal has crooked independently element (as in implantation process).
Fig. 8 E has shown another embodiment according to support element of the present invention.In Fig. 8 E, shown view only about 1/3 of the similar cutting of support element, so that more clearly illustrate its characteristic.Similar with the locking/holding element 602 shown in the 6B with Fig. 6 A, the support element shown in Fig. 8 E comprises that general location can crooked independently locking members 828 as a plurality of in the 804 support element zones of quoting, zone in Fig. 8 B.Locking member 828 formation can engage the biovalve of (for example) inefficacy or the hat from the body anchor ring of calcification from the outflow side.Support element among Fig. 8 E also comprises retaining element 830 (like annular groove).In Fig. 8 E, shown that locking member 828 is positioned on the essentially identical position/height along the central axis of support element.In other embodiments, different locking member 828 can be similar to the support shown in (for example) Fig. 7 B and have identical or different vertical position/highly along the central axis of support element.Some locking member at least in the locking member 828 have different position/height can help with (for example) different size from the body valve (what for example can be engaged by the locking member of spaced apart small distance is thin from the body valve, perhaps only can by spaced apart locking member far away engage thick in the body valve) engage.
Fig. 8 F has shown another embodiment according to support element of the present invention.In Fig. 8 F, shown view only about 1/3 of the similar cutting of support element, so that more clearly illustrate its characteristic.But Fig. 8 F comprise be used to hold valve member reach synthetic fibre (Dacron) bag 832, wherein, sew up along valve free margins 834 but reach the synthetic fibre bag.As shown in the figure, than holding more near attachment element 836 among the embodiment shown in Fig. 9 C, this attachment element 836 is similar with the attachment element 808 among Fig. 8 B in the embodiment of Fig. 8 F for the valve member in the bag 832.But intermediary inversion U-shaped pole 838 is slipped into and is reached in the synthetic fibre bag 832.Valve/bag is sewn onto on the outside inversion U-shaped pole 840.But inner U-shaped pole 842 is positioned at and reaches synthetic fibre bag 832 outsides, but and is utilizing conveyer device to pack into/discharge/recapture in the process of implant and be used as brake through reducing to reach frictional force between synthetic fibre bag 832 and the oversheath.But inner U-shaped pole 842 also can be sewed up on the arrival synthetic fibre bag 832.In certain embodiments, but reach synthetic fibre bag 832 and can sew up 844 closures with other.Though not in the bottom of support shown in Fig. 8 F, in certain embodiments, it can comprise the similar retaining element (like annular groove) of retaining element 802 among (for example) and Fig. 8 B.
Fig. 9 A-9C has shown another instance with support element 900 of integrated form attachment element 902 according to an embodiment of the invention.Fig. 9 A shown the support element 900 that is in contracted configurations perspective view and support element 900 explanation about the view of the similar cutting of the details of its structure.Fig. 9 B is the perspective view that is in the support element 900 of deployment configuration.Fig. 9 C has shown support element 900 (having the integrated form valve member), and it is positioned at the scale next door to show its size (4 centimetres according to appointment).As shown in the figure, each attachment element 902 comprises through two supporting members 904 (like wire rod) and is attached to the circular or avette opening on the support element 900.And each all is attached on the mast 906 (like engaging lever) in the network supporting member 904.On the contrary, the attachment element 808 among Fig. 8 B wherein each is attached on the support element 800 through single supporting member 810, and each supporting member 810 all is attached on the mast 812.All support elements shown in Fig. 8 A-16 all comprise three masts, but should be appreciated that according to some embodiment of the present invention, the mast of other right quantity can be provided or mast (like Fig. 2 A) is not provided fully.Support element 900 also comprise can with the similar basically retaining element 908 of retaining element 202 (Fig. 2 A).In the embodiment of Fig. 9 C, valve member is sewed up around its anchor ring.Wherein each lobule of three lobules of valve member is also put and is sewn onto on the support, to allow valvular function property.Can select the position sewed up, between folding period, prolong support and do not damage valve or stitching so that allow.For example, can cover inflow (as in the zone shown in Fig. 8 B 802) with fabric (like net) on the inboard of support.Fabric and valve member can be in the zones of proximal ring connected in star, and (like the holder part 802 in Fig. 8 B and 804 border) is sewn onto (as using technology successive and/or that interrupt) on the support.The unnecessary fabric of on the inflow side some can fold on the outside of support, and formerly near suture location (as further towards part 804) is stitched together with valve member.The joint of valve member can also be attached to maybe be before on the corresponding cradling piece with fabric (but as reach synthetic fibre) covering.Perhaps, available pericardium or other suitable material cover support element.In certain embodiments, valve member can be the pig valve member, and it can obtain or compile from each donor like this, so that have the optimum matching between the tricuspid.Can also use cattle valve and the horse valve processed by pericardium.Also can use other suitable source of valve member.
Figure 10 A-10B has shown support element 1000 another instances with integrated form attachment element 1002 according to an embodiment of the invention.Figure 10 A shown the support element 1000 that is in contracted configurations perspective view and support element 1000 explanation about the view of the similar cutting of the details of its structure.Figure 10 B is the perspective view that is in the support element 1000 of deployment configuration.As shown in the figure, at least one pair of in the attachment element 1002 (as all to) utilize support component 1004 attached to each other.Each support component 1004 is attached on first attachment element 1002 on can be at one end, and is being attached on the other end on second attachment element 1002.In certain embodiments, support component 1004 can comprise the wire rod that is configured as similar triangle wave.When all attachment element 1002 comprised support component 1004, support component 1004 can form around the annulus of the periphery of support element 1000 jointly.Support element 1000 can be basic identical with support element 800 (Fig. 8 B) in all others.
Figure 11-16 has shown the other instance according to the support element with integrated form attachment element of some embodiment of the present invention.Each figure among Figure 11-16 all comprise the support element that is in contracted configurations perspective view and support element explanation about the view of the similar cutting of the details of its structure.Below the various characteristics of the support element shown in Figure 11-16 have been summarized in explanation.According to accompanying drawing, to those skilled in the art, the other Structural Characteristics of the embodiment shown in Fig. 8 A-16 will be obvious.
Figure 11 has shown the support element that comprises the shorter supporting member (promptly comparing shorter with the supporting member 810 of Fig. 8 B) on the avette/circular attachment element that is used to be attached to respective amount.The mast that being used among Figure 11 is attached on the supporting member can be basic identical with the mast 906 of Fig. 9 B.
Figure 12 has shown and has comprised the support element that is used to be attached to two supporting members on each avette/circular attachment element.Each all is attached to mast to supporting member, thereby forms the supporting that (for example) be used to increase when supporting member and mast are common and/or be used for second avette/circular open as other or alternative attachment element.Mast among Figure 12 can be basic identical with the mast 906 among Fig. 9 B.
Figure 13 shown comprise the addition item that is used for being attached to conveyer device with mating (as circular or/avette opening) the support element of non-circular/avette attachment member (for example, such as wire rod, hook, band or its combination).When with the attachment element quantity (as three) of support element 900 (Fig. 9 A and 9B) when comparing, the support element among Figure 13 also comprises the attachment element (as six) of greater number.In Figure 13, attachment element directly is attached on the mast of support element, attached two attachment element on the every mast.Mast among Figure 13 can be basic identical with the mast 906 among Fig. 9 B.
Figure 14 has shown the support element that replaces the wire rod/hook attachment element among Figure 13 with long narrow opening (long and narrow as comparing with the attachment element 902 of Fig. 9 A).Mast among Figure 14 can be basic identical with the mast 906 among Fig. 9 B.
Figure 15 has shown the have modified network support element of (comprising modified mast arrangement).Support element among Figure 15 also comprises circle/avette attachment element, and wherein each attachment element is attached to mast through two supporting members.Each can form second circle/avette opening by the mode that is similar to supporting member shown in Figure 12/mast structure to supporting member and corresponding mast.
Figure 16 has shown to have the support element that has carried out the attachment element of modification with respect to attachment element shown in Figure 15.Each attachment element among Figure 16 comprises wire rod (like " U " shape wire rod), and wherein the two ends of wire rod are attached directly on the same mast, thereby attachment element/mast structure forms avette basically/circular opening.Mast among Figure 16 can be basic identical with mast shown in Figure 15.
Figure 17/18,19 and 20 have shown the other instance according to the double bracket valve of some embodiment of the present invention.The single-side stand valve 1700 of Figure 17 comprises support 1702 and valve member 1704.Figure 18 has shown the double bracket valve that comprises stent valve 1700 and locating support 1802, and stent valve 1700 can be adhered together through (for example) annular groove and corresponding annular depression with locating support 1802.Support element 1802 can be coated with (for example) pericardium, reveals so that prevent valve periphery.The double bracket valve of Figure 18 can have the shape of the general cylindrical that is applicable to that (for example) lung and/or aorta are used.
Existing referring to Figure 19 and 20, Figure 19 has shown the double bracket valve with first support 1902, second support 1904 and valve member 1906.Figure 20 has shown the double bracket valve with first support 2002, second support 2004 and valve member 2006.In addition, can cover the locating support among (as using pericardium) Figure 19 and 20, reveal so that prevent valve periphery.Figure 19 and 20 support go for (for example) lung valve replacement (as under the aneurysmal situation that the distortion of producing is arranged, and under the situation of the metathetical appropriate edge that is not used in band groove stent valve).More specifically, use about the lung valve, the candidate of many lung valve replacements has aneurysm or has the funnel type structure in inflow or outflow place.Therefore, first support 1902 and 2002 can be suitable for this funnel type pulmonary artery structure, and can be provided for the circular hole of fixed support valve (1904,1906) or (2004,2006).In certain embodiments; The double bracket valve similar with the double bracket valve of Figure 20 can be provided; It is applicable to Bicuspid valve and/or Tricuspid valve application; Wherein locating support has the elliptical configuration of the height that reduces and the circular edge that is provided for being attached to stent valve groove (perhaps, can use hook and loop fastening system).Perhaps or in addition, locating support can have secure fit is provided at the implant site place can crooked independently element.According to accompanying drawing, the other Structural Characteristics of the embodiment shown in Figure 17-20 and to those skilled in the art will be obvious about its details that is used for the usage of valve replacement.
Figure 21 A has shown another instance according to the stent valve 2100 of some embodiment of the present invention.Embodiment shown in Figure 21 A can be suitable for (for example) mitral valve replacement.Stent valve 2100 can be before stent valve 2100 be transported to implant site, is assembled by support element and valve member in that the patient is external.Stent valve 2100 can be to be suitable for replacing mitral stent valve that self-deploys.As shown in the figure, stent valve 2100 can have the shape that is similar to relative double comb.Stent valve 2100 can comprise that but sewing up 2102, two of Pulmonis Sus domestica valves that reach in the synthetic fibre conduit (repair pipe) self-deploys Nitinol Z support 2104 and 2106 and be sewn onto on the outer surface of prosthese to produce two modes that self-deploy hat.Can load and self-deploy stent valve, so that it is transported in special teflon sheath or other the suitable induction system.In this embodiment, be used to cover support, but can use other material in other embodiments, for example special teflon, silicon, pericardium etc. but reach synthetic fibre.In an operation method, can on left atrium, produce 1 centimetre otch, it is controlled by purse string suture.Can promote to have the special teflon sheath of the support of packing into along guide wire (atrium of having pierced through with the guide wire of pin and insertion), arrive mitral annulus up to the middle part of stent valve.Then, can retract sheath,, then Remove All sheath, to expose atrial side at first to dispose ventricular side." Double-crownedvalved stents for off-pump mitral valve replacement (the double comb valve bracket that is used for non-extracorporeal circulation mitral valve replacement) " people such as Liang Ma; European Journal of Cardio-ThoracicSurgery 28:194-199; June 13; 2005 (European cardiothoracic surgery periodicals; Publication on June 13rd, 2005 the 28th volume 194-199 page or leaf) described about stent valve 2100 and the other details that is used for it is transported to the operation method of implant site in, it combines in this article by reference and integrally.
Figure 21 B-E has shown the view according to the double cone shape support of some embodiment of the present invention.Referring to Figure 21 B and 21C; The support 2108 that double cone shape support can comprise the substantially cylindrical that carries valve 2110 with fix/be attached on the support 2108 (as making up) with VELCR
Figure G2007800412847D00221
, stitching thread, frictional fit, other suitable fixed mechanisms or its be essentially conical support (2112,2114).Figure 21 D has shown the cross section of the double cone shape support shown in Figure 21 B and the 21C.In other embodiments, at least one in the support 2112 and 2114 can have crown, and this is crown to have by the outstanding nail of opening or closed unit or Z support form.The first and second other supports (2112,2114) can form retaining element 2116 (Figure 21 C similar with retaining element shown in Fig. 2 A 202 jointly; Like annular groove).Retaining element 2116 can allow to be fixed in the aperture of (for example) inefficacy valve (its have with the support that carries valve member 2,110 2108 similar sizes), perhaps is fixed on the anchor supports with additional annular protrusion.In certain embodiments, support 2112 and 2114 (and support 2108) alternatively can replace with the single support that is double cone shape structure (like two taperers that in the district of retaining element 2116, are connected by the continuum).The advantage that use is used for the independent support of taperer/retaining element is that the mechanical stress of taperer/retaining element (like first support 2112 and second support 2114) can be isolated the support 2108 that comprises valve at least in part.In certain embodiments, the other at least support or its part that are positioned proximal to the tip (like support 2112) of induction system can be recaptured by induction system.In order to help this recapturing, can make other shelf-like become pyramid or wing cross-sectional configuration 2118 (Figure 21 E).In certain embodiments, can be at the wing or the nail that form support 2112 (and/or 2114) along each position/height place of the central axis of the support 2108 similar with the support shown in (for example) Fig. 7 B.At least some wing or nail have the engaging from the body valve that different position/height can help having with (for example) different size.In certain embodiments, the support shown in Figure 21 B-21E (like support 2108) can comprise at least one attachment element that is used for being attached to removedly conveyer device, and it is similar with the attachment element 808 shown in Fig. 8 B.
Figure 22 A-26C has shown the instance that is used for stent valve (like single-side stand valve or double bracket valve) is transported to the induction system of implant site according to some embodiment of the present invention.In certain embodiments, the invention provides the Minimally Invasive Surgery method, through this method, enforcement is performed the operation and need do not opened thoracic cavity body and cardiopulmonary bypass on dancing heart.Can thrust heart through the top through opening less relatively in patient's body (for example).For example, in order to replace the aortic valve of inefficacy, can go into patient's body through intercostal gap (like the 5th intercostal gap), the intercostal gap is the zone between two rib bones.From this inlet point, can on the top of heart, thrust left ventricle.In a method, the suitable stent valve induction system induction system 2600 (Figure 26 A-26C) of integrated form introducer (as comprise) can at first penetrate into health/heart.In another method, can use independent introducer sheath.Guide wire (hollow needle, conduit, rigidity guide wire etc.) is inserted pass introducer, with the conveying of guiding (for example) support element, valve member and/or other device (like the light limiter device).In certain embodiments, through the chamber, can be used for (for example) Tricuspid valve and/or mitral valve replacement through the atrium or through the ventricle access method.The right ventricle that also can get into heart is to carry out the lung valve replacement.This with carry other operation method of replacement valve opposite through opening the thoracic cavity body.In addition, as describing in more detail below in conjunction with Figure 22 A-28C, at first discharge the portions of proximal of stent valve according to the induction system of some embodiment of the present invention, when (for example) got into health with the mode of the wall through the chamber, this can allow to test valve.In case test successfully, just can discharge the distal part of stent valve.This stent delivery system with the distal part that at first discharges its associated supports is opposite.
Figure 22 A-22D has shown the induction system 2200 that comprises two part, first assembly (comprising element 2202-2210) and second assemblies (comprising element 2216-2230) that are provided with one heart.More specifically, first assembly can comprise tip 2202, axle 2204, oversheath 2206, the metal shaft 2208 on the distally that is positioned at induction system (wherein guide wire passes the length of induction system and passes the tip) and push away handle 2210.Second assembly can comprise outer shaft (distally) 2216, the outer shaft coupling piece 2218 of taper, outer shaft (nearside) 2220, support holder 2222, kink protector 2224, lever connector 2226, lever cup 2228 and O type circle 2230.As shown in the figure, push away the proximal end place that handle 2210 is positioned at induction system.In Figure 22 A and 22B, outer shaft 2220 along its length separately shows in greater detail out with the member that allows induction system 2200.Valve 2212 and support 2214 forms and can (for example) pack between first and second assemblies, and can be between them the 3rd assembly of fold.
About first assembly, interior axle 2204 usefulness act on the inner chamber of guide wire.Most advanced and sophisticated 2202 combine on its distally.As used herein, in conjunction with referring to any suitable fixing/retention mechanism, such as, for example use the adhesive bond of cyanoacrylate or ultraviolet photo-curing cementing agent, perhaps use heat energy to melt the thermal/welding of member to be assembled.Oversheath 2206 can be incorporated on the proximal part at tip 2202, and can tie bracket valve (2212,2214).Can bore a hole to oversheath 2206, to allow carrying out the device flushing through lever 2210.Can strengthen the portions of proximal of first assembly with metal shaft 2208, and it can end at the lever distally with Rule (luer) connector that is used for the flushing of guide wire inner chamber.
About second assembly, support holder 2222 can be attached on the distally outer shaft 2216 in the distally.Figure 22 D has shown the perspective view that the layout between stent valve (2212,2214) and the support holder 2222 is described better.Distally outer shaft 2216 can through convergent connector 2218 nearsides be attached on the nearside outer shaft 2220.Can be attached on the grab handle assembly through kink protector 2224 in abutting connection with outer shaft 2220, this grab handle assembly can comprise lever connector 2226 and lever cup 2228.Grab handle assembly can compress O type circle 2230, so that sealing induction system 2200.Rule (luer) connector can allow the device flushing.Flushing machine removes entrapped air before being used in the induction system insertion health from this induction system.Perhaps or in addition, flushing machine be used in discharge and/or recapture support before cool off this support (like the Nitinol support) through washing support with cool brine solution.The cooling support can cause the reversible modification of its structure, therefore reduces its Young (Young) modulus, and reduces the support radial force thus and be used for its conveying and recapture necessary power.
When (for example) pushes away handle 2210 contact lever cups 2228, claim that induction system 2200 is shown in an open position (Figure 22 C).In open position, stent valve (2212,2214) can separate from support holder 2222, and can launch fully at the implant site place.Before induction system 2200 arrives open positions, stent valve can be through (for example) fold mechanism and fold on induction system 2200, and be held in place by support holder 2222.Support holder 2222 can be fixed on the attachment element of the support shown in Fig. 8 A-16.The stent valve of fold can cover attachment member/support holders 2222 with oversheath 2206 thus through retracting first assembly structure that remains retracted.Thereby when removed oversheath 2206 its when no longer retraining attachment member since stent valve self-deploy character, stent valve can separate from support holder 2222 automatically.When oversheath 2206 fully surrounds stent valve (2212,2214), claim induction system 2200 be in the close position in (Figure 22 A and 22B), thereby make stent valve can not launch.
When (for example) partly pushes away handle 2210 towards lever cup 2228, claim that induction system 2200 is in a partly opened position.In this specific open position, stent valve (2212,2214) is disposed at nearside, and it still is attached on the support holder 2222 in the distally through attachment element.This allows the accurate implantation/location of support.For example, the implant site that stent valve can approach to expect partly discharges, and can promote a little in the distally, up to feeling resistance.The final release of stent valve (2212,2214) can make induction system 2200 arrival open positions take place through fully push away handle towards lever cup 2228.This position that partially opens has been described among Figure 28 B.In certain embodiments, imaging mechanism can be used for confirming whether support correctly is positioned at the implant site place.For example; Can use angiography, intravascular ultrasonic imaging (IVUS), ICE (ICE), TEE (TEE) or other mechanism or its to make up the figure structure of realizing the fluoroscopy FAXIA, can be integral with induction system at least in part or separate with it through the enough imaging mechanisms of this figure.
When implant frame valve (2212,2214), induction system 2200 can be before in patient's body, fetching (for example) through keeping first assembly and second assembly being promoted to be returned to make position towards most advanced and sophisticated 2202/ oversheath 2206 in the distally.In other embodiments, the handle that is used to discharge stent valve can comprise the screw mechanism that is used for rotatablely moving of handle converted to the translational motion of oversheath.Such delivery system can allow step by step, discharge more accurately and recapture support, and reduces the release force that the surgeon feels.
Figure 23 A-23D has shown another instance of induction system 2300 according to an embodiment of the invention.Except induction system 2300 can additionally comprise one or more folding sacculus 2302 (like nearside in stent valve), induction system 2300 can be similar basically (like the make position of Figure 23 A and 23B with induction system 2200 (Figure 22); The open position of Figure 23 C).Only if the mode with other indicates, the same characteristic features among Figure 23 A-23D does not still duplicate reference number corresponding to the same reference numerals among Figure 22 A-22D in Figure 23 A-23D, to avoid making accompanying drawing too complicated.This is equally applicable to the stent delivery system shown in Figure 24 A-D, Figure 25 A-C and Figure 26 A-C.Sacculus 2302 can be through other inner chamber expansion/flat the contracting in the nearside outer shaft 2304, and (for example) is so that stent valve (like the non-stent valve that self-deploys) is in place in the grappling of implant site place.Figure 23 D has shown " A-A " sectional view of the inner-cavity structure shown in Figure 23 C.Inner-cavity structure comprises 5 lumen tube 2306 and interior axle 2308.In other embodiments, can use other structure (like two lumen tube, wherein second inner chamber is used for inflation and flat contracting) that is used for lumen tube 2306.Induction system 2300 can comprise also and be used for inflation/flat access mechanism that contracts 2310 that it can allow to connect syringe or expansion gear expands/the flat sacculus that contracts.Perhaps or in addition, the pipe with attached cock can be connected on the access mechanism 2310.
Figure 24 A-24D has shown another instance of induction system 2400 according to an embodiment of the invention.In induction system 2400, nearside outer shaft 2402 is compared the diameter that can have increase with the diameter (Figure 22) of nearside outer shaft 2220.When using induction system under the situation that is not having introducer, the diameter of increase can reduce bleeds.Perhaps, when having used introducer, the diameter of increase can be complementary with the internal diameter of introducer, and this internal diameter can be depending on the external diameter of oversheath again.Very close to each other can reducing between introducer and induction system because the potential risk of fetching the problem of induction system through introducer that the blood of taking away causes.Therefore, induction system 2400 can comprise the unsteady pipe 2404 in the gap of filling up between intraware and the external module, reduces the risk that intraware reverses under compression thus, and this risk will cause support to recapture the higher frictional force in the induction system in the process.Induction system 2400 can be in all others (like the make position of Figure 24 A and 24B; The open position of Figure 24 C) similar basically with induction system 2200.
Figure 25 A-C has shown another instance of induction system 2500 according to an embodiment of the invention.Induction system 2500 can be included in one or more sacculus 2536 in stent valve distally.Have sacculus has avoided must induction system being introduced health and has more expanded so that carry out depths (as introducing in the aorta that rises) in the stent valve distally; Thereby reduce risk, and modifying device is handled (as on aortic arch, there not being the bending of rigid mount) to the infringement of health.Sacculus 2536 can be used for (for example) valve forming before the late expansion of the stent valve that stent valve is implanted and/or implanted, to improve the grappling of support.Figure 25 B and 25C have shown that respectively sacculus 2536 is in the close position and open position.
First assembly of induction system 2500 can comprise tip 2502, interior balloon shaft 2504, oversheath 2506 and the pipe 2508 that floats.Second assembly can comprise interior axle (distally) 2510, support holder adaptor 2512, support holder 2514, sleeve pipe 2516, convergent transaxle connector 2518 and outer shaft (nearside) 2520.The handle assembly can comprise lever connector 2522, lever cup 2524, O type circle 2526, metal shaft 2528 and push away handle 2530.The sacculus assembly can comprise outer shaft 2532, interior axle 2534, sacculus 2536 and Y shape connector 2538.
Figure 26 A-C has shown another instance of induction system 2600 according to an embodiment of the invention.Induction system 2600 can comprise integrated form introducer 2602, and it can be the other assembly that holds second assembly.The oversheath of induction system is illustrated as 2604.Introducer 2602 can comprise connecting line 2606, cock 2608 and be used for the housing 2610 of sealing film 2612.Cock 2608 can be with acting on the inlet point that (for example) comprises the syringe of fluid (like saline).Connecting line 2606 can be used for fluid is sent to from syringe in the inner chamber of introducer, and sealing film 2612 can seal introducer isolating exterior environment.When the implant frame valve, except introducer 2606, the member of induction system 2600 (like first assembly and second assembly) can be fetched through introducer.Then, can introduce another medical treatment devices through introducer 2602, such as, closing device for example.As another instance, can introduce intravascular ultrasonic imaging (IVUS) equipment (like miniature probe) through introducer 2602.Induction system 2600 can be similar basically with induction system 2200 in all others.
Figure 27 is the flow chart 2700 according to the illustrative stage of (as from body or artificial) valve that relates to the displacement inefficacy of some embodiment of the present invention.Figure 28 A-28C has explained each stage of the flow chart reference of (not limiting) Figure 27.At stages 2702 place, stent valve (like single-side stand valve or double bracket valve) can be attached to induction system removedly.For example, one or more attachment element of support element (like the attachment element 808 of Fig. 8 B) can be fixed on the support holder of conveyer device (like the support holder 2222 of Figure 22).Contraction elements (like the oversheath 2206 of Figure 22) can be arranged on attachment element/support holder, constructs and is attached on the induction system so that stent valve remains retracted.
At stages 2704 place, stent valve can be transported to implant site with contracted configurations.For example; Figure 28 A (" introducing " and " location ") has shown that stent valve 2802 is when still being attached on the induction system through support holder 2804 and fully being included in the oversheath 2806; Can be incorporated in patient's body along guide wire, thereby the valve 2812 of inefficacy is passed at the tip of induction system 2810.Can handle induction system forward and/or backward, for example, up to be sure oing correctly to have located stent valve.
At stages 2706 place, stent valve can partly launch, and whether (for example) has correctly located stent valve really to confirm (stage 2708), with and/or the operation whether correctly of test (stage 2710) stent valve.For example, Figure 28 A (" part discharge ") has shown that oversheath 2806 can remove from the ground, portions of proximal 2814 tops of stent valve, and the while attachment element 2816 of stent valve is still constrained on the support holder 2804 by oversheath 2806.
At stages 2712 place, when stent valve is correctly located at the implant site place, with and/or when stent valve correctly moves, stent valve can separate from induction system, so that make stent valve be extended to its complete deployment configuration.For example; Figure 28 C (" final release ") has shown when in oversheath 2806, having removed attachment element 2816 with support holder 2804; The attachment element 2816 of stent valve 2802 can be from the support holder 2804 automatically (or in other embodiments in response to inflation) separate, thereby make stent valve be extended to its complete deployment configuration.Then, second assembly of conveyer device can combine with first assembly/oversheath and in patient's body, remove again.For example, Figure 28 C (" conveyer device is fetched ") has shown that second assembly 2818 can pass displacement stent valve 2802 towards the distally of stent valve.Then, bonded again second assembly 2818 and first assembly/oversheath 2806 can pass stent valve 2802 along proximal direction once more before withdrawing from patient body.
When stent valve is not correctly located (stage 2708), at stages 2714 place, stent valve can be returned to contracted configurations, and in patient's body, reorientates.The explanation (" support is recaptured/reorientated ") of this situation has been described among Figure 28 B, and wherein, oversheath 2806 slides on the proximal part 2814 of stent valve, so that recapture stent valve along proximal direction.Then, reorientate and discharge stent valve, thereby the retaining element of stent valve 2820 receives the anchor ring 2822 of the valve that lost efficacy.Similarly, when stent valve was out of order in response to test (stage 2710), at stages 2716 place, stent valve can be returned to contracted configurations and in patient's body, remove.
Therefore can see the correlation technique and the system that stent valve (like single-side stand valve and double bracket valve) are provided and have been used to perform the operation.Though this paper has described specific embodiment in detail, this is to accomplish with the mode that only is used for illustration purpose, and is not intended to limit the scope about appending claims.Especially, the applicant has conceived and can under the situation of the spirit and scope of the present invention that do not depart from claims and limited, make various displacements, change and modification.Others, advantage and modification should be regarded as being within the scope of appending claims.The claims that proposed have been represented invention disclosed herein.Also conceived other unstated invention.The applicant is retained in the right that continues this invention in later claims.

Claims (32)

1. replacement valve that is used in human body, using, it comprises:
Valve member;
Support element comprises: be arranged on the proximal end place of said support element and comprise retaining element first, be used to hold the second portion of said valve member, and the third part that is arranged on the distal end portion place of said support element; Wherein said third part comprises at least one attachment element, and said at least one attachment element is configured for being attached on the conveyer device removedly.
2. replacement valve according to claim 1 is characterized in that, said at least one attachment element comprises the geometric openings on the complementary elements that is configured for being attached to removedly said conveyer device.
3. replacement valve according to claim 1 is characterized in that, said at least one attachment element comprises wire rod, hook or the band on the complementary elements that is configured for being attached to removedly said conveyer device.
4. replacement valve according to claim 1 is characterized in that, said at least one attachment element comprises at least two attachment element.
5. replacement valve according to claim 1 is characterized in that, said at least one attachment element comprises at least three attachment element.
6. replacement valve according to claim 1 is characterized in that, said at least one attachment element comprises three attachment element basically.
7. replacement valve according to claim 1 is characterized in that the retaining element of said first further comprises annular groove.
8. replacement valve according to claim 1 is characterized in that, said at least one attachment element is inwardly protruded towards the central axis of said support element at least in part.
9. replacement valve according to claim 1 is characterized in that, said third part has the diameter littler than the diameter of said second portion.
10. replacement valve according to claim 1 is characterized in that said valve member is a pig valve.
11. replacement valve according to claim 1 is characterized in that, said valve member is processed by pericardium.
12. a replacement valve that is used in human body, using, it comprises:
Valve member and
Support element, said support element comprises: the first that comprises the network retaining element; Be configured to so that hold the second portion of said valve member; And the third part that comprises at least one attachment element, wherein
Said second portion is arranged between said first and the third part vertically;
Each attachment element is arranged near the outflow end of said support element;
Said valve member is sewn onto on the said support element.
13. replacement valve according to claim 12 is characterized in that, the retaining element of said first further comprises annular groove.
14. replacement valve according to claim 12 is characterized in that, said attachment element comprises wire rod, hook or the band that forms opening.
15. replacement valve according to claim 12 is characterized in that, said valve member is a pig valve.
16. replacement valve according to claim 12 is characterized in that, said valve member is processed by pericardium.
17. replacement valve according to claim 12 is characterized in that, said valve member is a tissue valve prosthesis.
18. a replacement valve that is used in human body, using comprises:
Valve member (100); With
Support element (800,900,1000) comprising: first (802); Be used to hold the second portion (804) of said valve member (100), and third part (806), wherein, said third part (806) comprises and is configured for being attached to removedly conveyer device (2300; 2400,2500,2600) at least one attachment element (808,814 on; 836,902,1002)
It is characterized in that said support element (800,900,1000) comprises network, wherein, said first (802) has than said second portion (804) and/or the more thick grid cell of said third part (806) density.
19. replacement valve according to claim 18 is characterized in that, said at least one attachment element (808,814; 836,902,1002) comprise and be configured for being attached to removedly said conveyer device (2300; 2400,2500,2600) geometric openings on the complementary elements.
20. according to claim 18 or 19 described replacement valve, it is characterized in that,
Said at least one attachment element (808,814,836,902,1002) comprises wire rod, hook or the band on the complementary elements that is configured for being attached to removedly said conveyer device (2300,2400,2500,2600).
21., it is characterized in that said at least one attachment element (808,814,836,902,1002) comprises two attachment element (808,814,836,902,1002) at least according to claim 18 or 19 described replacement valve.
22., it is characterized in that said at least one attachment element (808,814,836,902,1002) comprises three attachment element (808,814,836,902,1002) at least according to claim 18 or 19 described replacement valve.
23., it is characterized in that said at least one attachment element (808,814,836,902,1002) comprises six attachment element (808,814,836,902,1002) at least according to claim 18 or 19 described replacement valve.
24. replacement valve according to claim 18 is characterized in that, said first (802) comprises a plurality of independently bendable (816), and each bendable (816) comprises the unit of single closure of the grid cell of said first (802).
25. replacement valve according to claim 18 is characterized in that, said third part (806) comprises the support component (1004) of common formation around the annulus of the periphery of said support element (1000).
26. replacement valve according to claim 18 is characterized in that, the said network of said support element comprises:
At least one engaging lever; With
Be used for said at least one engaging lever is connected at least one supporting member on said at least one attachment element (808,814,836,902,1002).
27., it is characterized in that said at least one attachment element (808,814,836,902,1002) is at least in part inwardly towards the central axis of said support element (200,800) and protrude according to claim 18 or 19 described replacement valve.
28., it is characterized in that said third part (806) has the diameter less than the diameter of said second portion (804) according to claim 18 or 19 described replacement valve.
29. replacement valve according to claim 24 is characterized in that, said first (802) comprises retaining element, and said retaining element comprises annular groove.
30. replacement valve according to claim 29 is characterized in that,
Said annular groove can be formed by crooked independently element (816) by a plurality of, and wherein, each bendable (816) comprises flexural deformation, and its position is confirmed by the length (822) of attached a pair of pole (818,820).
31., it is characterized in that said attachment element (808,814,836,902,1002) comprises wire rod, hook or the band that forms opening according to claim 18 or 19 described replacement valve.
32., it is characterized in that said second portion (804) comprises from least one outwards outstanding locking member of the outer surface of said second portion (804) according to claim 18 or 19 described replacement valve.
CN2007800412847A 2006-09-07 2007-08-23 Stent-valves for valve replacement and associated methods and systems for surgery Expired - Fee Related CN101636128B (en)

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US84318106P 2006-09-07 2006-09-07
US60/843,181 2006-09-07
US11/700,922 US20070213813A1 (en) 2005-12-22 2006-12-21 Stent-valves for valve replacement and associated methods and systems for surgery
US11/700,922 2006-12-21
PCT/EP2007/007413 WO2008028569A1 (en) 2006-09-07 2007-08-23 Stent-valves for valve replacement and associated methods and systems for surgery

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