CN113855328A - Transcatheter heart valve replacement system - Google Patents
Transcatheter heart valve replacement system Download PDFInfo
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- CN113855328A CN113855328A CN202111160963.4A CN202111160963A CN113855328A CN 113855328 A CN113855328 A CN 113855328A CN 202111160963 A CN202111160963 A CN 202111160963A CN 113855328 A CN113855328 A CN 113855328A
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- stent
- replacement system
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- 210000003709 heart valve Anatomy 0.000 title claims abstract description 33
- 230000008263 repair mechanism Effects 0.000 claims abstract description 87
- 238000004873 anchoring Methods 0.000 claims description 60
- 210000002837 heart atrium Anatomy 0.000 claims description 16
- 230000001746 atrial effect Effects 0.000 claims description 8
- 230000035479 physiological effects, processes and functions Effects 0.000 claims description 4
- 239000000956 alloy Substances 0.000 claims description 3
- 239000002184 metal Substances 0.000 claims description 3
- 230000002093 peripheral effect Effects 0.000 claims description 3
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims description 3
- 238000000926 separation method Methods 0.000 abstract description 4
- 238000002513 implantation Methods 0.000 abstract description 3
- 210000004115 mitral valve Anatomy 0.000 description 19
- 238000000034 method Methods 0.000 description 14
- 230000007246 mechanism Effects 0.000 description 7
- 210000001519 tissue Anatomy 0.000 description 6
- 230000002861 ventricular Effects 0.000 description 6
- 230000008569 process Effects 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 206010067171 Regurgitation Diseases 0.000 description 3
- 210000003484 anatomy Anatomy 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 238000003032 molecular docking Methods 0.000 description 3
- 210000003157 atrial septum Anatomy 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 210000003698 chordae tendineae Anatomy 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 238000006073 displacement reaction Methods 0.000 description 2
- 229920000295 expanded polytetrafluoroethylene Polymers 0.000 description 2
- 210000005003 heart tissue Anatomy 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 230000002265 prevention Effects 0.000 description 2
- 230000008439 repair process Effects 0.000 description 2
- 230000000717 retained effect Effects 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 210000000591 tricuspid valve Anatomy 0.000 description 2
- 210000001631 vena cava inferior Anatomy 0.000 description 2
- 208000011682 Mitral valve disease Diseases 0.000 description 1
- 206010040007 Sense of oppression Diseases 0.000 description 1
- 210000001008 atrial appendage Anatomy 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
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- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
Abstract
The present application relates to the field of medical devices, in particular to a transcatheter heart valve replacement system, comprising: a valve stent having a preset configuration; a repair mechanism configured to be positioned in a middle region of the native valve and to pinch the native valve leaflets; the repair mechanism has two forms of catching and separating; wherein when the repair mechanism is in the capture configuration and clamps the native valve leaflets, the valve stent is in the middle region of the repair mechanism, and the valve stent returns to the preset configuration and facilitates detachment and separation of the repair mechanism; before the valve stent replaced by the scheme is implanted, the autologous valve still can work normally, so that more time is won for the operation and the complications are effectively reduced; the valve stent can smoothly reach the middle area of the repair mechanism along the guide inner core, the positioning is accurate, the operation is more convenient, and when the valve stent gradually expands in the radial direction and recovers the preset shape, the repair mechanism is separated and encircles the periphery of the valve stent to complete the implantation.
Description
Technical Field
The present application relates to the field of medical devices, and in particular, to a transcatheter heart valve replacement system.
Background
From the viewpoint of heart structure, whether the mitral valve or the tricuspid valve has special physiological structure, so that the accurate positioning and fixing of the product are very difficult. The location of the mitral valve, particularly within the heart, and its complex anatomy present significant challenges to mitral valve replacement.
Prior art anchoring techniques have mostly employed radial support of the atrioventricular annulus by the stent. This technique has the disadvantage of easily causing compression of the tissue surrounding the annulus, which tends to cause the stent and the compressed tissue to affect the outflow tract. In a long term, with reduced regurgitation, ventricular atrial pressure is reduced, the heart structure is reconstructed, and the large-size stent can influence the reduction of the size of the valve annulus, so that the internal structure of the heart is influenced.
In addition to this, the anchoring technique is also used to fix the leaflets by implanting a docking device in advance at the leaflets, with the stent being spread inside the docking device. Patent CN109789019A describes a heart valve pair wire loop and system from Edwards Lifesciences. The leaflets and the stent are tightly hooped together by wrapping the docking device around the outside of the leaflets. The stent is fixed in a prominent way, but the anterior lobe is greatly hooped on the stent and the left outflow blood is blocked and is not solved.
Patent CN106255476B describes a system for implanting a heart valve from the company Highlife, comprising: a radially self-expanding tubular body having an inflow end and an outflow end and a protrusion extending from a side surface of the tubular body toward the inflow end; a valve disposed within and attached to the tubular body; a fabric configured to form a pocket between the tubular body and the protrusion; and an elongate outer member arranged to be moved into the pocket and to guide cardiac tissue into the pocket such that the cardiac tissue is located between the tubular body and the elongate outer member. The technical method is also that a clamping piece is placed outside valve leaflets, and then a self-expanding valve is implanted, the clamping piece fixes the bracket at the valve leaflets, and the clamping piece is an 'annular valve', although the annular valve avoids the oppression to the annular tissue, the obstruction to the left outflow tract is not solved.
Patent US20080033541 discloses a method of securing a mitral valve stent to the mitral valve annulus using a stent secured to the stent to impinge against a substantial portion of the left atrium, thereby achieving an anchoring effect. The problem with this design is that the prosthetic mitral valve is subject to large impact forces of up and down displacement during motion, and if the struts are not sufficiently rigid, they are difficult to anchor; however, if the struts are too rigid, atrial tissue is easily damaged.
Patent CN202110076329.6 discloses a transcatheter atrioventricular valve replacement system, which comprises a valve stent, artificial valve leaflets, anchors, a covering membrane and a fixing ring. The fixing ring is a circular ring-shaped structure, can be in a circle or a plurality of circles, is coiled around the chordae tendineae of the mitral valve or the tricuspid valve by adopting a method of implantation through a catheter, and draws the chordae tendineae under each valve leaflet from the periphery to the center. The valve support comprises a body support, an atrium plate surface and a connecting piece. The anchoring piece is a plurality of structures which are connected with the body support and are blunt at the tail end of the atrium side in a reverse bending way, and the anchoring piece can hook the fixing ring to fix the valve support. The technical scheme has the defects that: the fixing ring is implanted into the heart firstly, but the fixing ring and the autologous valve or the valve support implanted later do not have a fixed stress point, so that the fixing ring is difficult to anchor with the autologous valve leaflet and the valve support, the scheme of the fixing ring is lack of practicability in implementation, and the implementation difficulty in clinical operation is very high.
In view of the foregoing, although the above techniques have some clinical success, they are deficient and a new transcatheter heart valve replacement system is needed to solve the above problems.
Disclosure of Invention
The present application has been made in view of the above and other concepts. The primary object of the present application is to overcome some of the problems and deficiencies of the prior art.
In the aspect of the application of atrioventricular valve surgery, the present application aims to provide a transcatheter heart valve replacement system for patients who have lesions in the atrioventricular valve and need interventional therapy, so that the problems of the prior art that the heart valve replacement system causes compression on the native valve annulus and the leaflets block the outflow tract and the like can be solved.
According to an aspect of the present application, there is provided a transcatheter heart valve replacement system comprising: a valve stent having a preset configuration; a repair mechanism configured to be positioned in a middle region of the native valve and to pinch the native valve leaflets; the repair mechanism has two forms of catching and separating; wherein when the repair mechanism is in the capture configuration and clamps the native valve leaflets, the valve stent is in a middle region of the repair mechanism, and the valve stent returns to the preset configuration and facilitates detachment of the repair mechanism.
According to one embodiment, when the repair mechanism captures and pinches the native valve leaflets, the repair mechanism moves towards the atrium direction; thus, the height of the valve leaf can be lifted, and the obstruction to the left ventricular outflow tract is avoided.
According to one embodiment, the repair mechanism comprises a first clamping device and a second clamping device, wherein the first clamping device and the second clamping device are detachably connected; and the first clamping device and the second clamping device can respectively catch and clamp different autologous valve leaflets.
According to an embodiment, the first clamping device and the second clamping device are made of metal memory alloy materials.
According to one embodiment, the first and second clamping devices are each provided with an engagement structure that defines the relative positions of the first and second clamping devices and the native valve leaflet.
According to one embodiment, the occluding structure may be barbs or other structures that anchor to the leaflets so that the first and second occluding devices can securely bite into the native leaflets.
According to another embodiment, the occluding structure may be disposed at one end of each of the first and second occluding devices, and the occluding structure may "staple" the native valve leaflets to prevent slippage after the first and second occluding devices occlude the native valve leaflets.
According to one embodiment, a leaflet receiving cavity is formed at one end of the first and second clamping devices, and when the first and second clamping devices capture and clamp the native leaflets, a portion of the native leaflets is curled in the leaflet receiving cavity.
According to one embodiment, the device further comprises a guiding inner core; the far end of the guide inner core is provided with a controllable release part, and the controllable release part is detachably connected with the first clamping device and the second clamping device respectively.
According to an embodiment, the first clamping device is provided with a first support member, and the first support member is provided with a first disengaging portion; the second clamping device is provided with a second supporting member, and the second supporting member is provided with a second disengaging part; wherein, first portion of releaseing and second of releaseing pass through the guide inner core realizes dismantling the connection.
According to an embodiment, the controllable release portion is substantially cylindrical in configuration, the first and second release portions can be mutually engaged to form a snap-like connection, and then the controllable release portion is inserted between the first and second release portions to form a detachable connection; when the controllable releasing part withdraws from the middle of the first releasing part and the second releasing part, the valve support provides radial expansion force for the first clamping device and the second clamping device, so that the first clamping device and the second clamping device are completely detached and separated.
According to one embodiment, after the repair mechanism has completed capturing and pinching the leaflets, the valve stent may be advanced along the inner guide core and into the middle region of the repair mechanism.
According to one embodiment, an expandable channel is formed between the first and second support members when the repair mechanism is in the capture state; and after the valve stent enters the expandable channel, the controllable release part is detached and separated from the repair mechanism, and the valve stent radially expands to restore to a preset shape and promotes the first clamping device and the second clamping device to be separated.
According to one embodiment, the valve holder is provided with a leak-proof ring within the atrium, the leak-proof ring being configured to adapt to the morphology of the valve annulus physiology.
According to one embodiment, the anti-leakage ring has a predetermined shape, and is in a grid-like or zigzag-like or wavy structure.
According to another embodiment, the repair mechanism includes an atrial fixation portion configured to conform to the shape of the valve annulus anatomy.
According to an embodiment, the valve stent may be a ball-expanded stent or a self-expanding stent.
According to one embodiment, the repair mechanism includes an anchoring ring that is at the periphery of and encircles the native valve leaflet when the repair mechanism captures the native valve leaflet.
According to an embodiment, the anchoring ring is connected with the first and second clamping means, respectively.
According to an embodiment, the anchoring ring is substantially a ring-shaped structure; and the anchoring ring is a closed-loop structure or the anchoring ring and the repair mechanism are matched to form a closed-loop structure.
According to an embodiment, the circumference of the anchoring ring is smaller than the circumference of the valve stent; and, the anchoring ring has a circumference smaller than a circumference of the native annulus.
According to one embodiment, the anchoring ring cooperates with the valve support to curl native leaflets in an atrial direction during radial expansion back to the preset configuration.
According to one embodiment, said anchoring ring is substantially sheet-like, thread-like or twine-like.
According to one embodiment, the anchoring ring may be a suture, braid, ePTFE or other high molecular polymer, and may be made of a sheet, filament or other possible friction enhancing shape made of the material Niti.
According to one embodiment, the anchoring ring has a peripheral covering membrane that increases friction with the native leaflets.
According to one embodiment, the system further comprises a first delivery device for loading and delivering the repair mechanism, wherein the guiding core is disposed within the first delivery device, and a second delivery device for loading and delivering the valve stent, and wherein the second delivery device is accessible into the body along a path of the guiding core.
Compared with the prior art, the application has the advantages and beneficial technical effects that at least the following are included:
1. the traditional valve prosthesis can cause the autologous valve to be immediately out of work when the replacement is carried out; in one embodiment of the application, the repair mechanism is used for capturing and clamping the autologous valve leaflets to realize edge-to-edge repair, so that the regurgitation of the valve can be effectively reduced, and meanwhile, the autologous valve still can normally work before the replaced valve stent is implanted, so that more time is won for the operation and the complications are effectively reduced; meanwhile, the valve stent can smoothly reach the middle area of the repair mechanism along the guide inner core, the positioning is accurate, the operation is more convenient, and when the valve stent gradually expands in the radial direction and recovers the preset shape, the repair mechanism is separated and encircles the periphery of the valve stent to complete the implantation.
2. Different from the prior art, in one embodiment of the present application, after the controllable release portion is withdrawn from the middle of the first release portion and the second release portion, the valve stent provides radial expansion force to the first clamping device and the second clamping device during the gradual radial expansion to restore the preset shape, so as to complete the detachment and separation; the structure is simple to assemble, the disassembly operation is very convenient, the development of clinical operation is facilitated, and the clinical significance is good.
3. Different from the prior art, in one embodiment of the application, the leaflet containing cavities are formed in one end of the first clamping device and one end of the second clamping device, so that when the repair mechanism captures and clamps the leaflets, part of the autologous leaflets can be curled in the leaflet containing cavities, the length of the leaflets is shortened, the obstruction to the left ventricular outflow tract is effectively avoided, and the influence of native leaflet tissues on blood flow after replacement is reduced; especially when used for mitral valve replacement, the utility model is very applicable to the physiological characteristics of the mitral valve anterior lobe, and has good clinical significance.
4. Different from the prior art, in one embodiment of the application, the anchoring ring is connected with the repair mechanism, when the repair mechanism enters the heart to capture the valve leaflets, the anchoring ring is arranged on the periphery of the autologous valve leaflets, at the moment, the repair mechanism is lifted towards the direction of the atrium, so that part of the autologous valve leaflets can be fished up by the anchoring ring, the valve stent is further radially expanded to support the anchoring ring, and the anchoring ring and the autologous valve leaflets are anchored; and the anchoring ring limits the axial displacement of the valve stent, so that the valve stent is prevented from radially supporting the native valve annulus, and meanwhile, the anchoring ring can curl part of the native valve leaflets, so that the influence of the native valve leaflet tissue on blood flow after replacement is reduced.
Embodiments of the present application may realize other beneficial technical effects not listed individually, which other technical effects may be partially described below and which would be expected and understood by those skilled in the art after reading the present application.
Drawings
The above features and advantages and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, wherein:
FIGS. 1 a-1 b are schematic and schematic views of the overall structure of the valve stent and the repair mechanism of the present invention.
Fig. 2a to 2i are schematic structural diagrams and schematic diagrams of the repair mechanism, the core wire guide and the first conveying device according to the present invention.
Fig. 3 a-3 d are schematic views of the first delivery device of the present invention entering the heart and then the prosthetic device facing the orifice of the mitral valve.
Fig. 4 a-4 j are schematic diagrams illustrating the process of the repair mechanism of the present invention capturing and clamping the anterior and posterior leaflets of a mitral valve together with a second delivery device to release a valve stent.
Fig. 5 a-5 f are schematic views of a prosthetic device provided with an anchoring ring according to another embodiment of the present invention.
Fig. 6 a-6 j are schematic views illustrating a process for repairing a mitral valve according to another embodiment of the present invention.
FIGS. 7 a-7 b are schematic views of a prosthetic device with atrial appendages according to another embodiment of the present invention.
The names of the parts indicated by the numbers in the drawings are as follows: 1-a valve stent, 11-a containment ring, 2-a repair mechanism, 21-a first clamping device, 211-a first support member, 2111-a first release, 22-a second clamping device, 221-a second support member, 2211-a second release, 23-an occlusion structure, 24-a leaflet-receiving lumen, 25-an expandable channel, 26-an atrial fixation, 3-an anchoring ring, 4-a guiding core, 41-a controlled release, 5-a first delivery device, 6-a second delivery device.
Detailed Description
The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.
It is to be understood that the embodiments illustrated and described are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The illustrated embodiments are capable of other embodiments and of being practiced or of being carried out in various ways. Examples are provided by way of explanation of the disclosed embodiments, not limitation. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present application without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment, can be used with another embodiment to yield a still further embodiment. Accordingly, the disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.
Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items possible.
The present application will be described in more detail below with reference to various embodiments and examples of several aspects of the application.
In this application, proximal refers to the end proximal to the operator and distal refers to the end distal to the operator.
In the prior art, the native valve usually fails to work normally in the process of replacing the atrioventricular valve, and the traditional treatment means can cause the whole valve to be in an orifice regurgitation state in the process of replacing, thus causing short operation time and high risk, and possibly causing various diseases.
According to one embodiment, for example in the treatment of mitral valve disease, there is provided a transcatheter heart valve replacement system, as shown in fig. 1a and 1b, comprising: a valve stent 1 having a preset configuration; a repair mechanism 2 configured to be positioned in the middle region of the native valve and to clamp the native valve leaflets; the repair means 2 has two forms of catching and separating; wherein, when the repair mechanism 2 is in the capture shape and clamps the autologous valve leaflets, the valve support 1 is in the middle area of the repair mechanism 2, and the valve support 1 is restored to the preset shape and facilitates the disassembly and separation of the repair mechanism 2.
According to an example, the repair mechanism 2 comprises a first clamping device 21 and a second clamping device 22, the first clamping device 21 and the second clamping device 22 being detachably connected; moreover, the first and second clamping devices 21 and 22 can respectively capture and clamp different autologous valve leaflets; the first clamping device 21 captures and clamps the front valve leaflet, the second clamping device 22 captures and clamps the back valve leaflet, and the repairing mechanism 2 is moved towards the atrium after the repairing mechanism 2 clamps the self valve leaflet, so that the height of the valve leaflet can be lifted, and the left ventricular outflow tract is prevented from being blocked.
According to an example, the first clamping device 21 and the second clamping device 22 are made of a metal memory alloy material.
According to an example, the first and second clamping devices 21 and 22 are each provided with an engagement structure 23, wherein the engagement structure 23 can define the relative positions of the first and second clamping devices 21 and 22 and the native valve leaflets, as shown in fig. 2e and 2 f.
According to one embodiment, the occluding structure 23 may be barbs or other structures capable of anchoring with the leaflets so that the first and second occluding devices 21 and 22 can firmly grasp the native leaflets.
According to an example, one end of the first and second clamping devices 21 and 22 are each provided with a leaflet receiving cavity 24, and when the first and second clamping devices 21 and 22 capture and clamp the native leaflets, a portion of the native leaflets is curled within the leaflet receiving cavity 24; according to the physiological anatomical structure of the heart, the anterior valve leaflet of the mitral valve is long, and in the traditional replacement surgery, the autologous valve leaflet has no special treatment measures, so that the anterior valve leaflet can shield the left ventricular outflow tract and has great influence on blood outflow; the first clamping device 21 is provided with the valve leaflet accommodating cavity 24, so that when the first clamping device captures and clamps the front valve leaflet, the part of the front valve leaflet, which is close to the tip of the valve leaflet, can be curled in the valve leaflet accommodating cavity 24, the length of the front valve leaflet can be shortened, the left ventricular outflow tract is prevented from being shielded, and the repairing mechanism 2 is very convenient to capture and clamp the autologous valve leaflet and has good clinical significance.
According to an example, further comprises a guiding core 4; after the repair mechanism 2 finishes catching and clamping the valve leaflets, the valve stent 1 can enter and reach the middle area of the repair mechanism 2 along the inner guide core 4; the distal end of the guiding inner core 4 is provided with a controllable release portion 41, and the controllable release portion 41 is detachably connected with the first clamping device 21 and the second clamping device 22 respectively, as shown in fig. 2a to 2 i.
According to an example, the first clamping device 21 is provided with a first support member 211, and the first support member 211 is provided with a first disengagement portion 2111; the second nip device 22 is provided with a second support member 221, and the second support member 221 is provided with a second escaping portion 2211; wherein the first and second relief portions 2111 and 2211 are detachably connected by the guide core 4, as shown in fig. 2h and 2 i.
According to an example, the controllable release portion 41 has a substantially cylindrical configuration, the first and second release portions 2111 and 2211 can be engaged with each other to form a snap-like connection, and then the controllable release portion 41 is inserted between the first and second release portions 2111 and 2211 to form a detachable connection; after the controllable release portion 41 is withdrawn from the middle between the first and second release portions 2111 and 2211, the valve stent 1 provides radial expansion force to the first and second clamping devices 21 and 22, so that the first and second clamping devices complete detachment.
According to an example, when the repair mechanism 2 is in the capture state, the first support member 211 and the second support member 221 form an expandable channel 25 therebetween; and, after the valve-stent 1 enters the expandable channel 25, the controllable releasing part 41 is detached from the repair mechanism 2, and the valve-stent 1 is radially expanded to restore to the preset configuration and to facilitate the separation of the first clamping device 21 and the second clamping device 22.
According to an example, the valve holder 1 is provided with a leakage prevention ring 11 in the atrium, the leakage prevention ring 11 being configured to adapt to the shape of the valve annulus physiology.
According to an example, the valve stent 1 may be a balloon stent or a self-expanding stent.
According to an example, a first delivery device 5 for loading and delivering the repair mechanism 2 is further included, wherein the guiding core 4 is disposed within the first delivery device 5, and a second delivery device 6 for loading and delivering the valve stent 1, and wherein the second delivery device 6 is accessible into the body along the path of the guiding core 4.
An exemplary procedure for repairing a mitral valve in a transcatheter heart valve replacement system according to one embodiment is as follows:
1. operating the first delivery device 5 from the inferior vena cava into the heart, and subsequently operating the first delivery device 5 such that the repair mechanism 2 passes through the atrial septum, as shown in figures 3 a-3 c; continuing to operate the first delivery device 5 to bend so that the repair mechanism 2 is facing the orifice of the mitral valve, as shown in fig. 3 d;
2. operating the first delivery device 5 to make the first and second clamping devices 21 and 22 respectively capture and clamp the anterior and posterior leaflets of the mitral valve, as shown in fig. 4a and 4b, and when the repair mechanism 2 clamps the leaflets, the first delivery device 5 is withdrawn from the body and the guiding core 4 is retained, as shown in fig. 4 c;
3. operating the second delivery device 6 to enter the heart along the path of the guiding inner core 4, as shown in fig. 4d and 4e, operating the guiding inner core 4 to detach from the repairing mechanism 2 when the valve stent 1 enters the middle area of the repairing mechanism 2, further operating the second delivery device 6 to gradually release the valve stent 1, and radially expanding the valve stent 1 and restoring the preset shape, as shown in fig. 4 f-4 h;
4. the valve stent 1 is radially expanded to make the first and second clamping devices 21 and 22 thereof abut against the periphery of the valve stent 1 and return to the preset configuration and be anchored in the heart, as shown in fig. 4i and 4, the repair mechanism 2 is clamped between the valve stent 1 and the native leaflets, and then the second delivery device 6 is withdrawn from the body.
Example two:
the second embodiment is substantially the same as the first embodiment, except that the prosthetic device 2 in this embodiment further comprises an anchoring ring 3, wherein the anchoring ring 3 engages the valve stent 1 to anchor it to the native leaflets.
As shown in fig. 5a, in the present embodiment, a valve stent 1 is included, which has a preset shape; and a repair mechanism 2 configured to be positioned in a middle region of the native valve and to pinch the native valve leaflets; wherein the repair mechanism 2 comprises a first clamping device 21 and a second clamping device 22; the anchoring ring 3 is fixedly connected with the repairing mechanism 2; when the repair mechanism 2 catches and clamps the autologous valve leaflets, the anchoring ring 3 is positioned at the periphery of the autologous valve leaflets and embraces the autologous valve leaflets, and the valve stent 1 is positioned in the middle area of the repair mechanism 2; when the valve stent 1 is radially expanded to restore to the preset shape, the first clamping device 21 and the second clamping device 22 respectively lean against the periphery of the valve stent 1, the valve stent 1 radially supports the anchoring ring 3, and the anchoring ring 3 is matched with the valve stent 1 to realize anchoring with the autologous valve leaflets and limit the axial movement of the autologous valve leaflets.
In this embodiment, the valve stent 1 can enter and reach the middle region of the repair mechanism 2 along the inner guiding core 4 after the repair mechanism 2 finishes catching and clamping the valve leaflets.
In this embodiment, the first and second clamping devices 21 and 22 are two separate members and are axially arranged in the first delivery device 5, and when the first clamping device 21 is used to capture the anterior leaflet, the second clamping device 22 is released to capture and clamp the posterior leaflet.
In this embodiment, the anchoring ring 3 is connected to the first and second clamping means 21 and 22, respectively, as shown in fig. 5 b-5 d.
In the present embodiment, the anchoring ring 3 is substantially a ring-shaped structure; and, the anchoring ring 3 cooperates with the prosthetic mechanism 2 to form a closed loop structure.
In this embodiment, the circumference of the anchoring ring 3 is smaller than the circumference of the valve stent 1; and, the circumference of the anchoring ring 3 is smaller than the circumference of the native annulus.
In this embodiment, after the repair mechanism 2 captures and clamps the autologous leaflets, the guiding inner core 4 is pulled to make the repair mechanism 2 clamp the autologous leaflets and lift towards the atrium; when the valve support 1 enters the middle area of the repair mechanism 2 along the guide inner core 4, the guide inner core 4 withdraws towards the near end relative to the repair mechanism 2 to detach and separate the valve support 1, the anchoring ring 3 and the valve support 1 cooperate to curl the autologous valve leaflets towards the atrium direction in the process of radially expanding and restoring the valve support 1 to the preset shape, and the valve support 1 is fixed on the autologous valve leaflets through the anchoring ring 3.
In this embodiment, the anchoring ring 3 is substantially sheet-like, thread-like or twine-like, as shown in fig. 5c and 5 e.
In this embodiment, anchoring ring 3 may be a suture, braid, ePTFE or other high molecular polymer, and may be made of Niti material in sheet, thread or other possible shape that increases friction.
In this embodiment, the anchoring ring 3 has a peripheral membrane that increases the friction with the native leaflets, as shown in fig. 5 f.
An exemplary procedure for repairing a mitral valve of a transcatheter heart valve replacement system of the second embodiment is as follows:
1. operating the first delivery device 5 from the inferior vena cava into the heart, and subsequently operating the first delivery device 5 such that the repair mechanism 2 passes through the atrial septum, as shown in figures 3 a-3 c; continuing to operate the first delivery device 5 to bend so that the repair mechanism 2 is facing the orifice of the mitral valve, as shown in fig. 3 d;
2. operating the first delivery device 5 to make the first and second clamping devices 21 and 22 respectively capture and clamp the anterior and posterior leaflets of the mitral valve, and when the repair mechanism 2 clamps the leaflets, the first delivery device 5 is withdrawn from the body and the guiding inner core 4 is retained, as shown in fig. 6a and 6 b;
3. when the valve stent 1 enters the middle area of the repair mechanism 2, the second delivery device 6 is further operated to gradually release the valve stent 1, and the valve stent 1 radially expands and restores the preset shape, as shown in fig. 6 c-6 f;
4. the valve stent 1 is radially expanded so that the first and second clamping devices 21 and 22 thereof are placed against the outer circumference of the valve stent 1, further radially expanded so that it supports the anchoring ring 3 and returns to the preset configuration to be anchored in the heart, the native leaflets are clamped between the anchoring ring 3 and the valve stent 1, and then the second delivery device 6 is withdrawn from the body, as shown in fig. 6g to 6 j.
In this regard, the related configuration and concept of the second embodiment are similar to those of the first embodiment, and thus, the description thereof will not be repeated here.
Example three:
the third embodiment is substantially the same as the second embodiment except that the prosthetic device 2 further includes an atrial fixation portion 26.
As shown in fig. 7a, in the present embodiment, a valve stent 1 is included, which has a preset shape; and a repair mechanism 2 configured to be positioned in a middle region of the native valve and to pinch the native valve leaflets; wherein the repair mechanism 2 comprises a first clamping device 21 and a second clamping device 22; the repair mechanism 2 comprises an atrium fixing part 26, the atrium fixing part 26 is configured to adapt to the shape of the valve annulus physiological structure, the atrium fixing part 26 is fixedly connected with the first clamping device 21 and the second clamping device 22 respectively, and the anchoring ring 3, the anchoring ring 3 is matched and connected with the first clamping device 21 and the second clamping device 22 respectively; when the repair mechanism 2 catches and clamps the autologous valve leaflets, the anchoring ring 3 is positioned at the periphery of the autologous valve leaflets and embraces the autologous valve leaflets, and the valve stent 1 is positioned in the middle area of the repair mechanism 2; when the valve stent 1 is radially expanded to restore to the preset shape, the first clamping device 21 and the second clamping device 22 respectively lean against the periphery of the valve stent 1, the valve stent 1 radially supports the anchoring ring 3, and the anchoring ring 3 is matched with the valve stent 1 to realize anchoring with the autologous valve leaflets and limit the axial movement of the autologous valve leaflets.
In the present embodiment, the atrium fixing portion 26 has a predetermined shape, and the atrium fixing portion 26 has a grid-like or zigzag-like structure or a wave-like structure, as shown in fig. 7 b.
In this regard, the related configuration and concept of the third embodiment are similar to those of the second embodiment, and thus, the description thereof will not be repeated here.
The foregoing description of the example embodiments of the present application has been presented for the purposes of illustration and description. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration and/or construction disclosed, and obviously many modifications and variations are possible to those skilled in the art in light of the above teaching without departing from the invention. It is intended that the scope and equivalents of the invention be defined by the following claims.
Claims (20)
1. A transcatheter heart valve replacement system, comprising:
a valve stent; and a repair mechanism configured to be positioned in a middle region of the native valve and to pinch the native valve leaflets;
the repair mechanism has two forms of catching and separating;
wherein the valve stent is delivered to the intermediate region of the repair mechanism after the repair mechanism is in the capture configuration and pinches the native valve leaflets; when the repair mechanism is in the detached configuration, the valve stent is radially expanded and the repair mechanism is sandwiched between the valve stent and the inner wall of the heart.
2. The transcatheter heart valve replacement system of claim 1, wherein the repair mechanism comprises a first and a second clamping device, the first and second clamping devices being removably coupled;
and the first clamping device and the second clamping device can respectively catch and clamp different autologous valve leaflets.
3. The transcatheter heart valve replacement system of claim 1 or 2, wherein during the capturing and clamping of the native valve leaflets by the repair mechanism, the repair mechanism is moved in an atrial direction such that portions of the native valve leaflets are crimped within the first and second clamping devices.
4. The transcatheter heart valve replacement system of any one of the preceding claims, further comprising an inner guiding core;
the far end of the guide inner core is provided with a controllable release part, and the controllable release part is detachably connected with the first clamping device and the second clamping device respectively.
5. The transcatheter heart valve replacement system of claim 4, wherein the valve stent is configured to be advanced along the inner guiding core and to an intermediate region of the repair mechanism.
6. The transcatheter heart valve replacement system of claim 5, wherein the controllable release is detached from the repair mechanism when the valve stent is in the intermediate region of the repair mechanism;
wherein the valve stent radially expands and clamps the first and second clamping devices between the valve stent and the inner wall of the heart.
7. The transcatheter heart valve replacement system of any one of claims 3-6, wherein the first clamping device is provided with a first support member, and the first support member is provided with a first disengagement portion; the second clamping device is provided with a second supporting member, and the second supporting member is provided with a second disengaging part;
wherein, first portion of releaseing and second of releaseing pass through the guide inner core realizes dismantling the connection.
8. The transcatheter heart valve replacement system of claim 7, wherein the first support member and the second support member form an expandable channel therebetween when the repair mechanism is in the capture state;
and after the valve stent enters the expandable channel, the controllable release part is detached and separated from the repair mechanism, and the valve stent radially expands and clamps the first clamping device and the second clamping device between the valve stent and the inner wall of the heart.
9. The transcatheter heart valve replacement system of any one of claims 3-8, wherein the first and second clamping devices each include an engagement structure that defines a relative position between the first and second clamping devices and the native valve leaflets; and
and when the first clamping device and the second clamping device capture and clamp the autologous valve leaflets and lift the autologous valve leaflets towards the atrium, part of the autologous valve leaflets are curled in the valve leaflet containing cavities.
10. The transcatheter heart valve replacement system of claim 9, wherein the first and second clamping devices are made of a metal memory alloy material.
11. The transcatheter heart valve replacement system of any one of the preceding claims, wherein the valve stent has a leak-proof ring within the atrium, the leak-proof ring configured to conform to the shape of the valve annulus physiology.
12. The transcatheter heart valve replacement system of any one of claims 1-10, wherein the repair mechanism comprises an atrial fixation portion configured to conform to a shape of an annular physiology.
13. The transcatheter heart valve replacement system of any one of the preceding claims, wherein the valve stent may be a balloon stent or a self-expanding stent.
14. The transcatheter heart valve replacement system of any one of the preceding claims, wherein the repair mechanism includes an anchoring ring that is at a periphery of the native valve leaflet after the repair mechanism has pinched the native valve leaflet.
15. The transcatheter heart valve replacement system of claim 14, wherein the anchoring ring is coupled to the first and second clamping devices, respectively.
16. The transcatheter heart valve replacement system of claim 14, wherein the anchoring ring is a closed-loop structure or the anchoring ring cooperates with the repair mechanism to form a closed-loop structure.
17. The transcatheter heart valve replacement system of any one of claims 14-16, wherein a circumference of the anchoring ring is smaller than a circumference of the valve stent; and, the anchoring ring has a circumference smaller than a circumference of the native annulus.
18. The transcatheter heart valve replacement system of any one of claims 14-17, wherein when the valve stent is radially expanded, the repair mechanism abuts or bears against a periphery of the valve stent, the valve stent radially supporting the anchoring ring such that a portion of native leaflets is crimped.
19. The transcatheter heart valve replacement system of any one of claims 14-18, wherein the anchoring ring is generally sheet-like, wire-like, or twine-like.
20. The transcatheter heart valve replacement system of any one of claims 14-19, wherein the anchoring ring has a peripheral covering that increases friction with native valve leaflets.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111160963.4A CN113855328A (en) | 2021-09-30 | 2021-09-30 | Transcatheter heart valve replacement system |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111160963.4A CN113855328A (en) | 2021-09-30 | 2021-09-30 | Transcatheter heart valve replacement system |
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| CN113855328A true CN113855328A (en) | 2021-12-31 |
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| US11517718B2 (en) | 2016-11-07 | 2022-12-06 | Edwards Lifesciences Corporation | Apparatus for the introduction and manipulation of multiple telescoping catheters |
| US11547564B2 (en) | 2018-01-09 | 2023-01-10 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| US11602431B2 (en) | 2017-04-18 | 2023-03-14 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11612485B2 (en) | 2018-01-09 | 2023-03-28 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| US11660185B2 (en) | 2009-12-04 | 2023-05-30 | Edwards Lifesciences Corporation | Ventricular anchors for valve repair and replacement devices |
| US11690621B2 (en) | 2014-12-04 | 2023-07-04 | Edwards Lifesciences Corporation | Percutaneous clip for repairing a heart valve |
| US11723772B2 (en) | 2017-04-18 | 2023-08-15 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11730598B2 (en) | 2017-09-07 | 2023-08-22 | Edwards Lifesciences Corporation | Prosthetic device for heart valve |
| US11766330B2 (en) | 2018-10-10 | 2023-09-26 | Edwards Lifesciences Corporation | Valve repair devices for repairing a native valve of a patient |
| US11793642B2 (en) | 2015-05-14 | 2023-10-24 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11839544B2 (en) | 2019-02-14 | 2023-12-12 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11918469B2 (en) | 2018-01-09 | 2024-03-05 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| US11944762B2 (en) | 2017-09-19 | 2024-04-02 | Edwards Lifesciences Corporation | Multi-direction steerable handles for steering catheters |
| US11951263B2 (en) | 2016-03-21 | 2024-04-09 | Edwards Lifesciences Corporation | Multi-direction steerable handles |
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| US11660185B2 (en) | 2009-12-04 | 2023-05-30 | Edwards Lifesciences Corporation | Ventricular anchors for valve repair and replacement devices |
| US11911264B2 (en) | 2009-12-04 | 2024-02-27 | Edwards Lifesciences Corporation | Valve repair and replacement devices |
| US11690621B2 (en) | 2014-12-04 | 2023-07-04 | Edwards Lifesciences Corporation | Percutaneous clip for repairing a heart valve |
| US11793642B2 (en) | 2015-05-14 | 2023-10-24 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11951263B2 (en) | 2016-03-21 | 2024-04-09 | Edwards Lifesciences Corporation | Multi-direction steerable handles |
| US11517718B2 (en) | 2016-11-07 | 2022-12-06 | Edwards Lifesciences Corporation | Apparatus for the introduction and manipulation of multiple telescoping catheters |
| US11969346B2 (en) | 2017-01-05 | 2024-04-30 | Edwards Lifesciences Corporation | Heart valve coaptation device |
| US11602431B2 (en) | 2017-04-18 | 2023-03-14 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11723772B2 (en) | 2017-04-18 | 2023-08-15 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11850153B2 (en) | 2017-04-18 | 2023-12-26 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
| US11730598B2 (en) | 2017-09-07 | 2023-08-22 | Edwards Lifesciences Corporation | Prosthetic device for heart valve |
| US11944762B2 (en) | 2017-09-19 | 2024-04-02 | Edwards Lifesciences Corporation | Multi-direction steerable handles for steering catheters |
| US11850154B2 (en) | 2018-01-09 | 2023-12-26 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| US11918469B2 (en) | 2018-01-09 | 2024-03-05 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| US11612485B2 (en) | 2018-01-09 | 2023-03-28 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| US11547564B2 (en) | 2018-01-09 | 2023-01-10 | Edwards Lifesciences Corporation | Native valve repair devices and procedures |
| US11766330B2 (en) | 2018-10-10 | 2023-09-26 | Edwards Lifesciences Corporation | Valve repair devices for repairing a native valve of a patient |
| US11839544B2 (en) | 2019-02-14 | 2023-12-12 | Edwards Lifesciences Corporation | Heart valve sealing devices and delivery devices therefor |
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