CN117618153A - Heart valve repair device and method - Google Patents
Heart valve repair device and method Download PDFInfo
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- CN117618153A CN117618153A CN202210949535.8A CN202210949535A CN117618153A CN 117618153 A CN117618153 A CN 117618153A CN 202210949535 A CN202210949535 A CN 202210949535A CN 117618153 A CN117618153 A CN 117618153A
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- Prior art keywords
- mounting bracket
- leaflet
- repair device
- heart valve
- valve
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- 210000003709 heart valve Anatomy 0.000 title claims abstract description 31
- 230000008439 repair process Effects 0.000 title claims abstract description 31
- 238000000034 method Methods 0.000 title claims description 13
- 230000007246 mechanism Effects 0.000 claims abstract description 30
- 230000000151 anti-reflux effect Effects 0.000 claims abstract description 21
- 238000004873 anchoring Methods 0.000 claims abstract description 18
- 230000000149 penetrating effect Effects 0.000 claims description 23
- 230000001746 atrial effect Effects 0.000 claims description 8
- 210000000596 ventricular septum Anatomy 0.000 claims description 5
- 241000446313 Lamella Species 0.000 claims 1
- 210000005242 cardiac chamber Anatomy 0.000 claims 1
- 230000002861 ventricular Effects 0.000 abstract description 4
- 206010067171 Regurgitation Diseases 0.000 description 16
- 210000001519 tissue Anatomy 0.000 description 11
- 210000000591 tricuspid valve Anatomy 0.000 description 7
- 238000010276 construction Methods 0.000 description 6
- 238000002513 implantation Methods 0.000 description 6
- 230000033001 locomotion Effects 0.000 description 5
- 238000001356 surgical procedure Methods 0.000 description 4
- 230000008901 benefit Effects 0.000 description 3
- 239000007943 implant Substances 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 238000011282 treatment Methods 0.000 description 3
- 201000001943 Tricuspid Valve Insufficiency Diseases 0.000 description 2
- 206010044640 Tricuspid valve incompetence Diseases 0.000 description 2
- 210000001765 aortic valve Anatomy 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 210000002837 heart atrium Anatomy 0.000 description 2
- 230000000004 hemodynamic effect Effects 0.000 description 2
- 230000007794 irritation Effects 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 208000002815 pulmonary hypertension Diseases 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 206010003445 Ascites Diseases 0.000 description 1
- 206010013012 Dilatation ventricular Diseases 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 206010019705 Hepatic pain Diseases 0.000 description 1
- 208000006083 Hypokinesia Diseases 0.000 description 1
- 206010024119 Left ventricular failure Diseases 0.000 description 1
- 208000011682 Mitral valve disease Diseases 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 208000022531 anorexia Diseases 0.000 description 1
- 230000003466 anti-cipated effect Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 206010061428 decreased appetite Diseases 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 210000003191 femoral vein Anatomy 0.000 description 1
- 230000010247 heart contraction Effects 0.000 description 1
- 210000005003 heart tissue Anatomy 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 210000004115 mitral valve Anatomy 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 238000010992 reflux Methods 0.000 description 1
- 125000006850 spacer group Chemical group 0.000 description 1
- 208000028073 tricuspid valve disease Diseases 0.000 description 1
Classifications
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
-
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2463—Implants forming part of the valve leaflets
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The application relates to the field of medical equipment, in particular to a heart valve repair device, which comprises a mounting bracket, a single anti-reflux prosthesis used for replacing a single self-leaflet function, a valve She Maoding mechanism and a fixing piece, wherein one end of the single anti-reflux prosthesis is fixed on the mounting bracket, the proximal end of the mounting bracket is anchored on ventricular tissue through the fixing piece, one end of the valve She Maoding mechanism is fixed on the mounting bracket, when the mounting bracket is installed in place, a replaced self-leaflet is positioned between the mounting bracket and the leaflet anchoring mechanism, and the other end of the valve She Maoding mechanism penetrates through the replaced self-leaflet, so that the heart valve repair device can be firmly fixed in a heart.
Description
Technical Field
The application relates to the field of medical instruments, in particular to a heart valve repair device and an operation method.
Background
Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement, and tricuspid annulus dilation, and is clinically common in the etiology of tricuspid regurgitation (left heart failure, pulmonary hypertension, etc.). After the tricuspid valve is regurgitated, the patient can suffer from symptoms of serious heart failure such as hypodynamia, ascites, edema, liver pain, dyspepsia, anorexia and the like. Mild regurgitation of the tricuspid valve has no obvious clinical symptoms, but when there is severe regurgitation, surgical treatment is required.
Traditional treatments for mitral and tricuspid valve disease include medical treatment for mild to severe regurgitation, and surgical procedures with corresponding surgical indications. Among other surgical methods, valve replacement and valve repair are also included. In surgical procedures, typical open chest and open heart procedures are too invasive and require the establishment of extracorporeal circulation with a high incidence of complications and risk of infection. Many patients are intolerant of significant surgical risks and can only wait for death without being able to wait.
With the report of the first aortic valve interventional replacement, a great deal of work is done by a plurality of companies in the aspect of the aortic valve interventional technology, and the technology is mature gradually. However, there is still a large technical gap in the industry in terms of intervention of atrioventricular valves. Although few products are currently being used for transcatheter interventional valvuloplasty and repair, no mature, available products are yet internationally available for transcatheter interventional valve replacement.
Patent CN202210730620.5 discloses a prosthetic device for preventing valve regurgitation comprising a mounting bracket; and a single anti-regurgitation leaflet prosthesis for replacing the function of a single autologous leaflet; wherein one end of the single anti-reflux leaflet prosthesis is fixed on the mounting bracket. The prosthetic device only carries out replacement aiming at a single valve leaflet with problems, so that the original functions of the rest self valve leaflets are reserved, the form of the self valve annulus cannot be changed, the damage to the endocardial tissue is small, and meanwhile, the implantation amount of the implant is small and the irritation is small. According to the scheme, the mounting bracket is anchored in the ventricle by virtue of the fixing piece, the self valve leaflet is clamped by the auxiliary leaning part, but in the heart beating process, the distal end part of the mounting bracket cannot be clung to heart tissues, so that the mounting bracket inclines or swings, the position of the mounting bracket is unstable, and the problems of perivalvular leakage, thrombus and the like are caused.
Accordingly, there is a strong need in the art for an implant device that achieves reliable fixation, maximizes the use of native valve function, minimizes the impact on heart motion and hemodynamics, reduces the difficulty of surgical procedures, and is simple in construction.
Disclosure of Invention
The present invention has been made in view of the above and other concepts.
The technical problem of one aspect of the invention to be solved is to provide an innovative heart valve repair device which can be reliably fixed, can retain the functions of main self valve leaflets, has little influence on heart movement and hemodynamics, and has low operation difficulty and simple structure.
The basic inventive concept according to a further aspect of the present invention is that the prosthetic device of the present invention is intended to repair, rather than replace, the entire native heart valve. In other words, the prosthetic device of the present invention is intended to replace one or both of the native leaflets, rather than the entire number of native leaflets. For mitral valves, the prosthetic device of the present invention is intended to replace one of the native leaflets while leaving the other native leaflet functioning properly. For the tricuspid valve, the prosthetic device of the present invention is intended to replace one of the native leaflets, such as the posterior leaflet, while leaving the other two native leaflets working properly; alternatively, two prosthetic devices of the present invention are used to replace two native leaflets in the tricuspid valve, while the other native leaflet is maintained in normal operation.
Specifically, according to one aspect of the present invention, there is provided a heart valve repair device comprising a mounting bracket, a single anti-reflux prosthesis for replacing the function of a single native leaflet, a leaflet She Maoding mechanism, and a securing member, one end of the single anti-reflux prosthesis being secured to the mounting bracket, a proximal end of the mounting bracket being anchored to ventricular tissue by the securing member, one end of the leaflet She Maoding mechanism being secured to the mounting bracket, a replaced native leaflet being located between the mounting bracket and the leaflet anchoring mechanism when the mounting bracket is in place, and the other end of the leaflet She Maoding mechanism passing through the replaced native leaflet.
According to one embodiment, the distal end of the mounting bracket is provided with an anchoring region, and the other end of the flap She Maoding mechanism is fixedly attached to the anchoring region through the replaced native leaflet.
According to an embodiment, the other end of the flap She Maoding mechanism has a predetermined configuration, and when the mounting bracket is in place, the other end of the flap She Maoding mechanism passes through the replaced native leaflet and returns to the predetermined configuration to anchor with the replaced native leaflet.
According to an embodiment, the leaflet anchoring device comprises a clamping element and a piercing element, the piercing element being slidable relative to the clamping element, and, when the mounting bracket is mounted in place, the replaced native leaflet is located between the mounting bracket and the clamping element, the piercing element moving distally relative to the clamping element and passing through the replaced native leaflet.
According to an embodiment, one end of the clamping element is fixed to the mounting bracket, the other end of the clamping element is close to the proximal end of the mounting bracket when preloaded, and the other end of the clamping element is folded in the distal direction such that the native leaflet is clamped between the clamping element and the mounting bracket when the mounting bracket is delivered to the target location.
According to another embodiment, one end of the clamping element is fixed to the mounting bracket and the other end thereof is a free end; the gripping element has a constrained configuration in which the free end is proximate the proximal end of the mounting bracket and a preset configuration in which the free end is spaced from the distal end of the mounting bracket to form a valve-gripping lumen.
According to an embodiment, the clamping element is provided with a connecting piece, the puncture element is provided with a limiting piece, and the connecting piece is matched with the limiting piece to restrict the sliding stroke of the puncture element relative to the clamping element.
According to an embodiment, the penetrating member is moved distally relative to the clamping member and through the root region of the native leaflet when the mounting bracket is mounted in place.
According to an embodiment, the heart valve repair device further comprises an actuating element, one end of which is connected to the penetrating element, and when the mounting bracket is mounted in place, pulling the actuating element causes the penetrating element to move distally relative to the clamping element and through the native leaflet.
According to an embodiment, the distal end of the mounting bracket is provided with an atrial portion configured to accommodate the morphology of the native valve annulus tissue, and both sides of the atrial portion are provided at the juncture of the native valve leaflets after the mounting bracket is mounted in place.
According to an embodiment, the free edges of the single anti-regurgitation prosthesis and the free edges of the remaining native leaflets cooperate together to achieve normal closing of the valve or at least partially overlap with the free edges of the remaining native leaflets to prevent regurgitation of the valve when the native valve is in a closed state.
According to another embodiment, the fixing members are plural, and at least 2 fixing members are axially spaced apart.
According to another embodiment, the proximal section of the mounting bracket is abutted against the compartment space and the proximal end of the mounting bracket is anchored to the compartment space tissue by the anchor.
According to another embodiment, the anti-reflux prosthesis is selected from one of the following: an integrated membrane made of flexible material; and comprises a supporting framework and a biocompatible coating or membrane covered on the supporting framework; and implantable balloons.
According to another embodiment, the mounting bracket comprises a limiter configured to allow the single anti-reflux prosthesis to rest thereon and limit its deformation in the leaflet open state.
According to another embodiment, the fixed end of the single anti-reflux prosthesis is fixedly connected to the mounting bracket, and the free end of the anti-reflux prosthesis is movably connected to the mounting bracket through a traction wire; wherein, after the prosthetic device is installed in place, the free end of the single anti-reflux prosthesis is movable between a leaflet open state in which the single anti-reflux prosthesis is open along with the remaining native leaflets of the valve, except for the single native leaflet; in the closed with leaflet state, the single anti-regurgitation prosthesis closes with the remaining native leaflets to prevent valve regurgitation.
According to another aspect of the present application: operating the heart valve repair device into a surgical site; gradually releasing the mounting bracket from the proximal end and abutting the proximal end of the mounting bracket against the ventricular septum tissue, further releasing the mounting bracket such that the clamping element folds over the distal end of the mounting bracket and clamps the replaced native leaflet; pulling the actuating element to slide the penetrating element in a distal direction relative to the gripping element and through the replaced native valve leaflet, and further pulling the actuating element to fixedly connect the penetrating element to the anchoring region, wherein the actuating element is detached from the penetrating element (the specific structure and method of detachment thereof are prior art and therefore are not described in detail); further operating the heart valve repair device such that the proximal end of the mounting bracket is secured to the ventricular septum tissue by the securing member; and withdrawing the valve stent delivery device.
Compared with the prior art, the advantage of this application lies in:
1. in contrast to the prior art, in an embodiment of the present invention, the proximal end of the mounting bracket is anchored in the ventricle by the fixing element, and after the valve She Maoding device is restored to the preset shape, it passes through the replaced native valve leaflet, so that the mounting bracket and the native valve leaflet form a stable connection, thereby realizing the reliable fixation of the prosthetic device in the heart, and avoiding the occurrence of paravalvular leakage of the prosthetic device due to tilting or swinging of the prosthetic device after implantation.
2. Unlike the prior art, in one embodiment of the present invention, one end of the valve She Maoding device is fixed to the mounting bracket, and the other end of the valve She Maoding device is fixedly connected to the anchoring area through the replaced native valve leaflet, so that the valve She Maoding device is in closed loop connection with the mounting bracket, and the other end of the valve She Maoding device is through the native valve leaflet, so that the anchoring between the prosthetic device and the native valve leaflet is more stable, and tilting or swinging of the prosthetic device after implantation is avoided.
3. Unlike the prior art, in an embodiment of the present invention, when the clamping element is restored from the limiting configuration to the preset configuration, the other end of the clamping element is folded over and the native valve leaflet is located between the clamping element and the mounting bracket, and then the other end of the puncture element passes through the root region of the native valve leaflet, so that the muscle tissue of the root region of the native valve leaflet is thicker, the force that the puncture element can bear is larger, and the puncture element is anchored at the root position of the native valve leaflet so that the prosthetic device can be closely attached to one side of the inner wall of the heart, and the movement of other native valve leaflets is not affected while the problematic valve leaflet is replaced.
4. Compared with the prior art, in one embodiment of the invention, the repairing device is fixed on the ventricular tissue through the fixing piece, the valve She Maoding device, the replaced native valve She Maoding and the distal end are arranged on the native valve annulus, so that the repairing device can be firmly attached to one side of the replaced native valve leaflet of the native valve, and only the problematic valve leaflet is replaced, so that the original functions of the rest native valve leaflet are reserved, the shape of the native valve annulus is not changed, the damage to the endocardial tissue is small, the implantation amount of the implant is small, and the irritation is small.
5. Unlike the prior art, the fixing position of the repairing device is safe and risk-free in one embodiment of the invention; the room interval fixable area is much larger than the annulus and atrium fixable area, and the positioning requirement on the instrument is low; besides, other important branch blood vessels are not arranged near the room interval, so that the functional damage is avoided, and the safety is high; in the heart movement process, the movement amplitude of the inter-chamber space is smaller than that of the valve annulus, so that the fixation is stable, the success rate is high, and the effect is good.
Embodiments of the present application are capable of other advantageous technical effects not listed one by one, which may be described in part below and which will be anticipated and understood by those skilled in the art after reading the present application.
Drawings
The above-mentioned 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. 1a-1e are schematic representations of the overall construction of a prosthetic device according to the present invention, wherein FIG. 1c is a schematic representation of the construction of a connector according to the present invention, and FIG. 1d is a schematic representation of the construction of a piercing element according to the present invention.
Fig. 2a-2c are schematic views of a prosthetic device of the present invention after implantation.
Figures 3a-3c are schematic illustrations of regurgitation caused by improper coaptation of anterior, posterior and diaphragmatic leaflets.
Fig. 4a and 4b are schematic views showing normal closing of each leaflet after fixation of the prosthetic device of the present invention is completed.
Fig. 5a-5h are schematic views of the implantation process of the prosthetic device of the present invention.
The designations in the drawings indicate the following designations:
1-mounting bracket, 2-anti-reflux prosthesis, 3-flap She Maoding mechanism, 31-clamping element, 311-connector, 32-piercing element, 321-limiter, 4-anchor, 5-anchoring area, 6-actuating element, 7-atrial portion, 8-puller wire.
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 illustrated and described embodiments 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 drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. Examples are provided by way of explanation, not limitation, of the disclosed embodiments. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of the present application without departing from the scope or spirit of the disclosure. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still a further embodiment. Accordingly, this disclosure covers such modifications and variations as come 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.
The present application will be described in more detail below with reference to various embodiments and examples of aspects of the present application.
In this application, "proximal" refers to the end proximal to the apex of the heart and "distal" refers to the end distal to the apex of the heart.
Example 1
The tricuspid valve of the human heart has anterior, posterior and diaphragmatic leaflets. The anterior, posterior and diaphragmatic leaflets are in a closed state when the heart contracts, and valve regurgitation occurs when one of the anterior, posterior and diaphragmatic leaflets fails to close normally in the closed state, as shown in fig. 3a-3 c.
As shown in fig. 1a-1e, a heart valve repair device comprises a mounting bracket 1, a single anti-reflux prosthesis 2 for replacing the function of a single native leaflet, a leaflet She Maoding mechanism 3 and a fixing piece 4, wherein one end of the single anti-reflux prosthesis 2 is fixed on the mounting bracket 1, the proximal end of the mounting bracket 1 is anchored on ventricular tissue through the fixing piece 4, one end of the leaflet She Maoding mechanism 3 is fixed on the mounting bracket 1, the replaced native leaflet is positioned between the mounting bracket 1 and the leaflet She Maoding mechanism 3 after the mounting bracket 1 is mounted in place, and the other end of the leaflet She Maoding mechanism 3 passes through the replaced native leaflet.
The mounting bracket 1 does not affect the functions of the rest of the native valve leaflets after mounting.
The heart valve repair device may have a constrained state and a released state.
According to another example, in use for tricuspid valve treatment, the heart valve repair device replaces the leaflets of the valve.
According to one example, the distal end of the mounting bracket 1 is provided with an anchoring area 5, and the other end of the valve She Maoding mechanism 3 is fixedly connected with the anchoring area 5 through the replaced native valve leaflet, and the anchoring area 5 is covered with a film, so that the other end of the valve She Maoding mechanism 3 is fixedly connected with the anchoring area 5 after passing through the replaced native valve leaflet, as shown in fig. 2b and 2 c.
According to another example, the other end of the flap She Maoding mechanism 3 has a preset configuration, and when the mounting bracket 1 is mounted in place, the other end of the flap She Maoding mechanism 3 passes through the replaced native leaflet and returns to the preset configuration to anchor with the replaced native leaflet.
According to one example, the flap She Maoding mechanism 3 includes a gripping element 31 and a piercing element 32, the piercing element 32 being slidable relative to the gripping element 31, and, when the mounting bracket 1 is mounted in place, a replaced native leaflet is located between the mounting bracket 1 and the gripping element 31, the piercing element 32 moving distally relative to the gripping element 31 and passing through the replaced native leaflet.
According to one example, one end of the clamping element 31 is fixed to the mounting bracket 1, the other end of the clamping element 31 is close to the proximal end of the mounting bracket 1 when pre-assembled, and when the mounting bracket 1 is delivered to a target location, the other end of the clamping element 31 is folded in the distal direction such that the native leaflet is clamped between the clamping element 31 and the mounting bracket 1.
According to one example, the clamping element 31 is provided with a connector 311 and the penetrating element 32 is provided with a stop 321, as shown in fig. 1b-1d, the connector 311 cooperates with the stop 321 to restrict the sliding travel of the penetrating element 32 relative to the clamping element 31, wherein, when the mounting bracket 1 is mounted in place, the penetrating element 32 moves in distal direction relative to the clamping element 31 and passes through the root region of the native leaflet.
According to one example, the heart valve repair device further comprises an actuating element 6, one end of the actuating element 6 being connected to the penetrating element 32, and when the mounting bracket 1 is mounted in place, pulling the actuating element 6 moving the penetrating element 32 distally relative to the clamping element 31 and through the native valve leaflet, as shown in fig. 5e-5 g.
According to one example, the actuating element 6 is detachably connected to the penetrating element 32, and after the penetrating element 32 completes the penetration of the native valve leaflet, the actuating element 6 is detached from the penetrating element 32 and withdrawn from the body.
According to one example, the distal end of the mounting bracket 1 is provided with an atrial portion 7, the atrial portion 7 being configured to adapt to the morphology of the native valve annulus tissue, and both sides of the atrial portion 7 are arranged at the junction of the native valve leaflets after the mounting bracket 1 is mounted in place, as shown in fig. 2a and 2 c.
According to one example, the free edges of the single anti-regurgitation prosthesis 2 and the free edges of the remaining native leaflets cooperate together to achieve normal closing of the valve or at least partially overlap with the free edges of the remaining native leaflets when the native valve is in a closed state, to prevent regurgitation of the valve, as shown in fig. 4a and 4 b.
According to another example, the number of the fixing members 4 is 2, and the 2 fixing members 4 are spaced apart from each other in the axial direction, as shown in fig. 2 a.
According to another example, the proximal section of the mounting bracket 1 rests against the compartment space and the proximal end of the mounting bracket 1 is anchored to the compartment space tissue by the securing means 4.
According to another example, the fixed end of the single anti-reflux prosthesis 2 is fixedly connected to the mounting bracket 1, and the free end of the anti-reflux prosthesis 2 is movably connected to the mounting bracket 1 by a pulling wire 8, as shown in fig. 1 a; wherein, after the prosthetic device is installed in place, the free end of the single anti-reflux prosthesis 2 is movable between a leaflet open state in which the single anti-reflux prosthesis 2 is open along with the rest of the native leaflets of the valve except for the single native leaflet; in the closed state with the leaflets, the single anti-regurgitation prosthesis 2 closes together with the remaining native leaflets to prevent valve regurgitation, as shown in fig. 4a and 4 b.
The anti-reflux prosthesis 2 may also be provided with a pull wire 8 in other ways similar to the native leaflet configuration.
Similar to the native leaflet configuration, the anti-reflux prosthesis 2 may have a curved configuration similar to the native leaflet.
An exemplary heart atrioventricular tricuspid valve procedure for the prosthetic device for preventing valve regurgitation according to the first embodiment is as follows, as shown in fig. 5a-5 h:
1. the heart valve repairing device adopts a way of passing through a femoral approach, passes through a femoral vein, and reaches an atrioventricular port after entering an atrium;
2. positioning the mounting bracket 11 in a position against the valve leaflet, partially releasing the proximal end of the heart valve repair device and against the ventricular septum;
3. the heart valve repair device is gradually released from the distal end to the proximal end, so that the valve She Maoding mechanism 3 is restored to the preset shape from the limited shape, at this time, the free end of the valve She Maoding mechanism 3 is folded back from the distal end of the mounting bracket 1 to the proximal end as shown by the arrow in fig. 5c, and the self-leaflet (valve spacer leaflet) as the replacement target is clamped in the valve clamping cavity as shown in fig. 5c and 5 d;
4. the atrial portion 7 is further released against the native annulus as shown in fig. 5 e.
5. Continuing the procedure, the mounting bracket 1 is secured to the room space by the fasteners 4, thus substantially completing the main procedure of the prosthetic device.
The foregoing description of several embodiments of the present application has been presented for purposes of illustration. It is not intended to be exhaustive or to limit the application to the precise configuration, construction and/or steps disclosed, and obviously many modifications and variations are possible in light of the above teaching. The scope and equivalents of the invention are intended to be defined by the appended claims.
Claims (10)
1. A heart valve prosthetic device, includes the installing support, is used for replacing single anti-reflux prosthesis, lamella She Maoding mechanism and the mounting of single autologous valve leaflet function, single anti-reflux prosthesis's one end fix on the installing support, the proximal end of installing support passes through the mounting anchor is on the heart chamber tissue, its characterized in that: one end of the flap She Maoding mechanism is secured to the mounting bracket, the replaced native leaflet is positioned between the mounting bracket and the leaflet anchoring mechanism when the mounting bracket is mounted in place, and the other end of the flap She Maoding mechanism passes through the replaced native leaflet.
2. The heart valve repair device of claim 1, wherein: the distal end of the mounting bracket is provided with an anchoring region, and the other end of the flap She Maoding mechanism is fixedly connected with the anchoring region through the replaced native leaflet.
3. The heart valve repair device of claim 1, wherein: the other end of the valve She Maoding mechanism has a preset shape, and after the mounting bracket is mounted in place, the other end of the valve She Maoding mechanism passes through the replaced native valve leaflet and returns to the preset shape to anchor with the replaced native valve leaflet.
4. The heart valve repair device of claim 1, wherein: the leaflet anchoring device includes a clamping element and a penetrating element, the penetrating element being slidable relative to the clamping element, and, when the mounting bracket is mounted in place, a replaced native leaflet is positioned between the mounting bracket and the clamping element, the penetrating element moving in a distal direction relative to the clamping element and passing through the replaced native leaflet.
5. The heart valve repair device of claim 4, wherein: one end of the clamping element is fixed on the mounting bracket, when the mounting bracket is transported to the target position, the other end of the clamping element is folded in the far-end direction so that the self-leaflet is clamped between the clamping element and the mounting bracket.
6. The heart valve repair device of claim 4, wherein: the clamping element is provided with a connecting piece, the puncture element is provided with a limiting piece, and the connecting piece is matched with the limiting piece to restrict the sliding stroke of the puncture element relative to the clamping element.
7. The heart valve repair device of claim 4, wherein: when the mounting bracket is in place, the penetrating member moves distally relative to the clamping member and through the root region of the native leaflet.
8. The heart valve repair device of claim 4, wherein: the heart valve repair device further includes an actuating member having one end connected to the penetrating member, and when the mounting bracket is in place, pulling the actuating member causes the penetrating member to move distally relative to the clamping member and through the native leaflet.
9. The heart valve repair device of claim 1, wherein: the distal end of the mounting bracket is provided with an atrial portion configured to accommodate the morphology of the native valve annulus tissue, and after the mounting bracket is mounted in place, both sides of the atrial portion are disposed at the juncture of the native valve leaflets.
10. A method of operating the heart valve repair device of any one of claims 1-9: operating the heart valve repair device into a surgical site;
gradually releasing the mounting bracket from the proximal end and abutting the proximal end of the mounting bracket against the ventricular septum tissue, further releasing the mounting bracket such that the clamping element folds over the distal end of the mounting bracket and clamps the replaced native leaflet;
pulling the actuating element to cause the penetrating member to slide distally relative to the gripping element and through the replaced native leaflet, further pulling the actuating element to cause the penetrating member to fixedly connect with the anchoring region, whereupon the actuating element detaches from the penetrating member;
further operating the heart valve repair device such that the proximal end of the mounting bracket is secured to the ventricular septum tissue by the securing member; and
withdrawing the valve stent delivery device.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210949535.8A CN117618153A (en) | 2022-08-09 | 2022-08-09 | Heart valve repair device and method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210949535.8A CN117618153A (en) | 2022-08-09 | 2022-08-09 | Heart valve repair device and method |
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| CN117618153A true CN117618153A (en) | 2024-03-01 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202210949535.8A Pending CN117618153A (en) | 2022-08-09 | 2022-08-09 | Heart valve repair device and method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN119587222A (en) * | 2024-12-13 | 2025-03-11 | 复旦大学附属中山医院 | Valve leaflet repair device, system and method |
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2022
- 2022-08-09 CN CN202210949535.8A patent/CN117618153A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN119587222A (en) * | 2024-12-13 | 2025-03-11 | 复旦大学附属中山医院 | Valve leaflet repair device, system and method |
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