CN116869707A - Novel valve replacement device - Google Patents
Novel valve replacement device Download PDFInfo
- Publication number
- CN116869707A CN116869707A CN202311039646.6A CN202311039646A CN116869707A CN 116869707 A CN116869707 A CN 116869707A CN 202311039646 A CN202311039646 A CN 202311039646A CN 116869707 A CN116869707 A CN 116869707A
- Authority
- CN
- China
- Prior art keywords
- frame
- valve frame
- valve
- replacement device
- barb
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000005452 bending Methods 0.000 claims abstract description 55
- 230000008093 supporting effect Effects 0.000 claims abstract description 43
- 230000000149 penetrating effect Effects 0.000 claims abstract description 3
- 230000004888 barrier function Effects 0.000 claims description 28
- 241000446313 Lamella Species 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 6
- 230000008569 process Effects 0.000 claims description 6
- 238000009941 weaving Methods 0.000 claims description 3
- 230000017531 blood circulation Effects 0.000 abstract description 3
- 230000008859 change Effects 0.000 description 10
- 230000000694 effects Effects 0.000 description 10
- 210000003709 heart valve Anatomy 0.000 description 9
- 238000007789 sealing Methods 0.000 description 8
- 230000005489 elastic deformation Effects 0.000 description 6
- 230000000004 hemodynamic effect Effects 0.000 description 6
- 239000008280 blood Substances 0.000 description 5
- 210000004369 blood Anatomy 0.000 description 5
- 238000009958 sewing Methods 0.000 description 5
- 230000007704 transition Effects 0.000 description 5
- 210000003484 anatomy Anatomy 0.000 description 3
- 210000001765 aortic valve Anatomy 0.000 description 3
- 230000001746 atrial effect Effects 0.000 description 3
- 238000001125 extrusion Methods 0.000 description 3
- 238000010992 reflux Methods 0.000 description 3
- 229920002799 BoPET Polymers 0.000 description 2
- 230000001010 compromised effect Effects 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- 241000283690 Bos taurus Species 0.000 description 1
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 208000012287 Prolapse Diseases 0.000 description 1
- 238000010719 annulation reaction Methods 0.000 description 1
- 206010002906 aortic stenosis Diseases 0.000 description 1
- 210000005242 cardiac chamber Anatomy 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 238000002788 crimping Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 230000036244 malformation Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 210000004379 membrane Anatomy 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 210000003516 pericardium Anatomy 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 239000012781 shape memory material Substances 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000002861 ventricular Effects 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
- A61F2/2463—Implants forming part of the valve leaflets
-
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
Abstract
The invention discloses a novel valve replacement device which comprises an inner valve frame, barb arms, an outer valve frame and a supporting body. The inner valve frame is provided with a first end and a second end, a cavity channel penetrating through the first end and the second end is arranged in the inner valve frame, and a valve is arranged in the cavity channel; the barb arms are arranged on the outer side of the inner valve frame, a plurality of barb arms are distributed around the inner valve frame at intervals, one end of each barb arm is connected with the inner valve frame, the other end of each barb arm is a free end, and a bending section which is bent towards the inner valve frame is arranged on each barb arm; the outer valve frame is positioned between the inner valve frame and the barb arm, one end of the outer valve frame is connected with the inner valve frame, and a gap for accommodating a valve is formed between the barb arm and the outer valve frame; one end of the supporting body is connected with the inner valve frame, and the other end is connected or contacted with the outer valve frame. The novel valve replacement device provided by the invention not only can ensure that the valve blood flow dynamics in the inner valve frame is stable, but also can ensure that the novel valve replacement device is firmly fixed.
Description
Technical Field
The invention relates to the technical field of valve repair, in particular to a novel valve replacement device.
Background
When heart valves are malfunctioning, heart function may be severely compromised. Potential causes of heart valve dysfunction include paravalvular annulation, ventricular dilation, valve leaflet prolapse or malformation, and stenosis such as aortic stenosis. When the heart valve fails to close properly, blood within the heart chamber may either reflux or leak back through the valve. When the heart valve fails to open properly, forward blood flow (e.g., systolic blood flow) may be compromised. Valve failure can be treated by replacing or repairing a diseased valve (e.g., aortic valve), valve replacement is one of the most effective ways of treating a diseased valve currently accepted by the academy. Among other things, the concept of minimally invasive therapies, such as Transcatheter Aortic Valve Replacement (TAVR), involves the use of delivery catheters that are delivered to the heart through arterial passageways or other anatomical pathways to implant prosthetic heart valves to replace diseased valves.
In the prior art, the implanted artificial heart valve is difficult to firmly fix with the heart, leakage exists beside the artificial heart valve, and how to firmly fix the artificial heart valve and prevent leakage beside the artificial heart valve is a technical problem to be solved.
Disclosure of Invention
The invention aims to solve the defects in the prior art, provides a novel valve replacement device and aims to at least solve one of the technical problems in the prior art to a certain extent.
In order to achieve the above purpose, the present invention provides the following technical solutions:
a novel valve replacement device includes an inner valve frame, barb arms, an outer valve frame, and a support body. The inner valve frame is provided with a first end and a second end, a cavity channel penetrating through the first end and the second end is arranged in the inner valve frame, and a valve is arranged in the cavity channel; the barb arms are arranged on the outer side of the inner valve frame, a plurality of barb arms are distributed around the inner valve frame at intervals, one end of each barb arm is connected with the inner valve frame, the other end of each barb arm is a free end, and a bending section which is bent towards the inner valve frame is arranged on each barb arm; the outer valve frame is positioned between the inner valve frame and the barb arm, one end of the outer valve frame is connected with the inner valve frame, and a gap for accommodating a valve is formed between the barb arm and the outer valve frame; one end of the supporting body is connected with the inner valve frame, and the other end is connected or contacted with the outer valve frame.
Compared with the prior art, the outer valve frame of the embodiment can adapt to the D-shaped anatomical structure of the atrial wall and the valve annulus, and the dynamic change of the valve annulus caused by the systole and diastole is elastically adapted by the outer valve frame, so that the form of the inner valve frame is not influenced, and the stability of valve hemodynamics in the inner valve frame is ensured. In addition, the support provides a stable elastic support for the outer valve frame, so that when the native valve is clamped between the barb arms and the outer valve frame, the barb arms and the outer valve frame can provide proper clamping force, and the novel valve replacement device can be firmly fixed.
Preferably, the bent section is adjacent the free end of the barb arm.
When the novel valve replacement device is implanted into a human body, the bending section can be close to the root of the primary valve, so that the novel valve replacement device is guaranteed to have a good fixing effect.
Preferably, one end of the outer petal frame is connected with the first end of the inner petal frame, and one end of the barb arm is connected with the first end of the inner petal frame.
The novel valve replacement device can be ensured to have better integrity and smaller volume by connecting the outer valve frame, the barb arms and the first end of the inner valve frame, so that the influence of the implanted novel valve replacement device on the normal movement of the heart is reduced.
Preferably, the inner valve frame is attached with a first barrier film, and the outer valve frame is attached with a second barrier film.
The first barrier film and the second barrier film are provided to prevent the back flow of blood.
In some embodiments, the support body comprises a plurality of support arms spaced around the inner valve frame; one end of the supporting arm is connected with the inner valve frame, the other end of the supporting arm is contacted with the inner wall of the outer valve frame, and the outer valve frame can press the supporting arm to elastically deform along the radial direction of the inner valve frame.
The plurality of support arms provide stable elastic support for the outer valve frame, so that proper clamping force can be provided when the primary valve is clamped between the barb arms and the outer valve frame, and the novel valve replacement device can be further ensured to be firmly fixed.
Preferably, the two ends of the supporting arm are arc-shaped bending sections.
Through setting the both ends of support arm into crooked structure, guarantee that the support arm has stronger elastic deformation ability.
Preferably, along the axial direction of the inner valve frame, one end of the supporting arm adjacent to the outer valve frame is at the same height as the bending section, and the barb arms and the supporting arm are mutually matched so as to provide a strong clamping force.
Preferably, the number of the supporting arms is equal to that of the barb arms, the supporting arms correspond to the barb arms one by one, and the axis of the inner valve frame, the supporting arms and the barb arms corresponding to the supporting arms are coplanar.
The barb arms and the supporting arms are mutually matched to provide stronger clamping force, and the supporting arms can be well adapted to dynamic changes of the valve annulus, so that the shape of the inner valve frame is prevented from being influenced.
Preferably, the outer petal frame is provided with a skirt portion at an end thereof remote from the inner petal frame.
When the novel valve replacement device is implanted into a target position of a human body, the skirt edge part can be attached to an annulus, so that a good sealing effect is achieved, and the perivalvular leakage is effectively prevented.
In some embodiments, the support body comprises a circular ring part and a first connecting part, the circular ring part is provided with a through hole suitable for the inner valve frame to penetrate, the first connecting part is connected with the inner edge of the circular ring part and is fixed with the inner valve frame, and the outer edge of the circular ring part is connected with the outer valve frame.
The support body provides stable support for the outer valve frame, so that proper clamping force can be generated between the outer valve frame and the barb arm, and the novel valve replacement device can be firmly fixed.
Preferably, the outer edge of the annular portion is connected to an end of the outer petal shelf remote from the first end.
The dynamic change of the valve annulus caused by systole and diastole can be elastically adapted by the middle position of the outer valve frame, so that the influence on the shape of the inner valve frame is avoided.
Preferably, the plane of the annular part is perpendicular to the axis of the inner petal frame, so that the support body can provide good support effect.
Preferably, the first connecting portion is cylindrical, a through hole suitable for the inner valve frame to pass through is formed in the center of the first connecting portion, and the first connecting portion is sleeved on the outer side of the inner valve frame.
Through setting up cylindric with first connecting portion, can make the first connecting portion wrap up the interior lamella frame all-round, make the more firm of being connected between first connecting portion and the interior lamella frame, cylindric first connecting portion is processed relatively easily moreover.
Preferably, the circular ring part and the first connecting part are in smooth transition.
Through smooth transition between the annular part and the first connecting part, the skeleton elasticity of the outer valve frame can be enhanced, the inner valve frame is promoted to be elastically isolated, the extrusion force of the dynamic change of the valve ring to the inner valve frame is reduced, and the hemodynamic stability of the middle valve is further ensured.
Preferably, the outer flap frame is provided with a first bending part bending towards the bending section and a second bending part bending towards the inner flap frame, the first bending part is adjacent to the second bending part, and the first bending part is adjacent to the first end of the inner flap frame compared with the second bending part.
The first outward bending part on the outer valve frame and the bending section on the barb arm are matched with each other to form a space for clamping the primary valve, and the space can provide a proper clamping range and a large clamping force, so that the novel valve replacement device can be firmly fixed. In addition, the arrangement of the first bending part and the second bending part can also enhance the supporting rigidity of the first bending part on the outer flap frame.
Preferably, the outer petal frame further comprises a second connecting part, a cone part and a skirt part, wherein the second connecting part, the cone part, the first bending part, the second bending part and the skirt part are sequentially connected, and the second connecting part is fixed with the first end of the inner petal frame; the diameter of the cone part gradually increases from one end of the cone part close to the first end to one end of the cone part far away from the first end; the skirt portion extends in a direction away from the inner flap frame with one end of the second bending portion as a starting point, and an outer edge of the skirt portion is connected to an outer edge of the annular portion.
When the novel valve replacement device is implanted into a target position of a human body, the skirt edge part can be attached to an annulus, so that a good sealing effect is achieved, and the perivalvular leakage is effectively prevented. In addition, the outer valve frame can be better matched with physiological structures in the heart, and implantation operation is facilitated.
Preferably, the second connecting portion is cylindrical, a through hole suitable for the inner valve frame to pass through is formed in the center of the second connecting portion, and the second connecting portion is sleeved outside the first end of the inner valve frame.
Through setting up the second connecting portion to cylindric, can make the second connecting portion wrap up the interior lamella frame all-round, make the connection between second connecting portion and the interior lamella frame more firm, cylindric second connecting portion is processed relatively easily moreover.
Preferably, the second connecting portion and the cone portion are in smooth transition.
By smoothly transiting the second connecting part and the cone part, the skeleton elasticity of the outer valve frame can be enhanced, the inner valve frame is promoted to be elastically isolated, the extrusion force of the dynamic change of the valve ring to the inner valve frame is reduced, and the hemodynamic stability of the middle valve is further ensured.
Preferably, the skirt portion is substantially parallel to the annular portion.
The skirt edge part and the circular ring part form a double-layer plugging structure, the sealing performance between the plugging structure and the valve ring is better, and the valve periphery leakage can be prevented more effectively.
Preferably, the outer valve frame and the support body are integrally woven and formed by adopting a weaving process.
The outer valve frame and the support body manufactured by the process have excellent elastic deformation capability, and further ensure that the inner valve frame cannot be deformed due to dynamic change of the valve ring.
Preferably, the outer flap frame is integrally attached with the support body with a barrier film. Blood reflux is further prevented by providing a barrier membrane on the outer valve frame and the support body together.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 is a structural diagram of embodiment 1 of the present invention.
Fig. 2 is a front view of embodiment 1 of the present invention.
Fig. 3 is a structural view of the combination of the inner valve frame, the barb arms, and the support arms in embodiment 1 of the present invention.
Fig. 4 is a structural view of the inner flap frame of fig. 3 after sewing a barrier film thereto.
Fig. 5 is a structural view of an outer petal holder in embodiment 1 of the present invention.
Fig. 6 is a front view of the outer valve frame in embodiment 1 of the present invention.
Fig. 7 is a structural view of the outer flap frame of embodiment 1 of the present invention after sewing a barrier film.
Fig. 8 and 9 are perspective views of embodiment 2 of the present invention.
Fig. 10 is a front view of embodiment 2 of the present invention.
Fig. 11 is a top view of embodiment 2 of the present invention.
Fig. 12 is a structural view of the inner valve frame and the barb arms in embodiment 2 of the present invention after being assembled.
Fig. 13 is a structural view of the inner leaflet frame of fig. 12 after sewing a barrier film thereto.
Fig. 14 is a perspective view of the outer valve frame in embodiment 2 of the present invention.
Fig. 15 is a front view of the outer valve frame in embodiment 2 of the present invention.
FIG. 16 is a schematic cross-sectional view of the novel valve replacement device of example 2.
The reference numerals are explained as follows:
in the figure: 1. an inner petal rack; 11. a first end; 12. a second end; 2. barb arms; 21. a bending section; 3. an outer petal rack; 31. a skirt portion; 32. a first bending part; 33. a second bending part; 34. a cone portion; 35. a second connecting portion; 4. a support body; 41. a support arm; 42. a circular ring portion; 43. a first connection portion; 5. a valve; 6. a first barrier film; 7. a second barrier film; 8. and a connection hole.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, based on the examples herein, which are within the scope of the invention as defined by the claims, will be within the scope of the invention as defined by the claims.
Example 1
Referring to fig. 1-7, the present embodiment provides a novel valve replacement device comprising an inner valve frame 1, barb arms 2, an outer valve frame 3, and a support body 4. The inner valve frame 1 is provided with a first end 11 and a second end 12, a cavity which penetrates through the first end 11 and the second end 12 is arranged in the inner valve frame 1, three valves 5 are arranged in the cavity, the valves 5 can be fixedly connected with the inner valve frame 1 in a sewing or bonding mode, and the prosthetic valves 5 can replace a primary valve to realize the functions of the normal aortic valve 5. The barb arms 2 are arranged on the outer side of the inner valve frame 1, nine barb arms 2 are distributed around the inner valve frame 1 at intervals, the lower ends of the barb arms 2 are fixedly connected with the inner valve frame 1, the upper ends of the barb arms are free ends, and the barb arms 2 are provided with bending sections 21 which are bent towards the inner valve frame 1. The outer valve frame 3 is positioned between the inner valve frame 1 and the barb arm 2, the lower end of the outer valve frame 3 is connected with the inner valve frame 1, and a gap for accommodating the valve 5 is formed between the barb arm 2 and the outer valve frame 3. One end of the supporting body 4 is connected with the inner petal frame 1, and the other end is contacted with the outer petal frame 3.
In this embodiment, the inner valve frame 1 has a stronger rigidity, the outer valve frame 3 has a smaller rigidity, the outer valve frame 3 can adapt to the D-shaped anatomical structure of the atrial wall and the valve annulus, and the dynamic change of the valve annulus caused by systole and diastole is elastically adapted by the outer valve frame 3, so that the shape of the inner valve frame 1 is not affected, and the hemodynamics stability of the valve 5 in the inner valve frame 1 is ensured.
In this embodiment, the inner flap frame 1 is sewn with a first barrier film 6, the outer flap frame 3 is sewn with a second barrier film 7, the first barrier film 6 and the second barrier film 7 have tightness and biocompatibility, and the barrier films can be PET films in specific implementation. As shown in fig. 3 and 5, a plurality of connection holes 8 may be provided on the first end 11 of the inner valve frame 1 and the outer valve frame 3, and the outer valve frame 3 may be connected to the inner valve frame 1 by rivet-fastening. In addition to the riveted connection, the outer flap frame 3 can also be connected to the inner flap frame 1 by means of welding.
In this embodiment, the bending section 21 is adjacent to the free end of the barb arm 2, and when the novel valve replacement device is implanted in a human body, the bending section 21 can be adjacent to the root of the native valve, thereby ensuring that the novel valve replacement device has a better fixing effect. The lower extreme of outer valve frame 3 is connected with the first end 11 of interior valve frame 1, and the lower extreme of barb arm 2 is connected with the first end 11 of interior valve frame 1, and this kind of structural design can ensure that this novel valve replacement device has less volume to reduce the influence that implanted novel valve replacement device led to the fact to the normal activity of heart.
In the present embodiment, the support body 4 comprises nine support arms 41, the nine support arms 41 being spaced around the inner valve frame 1; one end of the support arm 41 is connected to the inner valve frame 1, and the other end is in contact with the inner wall of the outer valve frame 3, and the outer valve frame 3 can press the support arm 41 to elastically deform in the radial direction of the inner valve frame 1. The nine support arms 41 provide a stable elastic support for the outer valve frame 3, so that when the native valve is clamped between the barb arms 2 and the outer valve frame 3, the barb arms 2 and the outer valve frame 3 can provide a proper clamping force, thereby further ensuring that the novel valve replacement device can be firmly fixed.
In this embodiment, the two ends of the supporting arm 41 are curved in arc shape, so as to ensure that the supporting arm 41 has a strong elastic deformation capability. In addition, the outer valve frame 3 is provided with a skirt portion 31 extending outwards at one end far away from the inner valve frame 1, and when the novel valve replacement device is implanted in a target position of a human body, the skirt portion 31 can be attached to an annulus to achieve a good sealing effect, and the peripheral leakage of the valve is effectively prevented.
As shown in fig. 4, the end of the support arm 41 adjacent to the outer petal holder 3 is at the same height as the bent section 21 along the axial direction of the inner petal holder 1. The number of the supporting arms 41 is equal to that of the barb arms 2, the supporting arms 41 are in one-to-one correspondence with the barb arms 2, and the axis of the inner valve frame 1, the supporting arms 41 and the barb arms 2 corresponding to the supporting arms 41 are coplanar. A pair of clamping points are formed between the bending section 21 on the barb arm 2 and the outer end of the supporting arm 41, the barb arm 2 and the supporting arm 41 are mutually matched to provide stronger clamping force, and the supporting arm 41 has good elastic deformation capacity and can be well adapted to dynamic changes of an annulus, so that the shape of the inner valve frame 1 is prevented from being influenced.
Example 2
Referring to fig. 8-15, the present embodiment provides another novel valve replacement device comprising an inner valve frame 1, barb arms 2, an outer valve frame 3, and a support body 4. The inner valve frame 1 is provided with a first end 11 and a second end 12, a cavity which penetrates through the first end 11 and the second end 12 is arranged in the inner valve frame 1, three valves 5 are arranged in the cavity, and the valves 5 can be fixedly connected with the inner valve frame 1 in a sewing or bonding mode. The barb arms 2 are arranged on the outer side of the inner valve frame 1, nine barb arms 2 are distributed around the inner valve frame 1 at intervals, the lower ends of the barb arms 2 are fixedly connected with the inner valve frame 1, the upper ends of the barb arms are free ends, and the barb arms 2 are provided with bending sections 21 which are bent towards the inner valve frame 1. The outer valve frame 3 is positioned between the inner valve frame 1 and the barb arm 2, the lower end of the outer valve frame 3 is connected with the inner valve frame 1, and a gap for accommodating the valve 5 is formed between the barb arm 2 and the outer valve frame 3. One end of the supporting body 4 is connected with the inner valve frame 1, and the other end is connected with the outer valve frame 3.
In this embodiment, the inner valve frame 1 has a stronger rigidity, the outer valve frame 3 has a smaller rigidity, the outer valve frame 3 can adapt to the D-shaped anatomical structure of the atrial wall and the valve annulus, and the dynamic change of the valve annulus caused by systole and diastole is elastically adapted by the outer valve frame 3, so that the shape of the inner valve frame 1 is not affected, and the hemodynamics stability of the valve 5 in the inner valve frame 1 is ensured. The first barrier film 6 is sewn on the inner flap frame 1, the second barrier film 7 is sewn on the outer flap frame 3, the first barrier film 6 and the second barrier film 7 are both provided with sealing performance and biocompatibility, the blood backflow is prevented through the arranged first barrier film 6 and second barrier film 7, and a PET film can be adopted as the barrier film in specific implementation.
In this embodiment, the bending section 21 is adjacent to the free end of the barb arm 2, and when the novel valve replacement device is implanted in a human body, the bending section 21 can be adjacent to the root of the native valve, thereby ensuring that the novel valve replacement device has a better fixing effect. The lower extreme of outer valve frame 3 is connected with the first end 11 of interior valve frame 1, and the lower extreme of barb arm 2 is connected with the first end 11 of interior valve frame 1, and this kind of structural design can ensure that this novel valve replacement device has less volume to reduce the influence that implanted novel valve replacement device led to the fact to the normal activity of heart.
Fig. 16 schematically shows a cross-sectional structure of the novel valve replacement device in this embodiment, as shown in the figure, in this embodiment, the support body 4 includes a circular ring portion 42 and a first connection portion 43, the circular ring portion 42 is provided with a through hole suitable for the penetration of the inner valve frame 1, the diameter of the through hole is slightly larger than the outer diameter of the inner valve frame 1, the first connection portion 43 is connected with the inner edge of the circular ring portion 42 and fixed with the inner valve frame 1, and the outer edge of the circular ring portion 42 is connected with the outer valve frame 3. The support body 4 provides stable support for the outer valve frame 3, so that proper clamping force can be generated between the outer valve frame 3 and the barb arm 2, and the novel valve replacement device can be firmly fixed.
As shown in fig. 16, the outer edge of the annular portion 42 is connected to the end of the outer petal holder 3 remote from the first end 11, i.e., the outer edge of the annular portion 42 is connected to the upper end of the outer petal holder 3. When the novel valve replacement device is implanted into a target position of a human body, the bending section 21 of the barb arm 2 clamps a primary valve mainly through being matched with the middle position of the outer valve frame 3, so that when the outer edge of the circular ring part 42 is connected with the upper end of the outer valve frame 3, the middle position of the outer valve frame 3 also has certain elastic deformation capacity, the structure of the outer valve frame 3 is stable due to the structural design, and the dynamic change of an annulus caused by systole and diastole can be elastically adapted by the middle position of the outer valve frame 3, so that the influence on the shape of the inner valve frame 1 is avoided.
As shown in fig. 14 and 16, the outer petal holder 3 is provided with a first bending portion 32 bent toward the bending section 21 and a second bending portion 33 bent toward the inner petal holder 1, the first bending portion 32 is adjacent to the second bending portion 33, and the first bending portion 32 is adjacent to the first end 11 of the inner petal holder 1 compared to the second bending portion 33. The first outward bend 32 on the outer valve frame 3 cooperates with the bend 21 on the barb arm 2 to form a space for holding the native valve, which space can provide a suitable holding range and a large holding force, so that the novel valve replacement device can be firmly fixed. Furthermore, the provision of the first bent portion 32 and the second bent portion 33 also enhances the supporting rigidity of the first bent portion 32 on the outer flap frame 3.
Referring to fig. 16, the outer petal frame 3 further includes a second connecting portion 35, a cone portion 34 and a skirt portion 31, the second connecting portion 35, the cone portion 34, the first bending portion 32, the second bending portion 33 and the skirt portion 31 are sequentially connected, and the second connecting portion 35 is fixed to the first end 11 of the inner petal frame 1; the diameter of the cone portion 34 gradually increases from the end of the cone portion 34 adjacent to the first end 11 to the end of the cone portion 34 away from the first end 11; the skirt portion 31 extends in a direction away from the inner leaflet frame 1 from one end of the second bending portion 33, and the outer edge of the skirt portion 31 is connected to the outer edge of the annular portion 42. The taper 34 is generally parallel to the lower half of the barb arm 2, forming a region therebetween for receiving a native valve. When the novel valve replacement device is implanted in a target position of a human body, the skirt edge part 31 can be attached to an annulus, so that a good sealing effect is achieved, and the perivalvular leakage is effectively prevented. The outer valve frame 3 in the embodiment can be better matched with the physiological structure in the heart, so that the implantation operation is convenient.
In the present embodiment, the plane of the annular portion 42 is perpendicular to the axis of the inner petal frame 1, so as to ensure that the support body 4 can provide a good supporting effect. In addition, the first connecting portion 43 and the second connecting portion 35 are both cylindrical, a through hole suitable for the inner valve frame 1 to pass through is formed in the center of the first connecting portion 43 and the center of the second connecting portion 35, and the first connecting portion 43 and the second connecting portion 35 are sleeved on the outer side of the inner valve frame 1. By providing the first connecting portion 43 and the second connecting portion 35 in a cylindrical shape, the first connecting portion 43 and the second connecting portion 35 can be wrapped around the inner valve frame 1 in all directions, so that the connection between the first connecting portion 43, the second connecting portion 35 and the inner valve frame 1 is more firm, and the cylindrical first connecting portion 43 and second connecting portion 35 are easier to process.
The first connecting portion 43 and the second connecting portion 35 may be connected to the inner petal frame 1 by means of mechanical connection such as rivet riveting, welding, insert crimping, or the like. For example, when the second connection portion 35 is connected to the inner valve frame 1 by a rivet, a connection hole 8 for passing the rivet may be provided at the first end 11 of the inner valve frame 1.
As shown in fig. 16, the circular ring portion 42 and the first connecting portion 43 are in smooth transition, and the second connecting portion 35 and the cone portion 34 are in smooth transition, so that the structural design can enhance the elasticity of the skeleton of the outer valve frame 3, promote the inner valve frame 1 to be elastically isolated, reduce the extrusion force of the dynamic change of the valve ring to the inner valve frame 1, and further ensure the hemodynamic stability of the middle valve 5.
In the concrete implementation, the outer valve frame 3 and the supporting body 4 are integrally woven and formed by adopting a weaving process, the preparation process is mature, the yield can be ensured, and the outer valve frame 3 and the supporting body 4 prepared by the process have excellent elastic deformation capability, so that the inner valve frame 1 is further ensured not to be deformed due to dynamic change of an annulus. As shown in fig. 16, the skirt portion 31 is substantially parallel to the annular portion 42, and the skirt portion 31 and the annular portion 42 form a double-layered sealing structure, which has better sealing property with the annulus, and can more effectively prevent leakage around the valve. As shown in fig. 14, the outer valve frame 3 is integrally attached with the support body 4, that is, the sewn second barrier film 7 on the outer valve frame 3 extends to the support body 4 and is laid over the support body, and blood reflux is further prevented by providing barrier films on the outer valve frame 3 and the support body 4 together.
The number of barb arms 2 in both embodiments 1 and 2 of the present invention is nine, and in some embodiments the barb arms 2 may be other numbers. Preferably, the number of barb arms 2 is 6-12 in order to provide a sufficient number of gripping points to ensure that the new valve replacement device can be stably secured. The inner valve frame 1, the barb arms 2, the outer valve frame 3 and the supporting body 4 are made of shape memory materials, such as nickel-titanium alloy, so as to realize the expansion and contraction performance of the novel valve replacement device. The valve 5 may be of any suitable material, such as natural tissue (bovine pericardium) or synthetic material.
The foregoing is merely illustrative of the present invention, and the present invention is not limited thereto, and any person skilled in the art will readily recognize that variations or substitutions are within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.
Claims (19)
1. A novel valve replacement device, comprising:
an inner valve frame, wherein the inner valve frame is provided with a first end and a second end, a cavity channel penetrating through the first end and the second end is arranged in the inner valve frame, and a valve is arranged in the cavity channel;
the barb arms are positioned on the outer side of the inner valve frame, a plurality of barb arms are distributed around the inner valve frame at intervals, one end of each barb arm is connected with the inner valve frame, the other end of each barb arm is a free end, and bending sections which bend towards the inner valve frame are arranged on the barb arms;
an outer valve frame, wherein the outer valve frame is positioned between the inner valve frame and the barb arm, one end of the outer valve frame is connected with the inner valve frame, and a gap for accommodating a valve is formed between the barb arm and the outer valve frame;
and one end of the support body is connected with the inner valve frame, and the other end of the support body is connected or contacted with the outer valve frame.
2. The novel valve replacement device of claim 1, wherein: the bent section is adjacent to the free end of the barb arm.
3. The novel valve replacement device of claim 1, wherein: one end of the outer valve frame is connected with the first end of the inner valve frame, and one end of the barb arm is connected with the first end of the inner valve frame.
4. The novel valve replacement device of claim 1, wherein: the inner valve frame is attached with a first barrier film, and the outer valve frame is attached with a second barrier film.
5. The novel valve replacement device of any one of claims 1 to 4, wherein: the support body comprises a plurality of support arms which are distributed at intervals around the inner valve frame; one end of the supporting arm is connected with the inner valve frame, the other end of the supporting arm is in contact with the inner wall of the outer valve frame, and the outer valve frame can press the supporting arm to elastically deform along the radial direction of the inner valve frame.
6. The novel valve replacement device of claim 5, wherein: the two ends of the supporting arm are provided with arc-shaped bending sections.
7. The novel valve replacement device of claim 5, wherein: along the axial direction of the inner valve frame, one end, close to the outer valve frame, of the supporting arm is at the same height with the bending section.
8. The novel valve replacement device of claim 5, wherein: the number of the supporting arms is equal to that of the barb arms, the supporting arms correspond to the barb arms one by one, and the axis of the inner valve frame, the supporting arms and the barb arms corresponding to the supporting arms are coplanar.
9. The novel valve replacement device of claim 5, wherein: and one end of the outer petal frame, which is far away from the inner petal frame, is provided with a skirt edge part.
10. The novel valve replacement device of any one of claims 1 to 4, wherein: the support body comprises a circular ring part and a first connecting part, a through hole suitable for the inner valve frame to penetrate is formed in the circular ring part, the first connecting part is connected with the inner edge of the circular ring part and fixed with the inner valve frame, and the outer edge of the circular ring part is connected with the outer valve frame.
11. The novel valve replacement device of claim 10, wherein: the outer edge of the circular ring part is connected with one end of the outer valve frame far away from the first end.
12. The novel valve replacement device of claim 11, wherein: the plane of the circular ring part is perpendicular to the axis of the inner valve frame.
13. The novel valve replacement device of claim 10, wherein: the first connecting portion is cylindric, and the center of first connecting portion is equipped with the through-hole that is suitable for interior lamella frame passes, first connecting portion cover the outside of interior lamella frame.
14. The novel valve replacement device of claim 10, wherein: the outer flap frame is provided with a first bending part which bends towards the bending section and a second bending part which bends towards the inner flap frame, the first bending part is adjacent to the second bending part, and the first bending part is adjacent to the first end of the inner flap frame compared with the second bending part.
15. The novel valve replacement device of claim 14, wherein: the outer valve frame further comprises a second connecting part, a cone part and a skirt edge part, wherein the second connecting part, the cone part, the first bending part, the second bending part and the skirt edge part are sequentially connected, and the second connecting part is fixed with the first end of the inner valve frame; the diameter of the cone part gradually becomes larger from one end of the cone part close to the first end to one end of the cone part far away from the first end; the skirt portion extends in a direction away from the inner flap frame with an end of the second bent portion as a starting point, and an outer edge of the skirt portion is connected to an outer edge of the annular portion.
16. The novel valve replacement device of claim 15, wherein: the second connecting portion is cylindric, and the center of second connecting portion is equipped with the through-hole that is suitable for interior lamella frame passes, second connecting portion cover the outside of the first end of interior lamella frame.
17. The novel valve replacement device of claim 15, wherein: the skirt portion is substantially parallel to the annular portion.
18. The novel valve replacement device of claim 10, wherein: the outer valve frame and the supporting body are integrally woven and formed by adopting a weaving process.
19. The novel valve replacement device of claim 18, wherein: the outer valve frame and the supporting body are integrally attached with a barrier film.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311039646.6A CN116869707A (en) | 2023-08-17 | 2023-08-17 | Novel valve replacement device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311039646.6A CN116869707A (en) | 2023-08-17 | 2023-08-17 | Novel valve replacement device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN116869707A true CN116869707A (en) | 2023-10-13 |
Family
ID=88255218
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311039646.6A Pending CN116869707A (en) | 2023-08-17 | 2023-08-17 | Novel valve replacement device |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN116869707A (en) |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016055262A1 (en) * | 2014-10-06 | 2016-04-14 | Xpand Medical SAS | Aortic valve replacement prosthesis |
| CN106175987A (en) * | 2016-08-31 | 2016-12-07 | 上海纽脉医疗科技有限公司 | Cardiac valve prosthesis |
| CN107212950A (en) * | 2017-07-12 | 2017-09-29 | 宁波健世生物科技有限公司 | A kind of heart valve prosthesis with clamping device |
| CN107613907A (en) * | 2015-04-27 | 2018-01-19 | 杭州启明医疗器械有限公司 | Heart valve assemblies |
| US20180206983A1 (en) * | 2015-05-14 | 2018-07-26 | Spencer NOE | Replacement mitral valves |
| US20190038405A1 (en) * | 2017-08-03 | 2019-02-07 | Cardiovalve Ltd. | Prosthetic Heart Valve |
| CN109843218A (en) * | 2016-12-02 | 2019-06-04 | 赛诺医疗科学技术股份有限公司 | Low profile heart valve and transportation system |
| CN111110402A (en) * | 2020-01-09 | 2020-05-08 | 南京圣德医疗科技有限公司 | Structure-fitted transcatheter aortic valve implantation device |
| US20220378410A1 (en) * | 2010-07-21 | 2022-12-01 | Cardiovalve Ltd. | Helical anchor implantation |
-
2023
- 2023-08-17 CN CN202311039646.6A patent/CN116869707A/en active Pending
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20220378410A1 (en) * | 2010-07-21 | 2022-12-01 | Cardiovalve Ltd. | Helical anchor implantation |
| WO2016055262A1 (en) * | 2014-10-06 | 2016-04-14 | Xpand Medical SAS | Aortic valve replacement prosthesis |
| CN107613907A (en) * | 2015-04-27 | 2018-01-19 | 杭州启明医疗器械有限公司 | Heart valve assemblies |
| US20180206983A1 (en) * | 2015-05-14 | 2018-07-26 | Spencer NOE | Replacement mitral valves |
| CN106175987A (en) * | 2016-08-31 | 2016-12-07 | 上海纽脉医疗科技有限公司 | Cardiac valve prosthesis |
| CN109843218A (en) * | 2016-12-02 | 2019-06-04 | 赛诺医疗科学技术股份有限公司 | Low profile heart valve and transportation system |
| CN107212950A (en) * | 2017-07-12 | 2017-09-29 | 宁波健世生物科技有限公司 | A kind of heart valve prosthesis with clamping device |
| US20190038405A1 (en) * | 2017-08-03 | 2019-02-07 | Cardiovalve Ltd. | Prosthetic Heart Valve |
| CN111110402A (en) * | 2020-01-09 | 2020-05-08 | 南京圣德医疗科技有限公司 | Structure-fitted transcatheter aortic valve implantation device |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN108578016B (en) | Trans-apex implantable mitral valve device | |
| EP2359774B1 (en) | Connecting band and stress absorbing frame for higly flexible heart valve | |
| EP2918248A1 (en) | An expandable stent-valve and a delivery device | |
| JP2012508033A (en) | Heart valve device with stent | |
| JP2013543399A (en) | Prosthetic heart valve frame with flexible commissure | |
| KR102563467B1 (en) | Pulmonary ball valve assembly via catheter | |
| WO2022151622A1 (en) | Valve prosthesis and valve prosthesis system | |
| WO2023284663A1 (en) | Valve stent, valve prosthesis and valve prosthesis system | |
| CN113081394B (en) | Artificial heart valve | |
| JP6987890B2 (en) | Artificial bicuspid valve, artificial tricuspid valve and their stents | |
| US20220175523A1 (en) | Stent device for a prosthetic heart valve | |
| CN116269942B (en) | Artificial heart valve | |
| CN215688788U (en) | Valve prosthesis and valve prosthesis system | |
| US20220031452A1 (en) | Prosthesic heart valve | |
| CN218338568U (en) | Artificial heart valve support and heart valve prosthesis | |
| CN115105264A (en) | Valve stent and valve prosthesis system | |
| CN218338567U (en) | Implanted heart valve stent and heart valve prosthesis | |
| CN116869707A (en) | Novel valve replacement device | |
| CN115068172B (en) | Artificial heart valve support and heart valve prosthesis | |
| CN115177409A (en) | Implanted heart valve stent and heart valve prosthesis | |
| CN115252224A (en) | Heart valve support and heart valve prosthesis | |
| CN215425319U (en) | Valve prosthesis and valve prosthesis system | |
| CN218338569U (en) | Heart valve support and heart valve prosthesis | |
| CN217186592U (en) | Valve prosthesis | |
| CN116869708A (en) | Valve replacement device |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |