CN112773565A - Adjustable auxiliary device and system for heart valve - Google Patents
Adjustable auxiliary device and system for heart valve Download PDFInfo
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- CN112773565A CN112773565A CN202110177534.1A CN202110177534A CN112773565A CN 112773565 A CN112773565 A CN 112773565A CN 202110177534 A CN202110177534 A CN 202110177534A CN 112773565 A CN112773565 A CN 112773565A
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—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
-
- 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
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (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 invention relates to a heart valve adjustable auxiliary device and a system, which comprise an annular support piece, a plurality of connecting elements and a blocking piece; the annular support has an expandable annular mesh structure capable of anchoring to the annulus tissue and/or the atrial wall of the human body; a plurality of connecting elements connecting the annular support with a block piece which can be held by the plurality of connecting elements in an area substantially enclosed by the annular support; the plugging piece is used for providing a matching surface which is mutually contacted with the human valve leaflet; the blocking piece comprises a frame structure, a fixing piece fixed on one side of the inflow end of the frame structure, a flexible covering piece covering the outside of the frame structure, and at least one adjusting mechanism arranged inside the frame structure; the adjustment mechanism is used to adjust the height and/or shape of the frame structure. The auxiliary device and the auxiliary system have small damage to a human body and good durability, and can effectively relieve the regurgitation of the mitral valve or the tricuspid valve. The blocking piece can be adjusted in size and shape in multiple dimensions to meet the requirements of different patients.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to an adjustable heart valve auxiliary device and system.
Background
Heart valves are membranous structures that can be opened and closed inside the organs of humans or some animals. Each individual has four valves in the heart, namely an aortic valve that joins the left ventricle and the aorta, a pulmonary valve that joins the right ventricle and the pulmonary arteries, a mitral valve that joins the left atrium and left ventricle, and a tricuspid valve that joins the right atrium and right ventricle. They all act as one-way valves, allowing blood to flow only from one direction to the other, but not back.
Mitral regurgitation is a disease of the heart in which the leaflets of the mitral valve fail to coapt closed at peak systolic pressure, resulting in abnormal leakage of blood from the left ventricle into the left atrium. There are a number of structural factors that may affect proper closure of the mitral valve leaflets. For example, many patients with heart disease experience dilation of the heart muscle, resulting in enlargement of the mitral annulus. Dilation of the mitral annulus makes it difficult for the leaflets to coapt completely during systole. Stretching or tearing of the chordae tendineae may also affect proper closure of the mitral annulus. For example, chordae rupture may cause the valve leaflets to prolapse into the left atrium due to insufficient tension on the leaflets. Abnormal reflux also occurs when the function of the papillary muscles is impaired (e.g. due to ischemia). Since the left ventricle contracts during systole, the affected papillary muscles do not contract sufficiently to achieve proper closure. Currently, the methods for treating mitral regurgitation mainly include annuloplasty, repair of chordae tendineae, suturing or clamping of leaflet parts, and replacement of prosthetic valves.
Taking the prior art approach of transcatheter mitral valve replacement surgery (TMVR) with catheter intervention as an example, it compresses the prosthetic valve extracorporeally to a delivery system, delivers it to the mitral annulus of the human body, and releases the prosthetic valve to be fixed at the mitral annulus to replace the native valve. However, the durability of the biological leaflets in the replacement device, and the incorrect size of the annuloplasty ring, may present other problems to the patient. In addition, many revision surgeries are highly dependent on the skill of the cardiac surgeon, in which case improper placement or removal of the clamping device may affect the success of the surgery and the post-operative rehabilitation process.
There is also a class of valve repair devices in the prior art that provide a surface that mates with the valve leaflets to effect closure of the mitral valve. However, it does not form an ideal sealing surface for different cases.
Disclosure of Invention
The invention discloses an adjustable auxiliary device and an adjustable auxiliary system for a heart valve, and aims to solve the technical problems in the prior art.
The invention adopts the following technical scheme: a heart valve tunable assist device comprising an annular support, a plurality of connecting elements, and a closure; the annular support and the closure member being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration;
the annular support is an annular reticular structure and can be anchored on human valve annulus tissue and/or atrial wall;
a plurality of connecting elements connecting the annular support with a block piece which can be held by the plurality of connecting elements in an area substantially enclosed by the annular support;
the plugging piece is used for providing a matching surface which is mutually contacted with the human valve leaflet; the blocking piece comprises a frame structure, a fixing piece fixed on one side of the inflow end of the frame structure, a flexible covering piece covering the outside of the frame structure and at least one adjusting mechanism arranged inside the frame structure; the adjustment mechanism is used to adjust the height and/or shape of the frame structure.
Preferably, the annular support comprises a plurality of joints on the outflow end side, at least 3 of which are each connected to a connecting element.
Preferably, the plurality of joints are connected with an annular elastic member, and the annular elastic member is configured to be in a stretched state after the auxiliary device is implanted into a human body and released.
As a preferred solution, the device has four connecting elements, the curved ends of which are respectively integrally formed with four evenly distributed joints of the annular support; the straight ends of the four connecting elements are all connected with the plugging piece.
Preferably, the annular support comprises anchoring means for anchoring the annular support to the annulus of the human body.
Preferably, the anchoring structure comprises anchoring barbs arranged on the outer side of said annular support, said anchoring barbs being adapted to penetrate the annulus tissue and/or the atrial wall of the human body.
Preferably, the anchoring structure comprises a plurality of anchoring member fixing frames arranged on one side of the outflow end of the annular support member, the anchoring member fixing frames are connected to the net frame of the annular support member, and the anchoring member fixing frames are provided with hole arrays which allow the anchoring members to be screwed in.
Preferably, the anchoring structure comprises a plurality of top brackets arranged on one side of the inflow end of the annular support, at least part of the top brackets are provided with anchoring connecting frames, and the anchoring connecting frames are provided with hole arrays which allow the anchoring pieces to be screwed in.
Preferably, the anchoring structure includes a fixing hole provided to the plurality of engaging portions, the fixing hole allowing an anchor to pass therethrough.
Preferably, the anchor is a helical coil anchor or a barb anchor.
Preferably, the frame structure of the closure is made of a shape memory alloy, and the radial cross-section is substantially half-moon shaped, substantially meniscus shaped or substantially kidney shaped in the natural state.
As a preferred technical scheme, the adjusting mechanism comprises an axial telescopic mechanism, the axial telescopic mechanism comprises an axial adjusting screw rod and a screw cap, two ends of the axial telescopic mechanism are respectively connected with the fixing piece and the bottom of one side of the frame structure outflow end and used for adjusting the distance between the fixing piece and the bottom of one side of the frame structure outflow end, and then the height and/or the shape of the frame structure are adjusted.
As preferred technical scheme, the frame construction of shutoff piece includes latticed structure, and frame construction can reduce the axial height when the axial telescopic machanism contracts and radially expand simultaneously, and can increase the axial height when the axial telescopic machanism extends and radially contract simultaneously.
Preferably, the adjustment mechanism comprises a radial adjustment mechanism for applying a radial force to the frame structure, thereby adjusting the shape of the frame structure.
As the preferred technical scheme, the frame structure at least has a convex curved surface and a concave curved surface in a natural state; the radial adjusting mechanism is used for applying radial acting force to the concave curved surface and/or the convex curved surface so as to adjust the shape of the concave curved surface and/or the convex curved surface.
As a preferred technical solution, the radial adjusting mechanism includes a fixing sleeve, a radial adjusting screw passing through the fixing sleeve, at least one push rod hinged to the fixing sleeve at one end of a nut sleeved on the radial adjusting screw, and at least one connecting rod for respectively hinging the nut to the push rod.
Preferably, the axial adjusting screw or the radial adjusting screw of the axial telescopic mechanism or the radial adjusting mechanism passes through the fixing member and is rotatably connected with the fixing member, and the rotating shaft is fixedly connected with the connecting member on the outer surface of the fixing member.
As a preferred technical solution, the adjusting mechanism comprises a balloon arranged in the frame structure, and the balloon is provided with a fluid channel penetrating through the fixing piece; the balloon is capable of fluid inflation and release to adjust the height and/or shape of the frame structure.
As a preferred technical scheme, the cross section of the bottom of the annular support part is a D-shaped or elliptic closed loop surrounded by convex curves.
The invention also provides an adjustable heart valve auxiliary system, which comprises any one of the auxiliary devices and a conveying device; the conveying device comprises a guide pipe and a plurality of rotary operation pipes arranged in the guide pipe; the inner diameter of the conduit can accommodate the annular support and the plugging piece after radial collapse; the rotary operating pipe can be detachably connected to each of the coupling members by the coupling head.
As a preferred technical scheme, the device also comprises a plurality of anchoring parts, wherein each anchoring part comprises a spiral coil anchor or a barb anchor; the anchor has an implanted end and a connector.
Preferably, the plugging piece further comprises a fluid pipeline which can be communicated with the fluid channel of the plugging piece.
The technical scheme adopted by the invention can achieve the following beneficial effects: the adjustable heart valve auxiliary device and the adjustable heart valve auxiliary system have small damage to a human body and good durability, and can effectively relieve the regurgitation of the mitral valve or the tricuspid valve. The auxiliary device is suitable for being implanted into a mitral valve or a tricuspid valve of the left atrium or the right atrium of a heart of a human body through a catheter to form a complete closed surface, effectively eliminates the blood reflux condition, cannot damage the normal physiological function of valve leaflets of the human body after implantation, plays a role in limiting the expansion of valve ring tissues and promotes the postoperative rehabilitation of a patient. The blocking piece can be adjusted in size and shape in multiple dimensions to meet the requirements of different patients.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below to form a part of the present invention, and the exemplary embodiments and the description thereof illustrate the present invention and do not constitute a limitation of the present invention. In the drawings:
FIG. 1 is a schematic structural diagram of a heart valve adjustable auxiliary device disclosed in embodiment 1 of the present invention;
fig. 2 is a schematic structural diagram of the heart valve adjustable auxiliary device disclosed in embodiment 1 of the present invention.
FIG. 3 is a schematic structural diagram of the adjustable heart valve assist device disclosed in example 1 of the present invention;
FIG. 4 is a schematic structural diagram of the adjustable heart valve assist device disclosed in example 1 of the present invention;
FIG. 5 is a schematic structural diagram of the adjustable heart valve assist device disclosed in example 1 of the present invention;
FIG. 6 is a schematic structural diagram of a blocking piece of the adjustable heart valve assist device disclosed in example 1 of the present invention;
FIG. 7A is a schematic structural diagram of a blocking member of the adjustable heart valve assist device disclosed in example 2 of the present invention;
FIG. 7B is a schematic structural diagram of a blocking member of the adjustable heart valve assist device disclosed in example 2 of the present invention;
fig. 8A is a perspective view and a top view of an axial telescopic mechanism in a first telescopic state in embodiment 1 of the present invention;
fig. 8B is a perspective view and a top view of the axial retracting mechanism in the second retracting state in embodiment 1 of the present invention;
fig. 8C is a perspective view and a top view of the axial telescopic mechanism in the second telescopic state and the radial adjusting screw rod contracted in embodiment 2 of the present invention;
FIG. 9 is a schematic structural diagram of a blocking member of the adjustable heart valve assist device disclosed in example 3 of the present invention;
FIG. 10 is a schematic structural diagram of the adjustable heart valve assist system disclosed in example 4 of the present invention;
FIG. 11 is a schematic structural diagram of the adjustable heart valve assist system disclosed in example 4 of the present invention;
fig. 12 is a schematic structural diagram of the heart valve adjustable assist system disclosed in embodiment 4 of the present invention.
Description of reference numerals:
a heart valve adjustable assist device 100; a human valve 200; the anterior leaflet 200 a; posterior leaflet 200 b; human annulus tissue 300; the atrial wall 400;
an annular support 10; a top bracket 11; an anchor attachment bracket 111; an anchor 112; a joint portion 12; a fixing hole 121; an anchor mount 13; an annular elastic member 14; an anchoring spike 15;
a connecting element 20;
a blocking piece 30; a frame structure 31; a convex curved surface 311; a concave curved surface 312; an axial retracting mechanism 32; a fixing member 33; an axial telescopic coupling 331; the radial adjustment coupling 332; a fluid passage 333; a flexible cover 34; a radial adjustment mechanism 35; the fixed sleeve 351; a radial adjusting screw 352; a nut 353; the connecting rod 354; a first push rod 355; a second push rod 356; a balloon 36;
a conveying device 40; a conduit 41; rotating the handling tube 42; a coupling head 43.
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 clearly and completely described below with reference to the specific embodiments of the present invention and the accompanying drawings. In the description of the present invention, it is noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
As used herein, the "outflow tract" refers to the left ventricular outflow tract when the heart valve adjustable assist device 100 is a mitral valve, and the "outflow tract" refers to the right ventricular outflow tract when the heart valve adjustable assist device 100 is a tricuspid valve.
As used herein, "substantially enclosed" refers to an open space defined by open curves, rather than a closed space defined by a complete curve, and it is not intended that the space be enclosed above and below, nor that the closure 30 extend beyond the area between the loop supports 10.
It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
Example 1 provides a heart valve adjustable assist device 100, which according to fig. 1-5, 12 essentially comprises an annular support 10 arranged adjacent to human annular tissue 300 and/or atrial wall 400, and an occluding member 30 arranged in the middle of the annular support 10. In particular, comprising an annular support 10, a plurality of connecting elements 20 and a block piece 30; the annular support 10 and the closure member 30 are radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration.
The loop support 10 has an expandable loop mesh structure capable of anchoring to the human annulus tissue 300 and/or the atrial wall 400; a diamond grid structure is particularly preferred to facilitate collapsing in the conduit 41. Preferably comprises a single layer of diamond-shaped net frames distributed around the periphery, and a plurality of diamond-shaped net frames which are stacked and connected can also be adopted. Preferably, the annular support 10 is a unitary structure made from metal tubing by laser cutting.
According to fig. 1-5, the anchoring position of the annular support 10 may cover all or part of the area of the human annulus tissue 300 as well as part of the area of the atrial wall 400 near the annulus. According to fig. 1-3, the annular support 10, which is surrounded by curved surfaces, has a smaller circumference on the outflow end side and overall assumes an upwardly (towards the inflow end) open shape. Referring to fig. 12, the ring-shaped support 10 adheres well to both the human annulus tissue 300 and the atrial wall 400.
In another embodiment, according to fig. 4-5, the anchoring position of the loop-shaped support 10 covers only a partial area of the atrial wall 400 close to the annulus. According to fig. 4-5, the annular support 10, which is surrounded by curved surfaces, has approximately the same circumference on the outflow end side and on the inflow end side, and the annular support 10 can likewise be anchored stably on the atrial wall.
In another embodiment, the anchoring position of the loop support 10 can cover all or part of the area of the human annulus tissue 300 at the same time. It will be understood by those skilled in the art that when the width of the curved annular band of the annular support 10 is small, the annular support 10 can be anchored only to the human annular tissue 300, and of course, the annular support 10 can also achieve stable anchoring to the human annular tissue 300.
According to fig. 1 to 5, a plurality of connecting elements 20 connect the annular support 10 with the plug 30, the plug 30 being able to be held by the plurality of connecting elements 20 in an area substantially enclosed by the annular support 10. The connecting element 20 is made of a shape memory alloy, such as nitinol, for delivery through the catheter 41 to the heart valve of the human body in a compressed configuration, and returns to a predetermined expanded configuration after release by the protective sheath.
According to fig. 1-5, the number of connecting elements 20 is preferably 4, already providing a stable support in both the X-axis and the Y-axis. The curved ends of the 4 connecting elements 20 are each integrally formed with 4 evenly distributed (substantially equally spaced) engaging portions 12 of the annular support 10. In the preferred embodiment, the number of joints 12 at the lower end (outflow end) of the annular support 10 is 16, wherein one connecting element 20 is connected to each of the joints 12 of the 1 st, 5 th, 9 th and 13 th in sequence. It should be understood by those skilled in the art that the number of the engaging portions 12 is not limited to 16, and the present embodiment does not limit this. The connecting element 20 can be seen as a strip extending from the joint 12 to the stopper 30; and extends first downwardly and then upwardly and finally is a substantially straight segment near the end of the closure 30. The 4 connecting elements 20 are connected to the occluding member 30 at their linear ends, which are located higher than the annular support 10, i.e., the linear ends are located closer to the inflow end than the junctions 12 at the lower end of the annular support 10, so as to avoid interference of the body valve 200 with the connecting elements 20 in the closed state.
In another embodiment, the number of the connecting elements 20 can be 3, and the included angles between the connecting elements 20 are approximately 120 degrees. It is also possible to provide stable support while reducing obstruction to blood flow. Preferably, one of the connecting elements 20 faces the concave curve of the closure 30 and is parallel to the plane of symmetry of the closure 30.
Preferably, a plurality of joints 12 are connected to the annular elastic member 14, and the annular elastic member 14 is configured to be in a stretched state when the auxiliary device is implanted in a human body and released. The connection between the annular elastic member 14 and the joint portion 12 may be achieved by inserting the annular elastic member 14 through a hole or a ring formed in the joint portion 12, or placing the annular elastic member 14 into a fixing groove formed in the joint portion 12, or by welding or snapping.
Preferably, according to fig. 1, 3, 4, the plurality of joints 12 each have a fixation hole 121, the fixation hole 121 allowing the anchor 112 to pass through, the anchor 112 comprising a helical coil anchor or a barb anchor. Anchor 112 has an implanted end that is the portion that anchors into tissue, and a coupling that is the portion that mates with delivery device 40. The implant end is anchored to the annulus tissue 300 after passing through the fixation holes 121, and the coupler is sized larger than the fixation holes 121 and remains on one side of the fixation holes 121 (the inner side surrounded by the ring support 10) to thereby anchor the ring support 10 to the annulus. In a preferred embodiment, the anchor 112 may comprise a sleeve and a helical coil anchor or barb anchor (with barbs spreading apart after passing through tissue) received within the sleeve that is rotatably coupled to the working tool upon release to facilitate anchoring of the annular anchoring element into the annular tissue after release is complete.
In order to fix the position of the annular support 10 against the annulus of the human body and to stabilize the position of the occluding member 30, the following preferred embodiments provide a variety of anchoring structures.
Preferably, according to fig. 1, the annular support 10 is provided with anchoring barbs 15 on the outside for piercing the human annulus tissue 300 and/or the atrial wall 400. The anchoring spines 15 are circumferentially distributed, and the distribution band is preferably positioned on the side close to the outflow end so as to give stronger anchoring effect to the human valve annulus. The distribution of the anchoring spikes 15 can be a single loop, a double loop as shown in fig. 1, or multiple loops, even on the inflow end side.
Preferably, according to fig. 2-3 and 5, on the side of the annular support 10 close to the outflow end, there are a plurality of anchor holders 13. Preferably, according to fig. 2, the anchor holder 13 is connected at one end to the joint 12 and at the other end provides a screw hole allowing the anchor 112 to be screwed in or a barbed anchor to be inserted; preferably, according to fig. 2 and 5, the anchor holder 13 is attached to a diamond-shaped grid of the annular support 10, the free end of the anchor holder 13 having an array of holes which allow the helical coil anchor to be screwed in.
Preferably, the anchor mount 13 is positioned as close to the outflow end as possible, and therefore preferably screwed into the human annulus tissue 300 to provide a more stable anchoring action. At the same time, since the connecting element 20 is likewise connected to the side of the annular support 10 close to the outflow end, the anchor holder 13 and its helical coil anchor have a synergistic effect on stabilizing the position of the block piece 30.
Preferably, according to fig. 4, the annular support 10 comprises a plurality of top brackets 11 on the side of the inflow end, at least part of the top brackets 11 having anchoring lugs 111, the anchoring lugs 111 having an array of holes allowing the helical coil anchors to be screwed in. The number of the anchoring links 111 is preferably 4, corresponding to the diamond-shaped lattice structure units of the 4 connection elements 20. The helical coil anchor has a helical implanted end that is threaded into the hole array (e.g., five hole array) and then continues to thread outward into the atrial wall 400, and has an interference fit with the hole array to prevent undesired loosening or dislodging of the helical coil anchor.
The above preferred anchoring means of the annular support 10 can be implemented individually or in a mixture of several. With the above various preferred anchoring manners of the annular support 10, and the spring elements formed between the junctions 12, in a stretched state after the auxiliary device is implanted in the human body and released, the spring elements tend to circumferentially contract the annular support 10 (particularly the outflow end side of the annular support 10) so that the cross-sectional dimension of the native valve annulus anchored to the annular support 10 is maintained at a desired dimension. Further, through the combined action of the anchoring structure and the spring elements, the valve repair device can limit the size of the heart valve annulus that is further expanded, thereby bringing the native or artificial leaflets closer together again and better coaptation of the leaflets during systole.
The plugging member 30 will be described below with reference to fig. 6, 7A to 7B, and 8A to 8C. The occluding member 30 is adapted to provide a mating surface for interfacing with the body valve 200 in a mating relationship, as shown in fig. 11, to form a desired sealing surface to prevent regurgitation of blood into the heart by sufficient engagement of the mating surface of the occluding member 30 with the body valve 200. The frame structure 31 of the closure 30 is made of a shape memory alloy and is naturally of a generally half-moon or generally meniscus or generally kidney-shaped radial cross-section. It will be appreciated by those skilled in the art that the mating surfaces are circumferential sides of the closure 30. The top surface of the occluding member 30 is a streamlined structure, and the cross section thereof is gradually reduced from the top to the bottom (from the inflow end to the outflow end) of the occluding member 30 to reduce the resistance to blood flow.
The size, shape, and location of the mating surfaces of the occluding member 30 and the body valve leaflets in contact with each other have a significant effect on the effectiveness of the barrier to blood regurgitation. Since the damage and functional defects of the valve leaflets of different patients vary from person to person, the adjustment of the size, shape and position of the occluding piece 30 can be accurately adapted to the specific conditions of the patient, providing a more ideal occluding effect.
According to fig. 4, the closure element 30 comprises a frame structure 31, a fastening element 33 fastened to the inflow end side of the frame structure 31, a flexible covering element 34 covering the frame structure 31, and at least one adjusting mechanism arranged inside the frame structure 31, which adjusting mechanism consists of a device reversibly adjustable by means of an external operating mechanism for reversibly adjusting the height and/or shape of the frame structure 31. Preferably, the frame structure 31 is made of a shape memory element with good biocompatibility, preferably an interlaced net structure, such as a diamond grid structure, the frame structure 31 can be deformed under an external force to change the shape and size of the natural shape, and specifically, the frame structure 31 can reduce the axial height while expanding radially when the axial expansion mechanism 32 contracts, and can increase the axial height while contracting radially when the axial expansion mechanism 32 expands.
The flexible cover 34 is preferably a flexible fabric and blocks blood from entering the interior of the closure 30. The shape of the fixing member 33 is preferably a circular truncated cone, and the upper portion of the circular truncated cone is a streamline curved surface to reduce the blood flow resistance. The securing elements 33 serve on the one hand to connect the frame structure 31 and provide the point of application of the adjustment mechanism and on the other hand to be fixedly connected to the connecting elements 20, so that the entire occluding element 30 is stably held in a position in which the body leaflets do not close well.
According to fig. 6, the adjusting mechanism comprises an axial telescopic mechanism 32, and two ends of the axial telescopic mechanism 32 are respectively connected with the fixing member 33 and the bottom of the frame structure 31 at the outflow end side, so as to adjust the distance between the fixing member 33 and the bottom of the frame structure 31 at the outflow end side, and further adjust the height and/or shape of the frame structure 31. After the valve repair device is implanted in the human heart, the height of the frame structure 31 is changed by the adjustment mechanism (axial telescoping mechanism 32) to properly adjust the shape of the mating surface so that the occluding member 30 is brought into optimal contact fit with the human valve leaflets after implantation.
The adjusting effect of the adjusting mechanism will be described with reference to the figure of the profile-changing effect of the block piece 30. Fig. 8A shows a perspective view and a plan view of the closing member 30 when the axial retracting mechanism 32 is in the first retracted state. When the axial retracting mechanism 32 is adjusted to shorten, in a second retracted state, which is shorter than the first retracted state, the occluding member 30 is shown in fig. 8B in a perspective view and a top view, and it can be seen that the overall height of the occluding member 30 is reduced in the state, and the radial dimension is obviously increased, so that the valve closing defect is more serious for the patient.
According to fig. 6, the axial telescopic mechanism 32 has an axial adjusting screw and a sleeve with an internal thread inside, the threaded rotating shaft passes through the fixed member 33 and is fixedly connected with the axial telescopic coupling 331 at the outer surface of the fixed member 33. The axial adjusting screw is rotatably connected to the fixed part 33, and preferably, a flange and a groove for catching are provided at a rotational connection of the axial adjusting screw and the fixed part 33, allowing only rotation of the threaded rotating shaft within the fixed part 33 and not axial displacement of the threaded rotating shaft relative to the fixed part 33. When the connecting piece drives the axial adjusting screw to rotate, the sleeve realizes telescopic motion, the free end of the sleeve is fixedly connected with the bottom of one side of the outflow end of the frame structure 31, and the height and/or the shape of the frame structure 31 are/is adjusted. Wherein the adjustment of the shape includes, but is not limited to, a uniform or non-uniform increase and decrease in the radial direction of the frame structure 31. After the valve repair device is implanted in the human heart, the height of the frame structure 31 is changed by the adjustment mechanism to properly adjust the shape of the mating surface so that the occluding member 30 is brought into optimal contact engagement with the human valve leaflets after implantation.
When the occluding member 30 comprises only one adjustment mechanism, i.e. an axial retracting mechanism 32 as shown in fig. 5, it is preferred to use a smaller size of the fixation member 33, e.g. a disc-shaped fixation member 33 with a diameter controlled within 4mm, which can be accommodated in the catheter 41 more easily.
Preferably, the cross-section of the ring-shaped support 10 is a closed loop of D-shape or oval shape surrounded by a plurality of convex curves to more closely match the structure of the human annulus 300.
Example 2
Embodiment 2 provides different specific structures of the blocking member 30, mainly embodying the differences in the adjustment mechanisms, and bringing about the differences in the adjustment modes and effects. According to fig. 7A and 7B, on the basis of embodiment 1, the adjusting mechanism further comprises a radial adjusting mechanism 35, and the radial adjusting mechanism 35 is used for applying a radial force to the frame structure 31, so as to adjust the shape of the frame structure 31. The radial adjustment mechanism 35 preferably comprises a push rod and a helical telescopic rod, which passes through the fixed member 33 and is fixedly connected to the radial adjustment link 332 at the outer surface of the fixed member 33. The helical telescopic rod generates an approximately axial telescopic motion, and the axial telescopic motion is converted into an approximately radial motion of the push rod due to the fact that the push rod is provided with the hinge fixing point, and then the radial contraction and expansion of the frame structure 31 are driven. The hinge fixing points may be located on the fixing elements 33, on the axial telescopic mechanism 32 or on the frame structure 31. One or more push rods may be provided.
The frame structure 31 has at least a convex curved surface 311 and a concave curved surface 312 in a natural state, and the radial adjusting mechanism 35 is used for applying a radial acting force to the concave curved surface 312 and/or the convex curved surface 311 so as to adjust the shape of the concave curved surface 312 and/or the convex curved surface 311.
Preferably, according to fig. 7A, the radial adjustment mechanism 35 includes a fixed sleeve 351, a radial adjustment screw 352 penetrating through the fixed sleeve 351, a first push rod 355 and a second push rod 356 sleeved on one end of a nut 353 of the radial adjustment screw 352 and hinged to the fixed sleeve 351, and two connecting rods 354 for respectively hinging the nut 353 and the first push rod 355. In the preferred embodiment, the radial adjustment mechanism 35 is used to apply a radial force to the concave curved surface 312 and the convex curved surface 311, thereby adjusting the shapes of the concave curved surface 312 and the convex curved surface 311. Specifically, it is preferable to reduce the degree of concavity of the concave curved surface 312, and even to make the convex curved surface 311 appear on at least a partial area of the original concave curved surface 312, and it is preferable to make the original convex curved surface 311 continue to be convex radially outward.
In another embodiment of this embodiment 2, as shown in fig. 7B, the radial adjusting mechanism 35 includes a fixing sleeve 351, a radial adjusting screw 352 passing through the fixing sleeve 351, a first push rod 355 hinged to the fixing sleeve 351 at one end of a nut 353 sleeved on the radial adjusting screw 352, and a connecting rod 354 for respectively hinging the nut 353 and the first push rod 355. This embodiment preferably employs the radial adjustment mechanism 35 only for applying a radial force to the concave curved surface 312, thereby adjusting the shape of the concave curved surface 312.
It should be appreciated that the first push rod 355 and the second push rod 356 should be positioned a distance away from the axial retraction mechanism 32 to avoid interference therebetween. The radial adjustment screw 352 of the radial adjustment mechanism 35 may be disposed at a position offset from the symmetry axis of the block piece 30, but the first push rod 355 and the second push rod 356 may be disposed to have a curved section, and the free ends of the first push rod 355 and the second push rod 356 are preferably capable of contacting the symmetry axis of the concave curved surface 312 and the convex curved surface 311.
To explain the adjusting effect of the adjusting mechanism with reference to the figure of the shape change effect of the blocking member 30, when the axial telescoping mechanism 32 is in the second telescoping state, the perspective view and the top view of the blocking member 30 are shown in fig. 8B, and when the radial adjusting screw 352 of the radial adjusting mechanism 35 rotates to drive the nut 353 to contract upwards and the connecting rod 354 pushes the first push rod 355 to move upwards and radially outwards to push the concave curved surface 312 to protrude outwards under the condition that the axial telescoping mechanism 32 is not changed, at this time, the perspective view and the top view of the blocking member 30 are shown in fig. 8C. For example, in conjunction with fig. 11, when the defect in the leaflet closure function of the patient is more largely caused by the defect in the mitral valve anterior leaflet 200a, the helical extension rod of the radial adjustment mechanism 35 is extended to press the push rod against the concave curved surface 312 and to make the concave curved surface 312 less concave to match the defective mitral valve anterior leaflet 200 a.
Example 3
In this example 3, according to fig. 9, the adjustment mechanism comprises a balloon 36 placed inside the frame structure 31, the balloon 36 having a fluid channel 333 passing through the fixation member 33; the balloon 36 is capable of fluid inflation and release to adjust the height and/or shape of the frame structure 31 to achieve shape adjustment of the mating surface on the occluding member 30. The fluid comprises a gas or a liquid, preferably a contrast agent.
The upper end of the balloon 36 is fixed to the fixing member 33, and the connection of the balloon 36 and the fixing member 33 communicates with the fluid passage 333. The fluid channel 333 is connected to an operating device, such as a balloon 36 inflation pressure pump, via the fluid conduit 41. Upon inflation of balloon 36, collapsed framework structure 31 can be expanded and brought to a desired height, radial size and shape. In another embodiment, where the frame structure 31 is made of a shape memory metal, expansion of the balloon 36 can cause the frame structure 31 to have a radial dimension greater than its natural state.
A valve, such as a one-way valve, is preferably disposed in fluid passageway 333 and closes when the filling and releasing operations of the fluid are completed, and balloon 36 remains isolated from the blood environment after withdrawal of fluid conduit 41.
The adjustment mechanism of embodiment 3 can be implemented alone or in combination with the adjustment mechanism of embodiment 1. For example, the adjusting mechanism can have both the axial retracting mechanism 32 and the balloon 36, preferably, the balloon 36 is an annular balloon sleeve, and the axial retracting mechanism 32 passes through the middle of the balloon sleeve, and the two do not interfere with each other, so that the adjusting function can be realized respectively. In this solution, the axial telescopic mechanism 32 is used to adjust the distance between the fixing member 33 and the bottom of the frame structure 31 on the outflow end side, thereby adjusting the height of the frame structure 31 and changing the radial dimension of the frame structure 31 to some extent; and balloon 36 is used to provide a fine adjustment operation in the radial direction. Preferably, the balloon 36 may have an asymmetrical predetermined filling shape, such as a larger predetermined amount of filling on the side facing the concave curved surface 312, so that a larger radial expansion amplitude may be imparted to the concave curved surface 312 of the block-out piece 30 during filling of the balloon 36.
Example 4
Example 4 provides a heart valve adjustable assist system that includes not only the assist device itself, which is ultimately implanted into the body, but also other devices or components necessary for the implantation procedure. In particular, according to fig. 10-12, the heart valve adjustable assist system comprises the assist device of any of the above embodiments 1-3, further comprising a delivery device 40; the conveying device 40 includes a duct 41, and a plurality of rotary operation tubes 42 provided in the duct 41; the inner diameter of the catheter 41 is capable of accommodating the radially collapsed annular support 10 and the closure member 30; the rotary operation tube 42 can be detachably connected to each coupling member by a coupling head 43. The coupling head 43 of one part of the rotary operating tube 42 is detachably connected with the axial telescopic coupling 331 and/or the radial adjusting coupling 332 on the blocking piece 30, and the coupling head 43 of the other part of the rotary operating tube 42 is detachably connected with the coupling of the anchoring piece 112. After the implantation process is completed, the coupling head 43 of the rotary operation tube 42 is disengaged from all the coupling members.
Preferably, the system further comprises a plurality of anchors 112, the anchors 112 comprising helical coil anchors or barb anchors; anchor 112 has an implanted end and a coupling. During the implantation of the adjustable heart valve assist device 100, the helical coil anchor or the barb anchor rotates and extends the operating tube 42 to screw or tap the implantation end into the annulus and/or the atrial wall 400 of the human body, thereby anchoring the assist device.
Preferably, the heart valve tunable assist system further comprises a fluid conduit contained in the catheter 41, the fluid conduit being capable of communicating with the fluid passage 333 of the closure member 30, through which fluid passage 333 the balloon 36 is capable of filling and releasing fluid.
When the heart valve adjustable assist system includes the assist device of example 2, as shown in fig. 10, 2 rotating operation tubes 42 are required to be respectively engaged with the axial telescopic links 331 and the radial adjustment links 332. When the heart valve adjustable assist system comprises the assist device of example 3, 1 rotating operation tube 42 is required to be matched with the axial telescopic coupling 331, and the other fluid pipeline is matched with the fluid passage 333 and is in sealing connection.
The basic operation steps of the interventional operation implemented by using the heart valve adjustable auxiliary system of the embodiment are as follows, taking mitral valve repair interventional operation as an example:
first, delivering a heart valve adjustable assist device 100 through catheter 41 to the left atrium, e.g., into the left atrium via the interatrial septum;
secondly, expanding the plugging piece 30;
third, the annular support 10 is expanded (according to fig. 10);
a fourth step, closure adjustment, which may be performed by operating the axial telescoping coupler 331 and/or the radial adjustment coupler 332 or the fluid channel 333 with the rotating operating tube 42, preferably with the aid of a medical imaging device to confirm the adjustment effect;
a fifth step of anchoring the annular support 10 to the annulus tissue 300 and/or the atrial wall 400, wherein manipulation of the anchor 112 with the rotating handling tube 42 may be required to accomplish this step;
a sixth step separates all of the rotary operating tubes 42 from the coupling members or fluid passageways to achieve the state shown in fig. 11-12.
While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.
Claims (18)
1. A heart valve adjustable assist device comprising an annular support, a plurality of connecting elements and a closure member; the annular support and the closure being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration;
the annular support has an expandable annular mesh structure capable of anchoring to the annulus tissue and/or the atrial wall of the human body;
the plurality of connecting elements connecting the annular support with the block piece, the block piece being retainable by the plurality of connecting elements within an area substantially enclosed by the annular support;
the plugging piece is used for providing a matching surface which is mutually contacted with the valve leaflet of the human body; the blocking piece comprises a frame structure, a fixing piece fixed on one side of the inflow end of the frame structure, a flexible covering piece covering the outside of the frame structure, and at least one adjusting mechanism arranged inside the frame structure; the adjustment mechanism is used for adjusting the height and/or shape of the frame structure.
2. The supplemental device according to claim 1, wherein the annular support comprises a plurality of engaging portions on the side of the outflow end, at least 3 of which are respectively connected to the connecting elements.
3. An aid according to claim 2, wherein the said engagement portions are each connected to an annular resilient member arranged to be in a stretched condition when the aid is released following implantation in the body.
4. The aid device according to claim 2, characterized in that it has four connecting elements, the curvilinear ends of which are respectively integral with four uniformly distributed junctions of said annular support; the straight ends of the four connecting elements are connected with the plugging piece.
5. The aid of claim 1, wherein said loop-shaped support comprises anchoring structures for anchoring said loop-shaped support to the annulus tissue and/or the atrial wall of the human body.
6. Auxiliary device according to claim 5, characterized in that said anchoring structure comprises anchoring barbs arranged outside said annular support, for piercing the human annulus tissue and/or the atrial wall;
and/or the anchoring structure comprises a plurality of anchoring piece fixing frames arranged on one side of the outflow end of the annular supporting piece, the anchoring piece fixing frames are connected to the net frame of the annular supporting piece, and the anchoring piece fixing frames are provided with hole arrays which allow anchoring pieces to be screwed in;
and/or the anchoring structure comprises a plurality of top brackets arranged on one side of the inflow end of the annular support, at least part of the top brackets are provided with anchoring connecting brackets, and each anchoring connecting bracket is provided with a hole array which allows an anchoring piece to be screwed in;
and/or, the anchoring structure comprises fixing holes arranged at the plurality of joints, and the fixing holes allow an anchoring piece to pass through;
the anchoring member is a helical coil anchor or a barb anchor.
7. An aid according to any of claims 1-6, wherein the frame structure of the closure is made of a shape memory alloy, the radial cross-section in the natural state being substantially half-moon shaped or substantially meniscus shaped or substantially kidney shaped.
8. The auxiliary device as claimed in claim 1, wherein the adjusting mechanism comprises an axial telescopic mechanism, the axial telescopic mechanism comprises an axial adjusting screw and a nut, and two ends of the axial telescopic mechanism are respectively connected to the fixing member and the bottom of the frame structure on the outflow end side, so as to adjust the distance between the fixing member and the bottom of the frame structure on the outflow end side, and further adjust the height and/or shape of the frame structure.
9. Auxiliary device according to claim 8, characterized in that the frame structure of the block piece comprises a grid-like structure, which frame structure is capable of decreasing the axial height while expanding radially when the axial telescopic mechanism is contracted and of increasing the axial height while contracting radially when the axial telescopic mechanism is expanded.
10. The supplemental device of claim 1, wherein the adjustment mechanism comprises a radial adjustment mechanism for applying a radial force to the frame structure to adjust the shape of the frame structure.
11. The accessory of claim 10, wherein the frame structure naturally has at least one of a convex curvature and a concave curvature; the radial adjusting mechanism is used for applying radial acting force to the concave curved surface and/or the convex curved surface so as to adjust the shape of the concave curved surface and/or the convex curved surface.
12. The assisting apparatus as claimed in claim 11, wherein the radial adjusting mechanism includes a fixing sleeve, a radial adjusting screw passing through the fixing sleeve, at least one push rod hinged to the fixing sleeve at one end of a nut sleeved on the radial adjusting screw, and at least one link for respectively hinging the nut to the push rod.
13. Auxiliary device according to claim 8 or 12, wherein the axial adjusting screw or the radial adjusting screw of the axial telescoping mechanism or the radial adjusting mechanism passes through the fixing member and is rotatably connected to the fixing member, and the rotating shaft is fixedly connected to the coupling member at the outer surface of the fixing member.
14. The assistive device of claim 1, wherein the adjustment mechanism comprises a balloon disposed within the frame structure, the balloon having a fluid passage through the fixture; the balloon is capable of fluid inflation and release to adjust the height and/or shape of the frame structure.
15. An aid according to any of claims 1-14 wherein the bottom cross-section of the annular support is a closed loop of a D-shape or oval shape enclosed by a convex curve.
16. A heart valve adjustable assist system comprising the assist device of claim 6 or 13, further comprising a delivery device; the conveying device comprises a guide pipe and a plurality of rotary operation pipes arranged in the guide pipe; the catheter inner diameter is capable of receiving the annular support and the closure after radial collapse; the rotary operation pipe can be detachably connected with each of the coupling members through a coupling head.
17. The assistance system according to claim 16, further comprising a plurality of anchors, said anchors comprising helical coil anchors or barb anchors; the anchor has an implanted end and a coupling.
18. The auxiliary system of claim 16, further comprising a fluid conduit communicable with the fluid passage of the closure.
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| CN202110177534.1A CN112773565A (en) | 2021-02-09 | 2021-02-09 | Adjustable auxiliary device and system for heart valve |
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| CN202110177534.1A CN112773565A (en) | 2021-02-09 | 2021-02-09 | Adjustable auxiliary device and system for heart valve |
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| CN112773565A true CN112773565A (en) | 2021-05-11 |
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| CN202110177534.1A Pending CN112773565A (en) | 2021-02-09 | 2021-02-09 | Adjustable auxiliary device and system for heart valve |
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