CN116712126A - Perivalvular leakage plugging device - Google Patents
Perivalvular leakage plugging device Download PDFInfo
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- CN116712126A CN116712126A CN202310794671.9A CN202310794671A CN116712126A CN 116712126 A CN116712126 A CN 116712126A CN 202310794671 A CN202310794671 A CN 202310794671A CN 116712126 A CN116712126 A CN 116712126A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Surgical Instruments (AREA)
Abstract
The application discloses a perivalvular leakage blocking device, which is applied to the technical field of medical appliances and comprises: a skeleton portion provided with resiliency and configured to have a predetermined shape, to expand into the predetermined shape after entering the valve Zhou Louou region, for supporting and fixing the entire perivalvular leak-blocking device; the plugging part is arranged and wound on the outer side of the framework part and used for plugging the perivalvular leakage area; the expansion part is arranged to be expandable and attached to the outer side of the framework part, and the expansion part fills up a gap between the framework part and the plugging part after being expanded so as to realize the plugging effect. The perivalvular leakage plugging device has a simple structure, can be used for plugging accurately when being implanted into perivalvular leakage areas, and can ensure plugging effect.
Description
Technical Field
The application relates to the technical field of medical instruments, in particular to a perivalvular leakage plugging device.
Background
Perivalvular leak (PVL) is a special complication after surgical valve replacement, and occurs mainly due to excessive suture spacing, suture tearing or suture corrosion fracture caused by inflammation, and the like, which causes residual leakage between an artificial valve annulus and tissues, and is mainly clinically manifested as clinical symptoms such as heart failure, mechanical hemolysis, and the like.
The traditional treatment method needs to repair or replace the valve again by opening the chest extracorporeal circulation descending valve periphery leakage again, has huge operation wound, high risk and more complications, and has high probability of occurrence of the valve periphery leakage again; the percutaneous perivalvular leak interventional therapy is a novel minimally invasive therapy method, operation is not needed in the percutaneous perivalvular leak interventional therapy operation, the risk is small, the operation wound is small, the operation risk is obviously reduced, and the percutaneous perivalvular leak interventional therapy is gradually popularized in clinic. At present, a plurality of plugging devices used for percutaneous flap perileak interventional therapy are net structures woven by two NiTi alloy wires, the two net structures are connected through the same NiTi alloy wires, and finally, a plurality of NiTi wire terminals are welded together to form an integrated structure. The occluder is delivered from various routes such as transapical or transfemoral delivery into the perivalvular leak to be occluded using a small delivery catheter and is trapped between the valve and the vessel wall or heart wall to act as an occlusion.
However, the occluder with the above structure has the following defects: the structure of the braided plugging device is complex, and the plugging function is affected by the fact that the braided plugging device is easily implanted in different positions during delivery after extrusion deformation in a conveying system.
Disclosure of Invention
The application provides a perivalvular leakage plugging device which is simple in structure, accurate in plugging when being implanted into perivalvular leakage areas, and capable of guaranteeing plugging effects.
According to some embodiments, the present application provides a perivalvular leak occlusion device comprising: a skeleton portion provided with resiliency and configured to have a predetermined shape, to expand into the predetermined shape after entering the valve Zhou Louou region, for supporting and fixing the entire perivalvular leak-blocking device; the plugging part is arranged and wound on the outer side of the framework part and used for plugging the perivalvular leakage area; the expansion part is arranged to be expandable and attached to the outer side of the framework part, and the expansion part fills up a gap between the framework part and the plugging part after being expanded so as to realize the plugging effect.
By adopting the technical scheme: the frame part with rebound resilience is configured into a preset shape, after the perivalvular leakage plugging device is introduced into the perivalvular leakage area, the frame part can be expanded into the preset shape by rebound resilience and fix the perivalvular leakage plugging device in a gap between the artificial valve and the ventricular wall, and meanwhile, the expansion part expands and adheres to the frame part after entering a human body, and simultaneously, the expansion part can fill the gap between the frame part and the plugging part and plug the perivalvular leakage area together with the plugging part, so that the plugging effect is realized.
Preferably, the skeleton portion comprises a shaped wire coiled into a continuous wire-like structure to form the predetermined shape.
Preferably, the predetermined shape is set in a spiral shape, and the shaping wire is continuously spirally wound around an axis to form a variable diameter spiral structure having a cone shape with both ends symmetrical; alternatively, the predetermined shape is set to be cylindrical, the shaping wire is integrally and continuously wound to form a constant diameter round stacking structure having a supporting circular ring and blocking rods stacked on each other, and preferably, the blocking rods are staggered inside the supporting circular ring; alternatively, the predetermined shape is provided in a wave stripe stack shape, and the setting yarn is integrally and continuously wound to form a wave stripe stack structure having wave stripes stacked on each other.
Preferably, the shaping wire of the framework part is made of one or more metal materials selected from CoCr alloy, niTi alloy and stainless steel.
Preferably, the blocking part is provided in a braided wound spring structure and is closely attached to the outer sides of the framework part and the expansion part; the braided winding spring structure is a metal wire winding spring braided structure made of metal wires or a polymer wire net structure made of non-degradable polymer materials.
Preferably, the metal wire used for the metal wire made spring winding braiding structure comprises a stainless steel wire or a NiTi alloy wire, and the metal wire made spring winding braiding structure is braided by the metal wire; the non-degradable high polymer material used for preparing the reticular structure by the high polymer silk comprises polytetrafluoroethylene or polypropylene or polyethylene terephthalate or polydioxanone; the polymer silk net structure is woven by using the non-degradable polymer material.
Preferably, a film is attached to the surface of the blocking portion, and the film is attached to the inner surface or the outer surface of the blocking portion.
Preferably, the film is made of a non-degradable polymer material or a degradable polymer material; preferably, the non-degradable high polymer material comprises polytetrafluoroethylene or polycarbonate; preferably, the degradable high polymer material comprises polylactic acid-glycollic acid copolymer or racemized polylactic acid or levorotatory polylactic acid.
Preferably, the expansion parts are staggered or tightly wound on the outer side of the skeleton part.
Preferably, the expansion part is made of self-expanding materials, and the self-expanding materials comprise polypeptide small molecular materials or water-absorbent resin high molecular materials; the expansion part can spontaneously absorb water and expand after entering a human body, and fills up a gap between the framework part and the plugging part; alternatively, the expansion part is made of self-assembled material, and the self-assembled material comprises polycarbonate or polyethylene terephthalate modified by biological functional groups; the expansion part can spontaneously expand after entering the human body, and fills the gap between the framework part and the plugging part.
By adopting the technical scheme: after the perivalvular leakage plugging device is implanted into the Zhou Louou domain position, the expansion part can expand, so that the fixed framework part and the plugging part can be connected in an auxiliary manner, and the plugging effect can be improved.
Embodiments of the present disclosure have at least the following advantages:
firstly, after the perivalvular leakage plugging device is led into a perivalvular leakage area, the skeleton part can be expanded into a preset shape, the perivalvular leakage plugging device is fixed in a gap between a prosthetic valve and a ventricular wall, the expanded part is expanded and attached to the skeleton part after entering a human body, and simultaneously, the gap between the skeleton part and the plugging part is filled, and the perivalvular leakage plugging device and the plugging part together plug the perivalvular leakage area, so that the plugging effect is realized;
secondly, the perivalvular leakage plugging device provided by the application has the advantages that the plugging part is smooth, the biocompatibility is good, the framework part is tightly connected with the plugging part, and no potential safety hazard exists when the framework part is contacted with heart muscle and blood vessel wall for a long time, so that the prognosis effect is effectively improved;
thirdly, the perivalvular leakage plugging device provided by the application has the advantages that the structure and the size of the plugging part are convenient to adjust, the device can be suitable for various clinical situations, and the convenience of operation is improved.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the conventional technology, the drawings required for the embodiments will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to the drawings without inventive effort for those skilled in the art.
FIG. 1 is a schematic structural view of a perivalvular leak-blocking device according to an embodiment of the present application;
fig. 2 is a schematic structural view of a perivalvular leak-blocking device for blocking a perivalvular leak region in accordance with an embodiment of the present application;
FIG. 3 is a schematic view showing the structure of an attaching film of a perivalvular leak-blocking device according to an embodiment of the present application;
fig. 4 is a state diagram of the perivalvular leak blocking device according to the first embodiment of the present application disposed in a perivalvular leak region by a first pushing manner;
FIG. 5 is another state diagram of the perivalvular leak-blocking device according to the first embodiment of the present application disposed in a perivalvular leak region by a first type of pushing means;
FIG. 6 is a state diagram of the perivalvular leak-blocking device according to the first embodiment of the present application disposed in a perivalvular leak region by a second type of pushing means;
FIG. 7 is another state diagram of the perivalvular leak occlusion device according to the first embodiment of the present application disposed in a perivalvular leak region by a second type of pushing means;
FIG. 8 is a state diagram of the perivalvular leak occlusion device according to the first embodiment of the present application placed in the perivalvular leak region by a third analoging method;
FIG. 9 is another state diagram of the perivalvular leak occlusion device in accordance with the first embodiment of the present application disposed in the perivalvular leak region by a third analogizing procedure;
FIG. 10 is a schematic structural view of a skeleton portion in a second embodiment of the present application;
FIG. 11 is a top view of a skeleton portion in a second embodiment of the present application;
FIG. 12 is a schematic view of a skeleton portion in a third embodiment of the present application;
fig. 13 is a top view of a skeleton portion in a third embodiment of the application.
Reference numerals: 1. a perivalvular leak blocking device; 11. a skeleton portion; 111. a support ring; 112. a plugging rod; 113. wave stripe; 12. a blocking part; 13. an expansion section; 2. a film; 3. a left ventricle; 4. the left atrium.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the embodiments of the present application will be described in detail below with reference to the accompanying drawings. However, it will be understood by those of ordinary skill in the art that in various embodiments of the present application, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, the claimed technical solution of the present application can be realized without these technical details and various changes and modifications based on the following embodiments. The following embodiments are divided for convenience of description, and should not be construed as limiting the specific implementation of the present application, and the embodiments can be combined with each other and cited with each other without contradiction.
Herein, the terms "proximal", "distal" are relative orientations, relative positions, directions of elements or actions relative to each other from the perspective of a physician using the medical device, although "proximal", "distal" are not limiting, "proximal" generally refers to an end that is proximal to the physician during normal operation, and "distal" generally refers to an end that first enters the patient.
The following describes in detail a perivalvular leak occlusion device provided in this embodiment with reference to fig. 1 and 2, including: a skeleton portion 11, a blocking portion 12, and an expanding portion 13, the skeleton portion 11 being provided with resiliency and configured to have a predetermined shape, the skeleton portion 11 being introduced into the perivalvular drain region to expand into the predetermined shape for supporting and fixing the entire perivalvular drain blocking device 1 in use; the plugging part 12 is arranged to be wound on the outer side of the skeleton part 11 and is used for plugging the perivalvular leakage area; the expansion portion 13 is provided to be expandable and attached to the outside of the skeleton portion 11, and the expansion portion 13 is expanded to fill the gap between the skeleton portion 11 and the blocking portion 12, thereby achieving the blocking effect.
In the present embodiment, by arranging the skeleton portion 11 in a predetermined shape, after the perivalvular leakage occlusion device 1 is introduced into the perivalvular leakage region, the skeleton portion 11 can be expanded into a predetermined shape and the perivalvular leakage occlusion device 1 is fixed in the gap between the artificial valve and the ventricular wall, and the expanded portion 13 is expanded and attached to the skeleton portion 11 after entering the human body, and fills the gap between the skeleton portion 11 and the occlusion portion 12, and the perivalvular leakage region is occluded together with the occlusion portion 12, thereby achieving the occlusion effect; the perivalvular leakage plugging device 1 is simple in structure, convenient to implant, suitable for various implantation conditions, capable of reducing operation difficulty and increasing operation success rate, and can accurately plug the perivalvular leakage plugging device 1 when the skeleton part 11 is conveyed to the perivalvular leakage area to be expanded into a preset shape after being extruded and deformed in a conveying system, and can ensure plugging effect.
Referring to fig. 1 and 2, in the present embodiment, it should be noted that the skeleton portion 11 includes a shaping wire, the shaping wire is coiled into a continuous and smooth wire structure to form a predetermined shape, and when the skeleton portion 11 is finally formed, the skeleton portion 11 has no sharp folding angle, so as to avoid secondary damage caused by scratch during implantation; the shaping wire is made of one or more metal materials selected from CoCr alloy, niTi alloy and 316L stainless steel, or can be an implantation-level metal material with enough mechanical strength, and the shaping wire made of the material has certain strength and rebound resilience and can be configured into a preset shape. During the process of introducing the perivalvular leakage plugging device 1 into the perivalvular leakage area, the shape of the skeleton portion 11 is changed, and after the perivalvular leakage plugging device 1 is released in the perivalvular leakage area, the shape of the skeleton portion 11 is restored to a preset shape under the action of resilience force by the shaping wires of the skeleton portion 11, so that the fixation and plugging effect on the perivalvular leakage area are realized. In this embodiment, the shape of the skeleton portion 11 is maintained by the shaping wire, so that the perivalvular leak region can be effectively sealed.
With continued reference to fig. 1, in this embodiment, the predetermined shape may be a spiral shape, and the shaping wire is continuously spirally wound around an axis to form a tapered spiral structure with symmetrical two ends, so that the tapered spiral structure includes a proximal end and a distal end which are disposed opposite to each other, the proximal end and the distal end are connected by a waist, and the proximal end and the distal end are disposed with equal diameters, and the cross section of each of them is gradually reduced toward the waist, thereby forming a tapered spiral structure with thin waist and thick two ends. Of course, the shaped wire may also be helically wound about an axis to form a variable diameter helical structure having a single cone shape. When the framework 11 adopts the variable diameter spiral structure, the framework 11 can be processed and made of NiTi alloy or CoCr alloy, thereby playing a role of fixing and supporting.
In this embodiment, it should be noted that, other shapes, such as integrally formed spheres, rectangles, etc., may be adopted for the predetermined shape, which are not listed in the present application, and all fall within the scope of the present application as long as they fall within the spirit principles of the embodiments of the present application.
With continued reference to fig. 1, in this embodiment, it should be further noted that the blocking portion 12 is configured as an independent braided coiled spring structure and is closely adhered to the outer sides of the skeleton portion 11 and the expansion portion 13; the blocking portion 12 is provided as a wire-made wound spring braid structure made of a wire or a polymer wire-made net structure made of a non-degradable polymer material.
In one implementation, when the blocking portion 12 is configured as a wire-made coiled spring knitting structure, the wire used in the wire-made coiled spring knitting structure includes, but is not limited to, 316L stainless steel wire or NiTi alloy wire or other metallic materials with mechanical properties and biocompatibility meeting standards, and the wire-made coiled spring knitting structure of the blocking portion 12 is obtained by using the above materials to perform hand knitting or machine knitting.
In another implementation manner, when the plugging portion 12 is configured as a polymer filament mesh structure, polymer filaments used for the polymer filament mesh structure include, but are not limited to, polytetrafluoroethylene (PTFE) or Polycarbonate (PC) or polyethylene terephthalate (PET) or polydioxanone (PPDO) or other non-degradable polymer materials with good biocompatibility, and the polymer filament mesh structure of the plugging portion 12 is obtained by using the above materials to obtain an independent coiled spring structure through hand knitting or machine knitting.
Referring to fig. 1 to 3, in this embodiment, it should be further noted that a layer of film 2 may be attached to the surface of the plugging portion 12 to enhance the plugging effect, and the material used for the film 2 needs to be a polymer material with good film forming property to enhance the biocompatibility thereof, and may be specifically adjusted according to the use condition and the requirement; for example, in the present embodiment, the polymer may be a non-degradable polymer such as Polytetrafluoroethylene (PTFE) or Polycarbonate (PC); the polymer may be a degradable polymer such as polylactic acid-glycolic acid copolymer (PLGA), racemic polylactic acid (PDLLA) or levorotatory polylactic acid (PLLA). After the perivalvular leakage blocking device 1 enters the perivalvular leakage region, the skeleton portion 11 fixes the perivalvular leakage blocking device 1 at a gap between the artificial valve and the ventricular wall, and the blocking portion 12 serves as a carrier of the film 2 to block the perivalvular leakage region together, thereby realizing the blocking effect.
Preferably, the film 2 may be attached to the inner or outer surface of the blocking portion 12, and may be selected according to the actual circumstances.
With reference to fig. 1, in this embodiment, the expansion portion 13 is also provided with a filament structure, and is staggered or tightly wound on the outer side of the skeleton portion 11, and the expansion portion 13 is provided with an expandable material made of a polymer material, a small polymer material or a biological material, and expands after entering the valve Zhou Louou area, so that the skeleton portion 11 and the blocking portion 12 can be connected and fixed in an auxiliary manner, and the blocking effect can be improved.
In one implementation, the expansion portion 13 is made of a self-expanding material, including but not limited to a polypeptide-based small molecular material or a water-absorbent resin-based high molecular material, and the expansion portion 13 spontaneously absorbs water and expands after entering the human body and fills the gap between the skeleton portion 11 and the blocking portion 12.
In another implementation, the expansion portion 13 is made of a self-assembled material, including but not limited to Polycarbonate (PC), polyethylene terephthalate (PET), or other non-degradable polymeric material modified with biofunctional groups, and the expansion portion 13 spontaneously expands after entering the human body and fills the gap between the skeleton portion 11 and the blocking portion 12.
In this embodiment, by providing the expansion portion 13, after the perivalvular leakage plugging device 1 enters the perivalvular leakage region, the skeleton portion 11 fixes the perivalvular leakage plugging device 1 in the gap between the prosthetic valve and the ventricular wall, and the expansion portion 13 swells or spontaneously swells, adheres to the skeleton portion 11, and fills the gap between the skeleton portion 11 and the plugging portion 12, thereby plugging the perivalvular leakage region together with the plugging portion 12.
Referring to fig. 4 and 5, for the perivalvular leakage plugging device 1 in the present embodiment, a first pushing manner is adopted to place the perivalvular leakage plugging device 1 in a perivalvular leakage area during use, wherein the first pushing manner is that the perivalvular leakage plugging device 1 is pushed into a valve Zhou Louou area for plugging after the perivalvular leakage plugging device enters the left atrium 4 directly from the left ventricle 3 via the femoral artery.
Referring to fig. 6 and 7, for the perivalvular leakage plugging device 1 in the present embodiment, a second pushing method is adopted to place the perivalvular leakage plugging device 1 in the perivalvular leakage area during use, the second pushing method is that after implantation through the femoral artery, the perivalvular leakage plugging device 1 is pushed into the area of the valve Zhou Louou for plugging after performing atrial septum puncture from the left atrium 4 into the left ventricle 3.
Referring to fig. 8 and 9, for the perivalvular leakage plugging device 1 in the present embodiment, a third analoging method is adopted to place the perivalvular leakage plugging device 1 in the perivalvular leakage area during use, the third analoging method is that the perivalvular leakage plugging device 1 is pushed into the valve Zhou Louou area for plugging after being punctured by the apex of the heart and then enters the left ventricle 3 and then the left atrium 4.
In this embodiment, the manner of introduction may be selected according to the actual situation, and is not particularly limited in this embodiment.
In this example, it should also be noted that one way that can be achieved for the procedure of introduction is that the perivalvular leak interventional occlusion is performed in the hybridization operating room or cardiac catheter room. In the perivalvular leak interventional occlusion operation, the perivalvular leak occlusion device 1 is connected with a conveying guide wire, and then the perivalvular leak occlusion device 1 is integrally stretched and is received into a compression sheath; and (3) connecting the compression sheath with the delivery sheath, conveying the perivalvular leakage plugging device 1 to a proper position of a perivalvular leakage area along the delivery sheath, then releasing the perivalvular leakage plugging device 1, and retracting the delivery system, so that the perivalvular leakage plugging device 1 is accurately determined to be positioned at the perivalvular leakage opening position to realize plugging.
Example two
The second embodiment differs from the first embodiment only in that: referring to fig. 1, 10 and 11, the predetermined shape of the skeleton portion 11 may be a cylinder, the shaping wires of the skeleton portion 11 are coiled continuously around an axis to form an equal-diameter circular stacking structure with support rings 111 and blocking rods 112 stacked on each other, wherein the support rings 111 and the blocking rods 112 are in a continuous integral wire structure, the support rings 111 are stacked on each other to form an equal-diameter cylinder, so as to complete the supporting function of the perivalvular leakage blocking device 1, and the blocking rods 112 are staggered in the support rings 111 to perform a partial blocking function through the blocking rods 112. When the framework 11 adopts the equal diameter round stacked structure, the framework 11 can be made of NiTi alloy or CoCr alloy, and the expansion part 13 and the blocking part 12 are wound on the outer sides of the supporting ring 111 and the blocking rod 112 to block the perivalvular leakage area together, so that the blocking effect is realized.
Example III
The third embodiment differs from the first embodiment only in that: referring to fig. 1, 12 and 13, the predetermined shape of the skeleton portion 11 may be further configured as a stacked wavy stripe, the shaped filaments of the skeleton portion 11 are integrally and continuously coiled to form a stacked wavy stripe structure with wavy stripes 113 stacked on each other, the wavy stripes 113 are continuously and integrally formed into a filament structure, and when the stacked wavy stripe structure is adopted in the skeleton portion 11, the skeleton portion 11 may be made of NiTi alloy or 316L stainless steel alloy, so as to realize the dual functions of supporting the perivalve leakage plugging device 1 and plugging, and the expansion portion 13 and the plugging portion 12 are wound on the outer side of the wavy stripes 113 to plug the perivalve leakage area together, thereby realizing the plugging function.
It is to be understood that the above-described embodiments of the present application are merely illustrative of or explanation of the principles of the present application and are in no way limiting of the application. Accordingly, any modification, equivalent replacement, improvement, etc. made without departing from the spirit and scope of the present application should be included in the scope of the present application. Furthermore, the appended claims are intended to cover all such changes and modifications that fall within the scope and boundary of the appended claims, or equivalents of such scope and boundary.
Claims (10)
1. A perivalvular leak occlusion device, comprising:
a skeleton portion (11) provided with resiliency and configured to have a predetermined shape, to expand into the predetermined shape after entering the valve Zhou Louou region, for supporting and fixing the entire perivalvular leak shutoff device (1);
a blocking part (12) which is wound on the outer side of the framework part (11) and is used for blocking the perivalvular leakage area;
and an expansion part (13) which is arranged to be expandable and attached to the outer side of the framework part (11), wherein the expansion part (13) fills the gap between the framework part (11) and the plugging part (12) after being expanded so as to realize the plugging effect.
2. The paravalvular leakage blocking device according to claim 1, wherein,
the carcass portion (11) comprises shaped filaments coiled into a continuous filiform structure to form the predetermined shape.
3. The paravalvular leakage blocking device according to claim 2, wherein,
the preset shape is set into a spiral shape, and the shaping wire is continuously spirally wound around an axis to form a variable-diameter spiral structure with symmetrical conical shapes at two ends; or alternatively, the process may be performed,
the predetermined shape is set to be cylindrical, the shaping wire is continuously wound to form an equal diameter round stacking structure with a supporting circular ring (111) and blocking rods (112) stacked on each other, and preferably, the blocking rods (112) are staggered inside the supporting circular ring (111); or alternatively, the process may be performed,
the predetermined shape is provided in a wave stripe stack shape, and the setting yarn is continuously wound to form a wave stripe stack structure having wave stripes (113) stacked on each other.
4. The paravalvular leakage blocking device according to claim 2 or 3, wherein,
the shaping wire of the framework part (11) is made of one or more metal materials selected from CoCr alloy, niTi alloy and stainless steel.
5. The paravalvular leakage blocking device according to claim 1, wherein,
the plugging part (12) is in a braided spring structure and is tightly attached to the outer sides of the framework part (11) and the expansion part (13);
the braided winding spring structure is a metal wire winding spring braided structure made of metal wires or a polymer wire net structure made of non-degradable polymer materials.
6. The paravalvular leakage blocking device according to claim 5, wherein,
the metal wire used for the metal wire made winding spring braiding structure comprises a stainless steel wire or a NiTi alloy wire, and the metal wire made winding spring braiding structure is formed by braiding the metal wire;
the non-degradable high polymer material used for preparing the reticular structure by the high polymer silk comprises polytetrafluoroethylene or polypropylene or polyethylene terephthalate or polydioxanone; the polymer silk net structure is woven by using the non-degradable polymer material.
7. The paravalvular leakage blocking device according to claim 5 or 6, wherein,
a film (2) is attached to the surface of the blocking portion (12), and the film (2) is attached to the inner surface or the outer surface of the blocking portion (12).
8. The paravalvular leakage blocking device of claim 7, wherein,
the film (2) is made of non-degradable high polymer material or degradable high polymer material;
preferably, the non-degradable high polymer material comprises polytetrafluoroethylene or polycarbonate;
preferably, the degradable high polymer material comprises polylactic acid-glycollic acid copolymer or racemized polylactic acid or levorotatory polylactic acid.
9. The paravalvular leakage blocking device according to claim 1, wherein,
the expansion parts (13) are staggered or tightly wound on the outer side of the framework part (11).
10. The paravalvular leakage blocking device of claim 9, wherein,
the expansion part (13) is made of self-expanding materials, and the self-expanding materials comprise polypeptide small molecular materials or water-absorbent resin high molecular materials; the expansion part (13) can automatically absorb water and expand after entering a human body, and fills a gap between the framework part (11) and the plugging part (12); or alternatively, the process may be performed,
the expansion part (13) is made of self-assembled material, and the self-assembled material comprises polycarbonate or polyethylene terephthalate modified by biological functional groups; the expansion part (13) spontaneously expands after entering the human body, and fills the gap between the framework part (11) and the plugging part (12).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310794671.9A CN116712126A (en) | 2023-06-30 | 2023-06-30 | Perivalvular leakage plugging device |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310794671.9A CN116712126A (en) | 2023-06-30 | 2023-06-30 | Perivalvular leakage plugging device |
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| Publication Number | Publication Date |
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| CN116712126A true CN116712126A (en) | 2023-09-08 |
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|---|---|---|---|
| CN202310794671.9A Pending CN116712126A (en) | 2023-06-30 | 2023-06-30 | Perivalvular leakage plugging device |
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| Country | Link |
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| CN (1) | CN116712126A (en) |
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- 2023-06-30 CN CN202310794671.9A patent/CN116712126A/en active Pending
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