WO2025217962A1 - Dispositif d'occlusion du foramen ovale du septum auriculaire dégradable formé d'un seul tenant en forme de disque double - Google Patents

Dispositif d'occlusion du foramen ovale du septum auriculaire dégradable formé d'un seul tenant en forme de disque double

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Publication number
WO2025217962A1
WO2025217962A1 PCT/CN2024/091777 CN2024091777W WO2025217962A1 WO 2025217962 A1 WO2025217962 A1 WO 2025217962A1 CN 2024091777 W CN2024091777 W CN 2024091777W WO 2025217962 A1 WO2025217962 A1 WO 2025217962A1
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WO
WIPO (PCT)
Prior art keywords
disc
annular plate
rib
double
annular
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/CN2024/091777
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English (en)
Chinese (zh)
Inventor
邢泉生
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Individual
Original Assignee
Individual
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Filing date
Publication date
Priority claimed from CN202410451556.6A external-priority patent/CN121196626A/zh
Application filed by Individual filed Critical Individual
Publication of WO2025217962A1 publication Critical patent/WO2025217962A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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

Definitions

  • the present application relates to the field of medical devices, and in particular to a double-disc-shaped integrally formed degradable cardiac atrial septum foramen ovale occluder.
  • the foramen ovale is a physiological passageway in the atrial septum during the embryonic period.
  • the septum secundum and septum primum adhere and fuse to form a permanent atrial septum in most people. If this fails to fuse, a patent foramen ovale (PFO) forms.
  • PFO patent foramen ovale
  • minimally invasive intervention is a modern high-tech minimally invasive treatment.
  • the guide wire is passed along the femoral vein and inferior vena cava until it enters the right atrium, passes through the atrial septal defect and enters the left atrium.
  • the delivery catheter is placed along the guide wire to the site of the atrial septal defect, and finally the atrial septal defect occluder is pushed into the atrial septal defect through the delivery catheter to perform occlusion treatment.
  • This minimally invasive intervention has the advantages of no surgery, less trauma, fewer complications, faster recovery, good results, a wide range of indications and relatively low surgical costs.
  • the treatment method of implanting atrial septal defect occluder through minimally invasive interventional surgery has many advantages over traditional surgical procedures
  • the main stent of the atrial septal defect occluder currently used in clinical practice is mainly made of nickel-titanium alloy wire. Since this type of metal material cannot be degraded in the human body, long-term implantation will cause inflammation, coagulation and other reactions with human tissues, and even a certain degree of damage. Therefore, there are certain defects, and there may still be the following risks of use: (1) Nickel-titanium alloy is a non-degradable metal alloy material.
  • the ideal cardiac occluder should provide a temporary bridge for the heart's own cells to grow and grow. After completing its mission, it will be degraded by the body, allowing the defect to be completely repaired by the body's own tissues, thus avoiding the long-term complications and safety hazards caused by metal retention in the body.
  • the occluder currently widely used in clinical practice is a woven metal-nonwoven fabric occluder that has been gradually optimized based on the Amplatzer occluder.
  • the present application aims to address, at least to some extent, one of the technical problems in the related art.
  • one objective of the present application is to propose a double-disc, one-piece, degradable cardiac atrial septal foramen ovale occluder. This one-piece, degradable occluder avoids the long-term complications and safety hazards associated with metal retention in the body.
  • a double-disc-shaped, one-piece, degradable cardiac atrial septum foramen ovale occluder comprises: a first disc portion, a second disc portion, and a closure portion, wherein the first disc portion and the second disc portion are connected at both ends of the closure portion, the first disc portion, the second disc portion, and the closure portion are an integrally formed part, and are degradable parts; the first disc portion and the second disc portion are both elastic parts that can automatically restore their original shape; the plane where the edge of the first disc portion lies is a first plane, the plane where the edge of the second disc portion lies is a second plane, the angle between the axis of the closure portion and the first plane is an acute angle, and/or the angle between the axis of the closure portion and the second plane is an acute angle.
  • the occluder is an one-piece degradable part.
  • the occluder provides a temporary bridge for the heart to repair itself, allowing its own cell tissue to climb and grow, and then be degraded and absorbed in the body. It can avoid long-term complications and safety hazards caused by metal retention in the body.
  • the occluder has strong structural integrity, and the occluder degrades at a uniform rate in the human body without the risk of structural disintegration. It can overcome all the shortcomings of existing braided structure occluders and can also simplify surgical operations.
  • the first disc portion and/or the second disc portion are tilted relative to the occluding portion, so that the first disc portion and the second disc portion can adapt to heart wall structures of different shapes, thereby improving the occluding effect.
  • double-disc-shaped integrally formed degradable cardiac atrial septal foramen ovale occluder may also have the following additional technical features:
  • the first plane and the second plane are arranged in parallel.
  • At least a portion of at least one of the first disc portion and the second disc portion is in the form of a conical ring, and the conical ring extends from the center to the edge toward the center of the double-disc-shaped integrally formed degradable cardiac atrial septum foramen ovale occluder.
  • At least a portion of the first disc portion is a conical ring, at least a portion of the second disc portion is a conical ring, and the first disc portion
  • the second plate portion is interlocked with the second plate portion.
  • At least a portion of at least one of the first disc portion and the second disc portion is in the form of an inverted conical ring, and the inverted conical ring extends from the center to the edge toward a direction away from the center of the double-disc-shaped integrally molded degradable cardiac atrial septum foramen ovale occluder.
  • At least a portion of the first disc portion is in the form of an inverted conical ring, and at least a portion of the second disc portion is in the form of an inverted conical ring.
  • the first disc portion and the second disc portion are disc-shaped structures that are away from each other.
  • the first disk portion and the second disk portion are parallel disk bodies.
  • the first disk portion includes: a first annular plate and a first supporting rib, the first supporting rib is arranged on the first annular plate, and the first supporting rib is used to support the first annular plate to restore its original shape;
  • the second disk portion includes: a second annular plate and a second supporting rib, the second supporting rib is arranged on the second annular plate, and the second supporting rib is used to support the second annular plate to restore its original shape.
  • the first annular plate has a first inner surface and a first outer surface opposite to each other, the first inner surface is arranged toward the second disk portion, and the first support rib protrudes from at least one of the first inner surface and the first outer surface;
  • the second annular plate has a second inner surface and a second outer surface opposite to each other, the second inner surface is arranged toward the first disk portion, and the second support rib protrudes from at least one of the second inner surface and the second outer surface.
  • the cross-sectional shapes of the first annular plate and the second annular plate are circular, quasi-circular or polygonal.
  • the first support ribs include: a plurality of first radial ribs, the first radial ribs extend radially along the first annular plate, and the plurality of first radial ribs are arranged at intervals along the circumference of the first annular plate;
  • the second support ribs include: a plurality of second radial ribs, the second radial ribs extend radially along the second annular plate, and the plurality of second radial ribs are arranged at intervals along the circumference of the second annular plate.
  • the inner end of the first radial rib is connected to the sealing portion, and the outer end of the first radial rib extends to the outer edge of the first annular plate, or is spaced from the outer edge of the first annular plate; the inner end of the second radial rib is connected to the sealing portion, and the outer end of the second radial rib extends to the outer edge of the second annular plate, or is spaced from the outer edge of the second annular plate.
  • the first support rib also includes: a first annular rib, which extends along the circumference of the first annular plate, and there is at least one first annular rib; the second support rib also includes: a second annular rib, which extends along the circumference of the second annular plate, and there is at least one second annular rib.
  • the first support rib also includes: at least one first annular rib, which extends along the circumference of the first annular plate, and at least one first annular rib is connected to multiple first radial ribs;
  • the second support rib also includes: at least one second annular rib, which extends along the circumference of the second annular plate, and at least one second annular rib is connected to multiple second radial ribs.
  • At least one of the first annular ribs is provided on the outer edge of the first annular plate, and the outer ends of the plurality of the first radial ribs are provided on the outer edge of the first annular plate. It is connected to the first annular rib located on the outer edge of the first annular plate; at least one second annular rib is provided on the outer edge of the second annular plate, and the outer ends of multiple second radial ribs are connected to the second annular rib located on the outer edge of the second annular plate.
  • the occluder further comprises a delivery device connecting portion, which is integrally formed at one end of the occluding portion and is suitable for connecting to a pushing assembly in the occluder delivery device.
  • the connecting portion of the conveying device is constructed as a connecting block, and the surface of the connecting block is provided with anti-slip grooves.
  • FIG1 is a schematic structural diagram of a double-disc-shaped integrally formed degradable cardiac atrial septal foramen ovale occluder according to one embodiment of the present application;
  • FIG2 is a cross-sectional view of a double-disc-shaped integrally formed degradable cardiac atrial septal foramen ovale occluder according to one embodiment of the present application;
  • FIG3 is a schematic structural diagram of a double-disc-shaped integrally formed degradable cardiac atrial septal foramen ovale occluder according to another embodiment of the present application;
  • FIG4 is a schematic structural diagram of a double-disc-shaped integrally formed degradable cardiac atrial septum foramen ovale occluder according to another embodiment of the present application.
  • the following describes a double-disc-shaped, integrally molded, degradable cardiac atrial septal foramen ovale occluder 100 according to some embodiments of the present application with reference to FIG1 .
  • the occluder 100 is a degradable component.
  • the occluder 100 can be made of at least one of a degradable polymer material, a degradable metal material, a bioceramic component, and a bioglass component.
  • the occluder 100 includes: a first disc portion 10, a second disc portion 20, and a blocking portion 30. The first disc portion 10 and the second disc portion 20 are connected at both ends of the blocking portion 30. The blocking portion 30 penetrates the atrial septum to block the foramen ovale.
  • the first disc portion 10 and the second disc portion 20 are respectively located on both sides of the foramen ovale of the atrial septum.
  • the first disc portion 10 and the second disc portion 20 jointly clamp the atrial wall of the heart.
  • the first disc portion 10, the second disc portion 20, and the blocking portion 30 are integrally molded components, and the first disc portion 10 and the second disc portion 20 are both elastic components that can automatically return to their original shape.
  • the double-disc-shaped, one-piece, degradable heart atrial septal foramen ovale occluder 100 of the present application is a degradable component, which can be degraded and absorbed in the body within 6 months to 2 years after surgery.
  • the occluder 100 provides a temporary bridge for the heart's own repair, allowing its own cell tissue to climb and grow. After completing its mission, it is degraded by the body, allowing the atrial septal defect to be completely repaired by the body's own tissues, avoiding the impact of the occluder's permanent retention in the human body, and will not affect the surgical treatment of heart diseases that may occur in the future.
  • the double-disc-shaped, integrally molded, degradable cardiac atrial septum foramen ovale occluder 100 of the present application is an integrally molded, degradable part.
  • the occluder 100 of the embodiment of the present application can avoid the long-term complications and safety hazards caused by metal retention in the body.
  • the occluder 100 of the embodiment of the present application is an integral structure, the structural integrity of the occluder 100 is strong, the occluder 100 is formed of the same material, the degradation rate of the occluder 100 in the human body is uniform, and there is no risk of structural disintegration. It can overcome all the shortcomings of the braided structure occluder in the related art and can also simplify surgical operations.
  • the occluder for interventional treatment needs to be introduced into the lesion site through a thin sheath.
  • the occluder 100 of the present application can be deformed, and the occluder 100 is reduced in size to be accommodated in the sheath for easy transportation. After the occluder 100 is transported out of the sheath, the occluder 100 can automatically return to its original state to occlude the foramen ovale of the atrial septum.
  • the sheath is extended to the foramen ovale of the atrial septum, and the pushing assembly pushes the occluder 100 along the sheath to the atrial septal defect.
  • the second disc portion 20 is released from the sheath on the left atrium side, and the second disc portion 20 automatically returns to its original shape after being released, and the second disc portion 20 abuts against the left atrial wall; then the occluding portion 30 is released from the sheath, and the occluding portion 30 is positioned in the foramen ovale of the atrial septum to occlude the atrial septal defect; finally, the first disc portion 10 is released from the sheath on the right atrium side, and the first disc portion 10 automatically returns to its original shape after being released, and the first disc portion 10 abuts against the right atrial wall, so that the occluder 100 can occlude the foramen ovale of the atrial septum.
  • the occluder 100 of the embodiment of the present application is an elastic member.
  • the occluder 100 can be deformed into a smaller volume, so that it can be delivered by a sheath with a smaller diameter, which is beneficial to reducing surgical risks.
  • the occluder 100 can automatically Therefore, there is no need to set up an additional driving member to drive the occluder 100 to return to its original state, which can reduce manufacturing costs and simplify surgical operations.
  • the shape of the foramen ovale in the atrial septum is relatively complex.
  • the axial direction of the occluding part is parallel to the axes of the first disc part and the second disc part, after the occluding part is processed to occlude the foramen ovale, the expansion of the first disc part and the second disc part may be blocked by the inner wall of the heart, thereby reducing the occluding effect.
  • the sealing portion 30 of the double-disc-shaped one-piece biodegradable cardiac atrial septum foramen ovale occluder 100 of the embodiment of the present application is arranged at an angle, the plane where the edge of the first disc portion 10 is located is the first plane a, the plane where the edge of the second disc portion 20 is located is the second plane b, the angle between the axis c of the sealing portion 30 and the first plane a is an acute angle, and/or the angle between the axis c of the sealing portion 30 and the second plane b is an acute angle.
  • the first disc portion 10 and/or the second disc portion 10 are arranged obliquely relative to the occluding portion 30.
  • the double-disc-shaped one-piece degradable heart atrial septum foramen ovale occluder 100 of the embodiment of the present application can select the occluding portion 30, the first disc portion 10 and the second disc portion 20 in accordance with the shape structure of the heart wall in actual application, thereby improving the occluding effect of the double-disc-shaped one-piece degradable heart atrial septum foramen ovale occluder 100.
  • the occluder 100 is an integrally formed degradable part.
  • the occluder 100 provides a temporary bridge for the heart to repair itself, allowing its own cell tissue to climb and grow, and then be degraded and absorbed in the body. The long-term complications and safety hazards caused by metal retention in the body can be avoided.
  • the occluder 100 has strong structural integrity, and the occluder 100 has a uniform degradation rate in the human body without the risk of structural disintegration. It can overcome all the shortcomings of the existing braided structure occluder 100 and can also simplify surgical operations.
  • the first disc portion 10 and/or the second disc portion 10 are tilted relative to the occluding portion 30, so that the first disc portion 10 and the second disc portion 20 can adapt to the heart wall structure of different shapes, thereby improving the occlusion effect.
  • the angle between the axis c of the blocking portion 30 and the first plane a is an acute angle
  • the angle between the axis c of the blocking portion 30 and the second plane b is an acute angle
  • the angle between the axis c of the blocking portion 30 and the first plane a is equal to the angle between the axis c of the blocking portion 30 and the second plane b
  • the first plane a and the second plane b are arranged in parallel.
  • the sealing portion 30 is inclined compared to the first plane a and the second plane b.
  • the double-disc-shaped one-piece biodegradable heart atrial septum foramen ovale occluder 100 of the embodiment of the present application is suitable for the situation where the foramen ovale is inclined compared to the heart wall.
  • the sealing portion 30 blocks the foramen ovale, at least the edges of the first disc portion 10 and the second disc portion 20 are reliably in contact with the heart wall, which can further enhance the sealing effect.
  • the contact between the first disc portion 10 and the second disc portion 20 and the heart wall is conducive to the climbing and growth of cell tissue, which can enhance the repair effect.
  • the angle between the axis c of the blocking portion 30 and the first plane a is equal to the angle between the axis c of the blocking portion 30 and the second plane b, and the angle ⁇ between the axis c of the blocking portion 30 and the first plane a satisfies: 20° ⁇ 90°.
  • At least a portion of at least one of the first disc portion 10 and the second disc portion 20 is in the form of a conical ring, and the conical ring extends from the center to the edge toward the center of the double-disc-shaped, one-piece biodegradable cardiac atrial septum foramen ovale occluder 100.
  • first disc portion 10 and the second disc portion 20 are respectively connected to the two ends of the length direction of the occluding portion 30 , so the center position of the double-disc-shaped integrally molded degradable cardiac atrial septum foramen ovale occluder 100 is the middle part of the occluding portion 30 .
  • At least a portion of at least one of the first disc portion 10 and the second disc portion 20 is in the form of a conical ring.
  • the conical ring extends from the center to the edge toward the second disc portion 20; when at least a portion of the second disc portion 20 is in the form of a conical ring, the conical ring extends from the center to the edge toward the first disc portion 10.
  • At least a portion of the first disc portion 10 is a conical ring
  • at least a portion of the second disc portion 20 is a conical ring
  • the first disc portion 10 and the second disc portion 20 are interlocked.
  • At least a portion of at least one of the first disc portion 10 and the second disc portion 20 is in the form of an inverted conical ring, which extends from the center to the edge toward the center of the double-disc-shaped, one-piece biodegradable cardiac atrial septum foramen ovale occluder 100.
  • At least a portion of at least one of the first disc portion 10 and the second disc portion 20 is in the form of an inverted conical ring.
  • the conical ring extends from the center to the edge in a direction away from the second disc portion 20;
  • the conical ring extends from the center to the edge in a direction away from the first disc portion 10.
  • At least a portion of the first disc portion 10 is in the form of an inverted conical ring, and at least a portion of the second disc portion 20 is in the form of an inverted conical ring.
  • the first disc portion 10 and the second disc portion 20 are disc-shaped structures that are away from each other.
  • Both the first disc portion 10 and the second disc portion 20 are in the form of inverted conical rings, and are arranged in a reversed, diverging configuration.
  • the first disc portion 10 and the second disc portion 20 are prevented from obstructing the occluding portion 30, thereby minimizing the possibility of the first disc portion 10 or the second disc portion 20 obstructing the foramen ovale, thereby improving the operational reliability of the double-disc, integrally molded, degradable foramen ovale occluder 100.
  • At least a portion of one of the first disc portion 10 and the second disc portion 20 is in the form of a conical ring, which extends from the center to the edge toward the center of the double-disc-shaped, one-piece degradable heart atrial septum foramen ovale occluder 100, and at least a portion of at least one of the first disc portion 10 and the second disc portion 20 is in the form of an inverted conical ring, which extends from the center to the edge toward the center away from the double-disc-shaped, one-piece degradable heart atrial septum foramen ovale occluder 100.
  • One of the first disc portion 10 and the second disc portion 20 is arranged to bend inwardly toward the middle position of the sealing portion 10, and the other of the first disc portion 10 and the second disc portion 20 is extended in a direction away from the middle position of the sealing portion 10, which also falls within the scope of protection of the present application.
  • the first disc portion 10 and the second disc portion 20 are parallel discs.
  • the first disc portion 10 and the second disc portion 20 are arranged in parallel. After the first disc portion 10 and the second disc portion 20 return to their original state, the contact area with the heart wall is larger, which can improve the occlusion effect.
  • the first disc portion 10 includes a first annular plate 11 and a first support rib 12.
  • the first annular plate 11 is the main body of the first disc portion 10.
  • the first support rib 12 is disposed on the first annular plate 11 and is used to support the first annular plate 11 in its original shape.
  • the second disc portion 20 includes a second annular plate 21 and a second support rib 22.
  • the second annular plate 21 is the main body of the second disc portion 20.
  • the second support rib 22 is disposed on the second annular plate 21 and is used to support the second annular plate 21 in its original shape.
  • first annular plate 11 and the second annular plate 21 are constructed as a sheet structure.
  • the occluder 100 of the present application has a smaller spatial volume.
  • the occluder 100 can be deformed into a smaller volume and stored in the sheath, and can be transported through a sheath with a smaller diameter, which is beneficial to reducing surgical risks.
  • the speed at which the first annular plate 11 restores to its original state can be increased, and by providing the second support rib 22, the speed at which the second annular plate 21 restores to its original state can be increased, thereby reducing the occurrence of the first annular plate 11 and the second annular plate 21 being blocked and unable to fully restore to their original state, which is beneficial to the release of the occluder 100, improves the working reliability of the occluder 100, and improves the surgical efficiency.
  • the first annular plate 11 has a first inner surface and a first outer surface opposite to each other, the first inner surface is arranged toward the second disk portion 20, and the first support rib 12 protrudes from at least one of the first inner surface and the first outer surface;
  • the second annular plate 21 has a second inner surface and a second outer surface opposite to each other, the second inner surface is arranged toward the first disk portion 10, and the second support rib 22 protrudes from at least one of the second inner surface and the second outer surface.
  • the first support rib 12 may protrude from the first annular plate 11 in the direction of the first inner surface, or, further optionally, the first support rib 12 may protrude from the first annular plate 11 in the direction of the first outer surface, or, further optionally, the first support rib 12 may protrude from both the first inner surface and the first outer surface.
  • the second support rib 22 may protrude from the second inner surface, or, further optionally, the second support rib 22 may protrude from the second outer surface, or, further optionally, the second support rib 22 may protrude from both the second outer surface and the second inner surface.
  • the cross-sectional shape of the first annular plate 11 and the second annular plate 21 is circular, quasi-circular or polygonal.
  • the first annular plate 11 or the second annular plate 21 with the corresponding cross-sectional shape can be selected according to the shape of the atrial wall of the affected area. To fit the affected area.
  • the occluder 100 of the embodiment of the present application allows for direct trimming of the first annular plate 11 or the second annular plate 21 to conform the shape of the first disc 10 and the second disc 20 to the affected area. Because the occluder 100 of the embodiment of the present application is a one-piece structure, direct trimming of the first annular plate 11 or the second annular plate 21 does not damage the integrity of the first disc 10 and the second disc 20, allowing the first disc 10 and the second disc 20 to function normally. Therefore, the present application supports custom trimming, which allows the occluder 100 to have a wide range of applications and is highly targeted, thereby improving the repair effect and reducing the manufacturing cost of customized parts.
  • the first support rib 12 may only include a plurality of first radial ribs 121, which are arranged at intervals along the circumference of the first annular plate 11, and the first radial ribs 121 extend radially along the first annular plate 11;
  • the second support rib 22 only includes a plurality of second radial ribs 221, which are arranged at intervals along the circumference of the second annular plate 21, and the second radial ribs 221 extend radially along the second annular plate 21.
  • first support rib 12 may only include a first annular rib 122, which extends along the circumference of the first annular plate 11, and there is at least one first annular rib 122;
  • second support rib 22 only includes a second annular rib 222, which extends along the circumference of the second annular plate 21, and there is at least one second annular rib 222.
  • the first support rib 12 includes a first radial rib 121 and a first annular rib 122, a plurality of first radial ribs 121 are arranged at intervals along the circumference of the first annular plate 11, the first radial rib 121 extends radially along the first annular plate 11, the first annular rib 122 extends circumferentially along the first annular plate 11, and the first annular rib 122 is connected to the plurality of first radial ribs 121;
  • the second support rib 22 includes a second radial rib 221 and a second annular rib 222, a plurality of second radial ribs 221 are arranged at intervals along the circumference of the second annular plate 21, the second radial rib 221 extends radially along the second annular plate 21, the second annular rib 222 extends circumferentially along the second annular plate 21, and the second annular rib 222 is connected to the plurality of second rib 22
  • the inner end of the first radial rib 121 is connected to the sealing portion 30, and the outer end of the first radial rib 121 extends to the outer edge of the first annular plate 11, or is spaced from the outer edge of the first annular plate 11;
  • the inner end of the second radial rib 221 is connected to the sealing portion 30, and the outer end of the second radial rib 221 extends to the outer edge of the second annular plate 21, or is spaced from the outer edge of the second annular plate 21.
  • the inner end of the first radial rib 121 is connected to the sealing portion 30, which can enhance the structural strength of the first radial rib 121 and is conducive to supporting the first annular plate 11 to restore its original shape;
  • the inner end of the second radial rib 221 is connected to the sealing portion 30, which can enhance the structural strength of the second radial rib 221 and is conducive to supporting the second annular plate 22 to restore its original shape.
  • the outer ends of the first radial ribs 121 may extend to the outer edge of the first annular plate 11 to facilitate the first annular plate 11 to return to its original shape.
  • the outer end of the first radial rib 121 may also extend toward the outer edge of the first annular plate 11 and be spaced apart from the outer edge of the first annular plate 11 .
  • the outer end of the second radial rib 221 may extend to the outer edge of the second annular plate 21 to facilitate the The two annular plates 22 return to their original state.
  • the outer end of the second radial rib 221 extends toward the outer edge of the second annular plate 21 and is spaced apart from the outer edge of the second annular plate 21 .
  • At least one first annular rib 122 is provided on the outer edge of the first annular plate 11, and at least one second annular rib 222 is provided on the outer edge of the second annular plate 21.
  • the first annular rib 122 provided on the outer edge of the first annular plate 11 facilitates the restoration of the first annular plate 11 to its original shape.
  • the second annular rib 222 provided on the outer edge of the second annular plate 21 facilitates the restoration of the second annular plate 21 to its original shape.
  • the first support rib 12 includes a first radial rib 121 and a first annular rib 122
  • the second support rib 22 includes a second radial rib 221 and a second annular rib 222
  • at least one first annular rib 122 is arranged on the outer edge of the first annular plate 11, and the outer ends of multiple first radial ribs 121 are connected to the first annular rib 122 located on the outer edge of the first annular plate 11
  • at least one second annular rib 222 is arranged on the outer edge of the second annular plate 21, and the outer ends of multiple second radial ribs 221 are connected to the second annular rib 222 located on the outer edge of the second annular plate 21.
  • the outer ends of the plurality of first radial ribs 121 are connected to the first annular rib 122 located on the outer edge of the first annular plate 11, thereby connecting the first support rib 12 as a whole, improving the structural stability of the first support rib 12, and facilitating the restoration of the first annular plate 11 to its original shape.
  • the outer ends of the plurality of second radial ribs 221 are connected to the second annular rib 222 located on the outer edge of the second annular plate 21, thereby connecting the second support rib 22 as a whole, improving the structural stability of the second support rib 22, and facilitating the restoration of the first annular plate 11 to its original shape.
  • the number of the first radial ribs 121 is 1-100; the number of the second radial ribs 221 is 1-100.
  • the number of the first radial ribs 121 may be 1, 4, 5, 6, 8, 10, 20, 50, 100, etc.
  • the number of the second radial ribs 221 may be 1, 4, 5, 8, 10, 16, 30, 50, 100, etc.
  • the number of the first annular ribs 122 is 1-10, and the number of the second annular ribs 222 is 1-10.
  • first annular ribs 122 When there are too many first annular ribs 122 , it is not conducive to the deformation and accommodation of the first annular plate 11 ; similarly, when there are too many second annular ribs 222 , it is not conducive to the normal operation of the occluder 100 .
  • the number of the first annular ribs 122 may be 1, 2, 3, 4, 5, 6, 8, 10, etc.
  • the number of the second annular ribs 222 may be 1, 2, 3, 4, 5, 6, 8, 10, etc.
  • the first disc portion 10 and the second disc portion 20 are symmetrically arranged.
  • the shape, projected area and thickness of the first disc portion 10 and the second disc portion 20 are uniform; the number, structure and specifications of the first radial ribs 121 on the first disc portion 10 are consistent with the number, structure and specifications of the second radial ribs 221 on the second disc portion 20.
  • the specifications and dimensions are the same, and the number, structure and specifications and dimensions of the first annular ribs 122 on the first disc portion 10 are the same as the number, structure and specifications and dimensions of the second annular ribs 222 on the second disc portion 20 .
  • the first disc portion 10 and the second disc portion 20 are arranged asymmetrically.
  • the number, structure and specifications of the first radial ribs 121 on the first disc portion 10 are different from the number, structure and specifications of the second radial ribs 221 on the second disc portion 20; or, also optionally, the number, structure and specifications of the first annular ribs 122 on the first disc portion 10 are different from the number, structure and specifications of the second annular ribs 222 on the second disc portion 20.
  • the occluder 100 also includes a delivery device connection portion 40, which is integrally formed at one end of the occluding portion 30, and the delivery device connection portion 40 is suitable for connecting to a pushing component in the delivery device of the occluder 100.
  • the pushing assembly can be selectively connected to the conveying device connecting portion 40.
  • the pushing assembly When the pushing assembly is connected to the conveying device connecting portion 40, it can drive the occluder 100 to move.
  • the pushing assembly When the pushing assembly is separated from the conveying device connecting portion 40, the pushing assembly can be recovered.
  • the delivery device connecting portion 40 is disposed on one side of the first disc portion 10 on the blocking portion 30 .
  • the conveying device connection portion 40 may be a hole, a recess, or a protrusion structure, and the pushing assembly is coupled to the conveying device connection portion 40.
  • the hole, recess, or protrusion may be in the shape of a circle, an ellipse, a triangle, or a composite geometric figure; the hole may be a through-hole structure, the recess or protrusion structure may be a non-through-hole structure, and the protrusion structure may be a flat protrusion or a cylindrical protrusion structure.
  • the conveying device connecting portion 40 is constructed as a connecting block, and anti-slip grooves are provided on the surface of the connecting block.
  • the occluder 100 of the present application is an integrated structure, comprising an elastic member that automatically returns to its original shape. Upon being released from the sheath, the occluder 100 automatically returns to its original shape, eliminating the need for a separate actuator to return the occluder 100 to its original shape. This reduces manufacturing costs and simplifies surgical procedures.
  • the delivery device connector 40 is constructed as a connecting block, which utilizes a clamping member as a pushing component. The clamping member clamps the connecting block to connect to the occluder 100, simplifying the connection and release of the clamping member and simplifying surgical procedures.
  • the surface friction of the connecting block can be increased, the connection stability between the pushing component and the connecting block can be further improved, and the working reliability of the occluder 100 can be improved.
  • first and second are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as “first” or “second” may explicitly or implicitly include at least one of such features.
  • plural means at least two, for example, two, three, etc., unless otherwise specifically defined.
  • first feature when a first feature is “above” or “below” a second feature, it may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Furthermore, when a first feature is “above,” “above,” or “above” a second feature, it may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is at a higher level than the second feature. When a first feature is “below,” “below,” or “below” a second feature, it may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is at a lower level than the second feature.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif d'occlusion du foramen ovale du septum auriculaire dégradable formé d'un seul tenant en forme de disque double (100) comprenant : une première partie disque (10), une seconde partie disque (20) et une partie d'occlusion (30), la première partie disque (10) et la seconde partie disque (20) étant reliées à deux extrémités de la partie d'occlusion (30), la première partie disque (10), la seconde partie disque (20) et la partie d'occlusion (30) étant d'une structure formée d'un seul tenant, et la première partie disque (10) et la seconde partie disque (20) étant toutes deux des parties élastiques capables de reprendre automatiquement leur forme d'origine. Un plan dans lequel un bord de la première partie disque (10) est situé est un premier plan (a), un plan dans lequel un bord de la seconde partie disque (20) est situé est un second plan (b), un angle inclus entre l'axe de la partie d'occlusion (30) et le premier plan (a) est un angle aigu, et/ou un angle inclus entre l'axe de la partie d'occlusion (30) et le second plan (b) est un angle aigu.
PCT/CN2024/091777 2024-04-15 2024-05-08 Dispositif d'occlusion du foramen ovale du septum auriculaire dégradable formé d'un seul tenant en forme de disque double Pending WO2025217962A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202410451556.6 2024-04-15
CN202420776702.8 2024-04-15
CN202410451556.6A CN121196626A (zh) 2024-04-15 2024-04-15 双盘状一体成型可降解心脏房间隔卵圆孔封堵器
CN202420776702 2024-04-15

Publications (1)

Publication Number Publication Date
WO2025217962A1 true WO2025217962A1 (fr) 2025-10-23

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2024/091777 Pending WO2025217962A1 (fr) 2024-04-15 2024-05-08 Dispositif d'occlusion du foramen ovale du septum auriculaire dégradable formé d'un seul tenant en forme de disque double

Country Status (1)

Country Link
WO (1) WO2025217962A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050043759A1 (en) * 2003-07-14 2005-02-24 Nmt Medical, Inc. Tubular patent foramen ovale (PFO) closure device with catch system
US20050070957A1 (en) * 2002-03-01 2005-03-31 Das Gladwin S. Vascular occlusion device
US20050288786A1 (en) * 2004-05-07 2005-12-29 Nmt Medical, Inc. Closure device with hinges
US20080077180A1 (en) * 2006-09-26 2008-03-27 Nmt Medical, Inc. Scaffold for tubular septal occluder device and techniques for attachment
CN207837587U (zh) * 2017-04-11 2018-09-11 上海形状记忆合金材料有限公司 一种隧道状卵圆孔未闭封堵器械
US20220346803A1 (en) * 2019-12-18 2022-11-03 Hangzhou Dinova Ep Technology Co., Ltd Occluder, occluding system, and knotting method for tightening element in occluder
US20230122698A1 (en) * 2020-06-22 2023-04-20 Netbusiness Consulting Co., Ltd. Closure system, and manufacturing method of closure device

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050070957A1 (en) * 2002-03-01 2005-03-31 Das Gladwin S. Vascular occlusion device
US20050043759A1 (en) * 2003-07-14 2005-02-24 Nmt Medical, Inc. Tubular patent foramen ovale (PFO) closure device with catch system
US20050288786A1 (en) * 2004-05-07 2005-12-29 Nmt Medical, Inc. Closure device with hinges
US20080077180A1 (en) * 2006-09-26 2008-03-27 Nmt Medical, Inc. Scaffold for tubular septal occluder device and techniques for attachment
CN207837587U (zh) * 2017-04-11 2018-09-11 上海形状记忆合金材料有限公司 一种隧道状卵圆孔未闭封堵器械
US20220346803A1 (en) * 2019-12-18 2022-11-03 Hangzhou Dinova Ep Technology Co., Ltd Occluder, occluding system, and knotting method for tightening element in occluder
US20230122698A1 (en) * 2020-06-22 2023-04-20 Netbusiness Consulting Co., Ltd. Closure system, and manufacturing method of closure device

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