WO2019015617A1 - Dispositif de réglage de pression approprié pour être placé entre des oreillettes - Google Patents

Dispositif de réglage de pression approprié pour être placé entre des oreillettes Download PDF

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Publication number
WO2019015617A1
WO2019015617A1 PCT/CN2018/096169 CN2018096169W WO2019015617A1 WO 2019015617 A1 WO2019015617 A1 WO 2019015617A1 CN 2018096169 W CN2018096169 W CN 2018096169W WO 2019015617 A1 WO2019015617 A1 WO 2019015617A1
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WO
WIPO (PCT)
Prior art keywords
positioning portion
heart chamber
regulating device
pressure regulating
channel
Prior art date
Application number
PCT/CN2018/096169
Other languages
English (en)
Chinese (zh)
Inventor
王永胜
齐均
吴俊飞
李建民
訾振军
Original Assignee
杭州诺生医疗科技有限公司
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by 杭州诺生医疗科技有限公司 filed Critical 杭州诺生医疗科技有限公司
Publication of WO2019015617A1 publication Critical patent/WO2019015617A1/fr

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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, e.g. tourniquets
    • 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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor

Definitions

  • the invention relates to the field of medical instruments, in particular to a pressure regulating device suitable for a heart chamber.
  • Heart failure is called heart failure. It means that due to the systolic function and/or diastolic function of the heart, the blood can not be completely discharged from the heart, resulting in blood stasis in the venous system, insufficient blood perfusion in the arterial system, and then causing the heart. Circulatory disorder syndrome.
  • Heart failure is a serious disease with high incidence and mortality. According to the location of heart failure, it can be divided into left heart failure, right heart failure and whole heart failure. According to the clinical manifestations of heart failure, it can be divided into contractility. Heart failure and diastolic heart failure, of which diastolic heart failure Heart failure (DHF) accounts for about half of all heart failure patients. There are more than 12 million heart failure patients in China, that is, the incidence of heart failure is about 2 to 3%, of which about 6 million patients with diastolic heart failure, the heart failure of the elderly is mainly diastolic heart failure, the elderly The number of patients with diastolic heart failure accounted for 66.99% of the total number of patients with diastolic heart failure.
  • DHF diastolic heart failure Heart failure
  • the main causes of heart failure include hypertension, coronary heart disease, myocardial infarction, heart valve disease, atrial fibrillation, and cardiomyopathy.
  • Cardiovascular disease causes left ventricular damage, leading to pathological remodeling of the left ventricle, which in turn leads to cardiac dysfunction, which means that every successful treatment of a patient with myocardial infarction brings a potential heart failure patient.
  • CRT cardiac resynchronization therapy
  • LVAD Left ventricular assist device
  • One of the prior art solutions is to implant a shunt device between the left atrium and the right atrium, which has been proven clinically effective, but the existing shunt device needs further improvement in structure and performance, for example, Corvia Medical designed an all-metal alloy stent for left atrial to right atrial shunt for diastolic heart failure.
  • Corvia Medical designed an all-metal alloy stent for left atrial to right atrial shunt for diastolic heart failure.
  • There is no valve in the alloy stent and the internal blood flow channel is normally open, but it is easy to cause under non-ideal conditions.
  • Excessive shunting which forms a shunt of the right atrium to the left atrium, further aggravates the ability of the left atrium to fill oxygenated blood and has the risk of causing abnormal embolism.
  • There is no film in the alloy stent which is easy to block the blood flow channel due to endothelialization.
  • V-Wave designed an hourglass (diabolo)-like shunt device.
  • the hourglass-shaped shunt device is easily displaced under the scouring of blood flow, changing the installation angle, and forming an artificial small gap with the interatrial septum.
  • the angle is easy to form eddy currents and thrombus in the angled space, and the polymer ePTFE membrane is attached to the outer surface of the shunt device, which may cause complications such as thrombosis and hemolysis.
  • the technical problem to be solved by the present invention is to provide a pressure adjusting device suitable for a heart chamber according to the above-mentioned drawbacks of the prior art, and to reduce repeated embolism and complications by implanting a one-way open valve structure on the interatrial septum. happened.
  • the pressure regulating device suitable for the heart chamber is a cylindrical structure, and includes a room spacing channel and an outflow channel which are sequentially arranged along the blood flow direction in the axial direction of the cylindrical structure, and the side of the room spacing channel facing away from the outflow channel has
  • the flow inlet is provided with a one-way open valve flap
  • the cylindrical structure is provided with a first positioning portion and a second positioning portion respectively abutting on both sides of the room interval.
  • the pressure regulating device is used to balance the pressure between the left atrium and the right atrium.
  • the valve flap When the pressure difference between the left atrium and the right atrium exceeds a threshold, the valve flap is gradually opened, and the blood flow in the left atrium enters the atrial septum through the inflow port. Then, through the outflow channel into the right atrium, thereby alleviating the excessive pressure in the left atrium.
  • the valve flap closes, blocking blood flow between the left atrium and the right atrium through the atrial septum.
  • the diameter of the outflow tract is larger than the diameter of the interatrial septum, and some or all of the joints of the outflow tract and the interatrial septum abut against the interatrial septum. Used to ensure the sealing effect.
  • an inflow channel is also provided that is opposite the inlet to the interatrial channel.
  • the inflow channel, the interatrial channel and the outflow channel in the present invention all refer to the channel structure of the entity, which are respectively a section of the cylindrical structure.
  • the blood flow direction is from high pressure to low pressure, and the inflow channel is located upstream of the blood flow, that is, extends to a certain length in the high pressure direction, and the outflow channel is located downstream of the blood flow, that is, extends to a certain length in the low pressure direction.
  • the invention is applicable to the pressure regulating device of the heart chamber, or the valve flap can be omitted, and the outflow channel can be shortened or even omitted accordingly, that is, the invention is applicable to the pressure adjusting device of the heart chamber, and is a cylindrical structure, along the axis of the cylindrical structure.
  • the first positioning portion and the second positioning portion for abutting against the corresponding side of the room space are respectively connected to the room spacing channel including the central portion.
  • the room is located between the left atrium and the right atrium. After the pressure regulating device suitable for the heart chamber is released in the body, the first positioning portion and the second positioning portion are respectively located on both sides of the room interval, and are respectively pressed from both sides.
  • the room compartment defines the position of the pressure regulating device.
  • the first positioning portion and the second positioning portion are sandwiched by the two sides of the room interval to the room space, and both the inflow channel and the outflow channel extend a certain length in a direction away from the room space.
  • the inflow channel, the interatrial septum channel and the outflow channel are coaxially arranged.
  • the cross-sectional dimension of the interatrial septum channel should be as small as possible, but blood flow is also required.
  • the cross-section of the atrial septum is preferably a circular shape, or an elliptical shape, and the like, and the shape of the cross-section of the atrial septum is circular, and the cross-sectional diameter is preferably 3 to 6 mm.
  • the first positioning portion and the second positioning portion are each independently a wire frame structure or a mesh structure.
  • the first positioning portion and the second positioning portion may adopt a wire frame structure or a mesh structure, and the wire frame structure means that the first positioning portion and the second positioning portion have a skeleton structure that plays a supporting role.
  • the skeleton structure is sparse, when the first positioning portion and the second positioning portion hold the partition wall, the skeleton structure contacting the partition wall exerts a relatively concentrated force on different regions of the interatrial septum.
  • the mesh structure means that the first positioning portion and the second positioning portion have obvious latitude and longitude characteristics, and when the first positioning portion and the second positioning portion are clamped to the room interval, the pressure applied to the room partition wall is dispersed as much as possible, so that The pressure at each contact site is as small as possible, thereby ensuring that parts of the partition walls are not damaged by excessive pressure.
  • the first positioning portion, the second positioning portion, and the pressure adjusting device applicable to the heart chamber can be independently processed by knitting or cutting, and all of the three can adopt a regular or irregular wire frame structure, and when the wire frame structure is adopted
  • the skeleton is placed at a suitable position to increase the strength as needed, and the skeleton may have an increase in cross-sectional area or at least a higher strength with respect to other portions.
  • the first positioning portion, the second positioning portion, and the pressure adjusting device applicable to the heart chamber may each independently adopt a mesh structure, and the mesh structure may be a regular or irregular cell, preferably a diamond-shaped or approximately diamond-shaped cell.
  • the network structure has a distinct warp and weft structure, the warp and weft intersection can be a fixed node, more preferably a non-fixed node, that is, the warp and weft can be misaligned to provide compliance Sex and deformability.
  • the shape of the first positioning portion and the second positioning portion may be at least one of a plane, a tapered surface, and a curved surface.
  • the first positioning portion may be a plane, a cone surface, a curved surface, a combination of a plane and a cone surface, a combination of a plane and a curved surface, a combination of a cone surface and a curved surface, and a plane, a cone surface, and The combination of curved surfaces.
  • the plane is not required to be strictly planar, and an approximate plane can also be used.
  • the first positioning portion and the second positioning portion are in point contact or surface contact with the atrial space of the corresponding side.
  • the point contact is not strictly a point, but has a small contact area, approximately one point.
  • the area where the first positioning portion and the second positioning portion are in contact with the room as a support point needs to reduce the damage to the room space as small as possible, and therefore, point contact and line contact in a strict sense are excluded, and
  • the contact forms can be used, and are divided into point contact and surface contact according to the size of the contact area.
  • the first positioning portion and the second positioning portion each radiate radially outward along the cylindrical structure. That is, the contact points of the first positioning portion and the second positioning portion with the room partition wall are as larger as possible than the stoma area, and contact the interatrial space in a larger size range to achieve a better stabilization effect.
  • the one-way open valve flap can be realized by two valves, three valves, or even more valves.
  • the pressure in the left atrium is P1
  • the pressure in the right atrium is P2;
  • the flap begins to open.
  • the outflow passage includes a transition section and an outflow section which are sequentially disposed in the axial direction, wherein the transition section is connected to the atrial compartment passage.
  • the outflow section may adopt a cylindrical or truncated cone shape such that the cross section of the outflow section is larger than the cross section area of the interatrial septum passage, and the transition section is connected by the transition section between the outflow section and the interatrial passage passage, and the transition section is The cross-sectional area is gradually increased from the compartment to the outflow section.
  • the transition section can also play a limiting role to a certain extent, namely acting on the interatrial septum to prevent displacement of the valve support.
  • the first positioning portion and the second positioning portion may take various forms, for example, the first positioning portion or the second positioning portion includes a plurality of bifurcated support rods radiating radially outward along the cylindrical structure. The adjacent support rods meet each other through the fork.
  • the first positioning portion or the second positioning portion includes a plurality of pairs of support rods radiating outward in the radial direction of the cylindrical structure, and the pair of support rods of the same pair meet each other.
  • the structure of the first positioning portion and the second positioning portion is formed by the mutual separation of the support rods and the mutual intersection, and the outer circumference of each of the support rods does not have sharp edges and corners.
  • the inflow channel gradually tapers in the direction of blood flow (the radial direction gradually decreases).
  • the inflow channel forms a flared structure, and the flared structure prevents the endothelium from climbing on the one hand, and prevents the interatrial septum from being blocked.
  • the flow channel is gradually narrowed, and the blood generates a greater impact force. Relieve pressure by pushing open the valve flap.
  • the inflow channel radiates radially outward from the inlet side of the atrial compartment along the radial direction of the tubular structure, and the inflow channel doubles as the first positioning portion.
  • the axial dimension of the inflow channel is shorter as part of the first positioning portion.
  • the first positioning portion is connected to the joint portion of the inflow passage and the atrial compartment or to the inlet side of the inflow passage.
  • the connecting position of the first positioning portion is preferably an engaging portion of the inflow passage and the atrial spacing passage, or may be connected at any position in the axial direction of the inflow passage, for example, connected to the inlet side of the inflow passage.
  • the first positioning portion is bent toward the side of the atrial compartment channel while extending outward in the radial direction until it abuts against the interatrial septum.
  • the end of the first positioning portion is turned up in a direction away from the outflow channel.
  • the distal end of the first positioning portion is bent in a direction away from the interatrial septum to reduce direct puncture of the interatrial septum.
  • the second positioning portion is connected to at least one of the following locations:
  • the second positioning portion is connected to the outlet side of the outflow channel.
  • connection structure matching the conveying device may be disposed on the outlet side of the outflow channel, for example, a connection hole may be provided, and the connection hole may be selected according to various shapes to be able to achieve precise cooperation with the conveying system, for example, a circular hole. Rounded square holes, etc.
  • the second positioning portion is bent from the connection portion with the outflow channel or the atrial septum to the side of the atrial septum channel until it abuts against the interatrial septum.
  • the second positioning portion is bent from the outlet side of the outflow passage toward the side of the room spacing passage until it abuts against the room spacing.
  • the second positioning portion is deflected by a U-shaped bend on the outlet side of the outflow channel to achieve bending toward the side of the atrial compartment.
  • the edges of the outflow channel converge to at least two ends that are circumferentially spaced apart, each end being provided with a recovery connector.
  • the end portion can be gathered and collected into the delivery device by pulling the recovery connector, and the rest of the pressure regulating device is recompressed into the sheath under the tightening action of the delivery sheath so that Make the next release.
  • a portion of the edge of the outflow tract converges directly to the respective end, and the other portion converges to the respective end via the extension, which in the compressed state has an edge that is larger than the edge of the outflow tract Farther away from the axial position of the inflow channel.
  • the extension Since the extension is provided, in the compressed state, the end that converges through the extension is now longer in the axial dimension for the directly converging end, and the length of the traction cable can be adjusted to match the needs of the recovery.
  • the ends of the axial position are such that the ends are sequentially received in the delivery device in the order of the axial position.
  • edges of the extension and the outflow channel may also be substantially the same length.
  • the edge of the outflow channel converges to the respective end via an extension which, in the compressed state, extends axially from the edge of the outflow channel.
  • the extension may be formed by a straight rod or a V-shaped rod, that is, the straight rod and/or the V-shaped rod are uniformly or non-uniformly arranged around the circumference of the outflow passage to form an extension.
  • the extension in the released state, extends from the edge of the outflow channel in a direction away from the inflow opening (which is also understood to be remote from the inflow channel).
  • the extension in the released state, has an axial position that is further from the inflow channel than the edge of the outflow channel.
  • the extension in the released state, has a first bend towards the flow inlet (also understood as an inflow channel) and a back flow inlet from the edge of the outflow channel (also understood as The second bend back to the inflow channel).
  • the extension in the released state, constitutes the second positioning portion.
  • the extension serves to converge the edge of the outflow channel to the end, and on the other hand, the extension can also serve as a second positioning portion. Further preferably, when the extension portion constitutes the second positioning portion, the extension portion abuts the atrial space by the second bending.
  • the second positioning portion is turned up in a direction away from the flow inlet (also understood to be away from the side of the inflow channel) at a position against the atrial septum until adjacent to the outlet side of the outflow channel.
  • a recycling connector is disposed at an end of the second positioning portion.
  • the second positioning portion is deflected by a U-shaped bend at a position that abuts the atrial space to achieve a tilting toward the inflow path.
  • the pressure regulating device can be retracted into the conveying device by the traction recovery connector and released again.
  • the U-shaped bend described in the present invention is not strictly U-shaped, and is intended to define a smooth arc transition at the bend, without sharp corners.
  • the recovery connector is provided with a connection hole.
  • the connecting holes may be selected in various shapes as needed to enable precise cooperation with the conveying system, for example, round holes, rounded square holes, and the like.
  • the recovery joint is arranged in the circumferential direction of the tubular structure. That is, in the recycling process, the extending direction of the recovery connector is parallel to the axial direction of the pressure regulating device, so that the pressure regulating device can be admitted to the conveying device in the axial direction without adjusting the direction during the process of returning to the revenue conveying device.
  • the recovery connector is axially downstream from the outlet side of the outflow channel. Upon recovery, the recovery connector first enters the delivery device, and the remaining components are deformed to enter the sheath under the traction of the recovery connector and the compression of the sheath.
  • Downstream refers to the downstream of the blood flow when it is released, and actually corresponds to the direction of recovery during use, that is, closer to the delivery device for operation.
  • the outflow channel has a cell grid structure, and on the outlet side of the outflow channel, the vertices of all the cell grids are compliantly connected to one of the recovery connectors through the second positioning portion.
  • the isolated cell mesh vertices are not easily incorporated into the sheath during the recycling process because there is no traction of the recovery connector.
  • a film is placed between the valve flaps at a location corresponding to the interatrial septum in the interatrial septum. The membrane site is used to form a closed channel that directs blood flow from the interatrial septum into the valve flap.
  • At least one of the inflow channel, the outflow channel, and the atrial septum is covered.
  • the first positioning portion may be formed without a film, a whole film, or a partial film. Similarly, the second positioning portion may not be covered with a film, or all of the film may be partially coated.
  • the membrane, and the valve for the one-way open valve flap may independently adopt a biological valve or a polymer valve, and the biological valve includes a bovine pericardium, a pig pericardium, a horse pericardium, etc., and the polymer valve includes a poly IV. Fluorine, polyurethane, silicone rubber, etc.
  • all of the membrane may be coated or partially coated.
  • the pressure regulating device of the present invention has a diameter larger than a diameter of the atrial spacing channel, and the first positioning portion and the second positioning portion each have a diameter from a connection portion with the tubular structure. The trend of outward expansion.
  • the diameters of the outflow channel and the inflow channel are both larger than the diameter of the atrial septum channel, and the first positioning portion and the second positioning portion each have a diameter from a connection portion with the tubular structure. The trend of outward expansion.
  • the second positioning portion has a first bend toward the flow inlet and a second bend away from the flow inlet from the connection portion with the tubular structure.
  • the portion between the first bend and the second bend is radially expanded toward the flow inlet; the portion after the second bend is more radially converged away from the flow inlet.
  • the pressure regulating device suitable for the heart chamber provided by the present invention is formed on the atrial septum of the left and right heart chambers, so that a one-way open valve valve, a first positioning portion and a second positioning portion are formed on the interatrial septum.
  • the position is made more stable when the device is mated with the room, and when the release position is not correct, it can be recycled and released again.
  • Figure 1 is a front elevational view of a pressure regulating device of Embodiment 1 applied to a heart chamber;
  • FIG. 2 is a schematic view showing the valve opening of the pressure adjusting device applied to the heart chamber of Embodiment 1;
  • Figure 3 is a schematic view of the valve closure of the pressure regulating device of the embodiment 1 applied to the heart chamber;
  • Figure 4 is a front elevational view of a pressure regulating device of Embodiment 2 applicable to a heart chamber;
  • Figure 5 is a schematic view showing the valve opening of the pressure regulating device applied to the heart chamber of the embodiment 2;
  • Figure 6 is a schematic view showing the valve closing of the pressure regulating device of the embodiment 2 applied to the heart chamber;
  • Figure 7 is a front elevational view of a pressure regulating device of Embodiment 3 applied to a heart chamber;
  • Figure 8 is a schematic view showing the valve opening of the pressure adjusting device applied to the heart chamber of the third embodiment
  • Figure 9 is a schematic view showing the valve closing of the pressure regulating device of the embodiment 3 applied to the heart chamber;
  • Figure 10 is a front elevational view of a pressure regulating device of Embodiment 4 applied to a heart chamber;
  • Figure 11 is a schematic view showing the valve opening of the pressure adjusting device applied to the heart chamber of the fourth embodiment
  • Figure 12 is a schematic view showing the valve closure of the pressure regulating device of the embodiment 4 applied to the heart chamber;
  • Figure 13 is a front elevational view of a pressure regulating device of Embodiment 5 applied to a heart chamber;
  • Figure 14 is a schematic view showing the valve opening of the pressure adjusting device applied to the heart chamber of the embodiment 5;
  • Figure 15 is a schematic view showing the valve closure of the pressure regulating device of the embodiment 5 applied to the heart chamber;
  • Figure 16 is a perspective view showing the structure of a pressure adjusting device applied to a heart chamber of Embodiment 6;
  • Figure 17 is a front elevational view of a pressure regulating device of Embodiment 6 applicable to a heart chamber;
  • Figure 18 is a bottom plan view of the pressure adjusting device of Figure 17 applicable to the heart chamber;
  • Figure 19 is a top plan view of the pressure regulating device of Figure 17 suitable for use in a heart chamber.
  • a pressure regulating device 100 suitable for a heart chamber is a cylindrical structure, and includes an inflow channel 110 and a room which are sequentially arranged along the blood flow direction in the axial direction of the cylindrical structure.
  • the spacing channel 130 and the outflow channel 140 are provided with a one-way open valve flap in the outflow channel 140, and a first positioning portion 120 and a second portion on the inflow channel 110 and the outflow channel 140 respectively abutting the partition wall on the corresponding side.
  • Positioning unit 150 is provided with a one-way open valve flap in the outflow channel 140, and a first positioning portion 120 and a second portion on the inflow channel 110 and the outflow channel 140 respectively abutting the partition wall on the corresponding side.
  • the inflow passage 110 is gradually reduced in diameter in the direction of blood flow to form a truncated cone shape, the inlet end of the inflow passage 110 has a diameter of 10 mm, and the outlet end of the inflow passage 110 has a diameter of 6 mm.
  • the inflow channel 110 is composed of 12 support rods 111, and the support rods 111 are distributed around the circumferential direction of the inflow channel 110.
  • the two adjacent support rods 111 have a mirror-symmetric structure, and two adjacent support rods are used as a group (ie, the support rods 111a).
  • the support rod 111b) intersects the intersection 112 at the inlet end of the inflow channel 110.
  • two adjacent support bars such as the support bar 111a and the support bar 111c, intersect at the intersection 113 at the exit end of the inflow channel 110.
  • the first positioning portion 120 is connected to the connecting portion of the inflow channel 110 and the interatrial channel 130.
  • the first positioning portion 120 radiates outward in the radial direction of the cylinder to form an approximately planar truncated cone shape.
  • the surface diameter is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone is 18 mm, and the outer edge of the top surface of the truncated cone is connected to the outlet end of the inflow channel.
  • the bottom surface of the truncated cone is closer to the interatrial septum than the top surface.
  • the first positioning portion 120 is composed of six bifurcated support rods, and 12 support rods 121 are formed after the bifurcation.
  • the support rods 121 are distributed around the axis of the first positioning portion 120, and the two adjacent support rods 121 have a mirror-symmetric structure.
  • the two adjacent support bars 121 intersect at the intersection 122 at the bottom surface, and the adjacent two support bars 121 intersect at the intersection 123 at the top surface, and the intersection 123 is connected to the intersection 113.
  • the end 124 of the support rod 121 is turned up in a direction away from the outflow passage, and the tip end 124 is rounded and curved so as not to penetrate into the partition wall to reduce damage to the interatrial septum.
  • the first positioning portion can also be regarded as a plurality of bifurcated support rods radiating outward in the radial direction of the cylindrical structure, for example, a bifurcation portion of one of the support rods is an intersection point 123, and the support rod 121a is One of the forks has a bifurcated structure in the other support rod, and one of the forks is a support rod 121b, and the support rod 121a and the support rod 121b meet each other at the intersection point 122.
  • the interatrial channel 130 is approximately a cylindrical channel, the interatrial channel 130 has a diameter of 6 mm, and the interatrial channel 130 is composed of six support rods 131.
  • the six support rods 131 are parallel to each other and surround the cylindrical channel. The circumferential direction is evenly distributed, one end of the six support rods is connected to the intersection point 113, and the other end is connected to the inflow end of the outflow channel 140.
  • the outflow passage 140 is formed by a transition section 141 and a cylinder section 142.
  • the transition section 141 has a truncated cone shape, and the angle between the side surface of the truncated cone and the busbar is 65°.
  • the transition section 141 is composed of 12 support rods 143.
  • the two adjacent support rods 143 are mirror-symmetrical, and the support rods 143 are distributed around the axis of the transition section 141, and the adjacent two support rods 143 intersect on the side adjacent to the atrial compartment 130.
  • the adjacent two support rods 143 intersect at the intersection 145 on the side away from the interatrial channel 130.
  • the cylindrical section 142 has a diameter of 12 mm
  • the cylindrical section 142 is composed of 12 support rods 146
  • the adjacent two support rods 146 are mirror-symmetrical, and the support rods 146 are distributed around the axis of the cylinder section 142.
  • two adjacent support rods as a group such as the support rod 146a and the support rod 146b, intersecting the intersection point 145 on the side adjacent to the transition section 141;
  • the adjacent two support rods for example, the support rod 146a and the support rod 146c intersect at the intersection point 147 on the side away from the transition portion 141.
  • the second positioning portion 150 includes three pairs of support rods radiating radially outward along the cylindrical structure, that is, a total of six cut support rods 151, and each support rod 151 is distributed around the axis of the cylindrical structure.
  • One end of each of the support rods 151 is connected to the intersection point 147 by a U-shaped circular arc, and the other end is extended toward the room spacing passage until it abuts against the room space while radiating outward in the radial direction of the cylindrical structure.
  • the six support rods 151 are divided into three pairs, and the two support rods (the support rods 151a and the support rods 151b) of the same pair are adjacent to each other, and meet each other at one end close to the interatrial channel, and merge into an intersection point 152, which is not the same group.
  • the support rods 151 are not connected, and each of the support rods 151 is turned over at an intersection point 152 in a direction away from the inflow passage 110 to form a roll-up section 160, and the roll-up section 160 extends up to the exit side of the outflow passage 140, and the roll-over section 160 is axially As it extends, it gradually approaches the axis of the cylindrical structure.
  • the end of the turning section 160 is a recycling connector 162.
  • the length of the recycling connector 162 is about 3 to 5 mm, and the edge of the recycling connector 162 is smooth and has no sharp corners.
  • the recovery connector 162 is axially located downstream of the outlet side of the outflow channel 140, and the recovery connector 162 is disposed along the circumferential direction of the cylindrical structure.
  • the recovery connector 162 is provided with a connection hole 163, and the connection hole 163 is square rounded.
  • the structure is coupled to the delivery system using the attachment holes 163.
  • the second positioning portion 150 is substantially in the shape of a truncated cone.
  • the diameter of the top surface of the truncated cone is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone is 22 mm.
  • the channel surface (inside of the stent) of the inflow channel, the outflow channel, and the interatrial channel is covered with a layer of pig pericardium 170.
  • the pig pericardium 170 extends from the inlet end of the inflow channel to the outlet of the outflow channel. The end forms a cylindrical shape corresponding to the shape of the stent.
  • Three pig pericardial valves 180 are sewed inside the channel of the outflow channel 140.
  • Three porcine pericardial valves are used as one-way open valve flaps. When the pressure difference between the left atrium and the right atrium is greater than 4 mmHg, the valve flap begins to open, forming a left atrial direction.
  • the pressure adjusting device applied to the heart chamber is an integral structure, and the whole is cut on the cylindrical material and the various portions are obtained by heat setting.
  • the first positioning portion and the second positioning portion are both framed structures.
  • Each of the support rods in the pressure regulating device suitable for the heart chamber has a certain width, and when contacted with the tissue in the interatrial space, the contact area is appropriately increased to avoid the cutting action by the stress concentration by the surface contact.
  • intersections are not strictly at one point, but are based on the extension of the support rods with a certain area, or the intersection is completed by short distances, for example, at the intersection 113, the intersection of the support rods 121 and the support rods 131.
  • Each of the bends of the pressure regulating device applied to the heart chamber is a rounded curved bend, and there is no spike in the direction of the outlet of the outflow passage. There is also no spike on the entire ostomy valve, and the edge of the isolated apex portion is rounded, for example, the edge of the intersection 112 is rounded.
  • 1, 2, and 3 are the state after the setting, in the conveying process, the pressure adjusting device applied to the heart chamber is stretched at both ends of the recovery joint 162 and the inlet end of the inflow passage 110 until It is in a straight state to be carried in the conveyor system.
  • the device can be integrated into the delivery system by pulling the recovery connector 162 and released again.
  • a pressure regulating device 100 suitable for a heart chamber is a cylindrical structure, and includes an inflow channel 110 and a room which are sequentially disposed along the blood flow direction in the axial direction of the cylindrical structure.
  • the spacing channel 130 and the outflow channel 140 are provided with a one-way open valve flap in the outflow channel 140, and a first positioning portion 120 and a second portion on the inflow channel 110 and the outflow channel 140 respectively abutting the atrial space on the corresponding side.
  • Positioning unit 150 is provided with a one-way open valve flap in the outflow channel 140, and a first positioning portion 120 and a second portion on the inflow channel 110 and the outflow channel 140 respectively abutting the atrial space on the corresponding side.
  • the inflow passage 110 is gradually reduced in diameter in the direction of blood flow to form a truncated cone shape, the inlet end of the inflow passage 110 has a diameter of 8 mm, and the outlet end of the inflow passage 110 has a diameter of 4 mm.
  • the inflow channel 110 is composed of eight support rods 111, and each of the support rods 111 is distributed around the circumferential direction of the inflow channel 110.
  • the eight support rods 111 are divided into four groups, and the two support rods 111 of the same group are mirror-symmetrical structures inflow.
  • the exit end of the track intersects at intersection 113. Different sets of support rods 111 are not connected.
  • the first positioning portion 120 is connected to the joint portion of the inflow channel 110 and the interatrial channel 130, and the first positioning portion 120 radiates outward in the radial direction of the cylinder to form an approximately planar truncated cone shape.
  • the surface diameter is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone is 16 mm, and the outer edge of the top surface of the truncated cone is connected to the outlet end of the inflow channel.
  • the bottom surface of the truncated cone is closer to the interatrial septum than the top surface.
  • the first positioning portion 120 is composed of eight support rods 121.
  • the support rods 121 are distributed around the axis of the first positioning portion 120.
  • the two adjacent support rods 121 have a mirror-symmetric structure, and the adjacent two support rods 121 intersect at the bottom surface.
  • two adjacent support bars 121 intersect at an intersection 123 at the top surface, and the intersection 123 is connected to the intersection 113.
  • the end 124 of the support rod 121 is turned up in a direction away from the outflow channel, and the tip 124 is turned into a rounded curve to reduce damage to the interatrial septum.
  • the interatrial septum 130 is approximately a cylindrical passage, the interatrial septum 130 has a diameter of 4 mm, and the interatrial septum 130 is composed of four support rods 131, which are parallel to each other and surround the cylindrical passage. The circumferential direction is evenly distributed, one end of the four support rods is connected to the intersection point 113, and the other end is connected to the inflow end of the outflow channel 140.
  • the outflow passage 140 is formed by a transition section 141 and a cylinder section 142.
  • the transition section 141 has a truncated cone shape, and the angle between the side surface of the truncated cone and the busbar is 60°.
  • the transition section 141 is composed of eight support rods 143.
  • the two adjacent support rods 143 are mirror-symmetrical, and the support rods 143 are distributed around the axis of the transition section 141.
  • the two adjacent support rods 143 intersect on the side adjacent to the atrial compartment 130. At the intersection 144, the adjacent two support rods 143 intersect at the intersection 145 on the side away from the interatrial channel 130.
  • the cylindrical section 142 has a diameter of 10 mm
  • the cylindrical section 142 is composed of eight support rods 146
  • two adjacent support rods 146 are mirror-symmetrical, and each support rod 146 is distributed around the axis of the cylindrical section 142.
  • the two adjacent support bars 146 form an approximately diamond-shaped cell, and the two support bars constituting the same cell intersect at the intersection 144 on the side adjacent to the atrial compartment 130, and intersect at the intersection 147 on the side away from the transition 141.
  • the adjacent two support bars 146 intersect at the intersection 145 on the side adjacent to the transition segment 141.
  • the second positioning portion 150 includes eight cutting support rods 151, and each support rod 151 is distributed around the axis of the cylindrical structure, and one end of each support rod 151 is connected to the intersection point 147 through a U-shaped arc, and One end extends toward the interatrial septum while radiating radially outward along the tubular structure until it abuts the interatrial septum.
  • the eight support rods 151 are divided into four groups, and the two support rods 151 of the same group are adjacent to each other, and merged into an intersection point 152 at one end near the atrial compartment passage; adjacent non-same group support at one end away from the atrial compartment passage
  • the rods merge into an intersection 153, and the intersection 153 is joined to the intersection 147 to form both ends of the U-shaped arc.
  • Each of the support rods 151 is turned over at an intersection point 152 in a direction away from the inflow passage 110 to form a roll-up section 160.
  • the roll-up section 160 extends 8 mm along the axis of the second positioning portion, and the roll-up section 160 extends axially while gradually stepping toward the barrel. The axis of the structure is close.
  • the end of the rollover section 160 is a recovery joint 162.
  • the length of the recovery joint 162 is about 3 mm, and the edge of the recovery joint 162 is smooth and has no sharp corners.
  • the recovery connector 162 is axially located downstream of the outlet side of the outflow channel 140, and the recovery connector 162 is disposed along the circumferential direction of the cylindrical structure.
  • the recovery connector 162 is provided with a connection hole 163, and the connection hole 163 is square rounded.
  • the structure is coupled to the delivery system using the attachment holes 163.
  • the second positioning portion 150 is substantially in the shape of a truncated cone.
  • the diameter of the top surface of the truncated cone is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone is 22 mm.
  • two pieces of pig pericardial valve 180 are sewn in the channel of the outflow channel 140, and two pieces of pig pericardial valve are used as one-way open valve flaps.
  • the valve flap starts to open. Forming a one-way shunt of the left atrium to the right atrium; when the pressure is greater than 15 mmHg, the valve flap is fully opened, as shown in Figure 5; when the pressure difference between the right atrium and the left atrium is greater than 3 mm Hg, the valve flap is completely closed, as shown in Figure 6. Show.
  • a channel of pig pericardium 170 is coated on the inflow channel, the interatrial septum channel, and the channel surface of the part of the outflow channel (inside the stent).
  • the pig pericardium 170 is axially oriented from the inlet end of the inflow channel until the valve suture extends 1 to 2 mm.
  • the pressure adjusting device applied to the heart chamber is an integral structure, and the whole is cut on the cylindrical material and the various portions are obtained by heat setting.
  • the first positioning portion and the second positioning portion are both framed structures.
  • Each of the support rods in the pressure regulating device suitable for the heart chamber has a certain width, and when contacted with the tissue in the interatrial space, the contact area is appropriately increased to avoid the cutting action by the stress concentration by the surface contact.
  • intersections are not strictly at one point, but are based on the extension of the support rods with a certain area, or the intersection is completed by short distances, for example, at the intersection 113, the intersection of the support rods 121 and the support rods 131.
  • Each of the bends of the pressure regulating device applied to the heart chamber is a rounded curved bend, and there is no spike in the direction of the outlet of the outflow passage. There is also no spike on the entire ostomy valve, and the edge of the isolated apex portion is rounded, for example, the edge of the intersection 112 is rounded.
  • FIG. 4, FIG. 5, and FIG. 6 are all the states after the setting.
  • the pressure adjusting device applied to the heart chamber is stretched at both ends of the recovery joint 162 and the inlet end of the inflow passage 110 until It is in a straight state to be carried in the conveyor system.
  • the device can be integrated into the delivery system by pulling the recovery connector 162 and released again.
  • a pressure adjusting device 100 suitable for a heart chamber is a cylindrical structure, and includes an inflow channel 110 and a room which are sequentially disposed along the blood flow direction in the axial direction of the cylindrical structure.
  • the spacing channel 130 and the outflow channel 140 are provided with a one-way open valve flap in the outflow channel 140, and a first positioning portion 120 and a second portion on the inflow channel 110 and the outflow channel 140 respectively abutting the atrial space on the corresponding side.
  • Positioning unit 150 is provided with a one-way open valve flap in the outflow channel 140, and a first positioning portion 120 and a second portion on the inflow channel 110 and the outflow channel 140 respectively abutting the atrial space on the corresponding side.
  • the inflow passage 110 is gradually reduced in diameter in the direction of blood flow to form a truncated cone shape, the inlet end of the inflow passage 110 has a diameter of 8 mm, and the outlet end of the inflow passage 110 has a diameter of 5 mm.
  • the inflow channel 110 is composed of 12 support rods 111, and the support rods 111 are distributed around the circumferential direction of the inflow channel 110.
  • the two adjacent support rods 111 are mirror-symmetrical structures to form a group, and the two support rods 111 of the same group are flowing in.
  • the inlet ends of the channels 110 intersect at the intersection 112, and the adjacent two support bars 111 of the different groups intersect at the intersection 113 at the exit end of the inflow channel 110.
  • the first positioning 120 is connected to the inlet end of the inflow channel 110, and the first positioning portion 120 radiates radially outward in a cylindrical shape to form a truncated cone.
  • the height of the truncated cone is substantially equal to the axial length of the inflow channel.
  • the top surface diameter of the truncated cone is larger than the diameter of the bottom surface, and the top surface diameter H of the truncated cone is 24 mm, and the outer edge of the top surface of the truncated cone is connected to the outlet end of the inflow channel.
  • the bottom surface of the truncated cone is closer to the interatrial septum than the top surface.
  • the first positioning portion 120 is formed by six S-shaped support rods 121 .
  • the support rods 121 are distributed around the axis of the first positioning portion 120 .
  • One end of each support rod 121 starts from the intersection point 112 and the support rod 121 .
  • the other end of the support is bent toward the side of the atrial septum until it abuts against the interatrial septum, and the distal end 124 of the support rod 121 is turned upwards away from the outflow passage, and the tip 124 is rounded. Curved to reduce damage to the interatrial septum.
  • the interatrial channel 130 is approximately a cylindrical channel, the interatrial channel 130 has a diameter of 5 mm, and the interatrial channel 130 is composed of six support rods 131, which are parallel to each other and surround the cylindrical channel. The circumferential direction is evenly distributed, one end of the six support rods is connected to the intersection point 113, and the other end is connected to the inflow end of the outflow channel 140.
  • the outflow passage 140 is composed of a transition section 141 and a cylinder section 142.
  • the transition section 141 has a truncated cone shape, and the angle between the side surface of the truncated cone and the busbar is 65°.
  • the transition section 141 is composed of 12 support rods 143.
  • the two adjacent support rods 143 are mirror-symmetrical, and the support rods 143 are distributed around the axis of the transition section 141.
  • the two adjacent support rods 143 are adjacent to the side of the atrial compartment 130.
  • the support rods 131 intersect at an intersection 144, and adjacent two support rods 143 intersect at an intersection 145 on a side remote from the interatrial channel 130.
  • the cylindrical section 142 has a diameter of 8 mm, and the cylindrical section 142 is composed of six support rods 146.
  • Each of the support rods 146 is distributed around the axis of the cylindrical section 142, and the six support rods 146 are divided into three groups.
  • the two support rods 146 in the same group are adjacent to each other and are mirror-symmetrical, and the support rods of the same group form an inverted V-shaped structure.
  • the two support rods 146 of the same group intersect at the intersection point 147 on the side away from the transition portion 141.
  • the other ends are each connected to a different intersection point 145.
  • intersection 147 extends axially away from the outflow channel, and the formed extension is provided with a connection hole 148 for connection to the delivery system.
  • the second positioning portion 150 includes six cutting support rods 151, each of which is distributed around the axis of the cylindrical structure, and one end of each of the support rods 151 is connected to the intersection point 145 by a U-shaped arc, and One end extends toward the interatrial septum while radiating radially outward along the tubular structure until it abuts the interatrial septum.
  • the six support rods 151 are divided into three groups, and the two support rods 151 of the same group are adjacent to each other and merged into an intersection point 152 adjacent to the space adjacent to the room.
  • Each support rod 151 is turned over at an intersection point 152 in a direction away from the inflow passage 110 to form a roll-up section 160.
  • the roll-up section 160 extends 8 mm in the axial direction, and the roll-up section 160 extends axially while gradually toward the axis of the cylindrical structure. near.
  • the end of the flipping section 160 is a connector 161.
  • the length of the connector 161 is about 4 mm, and the edge of the connector 161 is smooth and has no sharp corners.
  • the connecting head 161 is axially located downstream of the outlet side of the outflow channel 140, and the connecting head 161 is arranged along the circumferential direction of the cylindrical structure.
  • the connecting head 161 is provided with a connecting hole 163, and the connecting hole 163 is a square rounded structure.
  • the connection hole 163 is mated with the delivery system.
  • the second positioning portion 150 is substantially in the shape of a truncated cone.
  • the diameter of the top surface of the truncated cone is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone is 22 mm.
  • the channel surface (inside the stent) of the inflow channel, the outflow channel, and the interatrial channel is covered with a layer of pig pericardium 170.
  • the pig pericardium 170 starts from the inlet end of the inflow channel until the valve extends.
  • the suture is 0 ⁇ 1mm.
  • Three pieces of pig pericardial valve 180 are sewed inside the channel of the outflow channel 140.
  • Three porcine pericardial valves are used as one-way open valve flaps. When the pressure difference between the left atrium and the right atrium is greater than 5 mmHg, the valve flap begins to open, forming a left atrial direction.
  • the pressure adjusting device applied to the heart chamber is an integral structure, and the whole is cut on the cylindrical material and the various portions are obtained by heat setting.
  • the first positioning portion and the second positioning portion are both framed structures.
  • Each of the support rods in the pressure regulating device suitable for the heart chamber has a certain width, and when contacted with the tissue in the interatrial space, the contact area is appropriately increased to avoid the cutting action by the stress concentration by the surface contact.
  • Each of the bends of the pressure regulating device applied to the heart chamber is a rounded curved bend, and there is no spike in the direction of the outlet of the outflow passage. There is also no spike on the entire ostomy valve, and the edge of the isolated apex portion is rounded, for example, the edge of the intersection 112 is rounded.
  • connection hole 148 and the connection hole 161 are connected to the delivery system.
  • a pressure regulating device 100 suitable for a heart chamber is a cylindrical structure including an inflow channel, a room spacing channel 130, and an outflow channel 140 which are sequentially disposed in the blood flow direction in the axial direction of the cylindrical structure.
  • a one-way open valve flap is disposed in the outflow passage 140, and the inflow passage radiates radially outward from the inlet side of the room spacing passage 130 along the radial direction of the tubular structure to form a first positioning portion 120 abutting against the partition wall of the room.
  • the outflow channel 140 is provided with a second positioning portion 150 that abuts the room spacing.
  • the first positioning portion 120 radiates radially outward from the inlet end of the atrial spacing channel 130 to form an approximately planar truncated cone shape.
  • the diameter of the top surface of the truncated cone is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone It is 18 mm, and the top outer edge of the truncated cone is connected to the inlet end of the interatrial channel 130.
  • the bottom surface of the truncated cone is closer to the interatrial septum than the top surface.
  • the first positioning portion 120 is composed of 12 support rods 121.
  • the support rods 121 are distributed around the axis of the first positioning portion 120.
  • the two adjacent support rods 121 have a mirror-symmetric structure, and two adjacent support rods 121 form a group.
  • the two support rods 121 of the same group intersect at the intersection point 122 at the bottom surface, and the two adjacent support rods 121 of the same group intersect at the intersection point 123 at the top surface.
  • the end 124 of the support rod 121 is turned up in a direction away from the outflow channel, and the tip 124 is turned into a rounded curve to reduce damage to the interatrial septum.
  • the interatrial septum 130 is approximately a cylindrical passage, the interatrial septum 130 has a diameter of 6 mm, and the interatrial septum 130 is composed of six support rods 131, which are parallel to each other and surround the cylindrical passage. The circumferential direction is evenly distributed, one end of the six support rods is connected to the intersection point 123, and the other end is connected to the inflow end of the outflow channel 140.
  • the outflow passage 140 is composed of a transition section 141 and a cylinder section 142.
  • the transition section 141 has a truncated cone shape, and the angle between the side of the truncated cone and the busbar is 75°.
  • the transition section 141 is composed of 12 support rods 143.
  • the two adjacent support rods 143 are mirror-symmetrical, and the support rods 143 are distributed around the axis of the transition section 141, and the adjacent two support rods 143 intersect on the side adjacent to the atrial compartment 130.
  • the adjacent two support rods 143 intersect at the intersection 145 on the side away from the interatrial channel 130.
  • the cylindrical section 142 has a diameter of 12 mm
  • the cylindrical section 142 is composed of 12 support rods 146
  • the adjacent two support rods 146 are mirror-symmetrical, and the support rods 146 are distributed around the axis of the cylindrical section 142.
  • the two adjacent support rods 146 intersect at the intersection 145 on the side adjacent to the transition section 141, and the adjacent two support rods 146 intersect at the intersection 147 on the side away from the transition section 141.
  • the second positioning portion 150 includes six cutting support rods 151, each of which is distributed around the axis of the cylindrical structure, and one end of each of the support rods 151 is connected by a U-shaped arc intersection 147, and the other end is connected. While radiating radially outward along the cylindrical structure, it extends toward the interatrial septum until it abuts the interatrial septum.
  • the six support rods 151 are divided into three groups, and the two support rods 151 of the same group are adjacent to each other, and are merged into an intersection point 152 at one end close to the room spacing passage, and the non-same group support rods 151 are not connected, and the support rods 151 are
  • the intersection point 152 is turned up against the inflow path 110 to form a rollover section 160, and the rollover section 160 extends to be adjacent to the outlet side of the outflow channel 140, and the rollover section 160 extends axially toward the axis of the cylindrical structure. .
  • the end of the turning section 160 is a recycling connector 162.
  • the length of the recycling connector 162 is about 3 to 5 mm, and the edge of the recycling connector 162 is smooth and has no sharp corners.
  • the recovery connector 162 is axially located downstream of the outlet side of the outflow channel 140, and the recovery connector 162 is disposed along the circumferential direction of the cylindrical structure.
  • the recovery connector 162 is provided with a connection hole 163, and the connection hole 163 is square rounded.
  • the structure is coupled to the delivery system using the attachment holes 163.
  • the second positioning portion 150 is substantially in the shape of a truncated cone.
  • the diameter of the top surface of the truncated cone is smaller than the diameter of the bottom surface, and the diameter of the bottom surface of the truncated cone is 22 mm.
  • the channel surface (inside of the stent) of the inflow channel, the outflow channel, and the interatrial channel is covered with a layer of pig pericardium 170.
  • the pig pericardium 170 extends from the inlet end of the inflow channel to the outlet of the outflow channel. The end forms a cylindrical shape corresponding to the shape of the stent.
  • Three pieces of pig pericardial valve 180 are sewed inside the channel of the outflow channel 140.
  • Three porcine pericardial valves are used as one-way open valve flaps. When the pressure difference between the left atrium and the right atrium is greater than 5 mmHg, the valve flap begins to open, forming a left atrial direction.
  • the pressure adjusting device applied to the heart chamber is an integral structure, and the whole is cut on the cylindrical material and the various portions are obtained by heat setting.
  • the first positioning portion and the second positioning portion are both framed structures.
  • Each of the support rods in the pressure regulating device suitable for the heart chamber has a certain width, and when contacted with the tissue in the interatrial space, the contact area is appropriately increased to avoid the cutting action by the stress concentration by the surface contact.
  • the intersections described are not strictly intersected, but are based on the extension of the support bar with a certain area.
  • Each of the bends of the pressure regulating device applied to the heart chamber is a rounded curved bend, and there is no spike in the direction of the outlet of the outflow passage.
  • the room partition valve does not have a spike as a whole, and the edge of the isolated vertex portion is rounded, for example, the end edge of the support rod 121 is rounded.
  • FIG. 10, FIG. 11, and FIG. 12 are all the states after the setting.
  • the pressure adjusting device applied to the heart chamber is stretched at both ends of the recovery joint 162 and the inlet end of the inflow passage until it is at Straightened to be carried in the conveyor system.
  • the device can be integrated into the delivery system by pulling the recovery connector 162 and released again.
  • a pressure adjusting device suitable for a heart chamber of the present embodiment has a tubular structure, and includes an inflow channel 110 sequentially disposed along a blood flow direction in an axial direction of the tubular structure,
  • the room compartment channel 130 and the outflow channel 140 are provided with one-way open valve flaps in the outflow channel 140, and the cylindrical structure is respectively provided with a first positioning portion 120 and a second positioning portion 150 abutting against the room partition wall on the respective sides.
  • the first positioning portion 120 is connected to the joint portion of the inflow passage 110 and the interatrial septum 130 in the tubular structure.
  • the second positioning portion 150 is coupled to the engagement portion of the outflow channel 140 and the interatrial septum 130 in the tubular structure.
  • the channel surface (inside the stent) of the inflow channel, the outflow channel and the interatrial channel is covered with a layer of pig pericardium 170.
  • the pig pericardium 170 extends from the inlet end of the inflow channel to the outlet end of the outflow channel, forming a bracket Corresponding cylindrical shape.
  • Three pig pericardial valves 180 are sewed inside the channel of the outflow channel 140.
  • Three porcine pericardial valves are used as one-way open valve flaps. When the pressure difference between the left atrium and the right atrium is greater than 2 mmHg, the valve flap begins to open, forming a left atrial direction.
  • connection position of the second positioning portion 150 is closer to the atrial spacing channel 130, and the second positioning portion 150 no longer has the intersection of the support rods, and only 6 radiation-distributing support rods 151.
  • the support rod 151 extends substantially radially outward, with a recovery joint at the end of each support rod, and is bent at a distal end portion away from the inflow passage.
  • the pressure adjusting device applied to the heart chamber in the present embodiment has a cylindrical structure, and includes a central interatrial channel 200 in the axial direction of the cylindrical structure.
  • the spacing channel 200 is provided with a first positioning portion 210 toward the left atrium side, and the atrial spacing channel 200 is provided with a second positioning portion 220 toward the right atrium side (in the environment of use).
  • the valve flap is not provided in this embodiment, so that the axial sides of the atrial compartment 200 directly abut the positioning portions compared to other embodiments. Although the valve flap is not used, a layer of pig pericardium can be covered as needed in the atrial septal channel.
  • the pressure regulating device is cut by a pipe as a whole, and is a frame structure after being released in the body, and can keep the passage of the room interval.
  • it can be processed by weaving, or partial weaving combined with partial pipe cutting, and different parts can be welded or They are fixed to each other by connectors.
  • the first positioning portion 210 and the second positioning portion 220 are both integrated with the atrial spacing channel 200.
  • the atrial spacing channel 200 is a wave undulating structure in the circumferential direction, and a plurality of V-shaped units are partially arranged and connected in sequence.
  • a plurality of X-shaped units are arranged in a row to form a completely even grid structure, which generally requires easy radial compression and maintains the necessary strength.
  • the room compartment channel 200 has a plurality of structural end points, such as mesh end points or intersections, on the first positioning portion 210 side and the second positioning portion 220 side, respectively.
  • An end point 203 and an end point 204 are visible on one side of the first positioning portion 210, and the first positioning portion 210 includes two branches radiating radially outward from each structural end point of the corresponding side of the interatrial channel 200, each branch being adjacent to Adjacent branch junctions of the structure endpoints.
  • the end point 203 radiates two branches radially outward, one of which is a branch 211;
  • the end point 204 radiates two branches radially outward, one of which is a branch 212;
  • Branch 211 and branch 212 are concatenated at endpoint 213.
  • the first positioning portion 210 is a plurality of support rod structures radiating outward in the radial direction.
  • the first positioning portion 210 is generally obliquely bent toward the atrial spacing channel 200 while being radiated outwardly, adjacent to the first positioning portion 210.
  • the outermost end of the direction is slightly inclined away from the interatrial channel 200.
  • the length of the first positioning portion 210 in the axial direction is short.
  • the first positioning portion 210 can also adopt a more complicated circuitous manner. This embodiment illustrates only the preferred mode in the figures.
  • the support rod 201 and the support rod 202 are included, and the support rod 201 and the support rod 202 meet at the end point 205 on the side of the second positioning portion 220, as shown in the figure. Endpoint 205 is in turn adjacent to another endpoint 206 and endpoint 207.
  • the second positioning portion 220 includes two branches radiating radially outward from each of the structural end points of the respective sides of the atrial spacing channel 200, each branch intersecting a neighboring branch from an adjacent structural end point as a support rod, all of which are circumferentially supported
  • the support rods having a plurality of pairs of the same pair are mutually joined, and a recycling joint is provided at the intersection.
  • the second positioning portion 220 is gradually converges from the end of each structure of the corresponding side of the atrial compartment channel 200 until it converges to 2 to 8 endpoints, and a recovery connector is disposed at each end point. In the example, it is 4 endpoints.
  • the branches meet as support rods, and the same pair of support rods meet each other again, which can be regarded as a two-level convergence convergence structure.
  • Convergence refers to the convergence and reduction of the number of grids, which is not necessarily related to the shape, and adopts a complex grid structure. More levels of intersection structure can be employed.
  • the end point 205 radiates two branches radially outward, being a branch 221 and a branch 222;
  • the end point 206 radiates two branches radially outward, being a branch 223 and a branch 224;
  • the end point 207 radiates two branches radially outward, being a branch 225 and a branch 226;
  • Branch 222 and branch 223 meet as a support rod 227;
  • Branch 224 and branch 225 meet as a support rod 228;
  • the support rod 227 and the support rod 228 are both in the same pair and meet to the end point 229; the end point 229 is provided with a connection hole 230 as a recovery joint.
  • the length of the recycling connector is about 3 ⁇ 5mm, the edge is smooth and has no sharp corners, all the recycling connectors are arranged along the circumferential direction of the cylindrical structure, and the connecting hole 230 is a circular hole, an elliptical hole or a square rounded structure, which is beneficial to the conveying system. Cooperate.
  • the second positioning portion 220 extends toward the atrial septum channel 200 while advancing outward in the radial direction of the cylindrical structure until it abuts against the atrial septum, and then turns back and away from the atrial septum channel 200 until the adjacent interatrial septum 200 The exit side.
  • Each branch of the second positioning portion 220 extends to a portion that abuts the atrial space, and then converges and folds in the form of a support rod, and a circular or elliptical extension path can be formed throughout the tilting portion.
  • the ends of the second positioning portion 220 are respective recovery connectors, and the respective recovery connectors are directed away from the interatrial channel 200 for recovery.
  • the directions of the respective recovery connectors are substantially parallel or opposite to the axis of the atrial septal channel 200. Small angles, for example less than 45 degrees, preferably less than 30 degrees, with individual angles, can be gathered either toward the axis of the interatrial channel 200 or from the axis of the interatrial channel 200.

Abstract

L'invention concerne un dispositif de réglage de pression (100) approprié pour être placé entre des oreillettes, le dispositif étant d'une structure cylindrique. Le dispositif comprend, dans une direction axiale de la structure cylindrique, un passage de septum auriculaire (130) et un conduit de sortie (140) agencés successivement dans une direction d'écoulement de sang, un côté, à l'opposé du conduit de sortie (140), du passage de septum auriculaire (130) étant pourvu d'un orifice d'entrée; un clapet de valve qui s'ouvre de façon unidirectionnelle étant agencé dans le conduit de sortie (140), et la structure cylindrique étant pourvue d'une première partie de positionnement (120) et d'une seconde partie de positionnement (150) prenant appui respectivement contre deux côtés d'un septum auriculaire. Au moyen du dispositif de réglage de pression (100) approprié pour être placé entre les oreillettes, une structure de valve qui s'ouvre de façon unidirectionnelle est formée sur le septum auriculaire, la position dans laquelle la structure de valve correspond au septum auriculaire est stable, et, lorsque la position dans laquelle la structure de valve est réglée est inappropriée, il est possible de retirer la structure de valve et de la libérer à nouveau.
PCT/CN2018/096169 2017-07-18 2018-07-18 Dispositif de réglage de pression approprié pour être placé entre des oreillettes WO2019015617A1 (fr)

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US10898698B1 (en) 2020-05-04 2021-01-26 V-Wave Ltd. Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
US10912645B2 (en) 2004-02-03 2021-02-09 V-Wave Ltd. Device and method for controlling in-vivo pressure
US10925706B2 (en) 2009-05-04 2021-02-23 V-Wave Ltd. Shunt for redistributing atrial blood volume
US10940296B2 (en) 2015-05-07 2021-03-09 The Medical Research, Infrastructure and Health Services Fund of the Tel Aviv Medical Center Temporary interatrial shunts
US11109988B2 (en) 2016-05-31 2021-09-07 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11135054B2 (en) 2011-07-28 2021-10-05 V-Wave Ltd. Interatrial shunts having biodegradable material, and methods of making and using same
US11234702B1 (en) 2020-11-13 2022-02-01 V-Wave Ltd. Interatrial shunt having physiologic sensor
US11253353B2 (en) 2006-01-23 2022-02-22 V-Wave Ltd. Heart anchor device
US11291807B2 (en) 2017-03-03 2022-04-05 V-Wave Ltd. Asymmetric shunt for redistributing atrial blood volume
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US11458287B2 (en) 2018-01-20 2022-10-04 V-Wave Ltd. Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
US11612385B2 (en) 2019-04-03 2023-03-28 V-Wave Ltd. Systems and methods for delivering implantable devices across an atrial septum
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US11382747B2 (en) 2004-02-03 2022-07-12 V-Wave, Ltd. Device and method for controlling in-vivo pressure
US10912645B2 (en) 2004-02-03 2021-02-09 V-Wave Ltd. Device and method for controlling in-vivo pressure
US11266501B2 (en) 2004-02-03 2022-03-08 V-Wave Ltd. Device and method for controlling in-vivo pressure
US11253353B2 (en) 2006-01-23 2022-02-22 V-Wave Ltd. Heart anchor device
US10925706B2 (en) 2009-05-04 2021-02-23 V-Wave Ltd. Shunt for redistributing atrial blood volume
US11850138B2 (en) 2009-05-04 2023-12-26 V-Wave Ltd. Shunt for redistributing atrial blood volume
US11135054B2 (en) 2011-07-28 2021-10-05 V-Wave Ltd. Interatrial shunts having biodegradable material, and methods of making and using same
US11690976B2 (en) 2013-05-21 2023-07-04 V-Wave Ltd. Apparatus and methods for delivering devices for reducing left atrial pressure
US10940296B2 (en) 2015-05-07 2021-03-09 The Medical Research, Infrastructure and Health Services Fund of the Tel Aviv Medical Center Temporary interatrial shunts
US11304831B2 (en) 2016-05-31 2022-04-19 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11497631B2 (en) 2016-05-31 2022-11-15 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11607327B2 (en) 2016-05-31 2023-03-21 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11109988B2 (en) 2016-05-31 2021-09-07 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11291807B2 (en) 2017-03-03 2022-04-05 V-Wave Ltd. Asymmetric shunt for redistributing atrial blood volume
US11458287B2 (en) 2018-01-20 2022-10-04 V-Wave Ltd. Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
US11744589B2 (en) 2018-01-20 2023-09-05 V-Wave Ltd. Devices and methods for providing passage between heart chambers
US11612385B2 (en) 2019-04-03 2023-03-28 V-Wave Ltd. Systems and methods for delivering implantable devices across an atrial septum
US11865282B2 (en) 2019-05-20 2024-01-09 V-Wave Ltd. Systems and methods for creating an interatrial shunt
US10898698B1 (en) 2020-05-04 2021-01-26 V-Wave Ltd. Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
US11234702B1 (en) 2020-11-13 2022-02-01 V-Wave Ltd. Interatrial shunt having physiologic sensor
US11813386B2 (en) 2022-04-14 2023-11-14 V-Wave Ltd. Interatrial shunt with expanded neck region

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