WO2023116205A1 - Dispositif de septostomie auriculaire - Google Patents

Dispositif de septostomie auriculaire Download PDF

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Publication number
WO2023116205A1
WO2023116205A1 PCT/CN2022/128691 CN2022128691W WO2023116205A1 WO 2023116205 A1 WO2023116205 A1 WO 2023116205A1 CN 2022128691 W CN2022128691 W CN 2022128691W WO 2023116205 A1 WO2023116205 A1 WO 2023116205A1
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WIPO (PCT)
Prior art keywords
cutting
drug
hole
push
pull rod
Prior art date
Application number
PCT/CN2022/128691
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English (en)
Chinese (zh)
Inventor
邱硕实
王钰
刘玉博
范军
焦政军
王森
宋睿
周国磊
周裔盛
Original Assignee
上海申淇医疗科技有限公司
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.)
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Publication date
Priority claimed from CN202111572477.3A external-priority patent/CN114176720B/zh
Priority claimed from CN202111574517.8A external-priority patent/CN114098916B/zh
Priority claimed from CN202210362009.1A external-priority patent/CN116919538A/zh
Application filed by 上海申淇医疗科技有限公司 filed Critical 上海申淇医疗科技有限公司
Publication of WO2023116205A1 publication Critical patent/WO2023116205A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments

Definitions

  • the present application relates to the technical field of medical devices, in particular to an atrial septostomy device.
  • heart failure As the severe and terminal stage of various heart diseases, heart failure has a high incidence rate and is one of the most serious cardiovascular diseases today. According to the location of heart failure, it can be divided into left heart failure, right heart failure and whole heart failure. Clinically, atrial septostomy is usually used to treat pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt). .
  • a pre-opening hole is usually made on the atrial septum, and a guide wire is left at the pre-opening hole, and then the instrument is moved along the guide wire to the pre-opening hole, and then the instrument is used to close the pre-opening hole in the atrial septum.
  • Stoma at the hole When using an instrument to stoma the tissue, the grasping device first positions and grasps the part of the tissue to be cut, and then the cutting device cuts the part of the tissue grasped by the grasping device, and the cut part of the tissue is The grasping device is brought out of the body, creating the stoma.
  • the existing atrial septostomy still has a high risk, therefore, the atrial septostomy device still needs to be further improved to reduce the risk of atrial septostomy.
  • an atrial septostomy device including a first tube body, a second tube body and an auxiliary component.
  • the distal end of the second tube body is connected with a cutting knife, and the cutting knife is provided with a cavity communicating with the lumen of the second tube body, and the first tube body slides through the second tube body and inside the cutting knife.
  • the auxiliary assembly includes a push-pull rod and a cutting aid, the push-pull rod slides through the first tubular body, the proximal end of the cutting aid is connected to the distal end of the first tubular body, and the cutting aid
  • the distal end is connected to the distal end of the push-pull rod, and the push-pull rod can slide relative to the first tube body, so that the cutting aid can be switched between the unfolded state and the stretched state; the cutting aid is in the In the stretched state, it can be accommodated in the cavity; when the cutting aid is in the expanded state, it has a mesh surface facing the cutting knife, and the mesh surface is used to collect the cut
  • the knife excises the interatrial septal tissue and pulls it into the cavity.
  • a limiting platform is provided in the cavity, and the cutting aid can abut against the limiting platform.
  • the atrial septostomy device further includes a first driving assembly capable of driving the second tubular body to move axially.
  • the atrial septostomy device further includes a second drive assembly, the second drive assembly includes a second housing, the second housing is slidably connected to the first drive assembly, and the first tube passes through It is connected to the first drive assembly and fixedly connected to the inside of the second casing.
  • the atrial septostomy device further includes a third driving assembly, the third driving assembly includes a second driving member, the second driving member is connected to the proximal end of the second housing, and the second housing
  • the proximal end of the push-pull rod is provided with a second through hole, and the proximal end of the push-pull rod passes through the second through-hole to be connected to the second driving member, and the second drive member can drive the push-pull rod to move in the axial direction.
  • the outer diameter of the mesh surface is equal to or greater than the inner diameter of the cavity; when the cutting aid is in the unfolded state, the The angle between the mesh surface and the push-pull rod is 80-90 degrees.
  • the atrial septostomy device further includes a third tube, and the second tube slides through the third tube.
  • the first driving assembly includes a first housing and a first driving member, the proximal end of the second tube protrudes into the first housing, and the proximal end of the second tube A first guide piece is connected, and a first guide groove is opened on the inner wall of the first housing, and the first guide groove extends along the axial direction of the second pipe body, and the first guide piece is slidably arranged on the In the first guide groove, the first driving member can drive the second pipe body to move in the axial direction.
  • the first driving assembly also includes a first screw, the first driving member is disposed in the first housing, and a first threaded hole is opened on the first driving member, and the first screw is threadedly connected to In the first threaded hole, one end of the first screw rod is connected to the proximal end of the second tubular body, the other end of the first screw rod passes through the first driving member, and the first guide member Connect the side wall of the first screw.
  • the proximal end of the first casing extends along the axial direction of the first tubular body with a connecting portion, and a first through hole is formed coaxially on the connecting portion, and the first through hole is connected with the first casing.
  • the inner cavity communicates, the connecting part protrudes into the second casing, and the second casing can slide along the connecting part, and the end of the first tube passes through the first through hole and is fixed connected to the inside of the second casing.
  • the third driving assembly further includes a connecting rod and a second screw rod, the connecting rod is coaxially connected to the proximal end of the push-pull rod, and the connecting rod is at least partially placed in the second through hole Inside, the end of the connecting rod away from the push-pull rod passes through the second through hole and is coaxially connected with the second screw rod, and a second threaded hole is opened on the second driving member, and the second screw rod Screwed with the second threaded hole, the second driving member is rotatably connected to an end of the second housing away from the first housing.
  • the cutting aid comprises a first extension and a second extension arranged sequentially in a proximal-to-distal direction; the first extension is tubular; the second extension comprises a fixation member and a telescopic part, the fixing part is connected to the first extension part, and the fixing part has an annular mesh surface; the telescoping part enables the cutting aid to be switched between an unfolded state and a stretched state.
  • the telescoping member includes a transition section and a distal section arranged in sequence along the direction from the proximal end to the distal end, and when the cutting aid is in an unfolded state, the transition section is in the shape of a truncated cone.
  • the cutting aid is an elastic braided mesh
  • the first extension part is sleeved on the distal end of the first tube body
  • the push-pull rod passes through the first extension part and is connected to the second extension.
  • the outer diameter of the annular mesh surface is larger than the outer diameter of the first extension; the atrial septostomy device further includes an annular cutting knife, and the inner diameter of the cutting knife is the same as that of the annular mesh.
  • the difference between the outer diameters of the surfaces shall not be greater than 1mm.
  • the atrial septostomy device further includes a first clamping assembly and a second clamping assembly
  • the first clamping assembly includes a first outer ring and a ring sleeved in the first outer ring
  • the first inner ring one end of the first inner ring is clamped to the push-pull rod, and the distal end of the telescopic member is clamped between the first outer ring and the first inner ring
  • the second clamping The assembly includes a second outer ring and a second inner ring sleeved in the second outer ring, one end of the second inner ring is clipped to the first tube body, and the proximal end of the first extension part is clipped to between the second outer ring and the second inner ring.
  • the included angle between the annular mesh surface and the axial direction of the push-pull rod is 80°-100°.
  • the cutting knife includes a cutting knife body and a drug-loaded structure, the cutting knife body is provided with a through hole along the axis direction, one end of the cutting knife body is a cutting end, and the other end is a connecting end ;
  • the drug-loading structure is arranged on the outer wall of the cutting knife body, and the drug-loading structure is used to carry drugs.
  • the drug-loading structure is a drug-loading groove opened on the outer wall of the cutting knife.
  • the drug-loading groove is an annular groove arranged along the circumference of the cutting blade body.
  • the bottom surface of the drug-loading groove is an inclined surface, and along the cutting direction, the drug-loading depth of the drug-loading groove gradually decreases.
  • the drug-loaded groove includes a plurality of drug-loaded sub-grooves, and the plurality of drug-loaded sub-grooves are arranged at intervals along the circumferential direction or the cutting direction of the cutting blade body.
  • an adsorption structure is provided on the inner wall of the drug-loading tank, and the adsorption structure is used to adsorb the drug; the adsorption structure is an adsorption film, and the adsorption film is attached to the drug-loading tank or, the adsorption structure is an adsorption rough surface, and the inner wall of the drug-loading tank is configured to form the adsorption rough surface.
  • the cutting body includes a first part and a second part connected in a stepped shape, both of the first part and the second part are cylindrical, and the outer diameter of the first part is larger than The outer diameter of the second part, the end of the first part far away from the second part is the cutting end, the end of the second part far away from the first part is the connecting end, and the loading
  • the medicine structure is arranged on the outer wall of the first part.
  • the through hole includes a first hole connected in a stepped shape and a second hole, the first hole is located inside the first part, at least part of the second hole is located in the second part, and the first hole is located inside the first part.
  • the inner diameter of the hole is larger than the inner diameter of the second hole.
  • Fig. 1 is a schematic structural view of a cutting aid in a stretched state in an atrial septostomy device provided by an embodiment of the present application;
  • Fig. 2 is a schematic structural view of the cutting aid in the unfolded state of the atrial septostomy device provided by the embodiment of the present application;
  • Fig. 3 is a schematic diagram of the first structure of the cutting knife provided by the embodiment of the present application.
  • Fig. 4 is a second structural schematic diagram of the cutting knife provided by the embodiment of the present application.
  • Fig. 5 is a schematic diagram of the third structure of the cutting knife provided by the embodiment of the present application.
  • Fig. 6 is a schematic structural diagram of a cutting aid provided by an embodiment of the present application.
  • Fig. 7 is a schematic structural view of an atrial septostomy device provided in an embodiment of the present application.
  • Fig. 8 is a cross-sectional view of a first viewing angle of the atrial septostomy device provided by the embodiment of the present application;
  • Fig. 9 is a cross-sectional view of the atrial septostomy device provided by the embodiment of the present application at a second viewing angle;
  • Fig. 10 is a schematic structural diagram of the first drive assembly provided by the embodiment of the present application.
  • Fig. 11 is a schematic structural diagram of a second driving assembly provided by an embodiment of the present application.
  • Fig. 12 is a schematic structural diagram of a third drive assembly provided by an embodiment of the present application.
  • Fig. 13 is a schematic structural view of an atrial septostomy device provided by another embodiment of the present application.
  • Fig. 14 is a schematic structural view of an elastic braided net provided by another embodiment of the present application.
  • Fig. 15 is a schematic structural view of an atrial septostomy device provided by another embodiment of the present application.
  • Fig. 16 is a schematic structural view of an atrial septostomy device provided by another embodiment of the present application.
  • Fig. 17 is a schematic diagram of the atrial septostomy device provided in the embodiment of the present application during stoma operation;
  • Fig. 18 is a schematic diagram of the atrial septostomy device provided in the embodiment of the present application during the operation of applying medicine.
  • connection should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integrated ; It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediary, and it can be the internal communication of two components or the interaction relationship between two components.
  • connection can be a fixed connection, a detachable connection, or an integrated ; It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediary, and it can be the internal communication of two components or the interaction relationship between two components.
  • a first feature being “on” or “under” a second feature may include direct contact between the first and second features, and may also include the first and second features Not in direct contact but through another characteristic contact between them.
  • “above”, “above” and “above” the first feature on the second feature include that the first feature is directly above and obliquely above the second feature, or simply means that the first feature is horizontally higher than the second feature.
  • “Below”, “under” and “under” the first feature include the first feature directly below and obliquely below the second feature, or simply mean that the first feature is less horizontally than the second feature.
  • distal end refers to the end of the component that is away from the operator when in use, that is, the end near the heart
  • proximal end refers to the end of the part that is close to the heart when in use. The part is close to the end of the operator, that is, away from the heart.
  • the existing atrial septostomy has a high risk, such as loosening of the grasping device during the operation or recovery after the operation, which may cause the cut tissue to fall off and form an embolism.
  • the grasping device loosens during the cutting process, other myocardial tissues are easily damaged, and the device of this method has a complex structure and is inconvenient to operate.
  • one of the objectives of the present application is to provide an atrial septostomy device, which can prevent the cut atrial septal tissue from falling off during the operation or during postoperative recovery, and prevent the formation of embolism or damage to myocardial tissue.
  • an atrial septostomy device including a first tubular body, a second tubular body and an auxiliary component.
  • the distal end of the second tube body is connected with a cutting knife, and the cutting knife is provided with a cavity communicating with the lumen of the second tube body, and the first tube body slides through the second tube body and the cutting knife.
  • the auxiliary assembly includes a push-pull rod and a cutting auxiliary piece.
  • the push-pull rod slides through the first tube body.
  • the proximal end of the cutting auxiliary piece is connected to the distal end of the first tube body.
  • the pull rod is slidable relative to the first tubular body to switch the cutting aid between a deployed state and a stretched state. When the cutting aid is in a stretched state, it can be accommodated in the cavity. In the deployed state, the cutting aid has a meshed surface facing the cutter for collecting atrial septal tissue resected by the cutter and drawing it into the cavity.
  • this embodiment provides an atrial septostomy device, which includes a first tube body 1 , a second tube body 2 and an auxiliary component 5 .
  • the auxiliary assembly 5 includes a push-pull rod 51 and a cutting aid 52.
  • the push-pull rod 51 slides through the first tube body 1 and can protrude from the first tube body 1.
  • the proximal end of the cutting aid 52 is connected to the first tube
  • the distal end of the body 1 and the distal end of the cutting aid 52 are connected to the distal end of the push-pull rod 51 , and the push-pull rod 51 can slide relative to the first tubular body 1 .
  • Cutting aid 52 has a deployed state and a stretched state. When the cutting aid 52 is in a stretched state, the cutting aid 52 can cover the outer surface of the push-pull rod 51. At this time, the cutting aid 52 has a smaller outer diameter and can be accommodated in the cavity 41 of the cutting knife 4 , and can pass through the pre-opened hole on the interatrial septum 100 . When the cutting aid 52 protrudes from the cavity 41 of the cutting knife 4 and is in an unfolded state, it has a mesh surface facing the cutting knife 4, the outer diameter of the mesh surface is equal to or greater than or slightly smaller than the inner diameter of the cavity 41, It can be used to collect interatrial septal tissue excised by cutting knife 4 and pull it into cavity 41 .
  • the push-pull rod 51 can move relative to the first tubular body 1 to switch the cutting aid 52 between the expanded state and the stretched state.
  • the cutting aid 52 contracts in the axial direction and simultaneously expands in the radial direction, so that the cutting aid 52 is switched from the stretched state to the expanded state .
  • the cutting aid 52 is stretched in the axial direction and contracted in the radial direction at the same time, so that the cutting aid 52 is switched from the expanded state to the stretched state. state.
  • the cutting aid 52 of this embodiment can be accommodated in the cavity 41 of the cutting knife 4 in a stretched state, so that the cutting knife 4 and the auxiliary assembly 5 can be delivered to the interatrial septum 100 at the same time without moving the cutting knife 4 and the auxiliary component 5 are delivered separately to the interatrial septum 100 successively, which simplifies the operation steps and saves operation time.
  • the cutting knife 4 and the cutting aid 52 are delivered to the atrial septum 100 at the same time.
  • the cutting aid 52 is in a stretched state and accommodated in the cutting In the cavity 41 of the knife 4.
  • Drive the first tubular body 1 to move the first tubular body 1 relative to the second tubular body 2 from the proximal end to the distal end, so that the cutting aid 52 protrudes from the cavity 41 of the cutting knife 4 and passes through the room.
  • the push-pull rod 51 When the cutting aid 52 passes through the pre-opening hole, the push-pull rod 51 is driven to move the push-pull rod 51 relative to the first tube body 1 along the direction from the distal end to the proximal end, so that the cutting aid 52 is switched from the stretched state to the unfolded state .
  • the cutting aid 52 In the unfolded state, the cutting aid 52 has a mesh surface facing the cutting knife 4, and can abut against the side of the interatrial septum 100 away from the cutting knife 4, so as to be fixed with the cutting knife 4 from both sides of the interatrial septum 100 as needed. resected tissue.
  • the second tubular body 2 is driven to move the second tubular body 2 from the proximal end to the distal end relative to the first tubular body 1, and the second tubular body 2 drives the cutting knife 4 to move toward the interatrial septum 100, and the cutting aid
  • the atrial septal tissue was cut under the fixation of 52.
  • the cutting aid 52 can locate and fix the atrial septal tissue to be cut, so that the cutting operation of the cutting knife 4 is faster and more accurate.
  • the resected atrial septal tissue can enter the cavity 41 of the cutting knife 4 under the fixing of the cutting aid 52, so as to avoid damage to the embolized myocardial tissue caused by atrial septal tissue shedding.
  • Cutting aid 52 may be an elastic woven mesh and have a pre-shaped structure. Specifically, when the cutting aid 52 is in an unfolded state, it has a mesh surface facing the cutting knife 4, and the mesh surface is a predetermined structure. Through the movement of the push-pull rod 51 relative to the first tubular body 1, the degree of elastic deformation of the cutting aid 52 can be controlled, and further the abutting force of the cutting aid 52 against the interatrial septum 100 can be controlled, and the degree of cooperation with the cutting knife 4 is higher. The safety of the operation is improved.
  • the outer diameter of the mesh surface may be greater than, equal to or slightly smaller than the inner diameter of the cavity 41 .
  • the mesh surface can pull the resected atrial septal tissue into the cavity 41, while the mesh At least part of the surface can also be drawn into the cavity 41 .
  • the cutting knife 4 cuts off the atrial septal tissue and then pulls the push-pull rod 51, and the mesh surface pulls the excised atrial septal tissue into the cavity 41 and leans against it.
  • the shape of the mesh surface can be controlled by the push-pull rod 51.
  • the push-pull rod 51 is controlled from the proximal end to the The slight movement in the distal direction reduces the outer diameter of the mesh surface to be equal to or smaller than the inner diameter of cavity 41 .
  • a limiting platform 42 may be provided in the cavity 41 . After the second tubular body 2 and the cutting knife 4 cut off the interatrial septal tissue, if they continue to move from the proximal end to the distal end, the cutting auxiliary member 52 will abut against the limit platform 42, and at this time the second tubular body 2 and the cutting knife 4 stop Move and complete the stoma.
  • connection manner between the cutting knife 4 and the second pipe body 2 includes but not limited to the manner shown in Fig. 3-Fig. 5 .
  • the proximal end of the cutting knife 4 is provided with an accommodating cavity 43 extending along its circumference, and the inner diameter of the cutting knife 4 at the opening of the accommodating cavity 43 may be the same as the outer diameter of the second tube body 2 .
  • the distal end of the second tube body 2 extends into the accommodating cavity 43 , and the outer wall of the second tube body 2 is attached to the groove wall of the accommodating cavity 43 .
  • connection between the cutting knife 4 and the second tube body 2 is bonded by glue, or a heat-shrinkable tube is sleeved at the joint between the cutting knife 4 and the second tube body 2, and the heat-shrinkable tube is heated to realize the connection between the cutting knife 4 and the second tube body. Connection between body 2.
  • the cutting knife 4 protrudes into the distal end of the second tubular body 2 toward the end of the second tubular body 2 and is fixedly connected with the second tubular body 2 .
  • the outer diameter of the proximal end of the cutting knife 4 may be the same as the inner diameter of the distal end of the second tubular body 2 .
  • the cutting knife 4 extends into the second pipe body 2 toward one end of the second pipe body 2, and the inner wall of the second pipe body 2 is attached to the outer wall of the cutting knife 4 and bonded by glue, or the cutting knife 4 and the second pipe body A heat-shrinkable tube is sheathed at the junction of the body 2 , and the heat-shrinkable tube is heated to realize the connection between the cutting knife 4 and the second tube body 2 .
  • the end faces of the cutting knife 4 and the second pipe body 2 facing each other are opposed to and attached to each other.
  • the outer wall of the cutting knife 4 is provided with a glue storage tank 44 along the circumference, and the glue storage tank 44 does not pass through the end face of the cutting knife 4 .
  • glue is coated on the joint of the second pipe body 2 and the cutting knife 4 along the circumferential direction, and the glue is extended into the glue storage tank 44 to increase the connection area. Ensure the firmness of the bonding.
  • a heat-shrinkable tube can also be sleeved at the connection between the cutting knife 4 and the second tube body 2 , and the heat-shrinkable tube can be heated to realize the connection between the cutting knife 4 and the second tube body 2 .
  • the far end of cutting knife 4 can be provided with blade 45, and the shape of blade 45 is any shape such as ring, rectangle or ellipse, and this all is within the scope of protection of the present application, and the present embodiment does not refer to it here. Do limit.
  • the edge 45 is formed by chamfering the side wall of the cutting knife 4 .
  • the chamfering method can be chamfering the inner wall, chamfering the outer wall, or chamfering the inner and outer walls simultaneously to form the edge 45 .
  • the material of the cutting knife 4 can be stainless steel or titanium alloy, etc.
  • the axial length of the cutting knife 4 can be 10-20mm, the inner diameter can be 4-10mm, the outer diameter can be 6-12mm, and the angle of the chamfer at the blade 45 can be 15°-30°.
  • the cutting aid 52 is an elastic braided mesh
  • the elastic braided mesh includes a first extension portion 521 and a second extension portion 522 arranged in sequence along the direction from the proximal end to the distal end; the first extension portion 521 covers Connected to the distal end of the first tubular body 1, the push-pull rod 51 passes through the first extension part 521 and is connected to the second extension part 522; when the cutting aid 52 is in the unfolded state, the proximal end of the second extension part 522 has a direction toward the cutting Mesh side of knife 4.
  • the first extension part 521 may be cylindrical, the proximal end of the first extension part 521 has an opening, and is sleeved on the distal end of the first tube body 1 through the opening, and the first extension part 521 can pass through the interatrial septum 100 Pre-drilled.
  • the push-pull rod 51 enters the cutting aid 52 from the first tube body 1 through the opening.
  • the first extension portion 521 can accurately define the position of the cutting aid 52 without damaging the pre-opening hole.
  • One end of the second extension part 522 is fixedly connected to the other end of the first extension part 521 away from the first tube body 1, the push-pull rod 51 passes through the first extension part 521 and is connected to the bottom of the second extension part 522, and the push-pull rod 51 is oppositely cut During the pulling process of the auxiliary part 52, the second extension part 522 can expand and/or stretch.
  • the angle between the mesh surface and the push-pull rod 51 is 80-90 degrees, which improves the stability of the mesh surface and the fixation of the interatrial septum 100 .
  • the push-pull rod 51 is connected to the distal end of the second extension part 522 .
  • the cutting aid 52 forms a bag-shaped braided net, which can accommodate the push-pull rod 51 passing through it, and has better elastic expansion and contraction in the radial and axial directions, and is easy to It passes through the pre-opening hole of the interatrial septum 100, and can effectively fix the cut tissue.
  • the push-pull rod 51 is located in the cutting aid 52, and can provide axial guidance during the elastic deformation of the cutting aid 52, so as to avoid tilting during axial compression or fracture during radial compression.
  • the push-pull rod 51 is made of metal, and is welded to the cutting auxiliary part 52, which improves connection reliability and reduces the risk of the cutting auxiliary part 52 falling off.
  • the push-pull rod 51 includes a straight rod part and an elastic part arranged in the axial direction, the straight rod part is located at the proximal end of the push-pull rod 51, and the elastic part is located at the far end of the push-pull rod 51, and the straight rod part and the elastic part are welded and connected.
  • the elastic part enables the push-pull rod 51 to bend at the elastic part, which is more conducive to accurately reaching the position of the pre-drilled hole.
  • the elastic part may be a spring.
  • the cross-sectional shape of the second extension part 522 can be a regular or irregular polygon such as a triangle, rectangle, rhombus, star, or a shape with arc-shaped sides such as a circle or an ellipse. It is within the protection scope of this application, and this embodiment is not limited here.
  • the second extension part 522 includes a fixing part 5221 and a telescopic part 5222 , one side of the fixing part 5221 is connected to the first extension part 521 , and the other side is connected to the telescopic part 5222 .
  • the fixing member 5221 can be a pre-shaped mesh surface, and the shape of the mesh surface can be circular. Of course, in other embodiments of the present application, the mesh surface can also be regular or irregular shapes such as ellipse and rhombus. When the fixing member 5221 is in the form of a mesh surface, it can fit the side of the interatrial septum 100 away from the cutting knife 4, so that the clamping of the interatrial septum 100 with the cutting knife 4 is more firm.
  • the cutting auxiliary part 52 When the push-pull rod 51 slides along the direction from the distal end to the proximal end, the cutting auxiliary part 52 produces axial compression and radial expansion. At this time, the fixing part 5221 is in the form of a mesh surface, and the cutting auxiliary part 52 takes the fixing part 5221 as a reference plane. Accurate clamping of interatrial septum 100 is performed.
  • the telescoping member 5222 includes a transition section 52221 and a distal section arranged in sequence along the direction from the proximal end to the distal end.
  • the transition section 52221 has a predetermined structure.
  • the transition section 52221 can be in the shape of a truncated cone.
  • the diameter of the transition section 52221 gradually decreases from the proximal end to the distal end.
  • the fixing part 5221 plays a supporting role, which can further increase the anti-deformation ability of the fixing part 5221, prevent the fixing part 5221 from turning away from the cutting knife 4 during the cutting process, and increase the success rate of the operation.
  • the distal end of the push-pull rod 51 is detachably connected to the distal section of the telescoping member 5222 , and the distal section has a smaller diameter, which can better guide the cutting aid 52 through the pre-opening hole of the interatrial septum 100 .
  • the transition section 52221 has a larger diameter in the unfolded state, which can have a larger contact area with the interatrial septal tissue and better fixation effect.
  • the cutting aid 52 can be composed of a plurality of alloy wires braided, and the material of the alloy wires can be nickel alloy, or other alloy materials with memory ability, and the weaving method can be any existing weaving technology in the art, This embodiment is not limited here.
  • the wire diameter range of the alloy wire can be 0.05mm-0.15mm, and the pore density of the cutting aid 52 can be 30-80 intersections per inch, which can maintain good elastic deformability and have sufficient fixed support strength.
  • the mesh shape of the cutting aid 52 can be circular or polygonal, etc., which are all within the protection scope of the present application.
  • the first tube body 1 includes a plurality of buckles, the buckles are arranged at the distal end of the first tube body 1 , and the buckles can be engaged with the cutting aid 52 .
  • the buckle is engaged with the opening of the first extension part 521 , through the buckle, the first pipe body 1 and the cutting auxiliary part 52 can be quickly disassembled, and the work efficiency is higher.
  • the first tube body 1 can be a double-lumen tube, which includes a push-pull rod lumen 12 and a guide wire lumen 11 penetrating along its axial direction.
  • the push-pull rod lumen 12 is used for The push-pull rod 51 is threaded, and the guide wire cavity 11 is used for threading the guide wire.
  • the push-pull rod cavity 12 is arranged coaxially with the first tube body 1 .
  • the first tube body 1 can be a single-lumen tube, and the push-pull rod 51 can slide through the single-lumen tube.
  • the cutting aid 52 is provided with a guide wire through hole facing the guide wire chamber 11, and the guide wire can pass through the guide wire through hole and stretch into the guide wire chamber 11, or the mesh on the cutting aid 52 is aligned with the guide wire chamber 11.
  • the settings are not limited here.
  • the atrial septostomy device of the present application further includes a third tube body 3 , and the second tube body 2 is slidably passed through the third tube body 3 .
  • the third tube body 3 covers the first tube body 1, the second tube body 2, the cutting knife 4 and the auxiliary assembly 5, so as to prevent the cutting knife 4 from touching the blood vessel, and the first tube body
  • the body 1, the second pipe body 2, the cutting knife 4 and the auxiliary component 5 play a protective role and improve the operation safety.
  • the atrial septostomy device also includes a first drive assembly 6, a second drive assembly 7 and a third drive assembly 8, the first drive assembly 6 can drive the second tubular body 2 to move axially, the second The driving assembly 7 can drive the first tubular body 1 to move in the axial direction, and the third driving assembly 8 can drive the push-pull rod 51 to move in the axial direction, so that the cutting aid 52 can switch between the expanded state and the stretched state.
  • the first driving assembly 6 includes a first housing 61 and a first driving member 62, the proximal end of the second tube body 2 extends into the first housing 61, and the proximal end of the second tube body 2 The end is connected with a first guide piece 631, and a first guide groove 611 is opened on the inner wall of the first housing 61.
  • the first guide groove 611 extends along the axial direction of the second pipe body 2, and the first guide piece 631 is slidably placed in the second pipe body.
  • the first driving member 62 can drive the second pipe body 2 to move in the axial direction.
  • the reliability of the axial movement of the second tubular body 2 is improved, ensuring that the position of the pre-opening hole can be accurately reached, and the accuracy of the stoma position is ensured , ensuring the safety of the operation and reducing the risk of the operation, and the first housing 61 can protect the first guide 631 to ensure durability.
  • the distal end of the first shell 61 is connected to the third tube body 3 , and the proximal end of the third tube body 3 is coaxially connected with the connecting tube body 31 , and the connecting tube body 31 is connected to the first shell body 61 .
  • the proximal end of the third tube body 3 extends into the connecting tube body 31 , and the outer wall of the third tube body 3 is glued to the inner wall of the connecting tube body 31 .
  • the end face of the connecting pipe body 31 away from the third pipe body 3 is connected to the first housing 61, and a communication hole is opened on the first housing 61, so that the cavity of the first housing 61 communicates with the connecting pipe body 31, and the second pipe
  • the body 2 can pass through the first casing 61 into the third pipe body 3 through the communication hole.
  • the first driving assembly 6 also includes a first screw rod 63, the first driving member 62 is arranged in the first casing 61, and a first threaded hole is opened on the first driving member 62, and the first screw rod 63 is screwed to the In the first threaded hole, one end of the first screw rod 63 is connected to the proximal end of the second tubular body 2, the other end of the first screw rod 63 passes through the first driving member 62, and the first guide member 631 is connected to the end of the first screw rod 63. side wall.
  • the linear movement of the second pipe body 2 can be realized by rotating the first driving member 62 , and the structure is simple and the processing is convenient.
  • the first screw rod 63 is coaxially connected to the proximal end of the second tubular body 2, and a through hole is coaxially opened on the first screw rod 63, and the through hole runs through both axial ends of the first screw rod 63, so that the first tubular body 1 wear.
  • the proximal end of the second tube body 2 extends into the through hole of the first screw rod 63, and the side wall of the first screw rod 63 towards the end of the second tube body 2 offers a dispensing hole 632, and the dispensing hole 632 runs through the second tube body 2.
  • a through hole of the screw 63 can drop glue onto the side wall of the second tube body 2 through the glue dispensing hole 632 to realize the bonding of the second tube body 2 and the first screw rod 63 .
  • the connection between the second pipe body 2 and the first screw rod 63 can also be realized in other ways, which is not limited here.
  • an adjustment opening is provided on the side wall of the first housing 61, and the first driving member 62 can be exposed to the first housing 61 through the adjustment opening, and the operator can move the first driving member 62 through the adjustment opening. Rotation is convenient for adjusting the movement of the second pipe body 2 in the axial direction, which improves the practicability.
  • the outer wall of the first driving member 62 can be provided with a plurality of long grooves along the circumferential direction, and the long grooves are arranged along the axial direction of the second pipe body 2 to increase the friction force and facilitate the manual rotation of the first driving member 62.
  • the movement of the second pipe body 2 is realized.
  • the end of the first shell 61 away from the second pipe body 2 is provided with a connecting portion 612, the connecting portion 612 extends along the axial direction of the first pipe body 1, and the connecting portion 612 is provided for connecting the second driving assembly 7.
  • the connecting portion 612 is coaxially provided with a first through hole, and the first through hole communicates with the inner cavity of the first housing 61 , so that the first tube body 1 can pass through the first through hole to reach the second tube body 2 .
  • the second drive assembly 7 includes a second housing 71, the connecting portion 612 protrudes into the second housing 71, and the second housing 71 can slide along the connecting portion 612, and the second housing 71 can slide along the connecting portion 612.
  • the end of a pipe body 1 passes through the first through hole and is fixedly connected to the inside of the second housing 71.
  • the first pipe body 1 can move along the shaft. The movement in the direction, the structure is relatively simple, and it is convenient for production and processing.
  • the second drive assembly 7 also includes a second guide 72, a second guide groove 711 is formed on the inner wall of the second casing 71, and the second guide 72 is connected to the end of the connecting portion 612 away from the second pipe body 2 , the second guide member 72 is placed in the second guide slot 711 and can slide along the second guide slot 711 .
  • the connecting portion 612 is cylindrical
  • the second guiding member 72 protrudes from the side wall of the connecting portion 612
  • the protruding part of the second guiding member 72 is placed in the second guiding groove 711 .
  • the second driving assembly 7 further includes a locking screw 73 , a threaded through hole is opened on the side wall of the second housing 71 , the locking screw 73 is screwed into the threaded through hole and can abut against the connecting portion 612 .
  • the first pipe body 1 reaches the preset position, tighten the locking screw 73 so that the locking screw 73 abuts against the connecting portion 612 to limit the relative position between the second housing 71 and the connecting portion 612 to limit the second
  • the role of the position of the housing 71 prevents the movement of the first pipe body 1, avoids affecting the positions of the cutting knife 4 and the push-pull rod 51, and reduces the possibility of deviation of the cutting position.
  • the third drive assembly 8 includes a second drive member 81, the second drive member 81 is connected to an end of the second housing 71 away from the first housing 61, and the second housing 71 A second through hole is defined at an end away from the first housing 61 , and a proximal end of the push-pull rod 51 passes through the second through-hole to be connected to a second driving member 81 , and the second driving member 81 can drive the push-pull rod 51 to move axially.
  • the second driving member 81 is connected to the second housing 71.
  • first pipe body 1 is fixedly connected to the second housing 71, when the first pipe body 1 and the push-pull rod 51 are driven to move toward the pre-opening position, only Pushing the second casing 71 can drive the push-pull rod 51 and the first pipe body 1 to move simultaneously, which simplifies the operation process and improves the practicality.
  • the third drive assembly 8 also includes a connecting rod 83 and a third guide 84, the connecting rod 83 is coaxially connected to the proximal end of the push-pull rod 51, the connecting rod 83 is at least partially placed in the second through hole, and the second through hole
  • a third guide groove 712 is provided on the hole wall, and the third guide groove 712 extends along the axial direction of the push-pull rod 51.
  • the side wall of the connecting rod 83 is connected to the third guide member 84, and the third guide member 84 protrudes from the connecting rod 83. It is provided that the third guide member 84 is placed in the third guide groove 712 and can slide along the third guide groove 712 .
  • the third guide groove 712 and the third guide member 84 By setting the third guide groove 712 and the third guide member 84, the reliability of the axial movement of the push-pull rod 51 is improved, and it is ensured that the position of the pre-opened hole can be accurately reached, so that the cutting auxiliary member 52 can pass through the pre-opened hole.
  • the hole is switched to the unfolded state, which ensures the smooth progress of the stoma process. It can be understood that, in order to prevent the third guide member 84 from slipping off the third guide groove 712 , the third guide groove 712 does not communicate with both ends of the second through hole.
  • the third drive assembly 8 further includes a second screw 82, the end of the connecting rod 83 away from the push-pull rod 51 passes through the second hole and is coaxially connected with the second screw 82, and the second drive member 81 is provided with The second threaded hole, the second screw rod 82 is screwed into the second threaded hole, and the second driving member 81 is rotatably connected to the end of the second housing 71 away from the first housing 61 .
  • the above-mentioned structural arrangement has a simple structure and is convenient for production and processing.
  • the cutting knife 4 is annular, and the cutting knife 4 is made of metal, such as stainless steel.
  • One end of the cutting knife 4 is provided with an annular cutting edge, and the other end is connected to the second pipe body 2 , and the first pipe body 1 and the auxiliary assembly 5 are passed through the cutting knife 4 .
  • the second pipe body 2 is a structure in which the material of Pebax (polyether block polyamide) is coated on the braided layer of stainless steel.
  • the first drive assembly 6 , the second drive assembly 7 and the third drive assembly 8 are interconnected structures with a simple structure and reduced volume. Moreover, the push-pull rod 51 can not only move simultaneously with the first pipe body 1 through the second drive assembly 7, so that the auxiliary assembly 5 can pass through the pre-opened hole to reach the designated position, but the push-pull rod 51 can also be driven independently by the second drive member 81 to realize auxiliary Component 5 switches between stretched state and unfolded state.
  • the third tube body 3 covers the first tube body 1, the second tube body 2, the cutting knife 4 and the auxiliary component 5, and the cutting aid 52 is stretched, and the guide wire is inserted into the guide wire lumen 11.
  • the three tube bodies 3, the second tube body 2, the first tube body 1 and the auxiliary component 5 can reach the pre-opening position along the guide wire. Pushing the second casing 71 of the second drive assembly 7 makes the first pipe body 1 and the auxiliary assembly 5 move further towards the pre-opening position, so that the auxiliary assembly 5 passes through the pre-opening hole to reach the designated position.
  • the third driving assembly 8 uses the third driving assembly 8 to pull back the push-pull rod 51, so that the cutting auxiliary part 52 is in an unfolded state, and the cutting auxiliary part 52 abuts against one side of the pre-opened hole.
  • the first driving assembly 6 is used to drive the second tubular body 2 forward, the cutting knife 4 cuts the atrial septal tissue, and the resected tissue enters the cavity 41 under the fixing of the cutting aid 52 to complete the stoma.
  • the first driving assembly 6 and the second driving assembly 7 adjust the first tubular body 1, the second tubular body 2, the cutting knife 4 and the auxiliary assembly 5 to retreat into the third tubular body 3, and withdraw the atrial septostomy device as a whole. out.
  • the cutting aid in the stretched state is covered on the outer surface of the push-pull rod, the cutting aid has a smaller outer diameter and can be accommodated In the cavity of the cutting knife, the cutting knife and auxiliary components can move in the blood vessel at the same time, which simplifies the delivery process;
  • the cutting aid is stretched, that is, radially compressed and axially expanded, it can easily pass through the pre-opened hole;
  • the cutting aid passes through the pre-opened hole, when the push-pull rod slides in the opposite direction, the cutting aid is unfolded state, that is, produces axial compression and radial expansion, and the compressed cutting aid can abut against the side of the atrial septum away from the cutting knife, thereby fixing the tissue to be resected with the cutting knife from both sides of the atrial septum.
  • the cutting knife cuts the interatrial septum, and under the fixing of the cutting aid
  • the cutting aid can provide auxiliary control to fix and position the interatrial septum, so that The cutting action of the cutting knife is faster and more precise, preventing the removed tissue from falling off; after the cutting is completed, the removed atrial septal tissue enters the cavity of the cutting knife under the fixing of the cutting auxiliary parts, so as to avoid the embolism of the myocardium caused by the tissue falling off Tissue damage.
  • the elastic expansion and contraction of the cutting aid is controlled by the push-pull rod, which has a simple structure and will not loosen or fail to fix, making it safer and more efficient; through the sliding position of the push-pull rod, the degree of elastic deformation of the cutting aid can be controlled, and then the cutting aid can be controlled.
  • the resistance to the atrial septum and the degree of cooperation with the cutting knife are higher, which improves the safety of the operation.
  • the embodiment of the present application also provides an atrial septostomy device for stoma operation on the atrial septum 100.
  • the atrial septostomy device in this embodiment has been A puncture hole is made in the interatrial septum 100 using a puncture device.
  • the atrial septostomy device includes an elastic braided mesh 1a, the elastic braided mesh 1a includes a first extension 11a and a second extension 12a arranged in sequence along the direction from the proximal end to the distal end, the first extension 11a is tubular, and the second extension 12a is 12a includes a fixing part 121 and a telescoping part 122, the fixing part 121 is connected to the first extension part 11a, and the fixing part 121 has an annular mesh surface.
  • the tubular first extension part 11a can pass through the puncture hole on the interatrial septum 100, and the annular mesh surface can fit the puncture hole; because of its annular mesh surface, the fixing member 121 can be more It fits well on the interatrial septum 100, accurately limits the position of the elastic braided net 1a, and does not damage the puncture hole.
  • the second extension part 12a can cover the tissue that needs to be removed around the stoma from the distal side of the atrial septum 100, and fix and position the atrial septum 100, so as to provide auxiliary control during the cutting process of the tissue around the stoma, so that the cutting action Faster and more accurate, preventing the resected tissue from falling off; after the tissue is resected, the elastic braided mesh 1a can assist in clamping the cut tissue from the distal side of the interatrial septum 100 and bring the tissue out of the body to avoid tissue loss caused by Embolism or damage to heart muscle tissue.
  • the elastic braided net 1a is composed of a plurality of alloy wires.
  • the material of the alloy wires includes nickel alloy, or other alloy materials with memory capacity.
  • the weaving method is the prior art in this field. Examples are not limited here.
  • the wire diameter range of the alloy wire is 0.05mm-0.15mm
  • the pore density of the elastic braided net 1a is 30-80 crossings per inch
  • the mesh shape of the elastic braided net 1a can be circular or polygonal, which can It maintains good elastic deformation and has sufficient fixed support strength.
  • the cross-sectional shape of the telescopic member 122 can be regular or irregular polygons such as triangles, rectangles, rhombuses, and stars, and can also be circular, elliptical, etc. with arc-shaped sides, which are defined in this application. Within the scope of protection, this embodiment is not limited here.
  • the atrial septostomy device also includes a first tubular body 1 and a push-pull rod 3a
  • the first tubular body 1 may be a delivery sheath
  • the first tubular body 1 is hollow inside
  • the push-pull rod 3a is passed through the first tubular body 1 Inside, the proximal end of the first extension part 11a is connected to the distal end of the first tube body 1, and the push-pull rod 3a passes through the first extension part 11a and is connected to the distal end of the second extension part 12a.
  • one end of the first extension part 11a has an opening for connecting the first pipe body 1, the push-pull rod 3a enters the elastic braided net 1a from the first pipe body 1 through the opening of the first extension part 11a, and The distal end of the second extension 12a is connected.
  • the push-pull rod 3 a is supported in the elastic braided net 1 a, and can guide the elastic braided net 1 a through the puncture hole of the interatrial septum 100 .
  • the push-pull rod 3a can move axially relative to the first tube body 1, so that the second extension portion 12a can expand and contract radially and/or axially.
  • the elastic expansion and contraction of the elastic braided net 1a includes radial expansion and axial expansion and contraction: when the push-pull rod 3a slides to the left atrium and drives the elastic braided net 1a to pass through the puncture hole of the interatrial septum 100, the elastic braided net 1a produces Radial compression and axial expansion can easily pass through puncture holes with small apertures; when the push-pull rod 3a slides in reverse, the elastic braided net 1a produces axial compression and radial expansion, and the compressed elastic braided net 1a can stick to the Fitted on the annular mesh-shaped fixing member 121, the elastic braided mesh 1a after axial compression has a larger radial area, and can accurately abut and fix the atrial septum 100 with the annular mesh surface of the fixing member 121 as the reference plane
  • the elastic expansion and contraction of the elastic braided net a1 is controlled by the push-pull rod 3a, which has a simple structure and will not loosen or fail to fix, making it safer and more efficient; through the sliding position of the push-pull rod 3a, the degree of elastic deformation of the elastic braided net 1a can be controlled, and then Controlling the pressing force of the elastic braided net 1a against the interatrial septum 100 has a higher degree of cooperation with the cutting action.
  • the outer diameter of the annular mesh surface is larger than the outer diameter of the first extension part 11a, so that the annular mesh surface can have a larger contact area, on the one hand, it can fit more interatrial septum 100 areas, and the tissue clamping On the other hand, it can prevent the elastic braided mesh 1a from leaving the left atrium when the push-pull rod 3a slides in reverse, preventing the interatrial septum 100 from being damaged or the device from being damaged.
  • the atrial septostomy device further includes an annular cutting knife 4a, and the outer diameter of the annular mesh surface is equal to or slightly smaller than the inner diameter of the cutting knife 4a.
  • the difference between the inner diameter of the cutting knife 4a and the outer diameter of the annular mesh surface may not be greater than 1mm.
  • the cutting knife 4a is slidably connected to the outside of the first tube body 1, the first tube body 1 is aligned with the puncture hole, the cutting knife 4a slides on the first tube body 1, and can slide along the axial direction of the first tube body 1 , so as to abut against the interatrial septum 100 from the right atrium side, and the second extension part 12a is respectively located on both sides of the interatrial septum 100 .
  • the elastic braided net 1a is coaxially arranged with the cutting knife 4a, and when the outer diameter of the annular mesh surface of the fixing member 121 is slightly smaller than the inner diameter of the cutting knife 4a, the elastic braided net 1a can effectively fix the cut tissue At the same time, when the tissue is cut, the elastic braided mesh 1a can pull the cut tissue into the inner cavity of the cutting knife 4a to prevent the tissue from falling off.
  • the push-pull rod 3 a is detachably connected to the distal end of the telescoping member 122 .
  • the push-pull rod 3a is located in the elastic braided net 1a, and can provide axial guidance during the elastic deformation of the elastic braided net 1a, so as to avoid inclination during axial compression or fracture during radial compression;
  • the push-pull rod 3a is connected to the distal end of the telescopic member 122, It can control the expansion and contraction of the entire elastic braided net 1a, and it is easy to guide and drive the entire elastic braided net 1a to pass through the puncture hole of the atrial septum 100, and it has better fixation and recovery capabilities for the cut atrial septal tissue during the operation or after the operation .
  • the atrial septostomy device also includes a first clamping assembly (not shown in the figure), the first clamping assembly includes a first outer ring and a first inner ring sleeved in the first outer ring, the first inner ring One end of the ring is engaged with the push-pull rod 3a, and the distal end of the telescopic member 122 is engaged between the first outer ring and the first inner ring. It can be understood that there is a gap between the first outer ring and the first inner ring, which can accommodate and fix the distal end of the telescopic member 122.
  • the gap between the first outer ring and the first inner ring can also be Welding, and welding between the first inner ring and the push-pull rod 3a increases the connection reliability of the push-pull rod 3a and the telescopic member 122.
  • the atrial septostomy device also includes a second clamping assembly (not shown in the figure), the second clamping assembly includes a second outer ring and a second inner ring sleeved in the second outer ring, the second inner ring One end of the ring is engaged with the first tube body 1 , and the proximal end of the first extension part 11a is engaged between the second outer ring and the second inner ring. That is to say, the second clamping assembly has the same structure as the first clamping assembly, which is simple in structure, easy to realize disassembly and assembly between the first pipe body 1 and the elastic braided net 1a, and is reliable in fixing.
  • the included angle between the annular mesh surface and the axial direction of the push-pull rod 3a is preferably 80°-100°. Within this angle range, the second extension part 12a can easily pass through the puncture hole of the interatrial septum, and is not easy to fall off from the puncture hole and slide into the right atrium side.
  • the included angle between the annular mesh surface and the axial direction of the push-pull rod 3a may be 80°, 85°, 87°, 90°, 91°, 95°, 100° and so on. In other embodiments, the included angle between the annular mesh surface and the axial direction of the push-pull rod 3a can also be selected from other angles, which is not limited to this embodiment.
  • the telescopic member 122 includes a telescopic transition section 1221, the two ends of the telescopic transition section 1221 are respectively a large-diameter end and a small-diameter end, and the large-diameter end is connected to the annular mesh surface.
  • the transition section 1221 the telescopic member 122 is divided into two parts, and the small-diameter end with a smaller diameter is located at the far end of the telescopic member 122. It is easy to connect the push-pull rod 3a through the first clamping assembly, and can better guide the elastic braided net 1a to wear.
  • the large diameter end with a larger diameter can have a larger coverage area on the atrial septum 100 during radial expansion, and the fixing and clamping effect is better.
  • the cross-sectional shape of the telescopic transition section 1221 can be various shapes such as a circle, an ellipse, and a polygon, which are not limited in this embodiment.
  • the doctor needs to form a shunt opening on the heart with the help of a surgical knife, and after the shunt opening is formed, it is necessary to use other instruments to deliver medicine to the shunt opening.
  • anti-proliferative or immunosuppressive drugs are generally coated on the balloon catheter and then delivered to the shunt port, so that the tissues near the shunt port can absorb the drug, thereby maintaining the long-term unblocked flow of the shunt port.
  • the operation process is more complicated, and there are many steps, and the operation time is longer.
  • the embodiment of the present application also provides an atrial septostomy device, the atrial septostomy device can perform cutting operations and drug application operations, which simplifies the operation steps, shortens the operation time, and improves the operation effect.
  • the atrial septostomy device in the following embodiments may be a further improvement based on any of the above embodiments, or may be a further improvement on an existing atrial septostomy device, all of which are within the protection scope of the present application.
  • Some embodiments of the present application also provide an atrial septostomy device, and the atrial septostomy device is used for stoma operation and drug application operation in atrial septostomy.
  • the atrial septostomy device can also be used in other operations according to the needs. All the atrial septostomy devices provided in the embodiments are applicable.
  • the cutting knife of the atrial septostomy device may include a cutting knife body 10 and a drug-loaded structure.
  • the cutting knife body 10 is a columnar structure, and a through hole 110 is arranged on the cutting knife body 10 along the axial direction.
  • the other end of 10 is a connection end, through which the cutting knife body 10 can be connected with the delivery tool, and the doctor can transport the cutting knife body 10 to the target position through the delivery tool to perform stoma operation and medicine application.
  • the drug-loading structure is arranged on the outer wall of the cutting knife body 10, so as to ensure that the drug feeding operation can be performed sequentially after the stoma operation of the atrial septostomy device is completed.
  • the drug-loaded structure is used to carry drugs. After the cutting blade 120 completes the stoma operation, the atrial septostomy device continues to move until the drug-loaded structure moves to the incision, and the drug is released at the incision to play a role.
  • this embodiment directly arranges the drug-loaded structure on the incision of the atrial septostomy device. on the knife body 10, so that the cutting blade 120 can perform the medicine application operation in sequence after the stoma operation is completed (as shown in Figure 17 and Figure 18), since there is no need to change the tool between the stoma operation and the medicine application operation, so It can simplify the operation steps, shorten the operation time, improve the operation efficiency, and the improvement of the operation efficiency is beneficial to the postoperative recovery of patients.
  • the drugs carried by the drug-loaded structure include anti-proliferative drugs or immunosuppressive drugs, and the operation of applying drugs to the incision can slow down the speed of incision healing, so as to keep the formed shunt open for a long time.
  • the drugs carried in the drug-loading structure can also be replaced according to requirements, not limited to anti-proliferative drugs and immunosuppressive drugs.
  • the cutter body 10 includes a first portion 130 and a second portion 140 connected in a stepped shape. Both the first part 130 and the second part 140 are cylindrical, the outer diameter of the first part 130 is larger than the outer diameter of the second part 140, the end of the first part 130 away from the second part 140 is a cutting end, and the second part 140 is away from One end of the first part 130 is a connection end. Moreover, by setting the cutter body 10 in a stepped column shape, the delivery tool can be sleeved on the second part 140 and positioned against the stepped surface, thereby improving the connection stability between the atrial septostomy device and the delivery tool.
  • the through hole 110 provided in the cutter body 10 is a first hole 111 and a second hole 112 connected in a step shape, wherein the first hole 111 is located inside the first part 130, and at least part of the second hole 112 is located In the second part 140 , the inner diameter of the first hole 111 is larger than the inner diameter of the second hole 112 .
  • the length of the first hole 111 is shorter than the length of the first portion 130 of the cutting body 10, and the length of the second hole 112 is greater than the length of the second portion 140 of the cutting body 10, so that the length of the first hole 111 can be formed respectively
  • the inner and outer stepped surfaces of the inner and outer sides of the cutter body 10 are misaligned, so that not only the thickness of the cutter body 10 is uniform, but also the structural strength of the joint between the first part 130 and the second part 140 is ensured. The deformation or breakage of the atrial septostomy device during operation is avoided.
  • the thickness of at least part of the first portion 130 gradually decreases to form a cutting edge 120 at the cutting end.
  • the cutting edge 120 is a torus with a very small width. When the tissue to be cut 300 is applied and a force is applied, the cutting edge 120 can quickly form a hole-like structure on the tissue to be cut 300, thus completing the stoma operation and forming a shunt.
  • the through hole 110 also includes a third hole 113, the third hole 113 is arranged in the first part 130, and the third hole 113 and the second hole 112 are located in the second hole 113 On both sides of the first hole 111 , in this embodiment, the third hole 113 is a tapered hole, and the small-sized end of the third hole 113 is connected with the first hole 111 .
  • the cutting blade 120 can also be set in other shapes according to requirements, and is not limited to the torus in this embodiment.
  • the drug-loading structure is a drug-loading groove 200 provided on the outer wall of the cutting blade body 10, specifically, the drug-loading groove 200 is provided on the corresponding outer wall of the first part 130, and the drug-loading groove 200 is used for for carrying medicines.
  • the drug-loading structure is formed by directly slotting on the cutter body 10, not only the processing method is simple, the structure of the atrial septostomy device will not be complicated, and because the position of the drug-loading groove 200 on the cutter body 10 is fixed, no Movement will occur, so setting the drug-loading structure as the drug-loading groove 200 is beneficial to improve the stability of the drug inside.
  • the drug-loading groove 200 is an annular groove arranged along the circumference of the cutting blade body 10 .
  • the drug-carrying capacity of the annular groove is large, and the manufacturing method is simple.
  • a plurality of drug-loading grooves 200 can be arranged on the outer wall surface of the cutter body 10 along the cutting direction according to requirements, and each drug-loading groove 200 is annular. groove.
  • the medicines carried in the multiple medicine-loading grooves 200 can be the same or different.
  • the drug loading depth of each drug loading groove 200 can be the same or different.
  • the capacity of each drug-loading tank 200 can be the same or different.
  • the number of drug-loading grooves 200 is selected according to the type of medicine to be carried.
  • Each drug-loading groove 200 is used to carry a kind of medicine.
  • Each drug-loading groove 200 is an annular groove. The width is the same, but the drug-loading depth is different, so that the capacity of each drug-loading groove 200 is also different, and the capacity of the drug-loading groove 200 matches the amount of medicine in it.
  • the drug-loading tank 200 includes three inner wall surfaces, which are respectively two opposite side wall surfaces and a tank bottom surface.
  • the inner wall of the 200 is provided with an adsorption structure, and the adsorption structure is used for absorbing drugs, thereby achieving the purpose of preventing the drugs from falling from the drug-loading tank 200 .
  • the adsorption structure can be a solid structure, such as an adsorption film coated or arranged on the inner wall surface.
  • the adsorption structure can also be an adsorption rough surface. The adsorption rough surface is formed by increasing the surface roughness of the inner wall surface.
  • the drug can be mixed with the polymer and then sprayed into the drug-loading tank, the polymer can increase the viscosity of the drug, so that the drug can be stably placed in the drug-loading tank 200, so as to prevent the drug from being released from the drug-loading tank. Objects that drop within 200.
  • the depth of each place in the drug-loading groove 200 can be the same or different.
  • the depth of each place in the drug-loading groove 200 is different by setting the bottom surface of the groove as an inclined surface, so that the drug-loading groove can Medicines within 200 can be attached to the incision as much as possible.
  • the bottom surface of the groove is inclined in a direction away from the axial direction, so that the drug-loading depth of the drug-loading groove 200 gradually decreases.
  • the tissue 300 can push the medicine backward and upward during the process of being in contact with the medicine, so that as much medicine as possible can stick to the tissue 300 at the incision.
  • Some embodiments of the present application also provide an atrial septostomy device, and the atrial septostomy device is used for stoma operation and drug application operation in atrial septostomy.
  • the atrial septostomy device can also be used in other operations according to requirements.
  • the atrial septostomy devices provided in the example are applicable.
  • the atrial septostomy device includes a cutter body 10 and a drug-loaded structure.
  • the cutting knife body 10 is a columnar structure, and a through hole 110 is arranged on the cutting knife body 10 along the axial direction.
  • the other end of 10 is the connection end, through which the cutting knife body 10 can be connected with the delivery tool, and the doctor can transport the atrial septostomy device to the target position through the delivery tool to perform stoma operation and medicine application.
  • the drug-loading structure is arranged on the outer wall of the cutter body 10, and the drug-loading structure is arranged behind the cutting edge 120 along the cutting direction, so as to ensure that the drug feeding operation can be performed sequentially after the stoma operation of the atrial septostomy device is completed.
  • the drug-loaded structure is used to carry drugs. After the cutting blade 120 completes the stoma operation, the atrial septostomy device continues to move until the drug-loaded structure moves to the incision, and the drug is released at the incision to play a role.
  • this embodiment directly arranges the drug-loading structure on the cutting part of the atrial septostomy device. on the knife body 10, so that the atrial septostomy device can perform the medicine application operation in sequence after the stoma operation (as shown in Figure 17 and Figure 18), because there is no need to change the tool between the stoma operation and the medicine application operation , so the operation steps can be simplified, the operation time can be shortened, and the operation efficiency can be improved.
  • the improvement of operation efficiency is beneficial to the postoperative recovery of patients.
  • the drugs carried by the drug-loading structure include anti-proliferative drugs or immunosuppressive drugs, and applying drugs to the incision can slow down the speed of incision healing, so as to keep the formed shunt open for a long time.
  • the drugs carried in the drug-loading structure can also be replaced according to requirements, not limited to anti-proliferative drugs and immunosuppressive drugs.
  • the cutter body 10 includes a first portion 130 and a second portion 140 connected in a stepped shape. Both the first part 130 and the second part 140 are cylindrical, the diameter of the first part 130 is greater than the diameter of the second part 140, the end of the first part 130 away from the second part 140 is a cutting end, and the second part 140 is far away from the first part.
  • One end of the part 130 is a connection end, and the drug-loading structure is arranged on the outer wall of the first part 130 .
  • the delivery tool can be sleeved on the second part 140 and positioned against the stepped surface, thereby improving the connection stability between the atrial septostomy device and the delivery tool.
  • the through hole 110 provided in the cutter body 10 is a first hole 111 and a second hole 112 connected in a step shape, wherein the first hole 111 is located inside the first part 130, and at least part of the second hole 112 is located In the second portion 140 , the inner diameter of the first hole 111 is larger than the inner diameter of the second hole 112 .
  • the length of the first hole 111 is shorter than the length of the first portion 130 of the cutting body 10, and the length of the second hole 112 is greater than the length of the second portion 140 of the cutting body 10, so that the length of the first hole 111 can be formed respectively
  • the inner and outer stepped surfaces of the inner and outer sides of the cutter body 10 are misaligned, so that not only the thickness of the cutter body 10 is uniform, but also the structural strength of the joint between the first part 130 and the second part 140 is ensured. The deformation or breakage of the atrial septostomy device during operation is avoided.
  • the thickness of at least part of the first portion 130 gradually decreases to form a cutting edge 120 at the cutting end.
  • the cutting edge 120 is a torus with a very small width.
  • the through hole 110 also includes a third hole 113, the third hole 113 is arranged in the first part 130, and the third hole 113 and the second hole 112 are located in the second hole 113 On both sides of the first hole 111 , in this embodiment, the third hole 113 is a tapered hole, and the small-sized end of the third hole 113 is connected with the first hole 111 .
  • the cutting blade 120 can also be set in other shapes according to requirements, and is not limited to the torus in this embodiment.
  • the drug-loading structure is a drug-loading groove 200 provided on the outer wall of the cutting blade body 10, specifically, the drug-loading groove 200 is provided on the corresponding outer wall of the first part 130, and the drug-loading groove 200 is used for for carrying medicines.
  • the drug-loading structure is formed by directly slotting on the cutter body 10, not only the processing method is simple, the structure of the atrial septostomy device will not be complicated, and because the position of the drug-loading groove 200 on the cutter body 10 is fixed, no Movement will occur, so setting the drug-loading structure as the drug-loading groove 200 is beneficial to improve the stability of the drug inside.
  • the drug-loaded groove 200 includes a plurality of drug-loaded sub-grooves 210 , and the drug-loaded sub-grooves 210 are arranged at intervals along the circumference of the cutting blade body 10 .
  • the drug-loading groove 200 may be a regular groove such as a square groove, a circular groove, or a waist-shaped groove, or may be a special-shaped groove such as a flower shape or a corrugated shape.
  • the arrangement of multiple drug-loaded sub-grooves 210 can ensure the structural strength of the cutting blade body 10, and avoid the sharp decline in the structural strength of the cutting blade body 10 caused by continuous slotting, thereby avoiding the occurrence of breakage of the cutting blade body 10.
  • a plurality of drug-loaded grooves 200 may be arranged on the outer wall surface of the cutter body 10 along the cutting direction according to requirements, and each drug-loaded groove 200 includes multiple drug-loaded grooves.
  • each drug-carrying sub-groove 210 along the direction parallel to the axial direction, two adjacent drug-carrying sub-grooves 210 can be arranged in dislocation, or can be arranged in line.
  • the drugs loaded in different drug-loaded sub-tanks 210 may be the same or different.
  • the drug-loading depth of each drug-loading sub-groove 210 may be the same or different.
  • the capacity of each drug-carrying sub-tank 210 can be the same or different.
  • the number of drug-loading tanks 200 is selected according to the type of drug to be loaded, and each drug-loading tank 200 includes a plurality of drug-loading sub-channels 210 for loading the same drug.
  • the drug-carrying sub-groove 210 includes three inner wall surfaces, the three inner wall surfaces are respectively two opposite side wall surfaces and a groove bottom surface.
  • the inner wall of the drug sub-tank 210 is provided with an adsorption structure, and the adsorption structure is used for adsorbing the drug, so as to prevent the drug from falling from the drug-carrying sub-tank 210 .
  • the adsorption structure can be a solid structure, such as an adsorption film coated or arranged on the inner wall surface.
  • the adsorption structure can also be an adsorption rough surface.
  • the adsorption rough surface is obtained by increasing the thickness of the inner wall surface Surface roughness forms a rough surface with adsorption.
  • the drug can be mixed with the polymer and then sprayed into the drug-loaded tank, the polymer can increase the viscosity of the drug, so that the drug can be stably placed in the drug-loaded sub-groove 210 to prevent the drug from The purpose of dropping in the sub-slot 210.
  • the depth of each place in the drug-loading sub-groove 210 can be the same or different.
  • the depth of each place in the drug-loading sub-groove 210 is different by setting the bottom surface of the groove as an inclined surface, so as to facilitate loading.
  • the medicine in the medicine sub-groove 210 can be attached to the incision as much as possible.
  • the bottom surface of the groove is inclined in a direction away from the axial direction, so that the drug-loading depth of the drug-carrying sub-groove 210 gradually decreases.
  • the tissue 300 can push the medicine backward and upward during the process of contacting with the medicine, so that as much medicine as possible can stick to the tissue 300 at the incision.
  • the atrial septostomy device includes a cutting knife body and a drug-loading structure, the cutting knife body is provided with a through hole along the axial direction, the cutting knife body One end of the blade is a cutting end, and the other end is a connecting end.
  • the drug-loading structure is arranged on the outer wall of the cutting knife body, and the drug-loading structure is used for carrying drugs.
  • the atrial septostomy device is provided with a drug-loading structure, which can not only perform the cutting operation, but also perform the drug application operation after the cutting operation.
  • the drug application operation does not need to change tools, which greatly simplifies the operation steps and improves the operation efficiency. Efficiency shortens the operation time and facilitates the recovery of patients.

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

Abstract

L'invention concerne un dispositif de septostomie auriculaire, comprenant un premier corps de tube (1), un second corps de tube (2) et un ensemble auxiliaire (5), une extrémité distale du second corps de tube (2) étant reliée à un couteau de découpe (4) ; le couteau de découpe (4) est pourvu d'une cavité (41) en communication avec une cavité de tube du second corps de tube (2) ; et le premier corps de tube (1) est disposé de manière coulissante dans le second corps de tube (2) et le couteau de découpe (4) de manière pénétrante. L'ensemble auxiliaire (5) comprend une tige de poussée-traction (51) et un élément auxiliaire de découpe (52), la tige de poussée-traction (51) étant disposée de manière coulissante dans le premier corps de tube (1) de manière pénétrante ; une extrémité proximale de l'élément auxiliaire de découpe (52) est reliée à une extrémité distale du premier corps de tube (1) ; une extrémité distale de l'élément auxiliaire de découpe (52) est reliée à une extrémité distale de la tige de poussée-traction (51) ; et la tige de poussée-traction (51) peut coulisser par rapport au premier corps de tube (1), de telle sorte que l'élément auxiliaire de découpe (52) est commuté entre un état déplié et un état étiré. Lorsque l'élément auxiliaire de découpe (52) est dans l'état étiré, l'élément auxiliaire de découpe peut être logé à l'intérieur de la cavité (41). Lorsque l'élément auxiliaire de découpe (52) est dans l'état déplié, l'élément auxiliaire de découpe a une surface de maille faisant face au couteau de découpe (4) pour collecter des tissus de septum auriculaire qui sont coupés par le couteau de découpe (4) et tirer les tissus de septum auriculaire dans la cavité (41).
PCT/CN2022/128691 2021-12-21 2022-10-31 Dispositif de septostomie auriculaire WO2023116205A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
CN202111572477.3 2021-12-21
CN202111574517.8 2021-12-21
CN202111572477.3A CN114176720B (zh) 2021-12-21 2021-12-21 一种房间隔造口装置
CN202111574517.8A CN114098916B (zh) 2021-12-21 2021-12-21 一种房间隔造口装置
CN202210362009.1 2022-04-07
CN202210362009.1A CN116919538A (zh) 2022-04-07 2022-04-07 一种房间隔造口装置

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WO2023116205A1 true WO2023116205A1 (fr) 2023-06-29

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Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180064460A1 (en) * 2014-06-13 2018-03-08 InterShunt Technologies, Inc. Method and catheter for creating an interatrial aperture
CN109700525A (zh) * 2018-12-28 2019-05-03 先健科技(深圳)有限公司 造口器械
CN110494183A (zh) * 2017-02-10 2019-11-22 德克萨斯医疗中心 用于心房间吻合术的经导管装置
CN112568971A (zh) * 2019-09-30 2021-03-30 北京迈迪顶峰医疗科技有限公司 房间隔造口器
CN112568973A (zh) * 2019-09-30 2021-03-30 北京迈迪顶峰医疗科技有限公司 房间隔造口器
CN112790799A (zh) * 2021-03-16 2021-05-14 依奈德医疗技术（上海）有限公司 用于治疗心衰的房间隔分流装置
CN113576609A (zh) * 2021-08-12 2021-11-02 深圳佰特微医疗科技有限公司 造口器械
CN114098917A (zh) * 2021-12-21 2022-03-01 上海申淇医疗科技有限公司 一种房间隔造口装置
CN114098916A (zh) * 2021-12-21 2022-03-01 上海申淇医疗科技有限公司 一种房间隔造口装置
CN114176720A (zh) * 2021-12-21 2022-03-15 上海申淇医疗科技有限公司 一种房间隔造口装置

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180064460A1 (en) * 2014-06-13 2018-03-08 InterShunt Technologies, Inc. Method and catheter for creating an interatrial aperture
CN110494183A (zh) * 2017-02-10 2019-11-22 德克萨斯医疗中心 用于心房间吻合术的经导管装置
CN109700525A (zh) * 2018-12-28 2019-05-03 先健科技(深圳)有限公司 造口器械
CN112568971A (zh) * 2019-09-30 2021-03-30 北京迈迪顶峰医疗科技有限公司 房间隔造口器
CN112568973A (zh) * 2019-09-30 2021-03-30 北京迈迪顶峰医疗科技有限公司 房间隔造口器
CN112790799A (zh) * 2021-03-16 2021-05-14 依奈德医疗技术（上海）有限公司 用于治疗心衰的房间隔分流装置
CN113576609A (zh) * 2021-08-12 2021-11-02 深圳佰特微医疗科技有限公司 造口器械
CN114098917A (zh) * 2021-12-21 2022-03-01 上海申淇医疗科技有限公司 一种房间隔造口装置
CN114098916A (zh) * 2021-12-21 2022-03-01 上海申淇医疗科技有限公司 一种房间隔造口装置
CN114176720A (zh) * 2021-12-21 2022-03-15 上海申淇医疗科技有限公司 一种房间隔造口装置

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