Oval foramen suture needle and oval foramen suture system thereof

Abstract

The invention provides a foramen ovale suturing needle and a foramen ovale suturing system, and belongs to the technical field of medical instruments.The foramen ovale suturing needle adopts a section of spiral needle with a spiral line trend with the natural number being N screw pitches, and the top end of the spiral needle is in a sharp wedge face shape to form a needle head; the spiral tubular body is continuously communicated from the needle head to the tubular cavity at the tail end, the front end and the rear end of the spiral tubular body are open, and the cylindrical spiral line is a single spiral. The foramen ovale suturing system comprises a right atrium approach channel pipe sheath and a suturing mechanism composed of the foramen ovale suturing needle. The foramen ovale intervention plate intervenes between the primary septum and the secondary septum in the foramen ovale, the primary septum and the secondary septum, close to the two sides of the foramen ovale intervention plate, of the foramen ovale are instantly frozen, the freezing suction effect is achieved, and the spiral needle rotates to suture the primary septum and the secondary septum of the foramen ovale conveniently.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an oval foramen suture needle and an oval foramen suture system thereof. BACKGROUND

[0002] Generally, the oval foramen is a physiological channel in the embryonic period of the atrial septum of the heart. After birth, the secondary septum and the primary septum of the atrial septum of most people are mutually adhered and fused to form a permanent atrial septum after about 5-7 months. If they are not fused, an oval foramen patent is formed. About 25% to 34% of adults have two layers of septums in the oval fossa that are not completely fused, leaving a permanent crack-like defect in the middle.

[0003] In recent years, research has found that the risk of stroke, migraine, peripheral arterial embolism, decompression disease, etc. of patients with patent foramen ovale is several times higher than that of normal people. The pathogenic effect of patent foramen ovale has attracted widespread attention, and clinical exploration is carried out to close the oval foramen to prevent recurrence of stroke events and treat migraine and other diseases.

[0004] In the closure of patent foramen ovale, a memory alloy umbrella is generally used to block or a suture technique is used to suture between the primary septum and the secondary septum to solve the problem of the disease.

[0005] However, the use of the memory alloy umbrella still has the problem of not being able to completely close the patent foramen ovale, leading to thrombosis and seriously affecting the health of patients. The suture technique for patent foramen ovale is difficult to perform in the right atrium, and the suture technique between the primary septum and the secondary septum has a large difficulty, and complete closure may not be achieved in one operation. Due to the characteristics of traditional equipment and the limitations of right atrial operation, the number of suture needles in one operation cannot achieve the desired effect, and even after suture, there is still a risk of atrial regurgitation. SUMMARY

[0006] The technical task of the present application is to solve the problems of the prior art, and to provide an oval foramen suture needle and an oval foramen suture system thereof.

[0007] The technical solution of the present application is implemented in the following manner. The oval foramen suture needle and the oval foramen suture system thereof, wherein,

[0008] The oval foramen suture needle is characterized in that the oval foramen suture needle adopts a helical tubular body helical needle with a helical line running direction with a natural number N of pitches, the top end forms a needle head in the form of a sharp wedge surface, the helical tubular body is continuously through the tubular cavity from the needle head to the last end, and the front and rear ends are open, and the cylindrical helical line is a single helix.

[0009] The oval foramen suture needle adopts a stainless steel needle, and the main body shape is a helical needle with gradually changing pitches and / or gradually changing diameters.

[0010] The oval foramen suture needle preferably adopts a stainless steel needle, the main body section has a gradually changed thread lead angle, and a gradually changed diameter can also be attached.

[0011] The oval foramen suture needle or adopts a shape memory alloy spiral needle, the main body section has a gradually changed thread lead angle, and a gradually changed diameter can also be attached.

[0012] The spiral tubular cavity of the oval foramen suture needle is arranged with a continuous suture line, which can freely slide between the spiral tubular cavity and the inner wall of the cavity; the length of the suture line is greater than the spiral length of the oval foramen suture needle, and the end of the suture line extends to the outside of the end of the oval foramen suture needle.

[0013] The front end of the suture line is fixed with a blocking rod connected to the end of the suture line, the connection point is located in the middle section of the length of the blocking rod, and the blocking rod and the front section of the suture line form a T-shaped structure in the pulling state;

[0014] A section of the blocking rod near the connection point is provided with a reduced diameter section, and the reduced diameter end of the blocking rod can be embedded into the lumen of the needle; the blocking rod has a diameter expansion end which blocks the wedge surface at the front end of the needle, preventing the blocking rod from sliding into the lumen of the oval foramen suture needle.

[0015] The oval foramen suture needle is also provided with a suture route guide body matched and connected in its inner circumference;

[0016] The suture route guide body is composed of a front oval foramen interventional plate, a middle support body, and a tail push rod;

[0017] The support body is a cylindrical support body, and a continuous spiral groove is formed on the outer wall surface of the cylindrical support body, and the central axis of the spiral groove is the same as the central axis of the support body;

[0018] The oval foramen interventional plate is vertically fixed and connected to the end face of the front end of the cylindrical support body;

[0019] The tail end of the support body is fixedly connected with the push rod;

[0020] The oval foramen interventional plate, the support body, and the push rod are coaxially arranged;

[0021] The oval foramen suture needle penetrates the outer wall surface of the support body along the spiral groove of the support body in a spiral direction.

[0022] The oval foramen interventional plate is provided with an opening on the edge of each side in the length direction of the longitudinal axis, and the two side openings are arranged on the same spiral line track;

[0023] The spiral line track of the two side openings and the spiral line track of the spiral groove of the support body are continuous and the same spiral line track;

[0024] The helical slot of the outer wall of the support body has a pitch less than or equal to the pitch of the foramen ovale suture needle, constituting a close accommodation section of the foramen ovale suture needle by the support body, facilitating the close accommodation of the foramen ovale suture needle on the support body in a short span distance.

[0025] The helical slot of the outer wall of the support body has a pitch less than or equal to the pitch of the foramen ovale suture needle, constituting a close accommodation section of the foramen ovale suture needle by the support body, facilitating the close accommodation of the foramen ovale suture needle on the support body in a short span distance.

[0026] The foramen ovale suture needle adopted is helically accommodated and continues to be released after being helically withdrawn, and the foramen ovale suture needle is restored to an expanded pitch state and / or an expanded diameter state.

[0027] The shape memory alloy helical needle in the expanded pitch and / or expanded diameter state is beneficial to facilitate suturing of the primary and secondary septums of the foramen ovale after being helically withdrawn from the support body.

[0028] A frozen medium cavity is formed in the foramen ovale interventional plate, a support body liquid nitrogen inlet and outlet two-way freezing channel is formed in the support body to communicate with the liquid nitrogen cavity, and a push rod liquid nitrogen inlet and outlet passage is formed in the push rod.

[0029] The push rod liquid nitrogen inlet and outlet passage communicates with the support body liquid nitrogen inlet and outlet two-way freezing channel.

[0030] The push rod liquid nitrogen inlet and outlet passage is connected to an external terminal operating handle outside the body through two-way freezing transmission inlet and outlet pipes, and the two-way freezing transmission inlet and outlet pipes are provided with a freezing ablation instrument connected thereto at the terminal operating handle outside the body.

[0031] The foramen ovale suture needle is applied to the foramen ovale non-closure surgical device.

[0032] The foramen ovale suture system comprises a right atrial access channel tube sheath and a suture mechanism comprising the foramen ovale suture needle.

[0033] The suture mechanism comprises a suture access soft sheath tube, a suture route guide body, and a suture action body.

[0034] The suture route guide body and the suture action body are slidably connected in the lumen of the suture access soft sheath tube.

[0035] The suture route guide body is provided with a push rod having an axial pushing drive, an axial pulling drive, and a radial rotating drive.

[0036] The suture action body is composed of a foramen ovale suture needle, a suture line, and a rotating shaft.

[0037] The helical section of the foramen ovale suture needle is helically accommodated in the helical channel formed between the helical slot of the support body and the inner wall of the access soft sheath tube, and the helical channel provides a guide channel for the helical advancement or helical withdrawal of the foramen ovale suture needle.

[0038] The oval foramen suture needle tube cavity is provided with a spiral channel, and a suture line is arranged in the spiral channel; the front end of the suture line is provided with a T-shaped blocking rod; the T-shaped blocking rod is initially arranged in the inner cavity of the needle head end of the oval foramen suture needle tube;

[0039] The suture action body is provided with an action body driving controller connected with the rotating shaft and provided with axial propulsion driving and radial rotation driving;

[0040] The end of the suture line is arranged on the action body driving controller, and the suture line is provided with a length releaser on the action body driving controller;

[0041] The action body driving controller is provided with a hydraulic propulsion pipe, the front end of the hydraulic propulsion pipe is in communication with the end of the cavity of the oval foramen suture needle tube, and the end of the hydraulic propulsion pipe is provided with a hydraulic propulsion device on the action body driving controller;

[0042] The spiral channel of the cavity of the oval foramen suture needle tube and the pipe cavity of the hydraulic propulsion pipe are filled with a lubricating propulsion medium liquid;

[0043] The guide body driving controller and the action body driving controller are arranged on the extracorporeal end operation handle;

[0044] In the suture needle insertion state: the guide body driving controller drives the push rod to advance, the support body is driven by the push rod to advance in the axial direction, the oval foramen interposition plate is advanced, the action body driving controller drives the rotating shaft to rotate in the positive direction, the suture line and the oval foramen suture needle tube are synchronously spirally advanced to the root of the oval foramen interposition plate, the needle head of the oval foramen suture needle touches the primary septum or the secondary septum, the oval foramen suture needle continues to rotate and advance, in each spiral stroke, the needle head of the oval foramen suture needle penetrates the primary septum and the secondary septum on the two sides of the oval foramen interposition plate respectively, the oval foramen suture needle advances at least one spiral stroke, the primary septum and the secondary septum are continuously penetrated to establish a penetration channel, and the spiral stroke reaches the end stop point; the hydraulic propulsion device pushes the lubricating propulsion medium liquid and drives the T-shaped blocking rod to be discharged from the needle opening of the needle head of the oval foramen suture needle, the T-shaped blocking rod is released, and then the needle is withdrawn;

[0045] In the suture needle withdrawal state: the oval foramen suture needle is driven to rotate in the reverse direction, the blocking rod is blocked on one side of the oval foramen, the oval foramen suture needle is withdrawn, and the suture line is left on the primary septum and the secondary septum of the oval foramen;

[0046] The suture mechanism is withdrawn in the right atrial access channel pipe sheath;

[0047] The suture line exposed at the oval foramen of the right atrium is pulled tight in the blocking state that the T-shaped blocking rod adheres to the atrial septum, the T-shaped blocking rod is knotted, and the one-time spiral multi-point suture of the primary septum and the secondary septum is completed.

[0048] Compared with the prior art, the present application has the following beneficial effects:

[0049] The patent foramen ovale suture needle and its suture system of the present invention is a patent foramen ovale cryo-absorption spiral suture system. It uses a patent foramen ovale intervention plate to be inserted between the primary and secondary septa in the foramen ovale, and instantly freezes the primary and secondary septa on both sides of the foramen ovale to achieve the effect of cryo-absorption, which facilitates the spiral needle rotation suturing the primary and secondary septa of the foramen ovale.

[0050] The oval foramen suture system of the present invention is reasonably designed, simple in structure, safe and reliable, easy to use and easy to maintain, and has great value for promotion and use. Attached Figure Description

[0051] Appendix Figure 1 This is a schematic diagram of the spiral needle of the present invention;

[0052] Appendix Figure 2 This is a schematic diagram of the structure of the support body of the present invention;

[0053] Appendix Figure 3 This is a schematic diagram of the structure of the spiral needle and the support body of the present invention.

[0054] Appendix Figure 4 This is a schematic diagram of the primary and secondary septa at the foramen ovale;

[0055] Appendix Figure 5 This is a schematic diagram of the structure of the foramen ovale intervention plate of the present invention inserted between the primary and secondary septa within the foramen ovale;

[0056] Appendix Figure 6 This is a structural schematic diagram of the suturing process of the present invention;

[0057] Appendix Figure 7 This is a schematic diagram of the suture termination point of the present invention;

[0058] Appendix Figure 8 This is a front view structural diagram of the support body of the present invention;

[0059] Appendix Figure 9 This is a cross-sectional view of the support body of the present invention;

[0060] Appendix Figure 10 This is a side cross-sectional view of the support structure of the present invention;

[0061] Appendix Figure 11 This is a schematic diagram of the structure in the initial suturing state of the present invention;

[0062] Appendix Figure 12 This is a schematic diagram of the structure of the spiral needle protruding from the T-shaped blocking rod of the present invention;

[0063] Appendix Figure 13 This is a schematic diagram illustrating the suturing state of the present invention;

[0064] AppendixFigure 14 is the driving schematic diagram of the suturing state of the present application;

[0065] attached Figure 15 is the schematic diagram of the suturing starting state structure of the short pitch support body of the present application;

[0066] attached Figure 16 is the schematic diagram of the suturing end point state structure of the short pitch support body of the present application;

[0067] attached Figure 17 is the schematic diagram of the spiral suturing of the primary septum and the secondary septum of the foramen ovale of the present application;

[0068] attached Figure 18 is the schematic diagram of the spiral suturing of the primary septum and the secondary septum of the foramen ovale of the present application;

[0069] attached Figure 19 is the schematic diagram of the spiral needle of the present application using the guide wire to send in, the catcher to capture the guide wire, so as to pull the suture into the spiral needle, so as to form the double-stranded suture, which is convenient for the suture to form the knot closed loop after the spiral needle is withdrawn;

[0070] attached Figure 20 is the schematic diagram of the structure of the foramen ovale suturing needle, which is preferably a variable-diameter variable-angle spiral stainless steel needle;

[0071] attached Figure 21 is the schematic diagram of the operation of the variable-diameter spiral stainless steel foramen ovale suturing needle using the guide wire to pull and the catcher to capture the guide wire, so as to pull the suture along the spiral suturing cavity, and the suture forms a knot closed loop after the suturing needle is withdrawn;

[0072] attached Figure 22 is attached Figure 21 is the state diagram after the suturing needle is withdrawn;

[0073] attached Figure 23 is from the state of attached Figure 21 to the state of attached Figure 22 to the state of attached Figure 23 to the final schematic diagram of the suture forming a knot closed loop.

[0074] The marks in the attached drawings respectively represent:

[0075] 1, foramen ovale suturing needle, 2, wedge surface, 3, needle head,

[0076] 4, suture,

[0077] 5, blocking rod, 6, reduced diameter end, 7, expanded diameter end,

[0078] 8, suture route guide body,

[0079] 9, foramen ovale interventional plate, 10, support body, 11, push rod,

[0080] 12. helical slot,

[0081] 13. gap,

[0082] 14. helical track,

[0083] 15. tight storage section,

[0084] 16. cryogenic medium cavity, 17. liquid nitrogen channel, 18. push rod liquid nitrogen inlet and outlet passage, 19. cryogenic transmission inlet and outlet tube, 20. cryoablation instrument,

[0085] 21. right atrial access channel sheath, 22. suturing mechanism,

[0086] 23. suturing access soft sheath tube, 24. suturing action body,

[0087] 25. primary septum, 26. secondary septum. DETAILED DESCRIPTION

[0088] The oval foramen suturing needle and its oval foramen suturing system will be described in detail below in combination with the accompanying drawings.

[0089] As shown in the drawings, the oval foramen suturing needle and its oval foramen suturing system, wherein,

[0090] The oval foramen suturing needle is characterized in that the oval foramen suturing needle adopts a helical tubular body spiral needle with a helical line running of a natural number N of helical pitches, the top end is a sharp wedge surface to form a needle head, the helical tubular body is continuously through the tubular cavity from the needle head to the last end, and the front and rear ends are open, and the cylindrical helical line is a single helix.

[0091] The oval foramen suturing needle adopts a stainless steel needle, and the main body shape is a helical needle with gradually changing helical pitches and / or gradually changing diameters.

[0092] The oval foramen suturing needle preferably adopts a stainless steel needle, and the main body section has a gradually changing thread angle, and can also be accompanied by a gradually changing diameter.

[0093] The oval foramen suturing needle or adopts a shape memory alloy helical needle, and the main body section has a gradually changing thread angle, and can also be accompanied by a gradually changing diameter.

[0094] The helical tubular cavity of the oval foramen suturing needle is arranged with a continuous suture line, and the suture line can freely slide between the helical tubular cavity and the inner wall of the cavity; the length of the suture line is greater than the helical length of the oval foramen suturing needle, and the end of the suture line extends to the outside of the end of the oval foramen suturing needle.

[0095] The front end of the suture line is fixed with a blocking rod connected to the end of the suture line, and the connection point is located at the middle section of the length of the blocking rod, and the blocking rod and the front section of the suture line form a T-shaped structure in a pulling state;

[0096] The blocking rod near the connecting point is provided with a section of reduced diameter, and the reduced end of the blocking rod can be embedded into the lumen of the needle; the blocking rod has an enlarged end which blocks the wedge surface at the front end of the needle, preventing the blocking rod from sliding into the lumen of the oval hole suture needle.

[0097] The oval hole suture needle is also provided with a suture route guide body which is connected in cooperation with the inner periphery of the oval hole suture needle;

[0098] The suture route guide body is composed of an oval hole intervention plate at the front end, a support body at the middle section, and a push rod at the tail section;

[0099] The support body is a cylindrical support body, and a continuous spiral groove is formed on the outer wall surface of the cylindrical support body, and the central axis of the spiral groove is the same as the central axis of the support body;

[0100] The oval hole intervention plate is fixedly connected to the end surface of the cylindrical front end of the support body;

[0101] The tail end of the support body is fixedly connected to the push rod;

[0102] The oval hole intervention plate, the support body, and the push rod are coaxially arranged;

[0103] The oval hole suture needle penetrates the outer wall surface of the support body along the spiral groove of the support body in a spiral manner.

[0104] The oval hole intervention plate is provided with an opening on the edge of each side in the length direction of the longitudinal axis, and the two openings are arranged on the same spiral line track;

[0105] The spiral line track of the two openings is continuous with the spiral line track of the spiral groove of the support body and is the same spiral line track;

[0106] The spiral arrangement of the openings of the oval hole intervention plate and the spiral groove of the support body together form the spiral in-out spiral track of the oval hole suture needle.

[0107] The pitch of the spiral groove of the outer wall of the support body is less than or equal to the pitch of the oval hole suture needle, which forms a close accommodation section of the support body to the oval hole suture needle, facilitating the close accommodation of the oval hole suture needle on the support body in a short span distance;

[0108] The oval hole suture needle is used to rotate in and continue to rotate out, and then release to recover to the enlarged pitch and / or the oval hole suture needle in the enlarged diameter state;

[0109] The shape memory alloy spiral needle in the enlarged pitch and / or enlarged diameter state is beneficial to suture the primary and secondary septums of the oval hole after rotating out of the support body.

[0110] The oval foramen intervention plate is internally provided with a frozen medium cavity, the support is internally provided with two-way frozen channels for supporting liquid nitrogen in and out of the liquid nitrogen cavity, and the push rod is internally provided with a push rod liquid nitrogen in and out passage;

[0111] The push rod liquid nitrogen in and out passage is connected with the two-way frozen channels for supporting liquid nitrogen in and out.

[0112] The push rod liquid nitrogen in and out passage is connected with the two-way frozen transmission in and out pipes to the external terminal operating handle outside the body, and the two-way frozen transmission in and out pipes are provided with a frozen ablation instrument on the terminal operating handle outside the body.

[0113] The oval foramen suture needle is applied to the oval foramen non-closure surgical instrument.

[0114] The oval foramen suture system comprises a right atrium access channel pipe sheath and a suture mechanism comprising the oval foramen suture needle.

[0115] The suture mechanism comprises a suture access soft sheath pipe, a suture route guide body and a suture action body.

[0116] The suture route guide body and the suture action body are slidably connected in the lumen of the suture access soft sheath pipe.

[0117] The suture route guide body is provided with a guide body drive controller connected with the push rod and having axial push drive, axial pull drive and radial rotation drive.

[0118] The suture action body is composed of the oval foramen suture needle, a suture line and a rotating shaft.

[0119] The spiral section of the oval foramen suture needle is screwed into the spiral channel formed between the spiral groove of the support and the inner pipe wall of the access soft sheath pipe, and the spiral channel provides a guide channel for the spiral advancing or spiral retreating of the oval foramen suture needle.

[0120] A suture line is threaded into the lumen of the oval foramen suture needle along the spiral channel of the lumen, and the front end of the suture line is provided with a T-shaped blocking rod, which is initially located in the inner cavity of the needle head end of the oval foramen suture needle.

[0121] The suture action body is provided with an action body drive controller connected with the rotating shaft and having axial push drive and radial rotation drive.

[0122] The end of the suture line is arranged on the action body drive controller, and the suture line is provided with a length releaser on the action body drive controller.

[0123] The action body drive controller is provided with a hydraulic push pipe, the front end of the hydraulic push pipe is communicated with the end of the lumen of the oval foramen suture needle, and the end of the hydraulic push pipe is provided with a hydraulic pusher on the action body drive controller.

[0124] The spiral channel in the lumen of the foramen ovale suture needle tube and the lumen of the hydraulic propelling tube are filled with lubricating propelling medium liquid;

[0125] The guide body driving controller and the action body driving controller are arranged on the extracorporeal end operation handle;

[0126] In the suture needle insertion state: the guide body driving controller pushes the push rod forward, the support body is pushed forward by the push rod, the foramen ovale interventional plate is pushed forward, the action body driving controller drives the rotation shaft to rotate forward, the suture line and the foramen ovale suture needle tube are synchronously spirally advanced to the root of the foramen ovale interventional plate, the foramen ovale suture needle head touches the primary septum or the secondary septum, the foramen ovale suture needle continues to rotate, in each spiral stroke, the foramen ovale suture needle head penetrates the primary septum and the secondary septum on both sides of the foramen ovale interventional plate respectively, the foramen ovale suture needle advances at least two to four spiral strokes, the primary septum and the secondary septum are continuously penetrated to establish a penetration channel, the spiral stroke reaches the end point, the hydraulic propeller pushes the lubricating propelling medium liquid and the T-shaped blocking rod out of the needle port of the foramen ovale suture needle head, the T-shaped blocking rod is released, and then the needle is withdrawn;

[0127] In the suture needle withdrawal state: the action body driving controller drives the rotation shaft to reverse, the foramen ovale suture needle reverses and continuously exits the primary septum and the secondary septum for multiple times, while the needle is withdrawn, the hydraulic propeller of the action body driving controller continuously pressurizes and propels the lubricating propelling medium liquid through the lumen of the hydraulic propelling tube, the lumen of the foramen ovale suture needle tube and the needle port at the front end of the foramen ovale suture needle, so that the lubricating propelling medium liquid drives the suture line to stay on the penetration channel of the primary septum and the secondary septum by hydraulic impact; when the needle head of the foramen ovale suture needle completely exits the primary septum and the secondary septum and is withdrawn into the support body, the needle withdrawal is completed;

[0128] The suture mechanism is withdrawn in the right atrial access channel tube sheath;

[0129] The suture line exposed at the foramen ovale in the right atrium is tightened in the blocking state that the T-shaped blocking rod adheres to the atrial septum, the T-shaped blocking rod is knotted, and the one-time spiral multi-point suture of the primary septum and the secondary septum is completed.

[0130] The right atrial access channel tube sheath is a common ordinary delivery sheath tube composed of an outer sheath and a dilating sheath, and the dilating sheath has an axial through hole.

[0131] The end of the suture line is provided with a suture tightener.

[0132] The spiral needle body of the foramen ovale suture needle, hereinafter referred to as "spiral needle".

[0133] In specific implementation, the diameter of the spiral needle can be appropriately compressed before being pushed out of the sheath tube, and the diameter of the spiral needle is restored after being pushed out of the sheath tube, so that the diameter of the needle head part becomes larger, and it is easier to spirally advance to penetrate and suture the primary septum and the secondary septum of the foramen ovale of the atrial septum.

[0134] In fact, when the helical needle is in the sheath, the helical needle of shape memory alloy will be stretched and the helical diameter will be reduced. After the helical needle is pulled out of the sheath, the lift of the helical needle of shape memory alloy is restored and the diameter is also restored to be large. The aperture arrangement of the oval foramen interposition plate can be matched with the corresponding lift. The helical needle for variable lift is used.

[0135] The helical needle can adopt: variable lift helix, variable diameter helix, and other irregular but orderly special-shaped helical needles which are beneficial to oval foramen puncture.

[0136] The diameter of the needle part: can be set as a thick diameter section and a thin diameter section in the rear. In addition to facilitating puncture, the blocking rod can also be accommodated.

[0137] Because the primary septum is thin, the puncture needle can generally penetrate, while the secondary septum is thick, the puncture needle generally does not penetrate. That is, on the left atrial surface, the suture line can generally be seen, while on the right atrial surface, the suture line cannot be seen.

[0138] Regarding the primary septum and the secondary septum of the oval foramen, through the intervention of the oval foramen interposition plate, appropriate low-temperature cryoablation is performed before suturing, and the temperature is about -50℃ to -80℃, which can realize cryosuction.

[0139] Example two:

[0140] The helical needle is inserted into the guide wire in the lumen. (without inserting the suture line).

[0141] After the helical needle puncture is completed, a thin guide wire with a suture line at the tail end is sent along the helical needle inner hole channel, and then a catcher (loop shape) is used to catch and pull out the thin guide wire out of the body, so that the suture line can form a closed loop, and the double-stranded line is knotted and cut. Suturing operation can also be completed.

[0142] In addition,

[0143] The helical needle is preferably hollow, and can also be solid.

[0144] The last segment of the helical needle is a straight rod or a connected plastic tube, in order to pass the suture line. The helical needle is welded on the synchronous spring (anti-torsion spring), and the proximal end of the synchronous spring can be used to control the suturing and withdrawal of the helical needle.

[0145] The head end of the suture line is fixed with a short blocking rod, and the initial short rod is implanted in the needle hole of the helical needle. After suturing, the blocking rod is pushed out of the needle hole through the guide wire or high-pressure water. When the helical needle is rotated, the suture line is blocked by the blocking rod and remains in the helical puncture track.

Claims

1. An oval-shaped hole suture needle, characterized in that... The oval foramen suture needle is a spiral tubular needle with a spiral line of natural number N pitches. Its tip is a sharp wedge-shaped needle head. The spiral tubular body is continuously connected from the needle head to the tubular cavity at the end, and both ends are open. The cylindrical spiral line is a single spiral.

2. The oval foramen suture needle according to claim 1, characterized in that: The oval hole suture needle is made of stainless steel and its main body shape is a spiral needle with a gradually changing pitch and / or a gradually changing diameter.

3. The oval foramen suture needle according to claim 2, characterized in that: The foramen ovale suture needle has a continuous suture arranged inside its spiral tubular cavity. The suture can slide freely between the spiral tubular cavity and the inner wall of the cavity. The length of the suture is greater than the spiral length of the foramen ovale suture needle, and the end of the suture extends outward from the end of the foramen ovale suture needle.

4. The oval foramen suture needle according to claim 3, characterized in that: A stop bar is fixed to the front end of the suture and connected to the end of the suture. The connection point is located in the middle of the length of the stop bar. The stop bar and the front end of the suture form a T-shape when pulled together. The stop bar near the connection point has a reduced diameter section, and the reduced diameter end of the stop bar can be embedded into the inner cavity of the needle; the expanded diameter end of the stop bar blocks the wedge surface at the front end of the needle, preventing the stop bar from sliding into the inner cavity of the oval hole suture needle.

5. The oval foramen suture needle according to claim 4, characterized in that: The foramen ovale suture needle is also equipped with a suture path guide that is connected to its inner circumference; The suture route guide is composed of an oval foramen intervention plate at the front end, a support body in the middle section, and a push rod at the tail end, all integrated into one unit. The support is a cylindrical support with a continuous spiral groove on its outer wall surface. The central axis of the spiral groove is the same as the central axis of the support. The orifice oval intervention plate is vertically fixed to the end face of the front end of the support cylinder; A push rod is fixedly connected to the end of the support body; The foramen ovale intervention plate, support body, and push rod are coaxially arranged; The oval foramen suture needle is inserted into the outer wall surface of the support body in a helical direction along the direction of the helical groove of the support body.

6. The oval foramen suture needle according to claim 5, characterized in that: The oval orifice intervention plate has notches on both sides of its longitudinal axis, and the notches on both sides are arranged on the same spiral trajectory. The spiral trajectory of the two notches is continuous with the spiral trajectory of the spiral groove of the support body and is the same spiral trajectory. The spiral arrangement of the notches on the foramen ovale intervention plate and the spiral grooves of the support together form the spiral track for the foramen ovale suture needle to advance and retract.

7. The oval foramen suture needle according to claim 5, characterized in that: The pitch of the spiral groove on the outer wall of the support is less than or equal to the pitch of the foramen ovale suture needle, forming a tight-fitting section of the support for the foramen ovale suture needle, which facilitates the tight-fitting of the foramen ovale suture needle over a short span on the support. The oval foramen suture needle used is screwed in tightly and then released after being screwed out, restoring the oval foramen suture needle to its restored state with an enlarged pitch and / or an enlarged diameter. Shape memory alloy spiral needles with increased pitch and / or increased diameter facilitate suturing of the primary and secondary septa of the oval aperture after unscrewing the support.

8. The oval foramen suture needle according to claim 5, characterized in that: The foramen ovale intervention plate has a cryo-medium chamber, the support body has two cryo-medium channels connecting to the liquid nitrogen chamber, and the push rod has a push rod liquid nitrogen inlet and outlet passage. The push rod connects the liquid nitrogen inlet and outlet passages of the support body to the two freezing channels for liquid nitrogen inlet and outlet. The liquid nitrogen inlet and outlet passage of the push rod is connected to the external external terminal operating handle through two cryotransfer inlet and outlet tubes. The cryoablation device is connected to the external terminal operating handle through the two cryotransfer inlet and outlet tubes.

9. The use of the foramen ovale suture needle as described in any one of claims 1 to 8 in surgical instruments for patent foramen ovale.

10. An oval foramen suture system, characterized in that... It includes a right atrial access channel sheath and a suturing mechanism having a foramen ovale suture needle as described in any one of claims 1 to 8; The suturing mechanism includes a suturing inlet soft sheath, a suturing route guide, and a suturing action body; The suture approach soft sheath has a suture route guide and a suture action body that slide through the lumen of the sheath; The stitching route guide is equipped with a guide drive controller that connects to the push rod and has axial push drive, axial pull drive, and radial rotation drive. The suturing mechanism consists of an oval-shaped suture needle, suture thread, and a rotating shaft. The spiral section of the foramen ovale suture needle is screwed into the spiral channel formed between the spiral groove of the support and the inner wall of the soft sheath. The spiral channel provides a guide for the foramen ovale suture needle to spiral forward or spiral backward. A suture is threaded along the spiral channel of the foramen ovale suture needle. A T-shaped stop bar is provided at the front end of the suture. The initial position of the T-shaped stop bar is located in the inner cavity of the needle tip of the foramen ovale suture needle. The suture action body is equipped with an action body drive controller that is connected to a rotating shaft and has axial propulsion drive and radial rotation drive; The end of the suture is mounted on the motion body drive controller, and the suture is equipped with a length release device on the motion body drive controller; The motion drive controller is equipped with a hydraulic propulsion tube. The front end of the hydraulic propulsion tube is connected to the end of the lumen of the foramen ovale suture needle. The end of the hydraulic propulsion tube is equipped with a hydraulic thruster on the motion drive controller. The spiral channel of the foramen ovale suture needle and the lumen of the hydraulic propulsion tube are filled with lubricating propulsion medium. The guide body drive controller and the actuator drive controller are configured on the external end-effector handle; In the suture insertion state: the guide body drive controller pushes the push rod forward, which in turn pushes the support body forward axially; advancing the foramen ovale intervention plate; the action body drive controller drives the rotating shaft to rotate clockwise, and the suture and the foramen ovale suture needle tube spirally advance to the root of the foramen ovale intervention plate. The foramen ovale suture needle tip touches the primary or secondary septum, and the foramen ovale suture needle continues to spiral forward. In each spiral stroke, the foramen ovale suture needle tip punctures the primary and secondary septums on both sides of the foramen ovale intervention plate respectively; the foramen ovale suture needle travels at least one spiral stroke, continuously puncturing the primary and secondary septums to establish a puncture channel; when the spiral stroke reaches the end point, the hydraulic propeller propels the lubricating medium and pushes the T-shaped blocking rod out from the needle tip of the foramen ovale suture needle, releasing the T-shaped blocking rod, and then withdrawing the needle; In the suture retraction state: drive the foramen ovale suture needle to reverse, the blocking rod is blocked on one side of the foramen ovale, the foramen ovale suture needle retracts, and the suture is placed on the primary septum and secondary septum of the foramen ovale; Retreating suture mechanism within the sheath of the right atrial access route; For sutures exposed at the foramen ovale in the right atrium, the sutures are tightened under the obstruction of the interatrial septum by a T-shaped stop bar, the T-shaped stop bar is tied, and a one-time spiral multi-point suture is completed for the primary and secondary septa.

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