Delivery system of valve repair deviceTechnical Field
The invention relates to the technical field of medical equipment, in particular to a delivery system of a valve repair device.
Background
Mitral annuloplasty is an important surgical approach to the surgical treatment of mitral insufficiency, and among functional mitral insufficiency patients, mitral valve relative insufficiency due to left ventricular enlargement, such patients often do not incorporate mitral valve lesions, mitral annuloplasty being its predominant surgical approach. The operation type mainly reduces the mitral valve annular orifice through implanting an annular object, achieves the aim of treating mitral insufficiency, and reduces mitral regurgitation. The transcatheter mitral valve angioplasty adopts a similar principle, but has the advantages of small trauma, no need of extracorporeal circulation, less postoperative complications, quick postoperative recovery and the like compared with the surgical operation, but has the disadvantages of higher occurrence rate of adverse events such as myocardial infarction, coronary sinus rupture and the like.
Because the mitral valve of the human body is not round, but D-shaped, and the physiological structures of all people are different, the shape of the shaping ring and the angle and the position of the shaping ring during implantation need to be adjusted in the process of the transapical operation, so that the shaping ring can be ensured to be attached to the self-leaflet. In the prior art, the delivery system used in mitral valve angioplasty cannot be accurately controlled when being implanted, however, because of disturbance caused by heart pulsation, the forming ring can finally form a preset half moon shape, and whether the anchoring piece is implanted in place or not has certain defects, so that when the stay wire is pulled finally to shrink, the problems of uneven stress and overlarge stress of one or a plurality of anchoring pieces and tearing of the self valve leaflet occur.
Disclosure of Invention
Accordingly, the technical problem underlying the present invention is to provide a delivery system for a valve repair device, which is not adjustable during implantation of a shaped ring.
In order to solve the technical problems, the technical scheme of the invention is as follows:
A delivery system for a valve repair device, comprising:
The pushing assembly comprises a primary handle, a secondary handle and a tertiary handle which are sequentially arranged from a proximal end to a distal end, wherein the secondary handle can rotate relative to the primary handle, and the tertiary handle can slide back and forth relative to the secondary handle;
the distal end of the multi-cavity tube fixing seat is connected with a multi-cavity tube, and the stay wire mechanism is connected with a plurality of shaping guide stay wires which penetrate through the inner cavity of the multi-cavity tube and are connected to the valve repair device;
the pushing mechanism comprises a pushing piece arranged in the primary handle and a pushing rod pushing button which is connected with the pushing piece and is connected with the pushing piece in a sliding way in the pushing button travel groove, wherein a pushing tube for conveying a valve repairing device is fixed at the distal end of the pushing piece, and the pushing tube penetrates through the multi-cavity tube fixing seat to extend towards the distal end;
The thread cutting mechanism is used for cutting off the shaping guide stay wire at the far end of the stay wire mechanism;
The wire pulling mechanism is connected with a plurality of traction wires penetrating through the pushing tube, and the traction wires are connected with stop pins penetrating through the delivery valve repairing device;
and the outer sheath tube is positioned on the periphery of the multi-cavity tube and is fixed at the distal end of the tertiary handle.
Further, a rotating groove is formed in the inner wall of the far end of the primary handle, a rotating boss corresponding to the rotating groove is arranged on the outer side wall of the near end of the secondary handle, the rotating boss can rotate on the rotating groove, a limiting block is arranged on the inner wall of the far end of the secondary handle, a travel groove corresponding to the limiting block is formed in the inner wall of the near end of the tertiary handle, and the limiting block can slide on the travel groove.
Further, a main cavity and an auxiliary cavity are arranged in the outer sheath tube, the multi-cavity tube is located in the main cavity, a round cavity is arranged in the center of the multi-cavity tube, a plurality of branch cavities are arranged in the circumferential direction of the round cavity, the pushing tube is a single cavity and located in the round cavity, and each branch cavity is provided for one shaping guide stay wire to pass through.
Further, an outer sheath fixing seat for installing the outer sheath tube is arranged at the far end of the tertiary handle, an inner tube supporting seat for supporting the multi-cavity tube is arranged at the near end of the secondary handle, and the multi-cavity tube and the pushing tube extend to the near end through the inner tube supporting seat.
Further, the secondary handle proximal end is provided with the connecting block, be provided with anti-rotation boss and eccentric hole on the connecting block, be provided with the holding on the secondary handle proximal end inner wall the storage tank of connecting block, the edge of storage tank be equipped with anti-rotation boss corresponds complex spread groove.
Further, the proximal end face of the multi-cavity tube fixing seat is connected with a multi-cavity tube blood sealing tablet, and a multi-cavity tube blood sealing pad is further arranged between the multi-cavity tube fixing seat and the multi-cavity tube blood sealing tablet.
The secondary handle is provided with a rivet implantation branch end, a rivet fixing seat is arranged at the proximal end of the rivet implantation branch end, a rivet guide tube is arranged in the secondary handle, one end of the rivet guide tube penetrates through the inner tube supporting seat and is connected to the outer sheath fixing seat to be communicated with the auxiliary cavity, and the other end of the rivet guide tube is connected to the rivet fixing seat.
Further, a pin hole is formed in the joint of the secondary handle and the tertiary handle, and a positioning pin for locking the secondary handle and the tertiary handle is arranged on the pin hole.
Further, an angle mark is arranged on the outer wall of the far end of the primary handle, and an indication arrow for indicating the angle mark is arranged on the outer wall of the near end of the secondary handle.
Further, the wire pulling mechanism includes:
The wire pulling sleeve is arranged in the inner cavity of the primary handle and comprises a first circle center through hole which is arranged in the center and is communicated with the first circle center through hole and a plurality of first circumference through holes which are circumferentially distributed around the first circle center through hole, and a first wire channel for shaping and guiding a wire to enter the first circle center through hole is arranged between the first circle center through hole and any one of the first circumference through holes;
The stay wire guide block is arranged in the first circle center through hole and positioned at the far end of the stay wire sleeve, a plurality of stay wire outlet holes for shaping, guiding and stay wires to pass through are formed in the stay wire guide block, and the positions of the stay wire outlet holes and the positions of the first circumference through holes are in one-to-one correspondence.
Further, through stay wire travel grooves are formed in the side walls of the first circumferential through holes, and the stay wire mechanism further comprises:
The first rebound screw rod is coaxially arranged in the first circumference through hole, one end of the first rebound screw rod, which is close to the stay wire guide block, is connected with a stay wire turntable for shaping, guiding and winding a stay wire, and the other end of the first rebound screw rod is provided with a first rebound cap positioned at the proximal end of the stay wire sleeve;
the first screw travel nut is sleeved on the periphery of the first rebound screw rod in a threaded manner and is slidably mounted on the stay wire travel groove; a first guide extension block which protrudes outwards and is in sliding fit with the stay wire travel groove is arranged on the first screw rod travel nut;
The elastic force of the first compression spring drives the first screw stroke nut to move towards the far end of the first rebound screw so as to drive the first rebound screw to rotate in the first circumference through hole, and the stay wire turntable rotates along with the rotation of the first rebound screw so as to enable a shaping guide stay wire wound on the stay wire turntable to keep a tensioning state.
Further, on the cross section perpendicular to the axial direction of the guy sleeve, a connecting line between the circle center of the first circle center through hole and the circle center of the first circle center through hole passes through the circle center of the guy wire outlet hole.
Further, a plurality of shaping guide wire outlet holes are formed in the outer wall of the primary handle, a first locking wire pulling block is arranged on the shaping guide wire outlet holes, one end of the shaping guide wire is connected to the first locking wire pulling block, and the other end of the shaping guide wire is connected to the wire pulling rotary table.
Further, the wire pulling mechanism includes:
The wire pulling sleeve is arranged in the inner cavity of the primary handle and comprises a second circle center through hole which is arranged in the center and is communicated with the inner cavity of the primary handle and a plurality of second circumference through holes which are circumferentially distributed around the second circle center through hole;
The tail end wire dividing piece is arranged on the second circle center through hole, one end of the tail end wire dividing piece penetrates out of the second circle center through hole from the proximal end of the wire pulling sleeve, and a plurality of traction wire outlet holes for a traction wire to penetrate through are formed in the tail end wire dividing piece;
The wire pulling locking sleeve is arranged on the second circumferential through hole, one end of the wire pulling locking sleeve penetrates out of the second circumferential through hole from the proximal end of the wire pulling sleeve, a second wire channel for the traction wire in the wire pulling locking sleeve to extend outwards is arranged on the outer wall of the wire pulling locking sleeve, and the positions of the second wire channels and the traction wire outlet holes are arranged in a one-to-one correspondence mode.
Further, a through traction wire travel groove is formed in the side wall of the wire pulling locking sleeve;
the second rebound screw rod is coaxially arranged in the inner cavity of the wire pulling locking sleeve, one end of the second rebound screw rod, which is close to the wire pulling sleeve, is connected with a traction wire rotary table for winding a traction wire, and the other end of the second rebound screw rod is provided with a second rebound cap positioned at the far end of the wire pulling locking sleeve;
the second screw rod travel nut is sleeved on the periphery of the second rebound screw rod and is slidably mounted in the traction wire travel groove;
The second compression spring is sleeved on the second rebound screw rod and is positioned between the second screw rod travel nut and the second rebound cap, the elastic force of the second compression spring drives the second screw rod travel nut to move towards the distal end of the second rebound screw rod so as to drive the second rebound screw rod to rotate in the inner cavity of the wire pulling locking sleeve, and the traction wire turntable rotates along with the rotation of the second rebound screw rod so as to enable a traction wire wound on the traction wire turntable to keep a tensioning state.
Further, a second central hole for the push pipe to pass through is further formed in the middle of the tail end wire dividing piece, and the plurality of traction wire outlet holes are circumferentially and uniformly arranged on the periphery of the second central hole.
Further, the tail end wire dividing piece is fixed on the outer wall surface of the far end of the wire drawing sleeve, and the wire outlet hole of the traction wire is inclined outwards from the far end of the tail end wire dividing piece to the near end.
Further, the wire pulling locking sleeve is slidably mounted in the second circumferential through hole along the axial direction of the second circumferential through hole, and a locking button for locking the wire pulling locking sleeve on the second circumferential through hole is arranged on the wire pulling sleeve.
Further, a plurality of traction wire outlet holes are formed in the outer wall of the primary handle, a second locking wire pulling block is arranged on the traction wire outlet holes, one end of the traction wire is connected with the second locking wire pulling block, and the other end of the traction wire is connected with the traction wire rotating disc.
Further, the thread cutting mechanism includes:
A reinforcing pipe, wherein a plurality of wire passing holes extending along the axial direction of the reinforcing pipe are formed in the reinforcing pipe, and the wire passing holes are arranged along the circumferential direction of the reinforcing pipe; the middle of the reinforcing pipe is also provided with a central hole of the reinforcing pipe for the pushing pipe to pass through, and the plurality of wire passing holes are circumferentially and uniformly arranged on the periphery of the central hole of the reinforcing pipe;
The blade fixing disc is fixed on the primary handle and sleeved on the periphery of the reinforcing pipe, and a plurality of linear guide grooves are formed in one side edge of the blade fixing disc;
The blade turntable is sleeved on the periphery of the reinforcing pipe in a rotating way along the axial direction of the reinforcing pipe and is opposite to the blade fixing plate, and one side wall of the blade turntable, which faces the blade fixing plate, is provided with a plurality of arc-shaped guide grooves;
The cutting blades are positioned between the blade fixing disc and the blade rotating disc and positioned on the same plane with the dew wire groove, and are connected with blade guide rods;
And in the process of rotating the blade turntable, the blade guide rods of the plurality of cutting blades are driven to slide in the linear guide grooves and the arc-shaped guide grooves simultaneously, so that the cutting blades are close to or far away from the dew-point grooves on the reinforcing pipes.
Further, one end of the cutting blade, which is close to the reinforcing pipe, is provided with a blade cutting edge, the blade cutting edge is arc-shaped, and a plurality of arcs where the blade cutting edge is positioned are concentric with the dew slot.
Further, the cutting blade is provided with a first arc-shaped side face positioned on one side of the blade edge and a second arc-shaped side face positioned on the other side of the blade edge, when a plurality of cutting blades extend into the line exposing groove, the first arc-shaped side face of the cutting blade is matched with the second arc-shaped side face of one adjacent cutting blade, the first arc-shaped side face of the cutting blade is matched with the second arc-shaped side face of the other adjacent cutting blade, and the cutting blades are in a propeller shape.
Further, the outer wall of the primary handle is provided with a cut-off button travel groove, and the outer side wall of the blade turntable is connected with a cut-off button extending out of the cut-off button travel groove.
The rivet guiding tube is connected with a rivet implanting device, the rivet implanting device comprises a rivet integral handle, a rivet pushing handle, a medical rivet and a rivet connecting tube connected to the release of the medical rivet, and the rivet connecting tube extends into the rivet guiding tube.
Further, the medical rivet has a shape memory function, comprising:
A piercing tip located at a distal end of the medical rivet;
a rivet barb positioned at one end of the side wall of the medical rivet close to the puncture tip;
The rivet clearance groove is positioned on the outer side wall of the medical rivet and is arranged corresponding to the position of the rivet barb;
the release rod is positioned at the proximal end of the medical rivet and is used for being connected with a rivet connecting pipe;
the reverse elastic block is arranged at one end of the medical rivet close to the release pin;
the reverse spring block is provided with a reverse spring block initial state which is outwards bent and unfolded in a natural state and is arranged far away from the end part of the medical rivet towards the far end, and a reverse spring block loading state which is reversely bent towards the near end under the action of external force.
Further, the reverse elastic block and the medical rivet are integrally formed, or the reverse elastic block is at least two elastic sheets welded on the outer side of the medical rivet or is an arch elastic sheet penetrating through the middle of the medical rivet and welded and fixed on the medical rivet.
Further, the outer side of the medical rivet is coaxially sleeved with a rivet pressing sheet, the rivet pressing sheet is cylindrical, and a plurality of outwards protruding spikes are arranged at the distal end of the rivet pressing sheet.
Further, the gap between the rivet pressing piece and the medical rivet can be used for the cladding pipe to pass through, an open slot is formed in the far end of the cladding pipe, and a pressing piece boss in limit fit with the open slot is arranged on the inner side wall of the rivet pressing piece.
The integral rivet handle comprises a pipe outlet end and a pushing end, wherein a pushing cavity is formed in the pushing end, the front section of the rivet pushing handle stretches into the pushing cavity and can move back and forth relative to the axial direction of the pushing cavity, a rivet connecting pipe connecting cavity is formed in the rivet pushing handle, a rivet connecting pipe fixing block is arranged in the rivet connecting pipe connecting cavity, a rivet connecting pipe penetrates through the pipe outlet end and the pushing end and is fixedly connected with the rivet connecting pipe fixing block, a spring buckle is arranged on the cavity wall of the pushing cavity, and a stop boss in snap fit with the spring buckle is arranged on the outer wall of the front section of the rivet pushing handle.
Further, a cladding pipe is coaxially sleeved on the periphery of the rivet connecting pipe, a cladding pipe connecting cavity is further formed in the rivet pushing handle, the cladding pipe connecting cavity is located at the far end of the rivet connecting cavity, a cladding pipe connecting sliding block is arranged in the cladding pipe connecting cavity, a rebound spring is arranged between the cladding pipe connecting sliding block and the far end cavity wall of the cladding pipe connecting cavity, a spring fixing block and a release button are further arranged in the cladding pipe connecting cavity, the release button is elastically connected with the spring fixing block through a release spring, the cladding pipe connecting sliding block can slide back and forth relative to the cladding pipe connecting cavity, and the rivet connecting pipe penetrates through the cladding pipe connecting sliding block and is fixedly connected with the rivet connecting pipe fixing block.
The bending control device comprises a cover pipe, a rivet, a bending control knob cap, a bending control sliding guide rail, a bending control locking screw nut, a bending control guide wire and a bending control guide wire, wherein the bending control pipe is coaxially sleeved on the periphery of the cover pipe, the rivet is integrally sleeved on the rivet, the whole handle further comprises a first bending control end and a second bending control end which are communicated with the pipe end, bending control cavities are respectively arranged in the first bending control end and the second bending control end, a coaxial bending control sliding guide rail is arranged in the bending control cavities, the bending control knob cap is connected with the bending control sliding guide rail, a bending control locking screw nut which is connected to the inner wall of the bending control cavity in a sliding mode is connected to the periphery of the bending control sliding guide rail in a threaded mode, the bending control locking screw nut can be driven to reciprocate along the axial direction of the bending control sliding guide rail by rotating the bending control knob cap, and the other end of the bending control guide wire is connected to the bending control pipe.
Further, one end of the exit tube end, which is close to the first bending end and the second bending end, is fixed with a bending adjustment fixing seat, one end of the bending adjustment pipe is fixedly connected with the bending adjustment fixing seat, and the bending adjustment fixing seat is provided with a bending adjustment fixing seat central hole for the cladding pipe to pass through and a bending control guide wire groove for the bending control guide wire to pass through.
The bending control guide wire is arranged in the middle layer, a first traction ring and a second traction ring are arranged at the front section of the bending control pipe, the bending control guide wire at the first bending control end is connected with the first traction ring, and the bending control guide wire at the second bending control end is connected with the second traction ring.
Further, the valve repair device comprises a support table for conveying a delivery system of the valve repair device, the valve repair device comprises a bottom plate, a rack sliding rail arranged on the bottom plate, and a first support, a second support and a third support which are arranged on the rack sliding rail in a sliding mode, wherein a first sleeve for installing the primary handle is arranged on the first support, a second sleeve for installing the secondary handle is arranged on the second support, a third sleeve for installing the tertiary handle is arranged on the third support, and the first sleeve, the second sleeve and the third sleeve are positioned on the same straight line.
Further, the one side slope that the rack slide rail had the teeth of a cogwheel sets up, first sleeve with the second sleeve is located same straight line that inclines to the horizontal line, just the contained angle of straight line and horizontal line with the slope of rack slide rail is the same.
Further, the rack slide rail is provided with a slide block, the bottoms of the first support and the second support are fixed on the slide block, a gear meshed with the rack slide rail is mounted on the slide block, and a locking piece used for propping against the rack slide rail is connected to the side wall of the slide block.
Further, quick locking bolts are arranged on the first sleeve, the second sleeve and the third sleeve.
The technical scheme of the invention has the following advantages:
1. The delivery system of the valve repair device is provided with a primary handle, a secondary handle and a tertiary handle, wherein the tertiary handle can slide back and forth relative to the secondary handle, the secondary handle can rotate relative to the primary handle, the distance between the valve repair device and a mitral valve can be adjusted by sliding the secondary handle back and forth and rotating the secondary handle, the valve repair device is adjusted when a forming ring is implanted, a pushing mechanism is arranged, a pushing tube for conveying the valve repair device is fixed at the distal end of a pushing piece, the pushing tube can be driven to move to the distal end or the proximal end by pushing a pushing button of a pushing rod so as to enable the valve repair device to be close to or far away from the mitral valve, the pushing tube penetrates through a multi-cavity tube fixing seat to extend to the distal end and extend into the multi-cavity tube, and an outer sheath tube fixed at the distal end of the tertiary handle is arranged at the periphery of the multi-cavity tube.
2. According to the delivery system of the valve repair device, the rotating groove is formed in the inner wall of the far end of the primary handle, the rotating boss corresponding to the rotating groove is arranged on the outer side wall of the near end of the secondary handle, the rotating boss can rotate on the rotating groove, the limiting block is arranged on the inner wall of the far end of the secondary handle, the travel groove corresponding to the limiting block is arranged on the inner wall of the near end of the tertiary handle, the limiting block can slide on the travel groove, meanwhile, through the limiting structure of the travel groove and the limiting block, when the secondary handle rotates, the tertiary handle rotates together with the secondary handle, the movement consistency of the tertiary handle and the secondary handle can be guaranteed during adjustment, and the adjustment stability is guaranteed.
3. The delivery system of the valve repair device is characterized in that a main cavity and an auxiliary cavity are arranged in an outer sheath tube, a multi-cavity tube is arranged in the main cavity, a round cavity is arranged in the center of the multi-cavity tube, a plurality of branch cavities are arranged in the circumferential direction of the round cavity, a pushing tube is a single cavity and is arranged in the round cavity, and each branch cavity is provided with a shaping guide stay wire to pass through. By means of the design, the shaping guide stay wires are arranged in a one-to-one separation mode, and winding of the shaping guide stay wires can be avoided.
4. According to the delivery system of the valve repair device, the anti-rotation boss and the eccentric hole are arranged on the connecting block, the accommodating groove for accommodating the connecting block is arranged on the inner wall of the proximal end of the secondary handle, and the edge of the accommodating groove is provided with the connecting groove correspondingly matched with the anti-rotation boss. By means of the design, when the outer sheath tube can be guaranteed to rotate through the eccentric holes of the multi-cavity tube connecting block, the multi-cavity tube and the pushing tube cannot rotate.
5. The delivery system of the valve repair device provided by the invention is characterized in that a pin hole is formed at the joint of the secondary handle and the tertiary handle, and a positioning pin for locking the secondary handle and the tertiary handle is arranged on the pin hole. The design is that the pin hole penetrates into the locating pin in the initial state, and the locating pin is pulled out before pushing the secondary handle, so that the pushing of the secondary handle can be carried out, and the operation is convenient.
6. According to the delivery system of the valve repair device, the outer wall of the far end of the primary handle is provided with the angle mark, and the outer wall of the near end of the secondary handle is provided with the indication arrow for indicating the angle mark. The design is that the mitral valve of the human body is not round, but is D-shaped, and the physiological structures of all the human bodies are different, so that the secondary handle is required to be rotated to adjust the direction in the process of the transapical operation, and the rotation angle in the operation process can be conveniently observed through the angle mark.
7. According to the delivery system of the valve repair device, the stay wire sleeve is arranged in the handle, the through first circle center through holes and the first circumference through holes distributed around the circumference of the first circle center through holes are arranged in the stay wire sleeve, the first wiring channel for leading the shaping guide stay wire to enter the first circle center through holes is arranged between the first circle center through holes and any one of the first circumference through holes, the stay wire guide block is arranged in the first circle center through holes, and the stay wire guide block is provided with the plurality of stay wire outlet holes which are used for leading the shaping guide stay wire to pass through and are arranged in one-to-one correspondence with the positions of the plurality of first circumference through holes.
8. The delivery system of the valve repair device comprises a plurality of through-hole side walls, wherein through stay stroke grooves are formed in the through-holes, first rebound screws are coaxially arranged in the through-holes, one ends of the first rebound screws, which are close to stay guide blocks, are provided with stay turntables for shaping guide stay winding, the other ends of the first rebound screws are provided with first rebound caps, first screw stroke nuts are sleeved on the peripheries of the first rebound screws, first compression springs sleeved on the first rebound screws are arranged between the first screw stroke nuts and the first rebound caps, one ends of the shaping guide stay are fixed on the stay turntables, the first screw stroke nuts are always pushed by the action of the first rebound springs, the first screw stroke nuts drive the first rebound screws to rotate through threaded fit after being pushed, the stay turntables rotate along with the first rebound screws, the shaping guide stay is always tensioned by the stay turntables, the shaping guide stay is always kept in tension, and multiple groups of shaping guide stay is prevented from generating winding in a loose state. In addition, the tensioning force applied to the shaping guide stay wire can be changed by adjusting parameters of the stay wire device (such as the thread interval between the first screw stroke nut and the first rebound screw, the diameter ratio of the first rebound screw and the stay wire turntable and the elastic characteristic curve of the first rebound spring). The first guide extension block which protrudes outwards and is in sliding fit with the wire drawing travel groove is arranged on the first screw rod travel nut, so that the first screw rod travel nut can move back and forth relative to the wire drawing travel groove and cannot rotate.
9. The delivery system of the valve repair device provided by the invention is characterized in that a plurality of shaping guide wire outlet holes are formed in the outer wall of a primary handle, a first locking wire pull block is arranged on each shaping guide wire outlet hole, one end of each shaping guide pull wire is connected to the first locking wire pull block, and the other end of each shaping guide pull wire is connected to a pull wire rotary table. By means of the design, after the shaping guide stay wire is used, the stay wire pulling block can be directly pulled to pull out the unnecessary traction stay wire, and the operation is convenient.
10. According to the delivery system of the valve repair device, the second screw travel nut is provided with the traction wire guide block which protrudes outwards and is in sliding fit with the traction wire travel groove, and the second screw travel nut can move forwards and backwards relative to the traction wire travel groove and cannot rotate.
11. According to the delivery system of the valve repair device, the tail end wire dividing piece is fixed on the outer wall surface of the far end of the wire drawing sleeve, and the wire outlet hole of the traction wire is obliquely arranged outwards from the far end to the near end of the tail end wire dividing piece. By the design, the problems of high resistance and easy blocking when the traction stay wire is positioned at a 90-degree outgoing line can be avoided.
12. The delivery system of the valve repair device provided by the invention has the advantages that the wire pulling locking sleeve is arranged on the second circumferential through hole in a sliding way along the axial direction of the second circumferential through hole, and the wire pulling sleeve is provided with the locking button for locking the wire pulling locking sleeve on the second circumferential through hole. By the design, the wire pulling locking sleeve can be fixedly connected with the wire pulling sleeve through the locking button.
13. The delivery system of the valve repair device provided by the invention has the advantages that the outer wall of the handle is provided with the plurality of traction wire outlet holes, the traction wire outlet holes are provided with the second locking wire pulling blocks, one end of the traction wire is connected with the second locking wire pulling blocks, and the other end of the traction wire is connected with the traction wire rotating disc. By the design, after the traction stay wire is used, the stay wire pulling block can be directly pulled to pull out the unnecessary traction stay wire, so that the operation is convenient.
14. According to the delivery system of the valve repair device, the reinforcing pipe with the plurality of wire passing holes distributed along the axial direction is arranged, the wire exposing grooves communicated with the plurality of wire passing holes are formed in the peripheral wall of the reinforcing pipe, the blade fixing disc and the blade rotating disc are arranged on the periphery of the reinforcing pipe, the plurality of linear guide grooves are formed in one side edge of the blade fixing disc, the plurality of arc-shaped guide grooves are formed in one side wall of the blade rotating disc, which faces the blade fixing disc, the plurality of arc-shaped guide grooves and the plurality of linear guide grooves are arranged in a one-to-one correspondence manner, the plurality of cutting blades are arranged between the blade fixing disc and the blade rotating disc, the cutting blades and the wire exposing grooves are located on the same plane, the cutting blades are connected with the cutting blades, one ends of the blade guide rods extend into the linear guide grooves, the other ends of the blade guide rods extend into the corresponding arc-shaped guide grooves, the blade rotating disc and the blade fixing disc are close to or far away from the wire exposing grooves along with the movement of the blade rotating disc in the axial direction of the reinforcing pipe, the plurality of the cutting blades can cut off the plurality of stay wires located in the wire exposing grooves at the wire passing holes when the cutting blades rotate onto the wire exposing grooves, and the cutting blades are connected with the cutting blades in a one-to-one wire passing grooves, and the other side of the wire passing grooves, and the cutting device is not inclined, and the problem is avoided when the cutting device is implanted in a local situation is compared with the situation.
15. According to the delivery system of the valve repair device, one end of the cutting blade, which is close to the reinforcing pipe, is provided with the arc-shaped blade cutting edges, and the arcs where the plurality of blade cutting edges are positioned are concentric with the dew slot. By the design, the blade cutting edge can be all abutted on the wire exposing groove without leaving a hole, and the blade cutting edge is ensured to completely cut off the stay wire at the wire exposing groove.
16. The delivery system of the valve repair device provided by the invention is characterized in that the cutting blade is also provided with a first arc-shaped side surface which is matched with one side of the cutting edge of the blade and a second arc-shaped side surface which is positioned on the other side of the cutting edge of the blade, and the first arc-shaped side surface is matched with the second arc-shaped side surface of the adjacent cutting blade. By the design, the structure is good in compactness, the side faces of the cutting blades can be just matched and aligned when the cutting blades rotate to be abutted to the wire exposing groove, and the situation that the stay wires cannot be cut due to mutual interference is avoided.
17. The delivery system of the valve repair device comprises a puncture tip arranged at the distal end of a medical rivet, a rivet barb arranged on the side wall of the medical rivet close to the puncture tip, a rivet avoiding groove corresponding to the position of the rivet barb arranged on the outer side wall of the medical rivet, a release button connected with a rivet connecting pipe arranged at the proximal end of the medical rivet, a reverse spring block arranged at one end of the medical rivet close to the release button, wherein the rivet barb is provided with a rivet barb initial state which is unfolded outwards in a natural state and is arranged with the barb on the rivet barb facing to the proximal end, and a rivet barb loading state which is folded inwards in the rivet avoiding groove under the action of external force, and the reverse spring block is provided with a reverse spring block initial state which is unfolded outwards in a natural state and is arranged with the end of the reverse spring block far away from the medical rivet facing to the distal end, and a reverse spring block loading state which is folded inwards under the action of external force. The anchor effect of the distal end face of the operation part is provided through the rivet barb, the anchor effect of the proximal end face of the operation part is provided through the reverse elastic block, and then the double-sided anchor of the operation part is realized, so that the riveting strength of the medical rivet is enhanced, the fault tolerance is improved, and the error probability is reduced.
18. The delivery system of the valve repair device provided by the invention is characterized in that a rivet pressing sheet is coaxially sleeved on the outer side of a medical rivet and is cylindrical, and a plurality of outwards protruding spikes are arranged at the distal end of the rivet pressing sheet. By the design, the periphery of an operation part which is penetrated by the medical rivet can be firmly fixed through the nailing, so that the problem of expanding and tearing of the penetrated part when the medical rivet is pulled is avoided.
19. According to the delivery system of the valve repair device, a gap between the rivet pressing sheet and the medical rivet can be used for the cladding pipe to pass through, an open slot is formed in the distal end of the cladding pipe, and a pressing sheet boss in limit fit with the open slot is arranged on the inner side wall of the rivet pressing sheet. The design can enable the far end to be slightly opened through the open slot so as to facilitate loading the rivet into the implantation device, and meanwhile, the open slot and the pressing boss of the rivet pressing sheet form a stop mechanism so as to ensure that the rivet pressing sheet moves together in the pushing process of the cladding pipe, and ensure that the rivet pressing sheet can be left at the implantation position in the releasing process and cannot be carried out together.
20. According to the delivery system of the valve repair device, provided by the invention, the cavity wall of the pushing cavity is provided with the elastic buckle, and the outer wall of the front section of the rivet pushing handle is provided with the stop boss which is in snap fit with the elastic buckle. The elastic buckle is matched with the stop boss, so that the stop state can be kept after the rivet is implanted, and the medical rivet is prevented from returning due to manual operation.
21. According to the delivery system of the valve repair device, the outer periphery of the rivet connecting pipe is coaxially sleeved with the cladding pipe, and due to the design of the cladding pipe, the medical rivet can be enabled to be capable of adjusting the direction along with the bent pipe in the process of delivering the medical rivet to an operation position, and the better axial compression resistance and bending resistance are provided in the pushing process.
22. The delivery system of the valve repair device is characterized in that a cladding tube connecting cavity is further formed in a rivet pushing handle, a spring fixing block and a release button are further arranged in the cladding tube connecting cavity, the release button is elastically connected with the spring fixing block through a release spring, a cladding tube connecting sliding block can slide back and forth relative to the cladding tube connecting cavity, and a rivet connecting tube penetrates through the cladding tube connecting sliding block and is fixedly connected with the rivet connecting tube fixing block. Through the cooperation of cladding pipe and release button, after the puncture point passed the operation position, the release button was pressed, cladding pipe connection slider released the restriction, cladding pipe connection slider slides to the proximal end under the effect of release spring, cladding pipe connection slider drove cladding pipe to proximal end displacement for the puncture point breaks away from the restraint of cladding pipe, and release trip and rivet connecting pipe release the state of locking of holding simultaneously, break away from each other. The release button is directly pressed when the medical rivet is released, so that the release process is faster and more convenient, and the medical rivet dislocation caused by the manual control stroke is avoided.
23. The delivery system of the valve repair device comprises a covering pipe, a bending adjusting pipe coaxially sleeved on the periphery of the covering pipe, a first bending adjusting end and a second bending adjusting end which are communicated with the pipe end, bending adjusting cavities are formed in the first bending adjusting end and the second bending adjusting end, a bending adjusting sliding guide rail is coaxially arranged in the bending adjusting cavities, a bending control knob cap connected with the bending adjusting sliding guide rail is arranged at the proximal end of the bending adjusting cavity, a bending control locking screw nut connected to the inner wall of the bending adjusting cavity in a sliding mode is connected to the periphery of the bending adjusting sliding guide rail in a threaded mode, the bending control knob cap can be rotated to drive the bending control locking screw nut to reciprocate along the axial direction of the bending adjusting sliding guide rail, and a bending control guide wire is connected to the bending control locking screw nut, and the other end of the bending control guide wire is connected to the bending adjusting pipe. By means of the design, the first bending adjusting end and the second bending adjusting end are rotated, the bending knob cap arranged in the bending adjusting cavity drives the bending control wire locking nut to move in a reciprocating mode along the axial direction of the bending adjusting sliding guide rail, and further the bending control guide wire connected to the bending control wire locking nut is driven to move in a reciprocating mode in the axial direction, and the effect of bidirectional bending adjustment can be achieved.
24. The delivery system of the valve repair device is provided with a bottom plate with a rack sliding rail, wherein a first support and a second support are arranged on the rack sliding rail in a sliding manner, a first sleeve is arranged on the first support and used for installing a primary handle of a pushing device, a second sleeve is arranged on the second support and used for installing a secondary handle of the pushing device. When the rivet is implanted, the first sleeve can rotate the first handle, the second sleeve can limit the second handle to rotate along the central axis of the second sleeve, the first sleeve cannot rotate when the second sleeve is rotated, the success rate of implantation operation of the forming ring is improved, the first support and the second support are arranged on the rack sliding rail, the pushing device slides on a straight line formed by connecting the first support and the second support, the stability of the forming ring device in the pushing process when the forming ring is inserted into the operation can be guaranteed, the cooperation of the forming ring device with a human mitral valve when the forming ring is inserted into the operation is guaranteed, and the success rate of the insertion operation is improved.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
FIG. 1 is a diagram of the positional relationship between a shaped guide pull wire and a traction pull wire of a valve repair device provided by the present invention;
FIG. 2 is a perspective view of a valve repair device provided by the present invention;
FIG. 3 is a perspective view of a delivery system for a valve repair device provided by the present invention;
FIG. 4 is a perspective view of the interior of the primary handle of the present invention;
FIG. 5 is a schematic view showing the positional relationship between a multi-lumen sealing wafer and a multi-lumen sealing pad in the present invention;
FIG. 6 is a schematic view showing the positional relationship between a rotating groove and a rotating boss according to the present invention;
FIG. 7 is a perspective view of the interior of the secondary handle of the present invention;
FIG. 8 is a schematic diagram showing the positional relationship between a connecting block and a receiving groove in the present invention;
FIG. 9 is a perspective view of the interior of the three stage handle of the present invention;
FIG. 10 is a schematic diagram showing the positional relationship between a stopper and a travel slot according to the present invention;
FIG. 11 is a schematic view showing the positional relationship of an outer sheath, a multi-lumen tube and a pusher tube in the present invention;
FIG. 12 is a perspective view showing the positional relationship among the sheath tube, the multi-lumen tube and the push tube in the present invention;
FIG. 13 is a diagram showing the positional relationship between a wire pulling mechanism and a wire pulling mechanism according to an embodiment of the present invention;
FIG. 14 is a perspective view of a cord mechanism of the present invention;
FIG. 15 is a perspective view of a cable sleeve according to the present invention;
FIG. 16 is a perspective view of a first screw flight nut of the present invention;
FIG. 17 is a perspective view of a wire guide block of the present invention;
FIG. 18 is a perspective view of a cable turret according to the present invention;
FIG. 19 is a perspective view of the wire pulling mechanism of the present invention;
FIG. 20 is an enlarged view at A in FIG. 19;
FIG. 21 is a perspective view of a wire drawing sleeve of the present invention;
FIG. 22 is a perspective view of the tail end parting member of the present invention;
FIG. 23 is a schematic view of the tail end parting member of the present invention;
FIG. 24 is a cross-sectional view of A-A of the trailing wire-dividing member of the present invention;
FIG. 25 is a perspective view of a tangential mechanism for an interventional system provided by the present invention;
FIG. 26 is a schematic view showing the internal structure of the blade holding disk of the present invention;
FIG. 27 is a schematic view showing the internal structure of a blade turntable according to the present invention;
FIG. 28 is a perspective view of a reinforcing tube according to the present invention;
FIG. 29 is a schematic view of the structure of a reinforcing tube according to the present invention;
FIG. 30 is a perspective view showing the medical rivet and the rivet implanting device according to the present invention in an initial state;
FIG. 31 is a perspective view showing a medical rivet and a rivet implanting device according to the present invention in an implanted state;
FIG. 32 is a perspective view of a medical rivet according to the present invention in a disengaged state;
FIG. 33 is a perspective view of a rivet for Chinese medicine according to the present invention;
FIG. 34 is a perspective view of the rivet barb and reverse bullet of the present invention prior to implantation;
FIG. 35 is a schematic view of the connection between the integral rivet handle and the rivet pushing handle according to the present invention;
FIG. 36 is a cross-sectional view of the integral handle A-A of the rivet of the present invention;
FIG. 37 is a schematic view of the internal structure of the buckle end and rivet pushing handle of the present invention;
FIG. 38 is a schematic view of the location of a latch according to the present invention;
FIG. 39 is a schematic view of the position of the blood sealing tablet of the present invention;
FIG. 40 is a schematic view of the position of the stop boss of the present invention;
FIG. 41 is a schematic illustration of the position of a guidewire port in accordance with the present invention;
FIG. 42 is a top view of a tuning trap of the present invention;
FIG. 43 is a cross-sectional view of the tuning bend B-B of the present invention;
FIG. 44 is a cross-sectional view of the tuning bend C-C of the present invention;
FIG. 45 is a schematic view of a stand structure according to the present invention;
fig. 46 is a perspective view of a stand according to the present invention.
The reference numerals of figures 1-2 illustrate that 01, a forming ring body, 02, a shaping guide wire, 2, a head end metal strip, 3, a fixed end metal strip, 4, a head end metal pipe, 5, a fixed end metal pipe, 6, a connecting part metal pipe, 7, an elastic contraction piece, 8, a stop pin pull-out wire, 9, a stop pin, 10, a buckle assembly, 11, a buckle fixed end, 12 and a buckle traction wire.
Reference numerals in fig. 3-46 illustrate a1, a primary handle, a101, a multi-cavity tube holder, a102, a push button travel slot, a103, a push member, a push button, a105, a push tube, a106, an angle indicator, a107, a multi-cavity tube, a108, a circular cavity, a109, a branch cavity, a2, a secondary handle, a201, a rotation slot, a202, a rotation boss, a203, an inner tube support seat, a204, a connection block, a205, a receiving slot, a206, an anti-rotation boss, a207, a connection slot, a208, an eccentric hole, a209, a multi-cavity tube sealing tablet, a210, A multi-cavity tube blood sealing gasket, a212, a rivet fixing seat, a213, a rivet guide tube, a214, a locating pin, a3, a three-stage handle, a301, an outer sheath tube, a302, a main cavity, a303, an auxiliary cavity, a304, a limiting block, a305, a travel groove, a306, an outer sheath fixing seat, a307, a front-stage blood sealing tablet, b01, a wire pulling mechanism, b02, a wire pulling mechanism, b1, a wire pulling sleeve, b11, a first circle center through hole, b12, a first circle through hole, b13, a first wire channel, b14, a wire pulling travel groove, b2, a wire pulling guide block, b21, a wire pulling outlet hole, b22, A first central hole, b23, a stay wire connecting plate, b3, a first rebound screw, b4, a first screw travel nut, b41, a first guide extension block, b5, a first compression spring, b6, a first rebound cap, b7, a stay wire turntable, b71, a stay wire groove, b72, a stay wire fixing hole, b8, a first lock wire pull block, b9, a stay wire sleeve, b91, a second circle center through hole, b92, a second circle center through hole, b93, a second wire passage, b10, a stay wire locking sleeve, b101, a locking button, b102, a traction wire travel groove, b110, a tail end wire dividing piece, b111, a traction wire outlet hole, b120, A second rebound screw, a second screw travel nut, b131, a traction wire guide block, b140, a second rebound cap, b150, a traction wire turntable, b151, a traction wire groove, b152, a traction wire fixing hole, b160, a second locking wire pull block, b170, a second compression spring, c00, a wire cutting mechanism, c02, a reinforcing pipe, c021, a wire passing hole, c022, a wire exposing groove, c023, a guide conical surface, c024, a reinforcing pipe center hole, c025, a fixing element, c03, a blade fixing disc, c031, a linear guide groove, c04, a blade turntable, c041, Arc-shaped guide groove, c05, cutting blade, c051, blade guide rod, c052, blade cutting edge, c06, cutting button, d00, rivet implantation device, d100, medical rivet, d110, puncture tip, d120, rivet barb, d130, rivet clearance groove, d140, trip, d141, trip clamping groove, d142, trip protrusion, d143, trip inclined surface, d150, reverse spring block, d160, rivet pressing sheet, d161, nailing, d162, pressing sheet boss, d200, rivet integral handle, d210, pipe end, d211, bending adjustment fixing seat, d212, The device comprises a bending control guide wire groove, a d213, a positioning boss, a d214, a positioning groove, a d220, a pushing end, a d221, a pushing cavity, a d230, a first bending end, a d250, a bending adjusting cavity, a d251, a bending adjusting sliding guide rail, a d252, a bending control lock wire nut, a d253, a bending control knob cap, a d254, a bending control guide wire, a d256, a guide wire hole, a d257, a bending control guide wire clearance groove, a d260, a blood sealing tablet, a d261, a blood sealing tablet fixing hole, a d270, a blood sealing tablet, a d300, a rivet pushing handle, a d310, a rivet connecting pipe connecting cavity, a d311, a rivet connecting pipe fixing block, a d320, A cladding tube connecting cavity; d321, connecting the cladding pipe with the sliding block; d322, release button, d323, spring fixing block, d324, release spring, d325, rebound spring, d330, stop boss, d340, spring clip, d341, spring clip inclined plane, d400, rivet connecting pipe, d500, cladding pipe, d510, open slot, d600, adjusting bend pipe, d610, outer layer, d620, middle layer, d630, inner layer, d640, first traction ring, d650, second traction ring, e00, support table, e1, bottom plate, e2, rack slide rail, e3, gear tooth, e4, and inner layer, a first support; e5, a second support, e6, a third support, e7, a first sleeve, e8, a second sleeve, e9, a third sleeve, e10, a sliding block, e11, a gear, e12, a U-shaped groove, e13, a sliding rail locking screw, e14, a quick locking bolt, e15, a rear angle mark, e16 and a front angle mark.
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," "outer," and the like indicate orientations or positional relationships based on the orientation or positional relationships illustrated in the drawings, and "distal," "proximal" refer to an end distal or proximal to an applicator, merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, unless explicitly stated or limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected, mechanically connected, electrically connected, directly connected, indirectly connected via an intervening medium, or in communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
In addition, the technical features of the different embodiments of the present invention described below may be combined with each other as long as they do not collide with each other.
For ease of understanding, the following provides a valve repair device that may be implemented by the delivery system of the present invention, it being noted that the valve repair device is merely provided to facilitate description of the present invention, and is not intended to indicate or imply that the present invention is only applicable to the implementation of the valve repair device.
The valve repairing device shown in figures 1 and 2 comprises a forming ring body 01, wherein the forming ring body 01 comprises at least a head end metal strip 2, a fixed end metal strip 3, a head end metal tube 4 and a fixed end metal tube 5 which are respectively sleeved at the ends of the two metal strips, a connecting part metal tube 6 and an elastic contraction piece 7 which are sleeved between two adjacent metal strips, and contraction intervals are arranged between the connecting part metal tube 6 and the two metal tubes;
The head end metal strip 2, the fixed end metal strip 3, the head end metal tube 4, the fixed end metal tube 5 and the connecting part metal tube 6 are all wound with a shaping guide stay wire 02. The shaping guide stay wire 02 is tensioned, so that the shaping ring body 01 is shaped in an auxiliary mode and is attached to the surface of an autologous leaflet of a human body, and a rivet is implanted in the delivery device conveniently;
The traction wire comprises a stop pin pull-out wire 8 and a buckle traction wire 12, in particular:
The connecting part metal tube 6 is provided with a stop pin 9 in a penetrating way, the stop pin 9 is provided with a stop pin pull-out line 8 in a penetrating way, the stop pin 9 is pulled out through the stop pin pull-out line 8, the size of the forming ring body 01 is continuously reduced under the action of the elastic contraction piece 7, and the extension part of the cladding base material on the forming ring body 01 also pulls the self flap She Yibing to contract through a rivet, so that the repair forming operation of the self flap is realized.
Connect through buckle subassembly 10 between two tubular metal resonator, buckle subassembly 10 is including buckle head end and the buckle stiff end 11 of being connected with head end tubular metal resonator 4 and stiff end tubular metal resonator 5 respectively, and the buckle head end is located inside the buckle stiff end 11, wears to be equipped with buckle pull wire 12 between buckle head end and the buckle stiff end 11, and buckle pull wire 12's both ends wear out from stiff end tubular metal resonator 5. Through pulling buckle pull wire 12, make buckle head end insert buckle stiff end 11, automatic locking under the effect of buckle head end and buckle stiff end 11 specific structure forms complete annular.
A delivery system for a valve repair device as shown in fig. 3-12 includes a push assembly, a multi-lumen tube a107, a push tube a105, an outer sheath tube a301, a wire cutting mechanism c00, a wire pulling mechanism b01, a push mechanism, and a wire pulling mechanism b02. The pushing assembly comprises a primary handle a1, a secondary handle a2 and a tertiary handle a3 which are sequentially arranged from a proximal end to a distal end, the secondary handle a2 can rotate relative to the primary handle a1, the tertiary handle a3 can slide back and forth relative to the secondary handle a2, and a multi-cavity tube fixing seat a101, a cutting mechanism c00, a wire pulling mechanism b01, a pushing mechanism and a wire pulling mechanism b02 are sequentially arranged in the primary handle a1 from the distal end to the proximal end. The multi-cavity tube a107 is connected to the distal end of the multi-cavity tube fixing seat a101, and a plurality of shaping guide stay wires penetrating through the inner cavity of the multi-cavity tube a107 and connected to the valve repair device are connected to the stay wire mechanism b 01. The outer wall of the primary handle a1 is provided with a push button travel groove a102, the push mechanism comprises a push piece a103 arranged in the primary handle a1 and a push rod push button a104 connected with the push piece a103 and slidingly connected with the push button travel groove a102, a push tube a105 for conveying a valve repair device is fixed at the distal end of the push piece a103, and the push tube a105 penetrates through the multi-cavity tube fixing seat a101 to extend distally. The thread cutting mechanism c00 is used for cutting off the shaping guide stay wire at the distal end of the stay wire mechanism b 01. The wire pulling mechanism b02 is connected with a plurality of traction wires penetrating through the pushing tube a105, and the traction wires are connected with stop pins penetrating through the delivery valve repair device. The outer sheath tube a301 is located at the outer periphery of the multi-lumen tube a107 and is fixed to the distal end of the tertiary handle a 3.
The delivery system of the valve repair device is provided with a primary handle a1, a secondary handle a2 and a tertiary handle a3, wherein the tertiary handle a3 can slide back and forth relative to the secondary handle a2, the secondary handle a2 can rotate relative to the primary handle a1, the distance between the valve repair device and a mitral valve can be adjusted by sliding the secondary handle a2 back and forth and rotating the secondary handle a2, the valve repair device is adjusted when a forming ring is implanted, a pushing mechanism is provided, a pushing tube a105 for conveying the valve repair device is fixed at the distal end of a pushing piece a103, the pushing tube a105 can be driven to move distally or proximally by pushing a pushing rod push button a104 so as to enable the valve repair device to be close to or far away from the mitral valve, the pushing tube a105 penetrates through a multi-cavity tube fixing seat a101 to extend distally and into a tube a107, the periphery of the pushing tube a107 is provided with a sheath tube a301 fixed at the distal end of the tertiary handle a3, the multi-cavity tube a107 can be pushed and the multi-cavity tube a105 and the multi-cavity repair device can be rotated to further adjust the degree of matching of the multi-cavity repair ring with the multi-cavity repair device.
In the embodiment, a rotating groove a201 is formed in the inner wall of the distal end of the primary handle a1, a rotating boss a202 corresponding to the rotating groove a201 is arranged on the outer side wall of the proximal end of the secondary handle a2, the rotating boss a202 can rotate on the rotating groove a201, a limiting block a304 is arranged on the inner wall of the distal end of the secondary handle a2, a travel groove a305 corresponding to the limiting block a304 is formed in the inner wall of the proximal end of the tertiary handle a3, and the limiting block a304 can slide on the travel groove a 305. The inner wall of the far end of the primary handle a1 is provided with a rotating groove a201, the outer side wall of the near end of the secondary handle a2 is provided with a rotating boss a202 corresponding to the rotating groove a201, the rotating boss a202 can rotate on the rotating groove a201, the inner wall of the far end of the secondary handle a2 is provided with a limiting block a304, the inner wall of the near end of the tertiary handle a3 is provided with a travel groove a305 corresponding to the limiting block a304, the limiting block a304 can slide on the travel groove a305, meanwhile, through the limiting structure of the travel groove a305 and the limiting block a304, when the secondary handle a2 rotates, the tertiary handle a3 rotates along with the secondary handle a2, and the movement consistency of the tertiary handle a3 and the secondary handle a2 can be ensured during adjustment, and the adjustment stability is ensured.
In the embodiment, a main cavity a302 and an auxiliary cavity a303 are arranged in an outer sheath tube a301, a multi-cavity tube a107 is arranged in the main cavity a302, a round cavity a108 is arranged in the center of the multi-cavity tube a107, a plurality of branch cavities a109 are arranged in the circumferential direction of the round cavity a108, a pushing tube a105 is a single cavity and is arranged in the round cavity a108, and each branch cavity a109 is used for a shaping guide stay wire to pass through. The design of the main cavity a302 and the auxiliary cavity a303 can limit the distal ends of the pushing tube a105 and the multi-cavity tube a107, and simultaneously can ensure that the travel paths of different stay wires passing through the pushing tube a105 and the multi-cavity tube a107 are consistent, thereby ensuring the consistency and the stability of different stay wires in adjustment. The design of a plurality of branch cavities a109 on the circumference of the round cavity a108 can separate a plurality of shaping guide stay wires one by one, and avoids winding of a plurality of groups of shaping guide stay wires.
Specifically, the distal end of the three-stage handle a3 is provided with an outer sheath fixing seat a306, an outer sheath tube a301 is fixedly arranged on the outer sheath fixing seat a306, the proximal end face of the outer sheath fixing seat a306 is connected with a front section blood pressure sealing sheet a307, the proximal end of the two-stage handle a2 is provided with an inner tube supporting seat a203 for supporting the multi-cavity tube a107, and the multi-cavity tube a107 and the pushing tube a105 extend proximally through the inner tube supporting seat a 203.
In this embodiment, a connection block a204 is installed at the proximal end of the secondary handle a2, an anti-rotation boss a206 and an eccentric hole a208 are provided on the connection block a204, a containing groove a205 for containing the connection block a204 is provided on the inner wall of the proximal end of the secondary handle a2, and a connection groove a207 corresponding to the anti-rotation boss a206 is provided at the edge of the containing groove a 205. Specifically, the eccentric hole a208 on the connecting block a204 and the secondary handle a2 are coaxially arranged, the multi-cavity tube a107 is positioned in the eccentric hole a208, the proximal end face of the multi-cavity tube fixing seat a101 is connected with a multi-cavity tube sealing blood pressure sheet d260, and a multi-cavity tube sealing blood gasket d270 is further arranged between the multi-cavity tube fixing seat a101 and the multi-cavity tube sealing blood pressure sheet d 260. By such a design, it is ensured that the multi-lumen tube a107 and the pushing tube a105 in the multi-lumen tube a107 do not rotate when the outer sheath tube a301 rotates, and further displacement of the valve repair device can be prevented when the medical rivet d100 is delivered.
In this embodiment, an angle mark is provided on the outer wall of the distal end of the primary handle a1, and an indication arrow for indicating the angle mark is provided on the outer wall of the proximal end of the secondary handle a2. Because the mitral valve of the human body is not round, but is D-shaped, and the physiological structures of all the people are different, the secondary handle a2 needs to be rotated to adjust the direction in the process of the transapical operation, and the rotation angle in the operation process can be conveniently observed through the angle mark.
In this embodiment, a pin hole is provided at the connection between the secondary handle a2 and the tertiary handle a3, and a positioning pin a214 for locking the secondary handle a2 and the tertiary handle a3 is provided on the pin hole. In the initial state, the pin hole penetrates into the positioning pin a214, and before the secondary handle a2 is pushed, the positioning pin a214 is pulled out, so that the secondary handle a2 can be pushed, and the operation is convenient.
In this embodiment, as shown in fig. 13-24, the pull wire mechanism b01 is located in the distal lumen of the primary handle a1, and includes a pull wire sleeve b1 and a pull wire guide block b2. The stay wire sleeve b1 is installed in an inner cavity of the primary handle a1 and comprises a first circle center through hole b11 and a plurality of first circumference through holes b12, wherein the first circle center through hole b11 is arranged in the center in a penetrating mode, the first circumference through holes b12 are circumferentially distributed around the first circle center through hole b11, and a first wire channel b13 for shaping and guiding stay wires to enter the first circle center through hole b11 is arranged between the first circle center through hole b11 and any one of the first circumference through holes b 12. The stay wire guide block b2 is arranged in the first circle center through hole b11 and is positioned at the far end of the stay wire sleeve b1, a plurality of stay wire outlet holes b21 for shaping, guiding and stay wires to pass through are formed in the stay wire guide block, and the positions of the plurality of stay wire outlet holes b21 and the plurality of first circumference through holes b12 are arranged in a one-to-one correspondence mode.
The design of the wire pulling mechanism b01 is that a wire pulling sleeve b1 is installed in a primary handle a1, a through first circle center through hole b11 and a plurality of first circumference through holes b12 distributed around the circumference of the first circle center through hole b11 are arranged in the center of the wire pulling sleeve b1, a first wire routing channel b13 for a shaping guide wire to enter the first circle center through hole b11 is arranged between the first circle center through hole b11 and any one of the first circumference through holes b12, a wire pulling guide block b2 is arranged in the first circle center through hole b11, a plurality of wire pulling outlet holes b21 for the shaping guide wire to penetrate through and are arranged in one-to-one correspondence with the positions of the plurality of first circumference through holes b12 are arranged on the wire pulling guide block b2, and the design can enable a plurality of groups of shaping guide wires to be separated and arranged one by one, so that the plurality of groups of shaping guide wires are prevented from winding.
In this embodiment, the first circumferential through holes b12 are provided in six, the stay wire outlet holes b21 are correspondingly provided in six, and the shaping guide wires are provided in six groups. Specifically, the side walls of the six first circumference through holes b12 are provided with through stay wire travel grooves b14, and the stay wire travel grooves b14 are arranged along the radial direction of the first circle center through hole b 11. On the cross section perpendicular to the axial direction of the stay wire sleeve b1, a connecting line between the center of the first center through hole b11 and the center of the first circumference through hole b12 passes through the center of the stay wire outlet hole b 21.
In this embodiment, a first rebound screw b3 is coaxially disposed in the first circumferential through hole b12, one end of the first rebound screw b3, which is close to the stay wire guiding block b2, is connected with a stay wire rotating disc b7 for winding a shaping guide stay wire, a stay wire groove b71 for accommodating the shaping guide stay wire is disposed on the stay wire rotating disc b7, and a through stay wire fixing hole b72 is disposed at the bottom of the stay wire groove b 71. The shaping winding on the wire drawing turntable b7 guides the wire drawing to enter the wire drawing outlet hole b21 of the wire drawing guide block b2 through the first wire passage b 13.
In this embodiment, the other end of the first rebound screw b3 is provided with a first rebound cap b6 located at the proximal end of the stay wire sleeve b 1. The periphery of the first rebound screw b3 is also sleeved with a first screw travel nut b4 which is arranged on the stay wire travel groove b 14. The first rebound screw b3 is further sleeved with a first compression spring b5 positioned between the first screw travel nut b4 and the first rebound cap b6. Specifically, the first screw travel nut b4 is provided with a first guide extension b41 protruding outwards and slidably engaged with the wire travel groove b 14. By such a design, the first screw stroke nut b4 can move back and forth relative to the wire drawing stroke groove b14 without rotating.
In this embodiment, the elastic force of the first compression spring b5 drives the first screw travel nut b4 to move toward the distal end of the first rebound screw b3 to drive the first rebound screw b3 to rotate in the first circumferential through hole b12, and the wire rotating disc b7 rotates with the rotation of the first rebound screw b3 to keep the shaped guide wire wound thereon in a tensioned state. So design, first screw rod travel nut b4 receives the thrust back and drives first resilience screw rod b3 through screw thread fit and rotate, and the line carousel b7 rotates along with first resilience screw rod b3 rotates, and first resilience screw rod b3 receives the turning force all the time through the screw thread fit of first screw rod travel nut b4, and then makes line carousel b7 take up the design guide and act as go-between all the time, makes the design guide act as go-between remain the tensioning force all the time, avoids six groups design guide to act as go-between and produces the winding under the loose state. In addition, the tensioning force applied to the fixed guide stay wire can be changed by adjusting parameters of the stay wire device (such as the thread interval between the first screw stroke nut b4 and the first rebound screw b3, the diameter ratio of the first rebound screw b3 and the stay wire rotary table b7 and the elastic characteristic curve of the first rebound spring d 325).
In this embodiment, a first central hole b22 through which the push pipe a105 passes is further formed in the middle of the stay wire guide block b2, and six stay wire outlet holes b21 are uniformly circumferentially arranged at the periphery of the first central hole b 22. The far end of the stay wire guide block b2 is also integrally connected with a stay wire connecting plate b23, and the stay wire connecting plate b23 is fixed on the far end outer wall of the stay wire sleeve b 1.
In this embodiment, six shaping guide wire outlet holes are further formed in the outer wall of the primary handle a1, a first locking wire pulling block b8 is arranged on the shaping guide wire outlet hole, one end of the shaping guide wire is connected to the first locking wire pulling block b8, and the other end of the shaping guide wire is connected to the wire pulling rotary table b 7.
In this embodiment, the wire pulling mechanism b02 is disposed in the proximal lumen of the primary handle a1 and is located proximal to the wire pulling sleeve b 1. Specifically, the wire drawing mechanism b02 includes a wire drawing sleeve b9, a tail end wire dividing member b110, and a wire drawing locking sleeve b10.
The wire drawing sleeve b9 is arranged in the inner cavity of the proximal end of the primary handle a1 and comprises a second circle center through hole b91 which is arranged in the center and penetrates through the inner cavity, and three second circumference through holes b92 which are circumferentially distributed around the second circle center through hole b 91.
The tail end wire dividing piece b110 is arranged on the second circle center through hole b91, one end of the tail end wire dividing piece b penetrates out of the second circle center through hole b91 from the proximal end of the wire drawing sleeve b9, and three traction wire outlet holes b111 for the traction wire to penetrate through are formed in the tail end wire dividing piece b. The wire pulling locking sleeve b10 is arranged on the second circumference through hole b92, one end of the wire pulling locking sleeve b10 penetrates out of the second circumference through hole b92 from the proximal end of the wire pulling sleeve b9, a second wire channel b93 for the traction wire in the wire pulling locking sleeve b10 to extend outwards is arranged on the outer wall of the wire pulling locking sleeve b10, and the positions of the three second wire channels b93 and the three traction wire outlet holes b111 are arranged in a one-to-one correspondence mode.
Specifically, a through traction wire travel groove b102 is formed in the side wall of the wire pulling locking sleeve b10, and the traction wire travel groove b102 is arranged along the radial direction of the second circle center through hole b 91.
In this embodiment, a second rebound screw b120 is coaxially disposed in the inner cavity of the wire pulling locking sleeve b10, one end of the second rebound screw b120, which is close to the wire pulling sleeve b9, is connected with a pulling wire turntable b150 for winding a pulling wire, and the other end is provided with a second rebound cap b140 located at the distal end of the wire pulling locking sleeve b 10. Specifically, a traction wire groove b151 for accommodating a traction wire is formed in the traction wire turntable b150, and a through traction wire fixing hole b152 is formed in the groove bottom of the traction wire groove b 151.
In this embodiment, a second central hole through which the push tube a105 passes is further formed in the middle of the tail wire dividing member b110, and the three pull wire outlet holes b111 are circumferentially and uniformly arranged at the periphery of the second central hole. Specifically, the tail wire dividing member b110 is fixed on the outer wall surface of the distal end of the wire drawing sleeve b9, and the pull wire outlet hole b111 is inclined outward from the distal end to the proximal end of the tail wire dividing member b 110. By the design, the problems of high resistance and easy blocking when the traction stay wire is positioned at a 90-degree outgoing line can be avoided.
In this embodiment, the second rebound screw b120 is provided with a second screw travel nut b130 slidably mounted on the traction wire travel groove b102 at the outer circumference thereof. The second screw travel nut b130 is provided with a traction wire guide block b131 which protrudes outwards and is in sliding fit with the traction wire travel groove b 102. By such design, the second screw travel nut b130 can move back and forth relative to the traction wire travel groove b102 without rotating.
In this embodiment, the second rebound screw b120 is further sleeved with a second compression spring b170 located between the second screw travel nut b130 and the second rebound cap b 140. Specifically, the elastic force of the second compression spring b170 drives the second screw stroke nut b130 to move toward the distal end of the second rebound screw b120, so as to drive the second rebound screw b120 to rotate so as to maintain the tension state of the traction wire wound thereon.
In this embodiment, the wire pulling locking sleeve b10 is slidably mounted in the second circumferential through hole b92 along the axial direction of the second circumferential through hole b92, and the wire pulling sleeve b9 is provided with a locking button b101 for locking the wire pulling locking sleeve b10 on the second circumferential through hole b 92. By the design, the wire pulling locking sleeve b10 can be fixedly connected with the wire pulling sleeve b9 through the locking button b101.
In this embodiment, three pull wire outlet holes b111 are formed in the outer wall of the primary handle a1, a second locking wire pull block b160 is arranged on the pull wire outlet hole b111, one end of the pull wire is connected to the second locking wire pull block b160, and the other end is connected to the pull wire turntable b150. By the design, after the traction stay wire is used, the second stay wire pulling block b160 can be directly pulled to pull out the unnecessary traction stay wire, so that the operation is convenient.
In an alternative embodiment, four or eight or ten first circumferential through holes b12 may be provided, four or eight or ten stay wire outlet holes b21 are correspondingly provided, the number of shaping guide wires and shaping guide wire outlet holes is the same as that of the first circumferential through holes b12, and the number of the second circumferential through holes b92, the number of shaping guide wire outlet holes, the number of the traction stay wires and the number of the traction wire outlet holes b111 are half of that of the first circumferential through holes b 12.
In an alternative embodiment, one of the wire pulling mechanism b01 and the wire pulling guide block b2 and the tail end wire dividing piece b110 in the wire pulling mechanism b02 can be used at will, one of the wire pulling sleeve b1 and the wire pulling sleeve b9 can also be used, and the difference is that the combination of the locking button b101 and the wire pulling locking sleeve b10 can realize the wire pulling effect. In order to adapt to the effects of the wire pulling mechanism b01 and the wire pulling mechanism b02, the first rebound cap b6 of the wire pulling mechanism b01 may be provided with an inner hexagon head, and the second rebound cap b140 of the wire pulling mechanism b02 may be provided with a straight head.
In the present embodiment, the wire pulling mechanism b02 is different from the wire pulling mechanism b01 in that the wire pulling mechanism b01 provides the pulling force of the pulling wire through the wire pulling mechanism b01 in the use process, after the implantation of the implantation instrument is completed, the implantation instrument is directly cut off, one part of the pulling force is recovered by the wire pulling mechanism b01, the other part of the pulling force is extracted by the first locking wire pulling block b8, and the wire pulling mechanism b02 needs to extract part of the locking element (the stop pin) of the implantation instrument together with the pulling wire in the use process.
Therefore, the wire pulling mechanism b02 needs to pull out the locking button b101 inserted on the wire pulling locking sleeve b10, then clamp the handle of the second rebound cap b140, and directly pull out the wire pulling locking sleeve b10 from the wire pulling sleeve b 9. The wire pulling mechanism b02 can also have the same function (namely, cutting off the pulling wire) as the wire pulling mechanism b01, namely, manually cutting off the pulling wire at the second locking wire pulling block b160 and pulling out the wire pulling locking sleeve b10.
In this embodiment, as shown in fig. 25 to 29, a thread cutting mechanism c00 is installed at the distal end of the primary handle a1, and includes a reinforcing tube c02, a blade fixing disk c03, a blade turntable c04, and a plurality of cutting blades c05. Specifically, a plurality of wire passing holes c021 extending along the axial direction of the reinforcing tube c02 are formed in the reinforcing tube c02, the wire passing holes c021 are arranged along the circumferential direction of the reinforcing tube c02, and a wire exposing groove c022 communicated with the wire passing holes c021 is formed in the peripheral wall of the reinforcing tube c 02. The blade fixing disc c03 is fixed on the primary handle a1 and sleeved on the periphery of the reinforcing pipe c02, and a plurality of linear guide grooves c031 are formed in one side edge of the blade fixing disc c 03. The blade turntable c04 is rotatably sleeved on the periphery of the reinforcing pipe c02 along the axial direction of the reinforcing pipe c02 and is opposite to the blade fixing disc c03, a side wall of the blade turntable c04 facing the blade fixing disc c03 is provided with a plurality of arc-shaped guide grooves c041, and the arc-shaped guide grooves c041 and the straight-line guide grooves c031 are arranged in a one-to-one correspondence. The plurality of cutting blades c05 are positioned between the blade fixing disc c03 and the blade rotating disc c04 and positioned on the same plane with the wire exposing groove c022, a blade guide rod c051 is connected to the cutting blades c05, one end of the blade guide rod c051 extends into the linear guide groove c031, and the other end of the blade guide rod extends into the corresponding arc-shaped guide groove c 041. The blade turntable c04 drives the blade guide rods c051 of the plurality of cutting blades c05 to slide in the linear guide grooves c031 and the arc-shaped guide grooves c041 simultaneously in the process of rotating the blade turntable c04, so that the cutting blades c05 are close to or far from the dew-point grooves c022 on the reinforcing pipe c 02.
The design of the thread cutting mechanism c00 is that a reinforcing pipe c02 with a plurality of thread passing holes c021 distributed along the axial direction is arranged, a thread exposing groove c022 communicated with the plurality of thread passing holes c021 is arranged on the peripheral wall of the reinforcing pipe c02 so as to facilitate the exposure of a shaping guide stay wire in the reinforcing pipe c02, a blade fixing disc c03 and a blade rotary disc c04 are arranged on the periphery of the reinforcing pipe c02, a plurality of linear guide grooves c031 are formed on one side edge of the blade fixing disc c03, a plurality of arc-shaped guide grooves c041 are formed on one side wall of the blade rotary disc c04 facing the blade fixing disc c03, the plurality of arc-shaped guide grooves c041 and the plurality of linear guide grooves c031 are arranged in a one-to-one correspondence mode, a plurality of cutting blades c05 and the thread exposing groove c022 are arranged between the blade fixing disc c03 and the blade rotary disc c04 so that the cutting blades c05 are positioned on the same plane, one end of the blade fixing disc c03 extends into the linear guide groove c031, the other end of the blade fixing disc c04 extends into the corresponding guide groove c031, the other end of the blade fixing disc c03 extends into the corresponding guide groove c031, the other end of the blade fixing disc c02 is inclined along with the direction of the cutting disc c022, and the position of the cutting blade fixing disc c022 is inclined along with the line is inclined relative to the cutting groove c022, and the position of the cutting blade c022 is prevented from moving along with the cutting disc c022, and the line is inclined relative to the cutting blade c022 is positioned in the cutting disc c02, and the line is positioned in the direction is positioned on the line fixing disc side face side, and the fixing face is opposite line, the cutting blade has a lower side is positioned, and the lower side is compared with the cutting blade side is positioned, and the lower side is easy, and is easy.
In this embodiment, six linear guide grooves c031 are uniformly formed in the blade fixing disc c03 on a side close to the blade turntable c04 in the circumferential direction, and the guide directions of the six linear guide grooves c031 are all reversed along the radial direction of the blade fixing disc c03 and are not perpendicular to the radial direction of the blade fixing disc c 03.
In this embodiment, six arc-shaped guide grooves c041 are circumferentially formed in one side of the guide turntable, which is close to the blade fixing disc c03, and the six straight-line guide grooves c031 and the six arc-shaped guide grooves c041 are arranged in one-to-one correspondence, and the distances between the two end parts of the arc-shaped guide grooves c041 and the circle center of the blade turntable c04 are unequal.
In this embodiment, the reinforcing tube c02 is fixedly connected to the blade turntable c04, and a fixing element c025 which is sleeved on the periphery of the reinforcing tube c02 and is used for fixing the blade fixing disc c03 in the primary handle a1 is connected to the proximal end of the reinforcing tube c02, and the fixing element c025 protrudes outwards to form a clamping block and is clamped in the primary handle a1, so that the blade fixing disc c03 is fixed in the primary handle a 1. Six wire through holes c021 are circumferentially arranged on the reinforced pipe c02, a reinforced pipe center hole c024 for the pushing pipe a105 to pass through is also arranged in the middle of the reinforced pipe c02, and the six wire through holes c021 are circumferentially and uniformly arranged on the periphery of the reinforced pipe center hole c 024. The dew wire groove c022 is arranged in the middle of the reinforced pipe c02, the guide conical surface c023 is further arranged on the dew wire groove c022, and by means of the design, the blade cutting edge c052 of the cutting blade c05 can be abutted against the dew wire groove c022 more accurately, and the shearing effect can be improved through the cutting edges of the blade cutting edge c052 and the guide conical surface c 023.
In this embodiment, the number of the cutting blades c05 is six, and the cutting blades c05 are spiral, the blade guide rods c051 are uniformly formed on the six cutting blades c05, and two ends of the blade guide rods c051 on the six cutting blades c05 are respectively inserted into the six linear guide grooves c031 and the six arc-shaped guide grooves c041 in a one-to-one correspondence manner.
Specifically, one end of the cutting blade c05, which is close to the reinforcing pipe c02, is provided with an arc-shaped blade cutting edge c052, and arcs of the blade cutting edges c052 are concentric with the line exposing groove c 022. By the design, the blade cutting edge c052 can be all abutted on the exposed wire groove c022 without leaving a hole, and the shaping guide stay wire at the exposed wire groove c022 is ensured to be completely cut off by the blade cutting edge c 052.
Specifically, the cutting blade c05 has a first arc-shaped side surface positioned at one side of the blade edge c052 and a second arc-shaped side surface positioned at the other side of the blade edge c052, and when the plurality of cutting blades c05 extend into the line exposing groove c022, the first arc-shaped side surface of the cutting blade c05 is matched with the second arc-shaped side surface of an adjacent one of the cutting blades c05, and the first arc-shaped side surface of the cutting blade c05 is matched with the second arc-shaped side surface of an adjacent other cutting blade c 05. So design, compact structure is good, can make a plurality of cutting blades c05 rotate to the butt at dew wire groove c022 time the side just cooperate on the butt, avoid contradicting each other and lead to unable cutting off the design guide and act as go-between.
In this embodiment, a cut-off button travel groove is provided on the outer wall of the primary handle a1, and a cut-off button c06 extending out of the cut-off button travel groove is connected to the outer side of the blade turntable c 04.
In this embodiment, as shown in fig. 3 and 30-44, a rivet implantation branch end is provided on the secondary handle a2, a rivet fixing seat a212 is provided at a proximal end of the rivet implantation branch end, a rivet guide tube a213 is provided inside the secondary handle a2, one end of the rivet guide tube a213 passes through the inner tube support seat a203 and is connected to the outer sheath fixing seat a306 to communicate with the auxiliary cavity a303, and the other end of the rivet guide tube a213 is connected to the rivet fixing seat a 212.
In this embodiment, the rivet implanting device d00 is connected to the proximal end of the rivet guide tube a213, and includes a rivet integral handle d200, a rivet pushing handle d300, a medical rivet d100, and a rivet connecting tube d400 connected to a release button d140 of the medical rivet d100, wherein the rivet connecting tube d400 extends into the rivet guide tube a213, and the medical rivet d100 has a shape memory function. Specifically, the medical rivet d100 comprises a puncture tip d110, a rivet barb d120, a rivet clearance groove d130, a trip d140 and a reverse spring block d150, wherein the puncture tip d110 is located at the distal end of the medical rivet d100, the rivet barb d120 is located at one end, close to the puncture tip d110, of the side wall of the medical rivet d100, the rivet clearance groove d130 is located on the outer side wall of the medical rivet d100 and corresponds to the position of the rivet barb d120, the trip d140 is located at the proximal end of the medical rivet d100 and is used for being connected with a rivet connecting pipe d400, and the reverse spring block d150 is located at one end, close to the trip d140, of the medical rivet d 100. The rivet barb d120 has an initial state of the rivet barb d120 which is unfolded outwardly in a natural state and on which the barb is disposed toward the proximal end, and a loading state of the rivet barb d120 which is folded into the rivet avoiding groove d130 by an external force, and the reverse spring d150 has an initial state of the reverse spring d150 which is unfolded outwardly in a natural state and on which the end thereof remote from the medical rivet d100 is disposed toward the distal end, and a loading state of the reverse spring d150 which is folded reversely toward the proximal end by an external force.
The medical rivet d100 is designed by arranging a rivet barb d120 on the side wall of one end of the medical rivet d100 close to a puncture tip d110, providing an anchoring effect on the distal end face of an operation part under a natural state through the rivet barb d120, arranging a rivet avoiding groove d130, accommodating the rivet barb d120 during loading, further reducing the conveying diameter of a conveying system, arranging a reverse elastic block d150 at one end of the medical rivet d100 close to a release d140, expanding outwards under the natural state through the reverse elastic block d150, simultaneously expanding the barb on the reverse elastic block d outwards towards the distal end, and providing an anchoring effect on the proximal end face of the operation part under the action of a shape memory function through the reverse elastic block d150 after the medical rivet d100 is implanted, and further realizing the double-sided anchoring of the operation part by matching with the rivet barb d120, thereby enhancing the riveting strength of the medical rivet d100, improving the fault tolerance and reducing the error probability. In addition, compared with the medical rivet d100 in the prior art, the medical rivet d100 has shorter overall length under the condition of the same anchoring effect, and solves the problems of injury and inflammatory reaction of cardiac muscle caused by overlong puncture of cardiac muscle of the medical rivet d100 in the process of opening and closing movement of the mitral valve.
In this embodiment, the reverse spring d150 is integrally formed on both sides of the medical rivet d 100. In an alternative embodiment, the opposing spring blocks d150 are two spring plates respectively outside the medical rivet d 100. In an alternative embodiment, the reverse spring d150 is an arch spring penetrating through the middle of the medical rivet d100 and welded and fixed on the medical rivet d 100.
In this embodiment, the outer side of the medical rivet d100 is further coaxially sleeved with a rivet pressing piece d160, the rivet pressing piece d160 is cylindrical, and a plurality of outwardly protruding spikes d161 are further disposed at the distal end of the rivet pressing piece d 160. By the design, the periphery of the operation part penetrated by the medical rivet d100 can be firmly fixed through the nailing d161, so that the problem of expanding and tearing of the penetrated part when the medical rivet d100 is pulled is avoided.
In this embodiment, a gap between the rivet pressing piece d160 and the medical rivet d100 can be used for the cladding tube d500 to pass through, an open slot d510 is formed at the distal end of the cladding tube d500, and a pressing piece boss d162 in limit fit with the open slot d510 is formed on the inner side wall of the rivet pressing piece d 160. Through the design, the far end can be slightly opened through the open groove d510 so as to be convenient for loading the rivet into the implantation device, and meanwhile, the open groove d510 and the pressing boss d162 of the rivet pressing d160 can form a stop mechanism, so that the rivet pressing d160 is ensured to move together in the pushing process of the cladding tube d500, and the rivet pressing d160 can be left at the implantation position in the releasing process and cannot be carried out together.
In this embodiment, the implant device includes a rivet integral handle d200, a rivet pushing handle d300, a medical rivet d100, and a rivet connection tube d400 connected to a release button d140 of the medical rivet d 100. Specifically, the release buckle d140 is provided with a release clamping groove d141 and a release protrusion d142 positioned at the proximal end of the release buckle d140, the proximal end of the release clamping groove d141 is provided with a release inclined plane d143 positioned between the release protrusion d142 and the release clamping groove d141, the distal end of the rivet connecting pipe d400 is provided with a buckling structure matched with the release clamping groove d141 and the release inclined plane d143, and the rivet connecting pipe d400 is tightly connected with the release buckle d140 through the release protrusion d142 and the release clamping groove d 141.
In this embodiment, the integral rivet handle d200 includes a distal exit tube end d210 and a proximal push end d220, with a push cavity d221 disposed within the push end d 220. The front section of the rivet pushing handle extends into the pushing cavity d221 and can move back and forth relative to the axial direction of the pushing cavity d221, a rivet connecting cavity d310 is arranged in the rivet pushing handle d300, a rivet connecting pipe fixing block d311 is arranged in the rivet connecting cavity d310, the proximal end of the rivet connecting pipe d400 penetrates through the outlet pipe end d210 and the pushing end d220 to be fixedly connected with the rivet connecting pipe fixing block d311, a snap d340 is arranged on the cavity wall of the pushing cavity d221, a snap inclined surface d341 is arranged at the proximal end of the snap d340, and a stop boss d330 in snap fit with the snap d340 is arranged on the outer wall of the front section of the rivet pushing handle d 300. Through the design, the latch d340 is matched with the stop boss d330, the stop boss d330 moves towards the proximal end and passes through the latch inclined plane d341 of the latch d340, the stop boss d330 passes through the latch d340, and is stopped by the latch d340 after the latch d340 is automatically reset, and the rivet pushing handle d300 keeps a stop state after the rivet is implanted, so that the medical rivet d100 is prevented from being returned due to manual operation.
In this embodiment, the outer circumference of the rivet connection tube d400 is coaxially sleeved with a cladding tube d500. The design of the cladding tube d500 can enable the medical rivet d100 to be adjusted along with the bent tube d600 in the direction during the process of delivering the medical rivet d100 to the operation site, and provides better axial compression resistance and bending resistance during the pushing process.
In the embodiment, a cladding tube connecting cavity d320 is further arranged in the rivet pushing handle d300, the cladding tube connecting cavity d320 is located at the far end of the rivet connecting cavity d310, a cladding tube connecting sliding block d321 is arranged in the cladding tube connecting cavity d320, a rebound spring d325 is arranged between the cladding tube connecting sliding block d321 and the far end cavity wall of the cladding tube connecting cavity d320, a spring fixing block d323 and a release button d322 are further arranged in the cladding tube connecting cavity d320, the release button d322 is elastically connected with the spring fixing block d323 through a release spring d324, the cladding tube connecting sliding block d321 can slide back and forth relative to the cladding tube connecting cavity d320, and the rivet connecting tube d400 penetrates through the cladding tube connecting sliding block d321 to be fixedly connected with the rivet connecting tube fixing block d 311. Through the cooperation of cladding pipe d500 and release button d322, after puncture point d110 passed the operation position, pressed release button d322, cladding pipe connection slider d321 removes the restriction, cladding pipe connection slider d321 slides to the proximal end under the effect of release spring d324, drives cladding pipe d500 to the proximal end displacement for puncture point d110 breaks away from cladding pipe d 500's restraint, and release point d140 and rivet connecting pipe d400 release the state of locking simultaneously, break away from each other. The release button d322 is directly pressed during release, so that the release process is faster and more convenient, and the situation that the medical rivet d100 is misplaced when the medical rivet d100 is released due to manual control travel is avoided.
In this embodiment, a bending tube d600 is coaxially sleeved around the outer periphery of the cladding tube d500, the integral rivet handle d200 further comprises a first bending end d230 and a second bending end which are communicated with the pipe end d210, a bending cavity d250 is arranged in each of the first bending end d230 and the second bending end, a coaxial bending sliding guide rail d251 is arranged in the bending cavity d250, a bending control knob cap d253 is arranged at the proximal end of the bending cavity d250, the bending control knob cap d253 is connected with the bending sliding guide rail d251, a bending control locking nut d252 which is connected to the inner wall of the bending cavity d250 in a sliding manner is connected to the outer periphery of the bending sliding guide rail d251 in a threaded manner, the bending control locking nut d252 can be driven to reciprocate along the axial direction of the bending sliding guide rail d251 by rotating the bending control knob cap d253, a bending control guide wire d254 is connected to the bending control locking nut d252, and the other end of the bending control guide wire d254 is connected to the bending tube d600. Specifically, a wire guide hole d256 is formed in the bending control wire locking nut d252, and one end of the bending control wire guide d254 is fixedly connected to the wire guide hole d 256. By means of the design, the first bending adjusting end d230 and the second bending adjusting end are rotated, the bending knob cap arranged in the bending adjusting cavity d250 drives the bending control locking wire nut d252 to axially reciprocate along the bending adjusting sliding guide rail d251, and further drives the bending control guide wire d254 connected to the bending control locking wire nut d252 to axially reciprocate, and the bidirectional bending adjusting effect can be achieved.
In this embodiment, the tuning tube d600 includes an outer layer d610, an intermediate layer d620 and an inner layer d630 sequentially disposed from outside to inside, specifically, the outer layer d610 of the tuning tube d600 is made of PA and PEbax mixed materials, the intermediate layer d620 is made of stainless steel or nickel-titanium alloy materials, and the inner layer d630 is made of PDFE or PTFE materials. The front section of the bending adjusting pipe d600 is provided with a first traction ring d640 and a second traction ring d650, a bending control guide wire d254 of the first bending adjusting end d230 is connected with the first traction ring d640, and a bending control guide wire d254 of the second bending adjusting end is connected with the second traction ring d 650.
In this embodiment, a bending adjustment fixing seat d211 is fixedly arranged at one end of the pipe end d210, which is close to the first bending adjustment end d230 and the second bending adjustment end, one end of the bending adjustment pipe d600 is fixedly connected with the bending adjustment fixing seat d211, a bending adjustment fixing seat central hole for the cladding pipe d500 to pass through and a bending control guide wire groove d212 for the bending control guide wire d254 to pass through are arranged on the bending adjustment fixing seat d211, specifically, one section of the bending control guide wire d254 is fixed in the guide wire hole d256, and the other end of the bending control guide wire d254 passes through the bending control guide wire groove d212 arranged in the bending adjustment fixing seat d211 and finally stretches into the middle layer d620 of the bending adjustment pipe d 600.
In this embodiment, a blood pressure sealing sheet d260 is connected to the proximal end of the bending fixing seat d211, the distal end of the blood pressure sealing sheet d260 extends into the bending fixing seat d211, and a blood pressure sealing sheet fixing hole d261 and a bending control guide wire avoiding groove d257 are formed in the blood pressure sealing sheet d 260. The blood pressure sealing sheet d260 is fixedly connected with the bending fixing seat d211 through a screw passing through the blood pressure sealing sheet fixing hole d 261. The inside of the bending fixing seat d211 is also padded with a blood sealing pad d270 positioned at the far end of the blood sealing sheet d 260. The inner side wall of the bending adjustment fixing seat d211 is provided with a positioning boss d213, and the inner wall of the rivet integral handle d200 is provided with a positioning groove d214 corresponding to the positioning boss d 213. By the design, the stability of the bending adjustment fixing seat d211 in the integral rivet handle d200 can be ensured.
The using principle of the rivet implanting device d00 is that when the medical rivet d100 is loaded, the open slot d510 on the cladding tube d500 is matched, the open slot d510 can be slightly opened, the reverse elastic block d150 and the rivet barb d120 are pressed by fingers and plugged into the open slot d510, finally, the rivet pressing sheet d160 is sleeved outside the cladding tube d500 through the matching of the pressing sheet boss d162 and the open slot d510, and the loading of the medical rivet d100 is completed.
After loading is completed, the medical rivet d100 is delivered by the implantation device to a location where the medical rivet d100 is to be implanted.
In the delivery process, if bending is required, the bending adjustment pipe d600 can be correspondingly bent by rotating the bending control knob caps d253 of the first bending adjustment end d230 and the second bending adjustment end so as to adapt to the delivery path.
After reaching the predetermined position, the rivet pushing handle d300 is pushed to move the medical rivet d100 distally, and at this time, the sheathing tube d500 and the rivet connecting tube d400 are simultaneously moved distally, and the sheathing tube d500 and the medical rivet d100 pierce the surgical site together through the piercing tip d 110.
After the puncture tip d110 passes through the operation site, the release button d322 is pressed, the cladding tube connecting sliding block d321 immediately releases the fixing restriction, the medical rivet d100 slides proximally under the action of the rebound spring d325, meanwhile, the cladding tube d500 is driven to displace proximally, after the medical rivet d100 is released from the restraint of the cladding tube d500, the rivet barb d120 on the medical rivet d100 is automatically unfolded under the action of the shape memory function and hooks the distal end surface of the operation site, the reverse elastic block d150 of the medical rivet d100 is under the action of the shape memory function and can automatically rebound based on the reversely arranged bending shape, and the rivet pressing d160 is pressed at the same time of rebound, so that the rivet pressing d160 is tightly attached to the proximal end surface of the operation site. Because the far end surface of the rivet pressing piece d160 is provided with the miniature spike d161 which can slightly pierce the circumference of the puncture part, the medical rivet d100 can be prevented from being torn in an propagating way when the medical rivet d100 is stressed.
After the cladding tube d500 moves proximally beyond the position of the release button d140, the release button d140 of the medical rivet d100 and the rivet connecting tube d400 are released from each other and are locked in a mutually locked state, and are separated from each other. In the released state, the implantation of the medical rivet d100 has been completed, and the medical rivet d100 is perfectly left at the implanted surgical site.
In this embodiment, as shown in fig. 45-46, a stent table e00 for delivering a delivery system of a valve repair device is further included, comprising a base plate e1, a rack rail e2 fixed on the base plate e1, and a first support e4 and a second support e5 slidably disposed on the rack rail e 2. The first support e4 is provided with a first sleeve e7 for mounting the primary handle a1 of the pushing device, and the second support e5 is provided with a second sleeve e8 for mounting the secondary handle a2 of the pushing device.
The design of a support table e00 is that a first support e4 and a second support e5 are arranged on the rack slide rail e2 in a sliding mode through a base plate e1 with the rack slide rail e2, a first sleeve e7 is arranged on the first support e4, the first sleeve e7 is used for installing a primary handle a1 of a pushing device, a second sleeve e8 is arranged on the second support e5, and the second sleeve e8 is used for installing a secondary handle a2 of the pushing device. When the rivet is implanted, the first sleeve e7 can rotate the primary handle a1, the second sleeve e8 can limit the secondary handle a2 to rotate along the central axis of the second sleeve e8, the first sleeve e7 cannot rotate when the second sleeve e8 is rotated, the success rate of the implantation operation of the forming ring is improved, the first support e4 and the second support e5 are arranged on the rack slide rail e2, the pushing device slides on a straight line formed by connecting the first support e4 and the second support e5, the stability of the forming ring device in the pushing process during the intervention operation of the forming ring can be guaranteed, the cooperation of the forming ring with a human mitral valve during the intervention operation of the forming ring is guaranteed, and the success rate of the intervention operation is improved.
In this embodiment, two rack slide rails e2 are provided, the first support e4 and the second support e5 each have two legs, and the legs on the same side of the first support e4 and the second support e5 are connected with a slide block e10, and the two rack slide rails e2 are in sliding fit with the corresponding slide blocks e 10. The face that has gear e11 on the rack slide rail e2 is the slope setting, and first sleeve e7 and second sleeve e8 are located same slope on the straight line of being inclined to the horizontal line, and the contained angle of straight line and horizontal line is the same with rack slide rail e 2's slope.
In the embodiment, the bottoms of the first support e4 and the second support e5 are fixed on the same slide block e10, a gear e11 meshed with the rack slide rail e2 is arranged on the slide block e10, a U-shaped groove e12 is formed in the slide block e10, the gear e11 is arranged between two opposite side walls of the U-shaped groove e12, and the lower end of the slide block e10 is connected to a part of the rack slide rail e2 without gear teeth e3 in a sliding mode. The side wall of the sliding block e10 is also connected with a locking piece for abutting against the rack sliding rail e2, and the locking piece is specifically a sliding rail locking screw e13.
In the present embodiment, a rear angle mark e15 for recording the initial angle of the primary handle a1 is provided on the first sleeve e 7. The second sleeve e8 is provided with a front angle mark e16 for recording the rotation angle of the secondary handle a 2. The design of the rear angle mark e15 can adjust the matching degree of the forming ring and the D-shaped mitral valve by observing the angles indicated by the primary handle a1 and the rear angle mark e15. The design of the front angle mark e16 can observe the rotation angle of the secondary handle a2 relative to the primary handle a1 through the front angle mark e16, so that the rivet can be conveniently implanted when the secondary handle a2 rotates to the corresponding degree.
In the embodiment, a third support e6 is further arranged on the bottom plate e1, a third sleeve e9 for installing a three-stage handle a3 of the pushing device is arranged on the third support e6, and the first sleeve e7, the second sleeve e8 and the third sleeve e9 are all positioned on the same straight line. The first sleeve e7, the second sleeve e8 and the third sleeve e9 are provided with quick locking bolts e14.
The using method of the support stand e00 comprises the following steps:
In the shaping ring implantation step, the tertiary sleeves of the first, second and third supports e4, e5, e6 are respectively matched with the primary, secondary and tertiary handles a1, a2, a 3. The corresponding actions of the support stand e00 are as follows:
the quick locking bolts e14 of the first support e4, the second support e5 and the third support e6 are required to be locked before implantation, and the sliding rail locking screws e13 are released during implantation, so that the first support e4 and the second support e5 on the rack sliding rail e2 slide distally. After implantation, the slide rail locking screw e13 is screwed in, so that the support table e00 is kept still.
Then the quick locking bolts e14 of the first support e4, the second support e5 and the third support e6 are rotated to slightly loosen the three-stage sleeve, after fine adjustment is finished, the quick locking bolts e14 are locked again, and the degree of matching of the forming ring and the human mitral valve in a D shape is conveniently adjusted by observing the angle indicated by the first-stage handle a1 and the rear angle mark e 15. And remain stationary after reaching the exact implantation position. When the device which does not need to be left at the position is moved out, the quick locking bolts e14 of the second support e5 and the third support e6 are rotated again to enable the second sleeve e8 and the third sleeve e9 to be loosened, but the first support e4 is kept in a locking state, so that the secondary handle a2 and the tertiary handle a3 rotate relative to the primary handle a1 and return to the original positions, and the rotating angle can be judged by observing the secondary handle a2 and the front angle mark e 16. After returning to the original position, the handle is moved proximally to withdraw the delivery system, after which all quick lock bolts e14 are opened.
The use principle of the valve repair device:
The valve repair device comprises a forming ring body with a shape memory function, a buckle head end positioned at one end of the forming ring body, and a buckle fixing end positioned at the other end of the forming ring body. The initial state before delivery of the valve repair device is in a straight line, the valve repair device is placed in the main cavity a302 of the outer sheath tube a301, the fastening fixing end of the valve repair device is abutted against the distal end face of the multi-cavity tube a107, 6 shaping guide stay wires penetrate into 6 auxiliary cavities a303 of the multi-cavity tube a107, 2 stop pin pulling out wires and 1 traction stay wire penetrate into the pushing tube a 105.
When the outer sheath a301 is inserted into the vicinity of the mitral valve via the apex of the heart, delivery begins:
step one, the secondary handle a2 is pushed to the far end relative to the primary handle a1, the annuloplasty repair paper is pushed out of the outer sheath a301, and the shaping ring body automatically forms a ring shape under the characteristics of memory alloy and the tensioning of the shaping guide stay wire.
And secondly, the push rod push button a104 is shifted to enable the push tube a105 to move distally, the distal end face of the push tube a105 presses the surface of a buckle component of the valve repair device, and as a traction pull wire penetrates into the push tube a105 and is connected to the wire pulling mechanism b02, the effect that the traction pull wire pulls the buckle head end to buckle into the buckle fixed end is formed. The buckle component is buckled, and the forming ring body forms a closed ring shape. (at this time, the pulling wire can be cut off and the corresponding wire pulling locking sleeve in the wire pulling mechanism b02 can be pulled out)
Step three, (possibly needing fine adjustment) fine adjustment of a secondary handle a2 (pushing and rotating), wherein the secondary handle a2 and a tertiary handle a3 are synchronously locked and rotated together at the moment, so that a coating substrate on the forming ring body is attached to the upper surface of the self-body valve leaflet, and the D shape of the forming ring body is matched with the D shape of the human mitral valve;
And fourthly, penetrating a medical rivet d100 and a rivet implantation device d00 through a rivet guide tube a213, penetrating the medical rivet d100 from the lower surface of the self-flap, sequentially penetrating the self-flap, the lower PET mesh (lower coating film), the nickel titanium alloy mesh (mesh base material) and the upper PET mesh (upper coating film), hanging a lock on the upper PET mesh through a rivet barb d120, pressing the lower surface of the self-flap through a rivet pressing piece d160, and preventing the self-flap from being torn in a spreading way by a micro-nail penetration d161 of the rivet pressing piece d 160. After a medical rivet d100 is implanted, the rivet implantation device d00 is withdrawn.
And fifthly, operating the secondary handle a2, wherein the secondary handle a2 rotates relative to the primary handle a1, so that the outer sheath tube a301 and the rivet guide tube a213 rotate by a certain angle, and penetrating the medical rivet d100 and the implantation device thereof through the rivet guide tube a213 again, and repeating the steps for a plurality of times.
And step six, after the implantation of all the medical rivets d100 is completed, the cutting button c06 is shifted, and all 6 shaping guide stay wires are cut off at one time through the wire cutting mechanism c 00.
And step seven, pulling out the locking button b101 of the wire pulling sleeve b9, pulling out the wire pulling sleeve b9, and pulling out the 2 stop pin pulling out wires and the 2 stop pins of the valve repair forming device together.
And step eight, after the 2 stop pins are pulled out, automatically completing shrinkage of the forming ring body under the self shape memory function, and pulling the coating base material by the forming ring body in the shrinkage process, and pulling the self valve leaflet by the coating base material through the medical rivet d100, so as to finally realize shrinkage repair of the self valve leaflet.
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.