Disclosure of Invention
In order to solve the above technical problems, the present invention provides a stent delivery system.
In order to solve the technical problems, the invention adopts the following technical scheme:
the invention provides a vascular stent conveying system, which comprises a vascular stent and a recovery mechanism connected with the vascular stent;
The recovery mechanism comprises a plurality of guide wires, locking nails, locking wires, a middle pipe, a small sealing handle, locking buttons and rivets, wherein the guide wires are connected to the vascular stent in an inserted mode, the head ends of the guide wires are in a free state, the tail ends of the guide wires are limited to the locking nails, the locking nails are detachably fixed to the front ends of the middle pipe, the small sealing handle is sleeved on the tail ends of the middle pipe, locking wire through holes are formed in the middle pipe in a penetrating mode, the proximal ends of the locking wires are inserted into the locking nails, the distal ends of the locking wires penetrate through the locking wire through holes and are riveted to the locking buttons through the rivets, and the locking buttons are clamped to the small sealing handle.
Preferably, the guide wire is a medical stainless steel wire or a nickel-titanium memory alloy wire, and the diameter of the guide wire is 0.1-0.3 mm.
Preferably, the locking wire is a medical stainless steel wire or a nickel-titanium memory alloy wire, and the diameter of the locking wire is 0.3-0.5mm.
Preferably, the locking pin comprises a locking pin body, an end disc, a middle disc and external threads, wherein the end disc, the middle disc and the external threads are sleeved on the locking pin body, a middle hole is formed in the locking pin body in a penetrating mode, a plurality of lead-in wire holes are uniformly distributed in the end disc along the circumferential direction of the end disc, lead-in wires penetrate through the lead-in wire holes, the end disc and the middle disc are respectively provided with a wire locking hole penetrating through the end disc, the proximal end of each wire locking hole penetrates through the wire locking holes and is connected with the locking pin body, and the external threads are fixedly connected with the front end of the middle tube.
Preferably, the external thread is in threaded connection with the front end of the middle pipe.
Preferably, the diameter of the wire locking through hole is the same as the diameter of the wire locking hole and is larger than the diameter of the wire locking, and the wire locking can smoothly move in the wire locking hole and the wire locking through hole.
Preferably, the lock button comprises a limit post, a rivet hole penetrating through the limit post, a shoulder arranged at the middle position of the limit post, and a flat shoulder perpendicular to the shoulder, wherein the rivet is in interference fit with the rivet hole, the distal end of the lock wire is fixed in the rivet hole, and the shoulder and the flat shoulder are matched with the small sealing handle.
Preferably, a limiting groove is formed in the concave portion on one side of the small sealing handle, a limiting hole is formed in the limiting groove, and the lock button is matched with the limiting hole.
Preferably, the width of the flat shoulder is in clearance fit with the upper opening of the limit groove, the diameter of the limit post is in clearance fit with the diameter of the limit hole, the width of the shoulder is in clearance fit with the lower groove width of the limit groove, and the thickness of the shoulder is in clearance fit with the lower groove height of the limit groove.
Preferably, the wire locking hole, the wire locking through hole, the rivet and the lock button are respectively the same as the guide-in wires in number, the tail ends of the guide-in wires sequentially penetrate through the wire locking hole and the wire locking through hole to the rivet hole, and the rivet is used for fixing the tail ends of the guide-in wires in the rivet hole in a pressing mode and fixedly connected with the lock button.
Compared with the related art, in the embodiment of the invention, the leading-in wires are connected to the vascular stent in a penetrating way, the head ends of the leading-in wires are in a free state, the tail ends of the leading-in wires are limited at the locking nails, the locking nails are detachably fixed at the front ends of the middle tubes, the small sealing handles are sleeved at the tail ends of the middle tubes, the middle tubes are penetrated to form locking wire through holes, the proximal ends of the locking wires are inserted into the locking nails, the distal ends of the locking wires penetrate through the locking wire through holes and are riveted to the locking buttons through the rivets, and the locking buttons are clamped to the small sealing handles. Thus, after the front-end intravascular stent is released, if the intravascular stent is found to be inaccurate in position, the intravascular stent can be retracted into the sheath tube, the intravascular stent is released again after the position of the recovery mechanism is readjusted, and the operation is repeated until the intravascular stent is accurate in position, so that the intravascular stent is integrally released, the accurate positioning of the intravascular stent in a blood vessel is realized, and the treatment effect is improved.
Drawings
The present invention will be described in detail with reference to the accompanying drawings. The foregoing and other aspects of the invention will become more apparent and more readily appreciated from the following detailed description taken in conjunction with the accompanying drawings. Attached with
In the figure:
FIG. 1a is a schematic diagram of a stent delivery system according to an embodiment of the present invention;
FIG. 1b is an enlarged view of part I of FIG. 1 a;
FIG. 1c is an enlarged view of part II of FIG. 1 a;
FIG. 2 is a schematic view of a rear release mechanism according to an embodiment of the present invention;
FIG. 3 is a schematic view of a middle tube according to an embodiment of the present invention;
FIG. 4 is a schematic view showing the structure of a lock button according to an embodiment of the present invention;
FIG. 5 is a schematic view of a latch according to an embodiment of the present invention;
FIG. 6 is a schematic view of a small sealing handle in an embodiment of the invention;
FIG. 7 is a schematic view of a stent structure according to an embodiment of the present invention;
FIG. 8a is a cross-sectional view of a released state of a stent in an embodiment of the present invention;
FIG. 8b is a schematic view of a released state of a stent according to an embodiment of the present invention;
FIG. 8c is a schematic view showing the position of the lock button in the released state of the stent according to the embodiment of the present invention;
FIG. 9a is a cross-sectional view of a compressed state of a stent in an embodiment of the present invention;
FIG. 9b is a schematic view showing the position of the lock button in a compressed state of the stent according to the embodiment of the present invention;
FIG. 10a is a cross-sectional view of a stent in a semi-released state in an embodiment of the present invention;
FIG. 10b is a schematic view of a semi-released stent configuration according to an embodiment of the present invention;
FIG. 11 is a schematic view of a stent in an alternative embodiment of the present invention;
FIG. 12 is an enlarged view of a portion VIII of FIG. 11;
FIG. 13 is a schematic perspective view of a small handle in an embodiment of the invention;
FIG. 14 is a schematic view of a seal small handle in accordance with an embodiment of the present invention;
FIG. 15a is a schematic view showing the position of the lock button in a compressed state of the stent according to the embodiment of the present invention;
Fig. 15b is a schematic view showing the position of the lock button in the released state of the stent in the embodiment of the present invention.
Wherein 1, positioning guide head, 2, screw, 3, connecting piece, 4, sheath tube, 5, leading-in wire, 6, double-layer core tube, 7, locking nail, 71, locking nail body, 72, end disc, 73, middle disc, 74, external screw thread, 8, locking wire, 9, middle tube, 10, big handle, 11, sealing small handle, 12, locking button, 13, rivet, 14, small handle, 15, steel needle, 16, thick spring tube, 17, thin spring tube, 18, leading-in wire hole, 19, locking wire hole, 20, middle hole, 21, shoulder, 22, flat shoulder, 23, rivet hole, 24, bare stent, 25, stent ring, 251, first stent ring, 252, second stent ring, 253, third stent ring, 26, artificial vessel, 27, surgical suture, 28, crest, 29, trough, 30, limit groove, 31, limit hole, 32, limit post, 33, locking wire via, 34, core tube via, 35, nut, 36, pre-opened window, 37, development mark, 38, push nut, 39, internal thread, 40, vascular stent, 50, rear release mechanism, 51, rear release body, 60, recovery mechanism, 70, push mechanism.
Detailed Description
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs, the terms used in the description herein are used for the purpose of describing particular embodiments only and are not intended to limit the application, and the terms "comprising" and "having" and any variations thereof in the description of the application and the claims and the above description of the drawings are intended to cover non-exclusive inclusions. The terms first, second and the like in the description and in the claims or in the above-described figures, are used for distinguishing between different objects and not necessarily for describing a sequential or chronological order.
Reference herein to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the application. The appearances of such phrases in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Those of skill in the art will explicitly and implicitly appreciate that the embodiments described herein may be combined with other embodiments.
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. 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.
Referring to fig. 1a-10b, a stent delivery system according to an embodiment of the present invention includes a stent 40 and a retrieval mechanism 60 coupled to the stent 40.
The recovery mechanism 60 comprises a plurality of guide wires 5, locking nails 7, locking wires 8, a middle tube 9, a small sealing handle 11, locking buttons 12 and rivets 13, wherein a plurality of guide wires 5 are connected to the vascular stent 40 in a penetrating mode, the head ends of the guide wires 5 are in a free state, the tail ends of the guide wires 5 are limited to the locking nails 7, the locking nails 7 are detachably fixed to the front ends of the middle tube 9, the small sealing handle 11 is sleeved on the tail ends of the middle tube 9, locking wire through holes 33 are formed in the middle tube 9 in a penetrating mode, the proximal ends of the locking wires 8 are inserted into the locking nails 7, the distal ends of the locking wires 8 penetrate through the locking wire through holes 33 and are riveted to the locking buttons 12 through the rivets 13, and the locking buttons 12 are clamped to the small sealing handle 11.
Wherein, the proximal end of the locking wire 8 is a proximal end, and the distal end is a distal end.
Specifically, the tail ends of the plurality of guide wires 5 are connected to the vascular stent 40 in a penetrating manner, so that the head ends of the plurality of guide wires 5 are in a free state, the tail ends of the plurality of guide wires 5 are limited to the locking nails 7, limiting fixation is formed between the guide wires 5 and the locking nails 7, winding of the plurality of guide wires 5 is avoided, and the guide wires 5 are convenient to stretch and retract and adjust the vascular stent 40.
By rotating the lock knob 12, the lock knob 12 is separated from the small sealing handle 11, the lock knob 12 pulls the tail end of the lock wire 8 to drive the lock nail 7 to move, and the tail ends of the guide wires 5 are limited to the lock nail 7, so that the guide wires 5 also move along with the lock nail 7 in the moving process of the lock nail 7, and the vascular stent 40 can be contracted.
The locking nail 7 is detachably fixed at the front end of the middle pipe 9, so that the locking nail 7 is convenient to disassemble, assemble and fix, and convenient to replace and maintain. Optionally, the locking pin 7 is fastened and fixed at the front end of the middle tube 9.
Preferably, the locking pin 7 is welded and fixed to the front end of the middle tube 9. The locking nail 7 and the middle tube 9 are integrally formed, and the structural strength is high.
The vascular stent conveying system further comprises a positioning guide head 1, a rear release mechanism 50, a double-layer core tube 6, a sheath tube 4, a large handle 10, a small handle 14 and a pushing mechanism 70, wherein one end of the rear release mechanism 50 is fixedly connected with the positioning guide head 1, the other end of the rear release mechanism 50 is fixedly connected with one end of the double-layer core tube 6, the other end of the double-layer core tube 6 is fixed in one end of the middle tube 9, the sheath tube 4 is sleeved on the middle tube 9, the large handle 10 is fixed on the sheath tube 4, the small handle 14 is sleeved on the sheath tube 4 and is fixedly connected with the other end of the middle tube 9, the small handle 11 is hermetically arranged on the small handle 14, and the pushing mechanism 70 is connected with the small handle 14. Wherein, the positioning guide head 1 is arranged corresponding to one end of the sheath tube 4, and the small handle 14 is sleeved at the other end of the sheath tube 4.
The vascular stent 40 comprises a bare frame 24 with a head end and a plurality of sections of stent rings 25 with tail ends, the head end of the bare frame 24 corresponds to the other end of the rear release mechanism 50, the tail ends of the bare frame 24 are respectively connected with the head ends of the plurality of sections of stent rings 25 in a penetrating way through a plurality of guide wires 5, and the tail ends of the plurality of guide wires 5 are in limit connection with the locking nails 7. The bare frame 24 and the plurality of section support rings 25 are connected by a plurality of guide wires 5 in a penetrating way, the head ends of the guide wires 5 are in a free state, and the tail ends of the guide wires 5 are connected with the locking nails 7.
Specifically, the sheath tube 4 is driven to move backwards through the large handle 10, the bare frame 24 is opened, and after the bracket ring 25 at the front end is released, the front end of the bracket ring 25 is opened, so that the effect of expanding the blood vessel is realized. If the position of the intravascular stent 40 is found to be inaccurate, the distal end of the locking wire 8 is pulled through the loosening of the locking button 12, the proximal end of the locking wire 8 is connected with the locking pin 7, so that the locking pin 7 and the middle tube 9 are pulled to move to one end of the distal sheath tube 4, the intravascular stent 40 is retracted into the sheath tube 4 through the small handle 14 pulling the rear release mechanism 50, the front three stent rings 25 are released again after the position is readjusted, the operation is repeated until the intravascular stent 40 is wholly released after the position of the intravascular stent 40 is accurate, and therefore the intravascular stent 40 is accurately positioned in a blood vessel, and the treatment effect is improved.
In this embodiment, as shown in fig. 7, the multiple stent rings 25 include a first stent ring 251, a second stent ring 252 and a third stent ring 253, one end of the first stent ring 251 corresponds to the bare stent 24, and the bare stent 24 is sequentially connected with the first stent ring 251, the second stent ring 252 and the third stent ring 253 by inserting a plurality of guide wires 5. The bare frame 24, the stent ring 25 and the covering film are sutured together through surgical sutures 27 to form a vascular stent 40, the head ends of the plurality of the guide wires 5 are arranged corresponding to the other end of the rear release mechanism 50, and the tail ends of the plurality of the guide wires 5 are connected with the locking nails 7. The guide wires 5 are connected, so that the support ring 25 can be conveniently and telescopically adjusted to position the vascular support 40 in a blood vessel, and the positioning accuracy and the adjusting effect are high.
Preferably, N peaks 28 and N valleys 29 are provided on each of the bracket rings 25, wherein N is 3-8.
Specifically, the vascular stent 40 is manufactured by suturing a segment of bare stent 24, M (M.gtoreq.3) segment stent ring 25 to an artificial blood vessel 26 by surgical suture 27. One end of the bare frame 24 is a frame head end, the other end is a frame tail end, and the bare frame 24, the first section of frame ring 251, the second section of frame ring 252 and the Mth section of frame ring are sequentially arranged from the frame head end to the tail end. Each segment of the stent ring 25 has N (n=3-8) peaks 28 and N valleys 29, referred to as N-headed stent rings 25. The length of the artificial blood vessel 26 is L2, and developing marks 37 are sewn on both ends of the artificial blood vessel 26 and around the pre-opening window 36 of the pre-opening window vascular stent 40 for displaying the position of the vascular stent 40 in operation.
In this embodiment, as shown in fig. 8 a-10 b, when the front K (k.ltoreq.m) segment stent ring 25 and the bare stent 24 of the vascular stent 40 need to be recovered into the sheath 4 during operation, the head ends of N guide wires need to be pulled, the tail of the vascular stent 40 (fig. 7) is inserted into the sheath 4 one by one, the artificial blood vessel 26 is penetrated from the position 1-3 mm on the right side of the trough 29 of the K-th segment stent ring, the artificial blood vessel 26 is penetrated from the position 1-3 mm on the left side of the trough 29, and the same operation is performed on the K-1, K-2, the 1 st segment stent ring and the bare stent 24. Thus, the bare stent 24 of the N-headed vascular stent 40 and the N troughs of the anterior K-joint stent ring are respectively pressed by the N guide wires 5. The head ends of the N guide wires 5 are in a free state, and the tail ends of the N guide wires 5 are fixedly connected with the locking nails 7 through the N guide wire holes 5.
In this embodiment, as shown in fig. 1 a-1 c, the locking wire 8 is a medical stainless steel wire or a nickel-titanium memory alloy wire, and the diameter of the locking wire 8 is 0.3-0.5mm. The medical safety of the medical stainless steel wire or the nickel-titanium memory alloy wire is high, the diameter of the locking wire 8 is 0.3-0.5mm, the proximal end of the locking wire 8 is conveniently inserted into the locking nail 7, the distal end of the locking wire 8 passes through the middle tube 9 to the locking button 12, and the distal end of the locking wire is extruded by the rivet 13 to be fixed on the locking button 12.
In this embodiment, as shown in fig. 5, the locking pin 7 includes a locking pin body 71, an end disc 72 sleeved on the locking pin body 71, a middle disc 73 and external threads 74, wherein the locking pin body 71 is internally penetrated to form the middle hole 20, a plurality of lead-in wire holes 18 with the same number as the bracket rings 25 are uniformly distributed on the end disc 72 along the circumferential direction, the lead-in wires 5 are arranged through the lead-in wire holes 18, the end disc 72 and the middle disc 73 are respectively provided with a locking wire hole 19 penetrating through the lead-in wire holes, the locking wire 8 penetrates through the locking wire holes 19 and is connected with the locking pin body 71, the locking pin body 71 is fixed at the other end of the double-layer core tube 6, and the external threads 74 are fixedly connected with one end of the middle tube 9.
Specifically, the locking nail 7 is made of medical stainless steel. The tail end of the double-layer core tube 6 is disposed in the middle hole 20, the guide wire 5 passes through the guide wire hole 18, the end disc 72 and the middle disc 73 pass through the wire locking hole 19, the wire locking 8 passes through the wire locking hole 19 and is connected with the locking nail body 71, so that the locking button 12 is convenient to adjust the wire locking 8, and the vascular stent 40 is driven to move back and forth in the sheath tube 4, so as to adjust the position of the vascular stent 40.
In this embodiment, as shown in fig. 8a, the guide wire 5 is a medical stainless steel wire or a nitinol wire, the diameter of the guide wire is 0.1-0.3 mm, the length of the guide wire 5 is L1, and the number of the guide wires 5 is matched with the number of the stent rings 25. Wherein, the number of the guide wires 5 is N, and N is 3-8, namely 3-8 guide wires 5 are corresponding to the stent ring 25.
In this embodiment, as shown in fig. 4, the lock knob 12 is made of medical stainless steel, the lock knob 12 includes a limit post 32, a rivet hole 23 penetrating through the limit post 32, a shoulder 21 disposed in a middle position of the limit post 32, and a flat shoulder 22 perpendicular to the shoulder 21, the rivet 13 is in interference fit with the rivet hole 23, so as to fix a distal end of the lock wire 8 in the rivet hole 23, and the shoulder 21 and the flat shoulder 22 are matched with the small sealing handle 11.
Specifically, the lock knob 12 is made of medical stainless steel. The upper part of the lock knob 12 is a knob, the lock knob 12 can be rotated by manual twisting, a shoulder 21 and a flat shoulder 22 are designed in the middle of the lock knob 12 and are vertically distributed, the width of the flat shoulder 22 is A, the width of the shoulder 21 is B, the lower part of the lock knob 12 is a limit post 32, a rivet hole 23 is formed in the limit post 32, and the diameter of the limit post 32 is D.
In this embodiment, as shown in fig. 1 a-1 c, the material of the small sealing handle 11 includes one of POM, PVC, PP and ABS.
In this embodiment, as shown in fig. 8c, a limiting groove 30 is formed on one side of the small sealing handle 11 in a recessed manner, a limiting hole 31 is provided in the limiting groove 30, and the lock knob 12 is matched with the limiting hole 31.
In this embodiment, as shown in fig. 4 and fig. 6-8 c, the width of the flat shoulder 22 is in clearance fit with the upper opening of the limit groove 30, the diameter of the limit post 32 is in clearance fit with the diameter of the limit hole 31, the width of the shoulder 21 is in clearance fit with the lower groove width of the limit groove 30, and the thickness of the shoulder 21 is in clearance fit with the lower groove height of the limit groove 30.
Specifically, the small sealing handle 11 is provided with a limit groove 30 and a limit hole 31. The upper opening width of the limiting groove 30 is A1, the lower groove width is B1, and the inner diameter of the limiting hole 31 is D1, wherein B1 is greater than A1 and greater than D1. The width A of the flat shoulder 22 is in clearance fit with the opening A1 at the upper part of the limit groove 30, the diameter D of the limit post 32 is in clearance fit with the diameter D1 of the limit hole 31, the width B of the lock button shoulder 21 is in clearance fit with the width B1 of the lower part of the limit groove 30, and the thickness of the shoulder 21 is in interference fit with the groove height at the lower part of the limit groove 30.
By aligning the flat shoulder 22 on the lock knob 12 with the upper opening of the limit groove 30 and inserting the limit post 32 into the limit hole 31 on the small seal handle 11, rotating for 90 degrees, the shoulder 21 is screwed into and clamped in the groove at the lower part of the limit groove 30, the lock knob 12 is in a locking state, the lock knob 12 is rotated for 90 degrees again, the lock knob 12 is in an unlocking state, and the lock knob 12 can be lifted from the limit hole 31.
In this embodiment, as shown in fig. 3 to 5, a core pipe via hole 34 is disposed at the axial position of the middle pipe 9, an internal thread 39 is disposed at one end of the core pipe via hole 34 near the double-layer core pipe 6, the internal thread 39 is connected with the external thread 74, and a locking thread via hole 33 is disposed in the circumferential direction of the middle pipe 9.
In this embodiment, as shown in fig. 3, the diameter of the wire locking via hole 33 is the same as the diameter of the wire locking hole 19 and larger than the diameter of the wire locking 8, and the wire locking 8 can move smoothly in the wire locking hole 19 and the wire locking via hole 33.
Specifically, a core tube through hole 34 is arranged at the axial center of the middle tube 9, an internal thread 39 is arranged at the near center end of the core tube through hole 34, a locking wire through hole 33 is arranged in the circumferential direction of the middle tube 9, the diameter of the locking wire through hole 33 is equal to that of the locking wire through hole 19 and slightly larger than that of the locking wire 8, the center distance between the locking wire through hole 33 and the core tube through hole 34 is H1, H=H21, the locking wire through hole 19 and the locking wire through hole 33 are coaxial, and the locking wire 8 can be easily pumped in the locking wire through hole 19 and the locking wire through hole 33.
In this embodiment, as shown in fig. 3-7, the vascular stent 40 delivery system has N (n=3-8) guide wires 5 fixedly connected with the locking pins 7 through N guide wire holes 18 on the locking pins 7. The length L1 of the guide wire 5 and the length L2 of the artificial blood vessel 26 should satisfy the following relationship that L1-L2 is more than or equal to 0mm and less than or equal to 10mm.
The external thread 74 of the locking pin 7 is screwed with the internal thread 39 of the middle pipe 9 and is fixedly connected with the middle pipe 9, and the locking thread hole 19 on the locking pin 7 is coaxial with the locking thread through hole 33 on the middle pipe 9.
The locking wire 8 passes through the locking wire hole 19 and the locking wire through hole 33 to the other end of the middle tube 9, and the locking wire 8 is extruded and fixed in the rivet hole 23 through the rivet 13 and is connected and fixed with the locking button 12. The locking wire 8 can slide easily in the locking wire hole 19 and the locking wire through hole 33.
In this embodiment, as shown in fig. 2, the rear release mechanism 50 includes a rear release body 51, a screw 2 disposed on the rear release body 51, a connecting member 3, a plurality of steel needles 15, a thick spring tube 16, and a thin spring tube 17, the steel needles 15 are fixed together with the screw 2 and uniformly distributed along the circumferential direction of the screw 2, one end of the rear release body 51 is connected with the positioning guide head 1 through the screw 2, the other end of the rear release body 51 is connected with the thick spring tube 16 through the connecting member 3, and the screw 2 is connected with the thin spring tube 17. Preferably, the connector 3 is a polygonal connector, such as a five-pointed star connector.
Specifically, the rear release mechanism 50 is composed of a screw 2, a connecting piece 3 and N steel needles 15. The steel needles 15 are fixed with the screw 2 and are uniformly distributed along the circumferential direction of the screw 2. The front end of the rear release mechanism 50 is connected with the positioning guide head 1 through threads on the screw 2. The rear end of the rear release mechanism 50 is connected to the thick spring tube 16 via the connector 3 and to the thin spring tube 17 via the screw 2. The connecting piece 3 is evenly distributed with N pin holes along the circumferential direction, and the thin spring tube 17 can drive the screw 2 and the N steel needles 15 to reciprocate in the N pin holes. The middle part of the connecting piece 3 is provided with an annular groove, so that N wave crests 28 of the bare frame 24 on the vascular stent 40 can be embedded into the annular groove and are restrained in the groove by N steel needles 15 inserted into the pin holes, and the bare frame 24 is locked. Wherein N is 3-8.
In this embodiment, as shown in fig. 1a to 1c, the large handle 10 is provided with a long hole penetrating from front to back, and the middle tube 9 is connected to the small seal handle 11 through the long hole. The front end of the large handle 10 is fixedly connected with the rear end of the sheath tube 4, a sealing ring is arranged at the rear end of the large handle 10, and the sealing ring is extruded by screwing the nut 35, so that the middle tube 9 is compressed, and the middle tube 9 is locked.
In this embodiment, the push mechanism 70 includes a threaded rod coupled to the small handle 14 and a push nut 38 that is sleeved on the threaded rod. The push nut 38 is rotated to adjust the position of the small handle 14 and thus the vascular stent 40 to move within the sheath 4.
In this embodiment, the vascular stent and the delivery system are assembled as follows:
Firstly, all the guide wires 5 are connected with the vascular stent 40, then, the tail part of the vascular stent 40 is locked with the locking nails 7, namely, N guide wires 5 are guaranteed not to twist and wind, the trough which is positioned on the last section of stent ring 25 of the vascular stent 40 and is positioned in the same circumferential direction with the wire locking holes 19 is pressed into the groove between the end disc 72 and the middle disc 73 of the locking nails 7, and meanwhile, the wire locking 8 is penetrated into the two wire locking holes 19, so that the trough 29 is fixed in the groove of the locking nails 7, and the locking of the tail part of the vascular stent 40 and the locking nails 7 is realized. The locking knob 12 is locked on the small sealing handle 11, so that the locking wire 8 can be prevented from moving unexpectedly to enable the trough of the last section of bracket ring to be separated from the groove of the locking pin, and the tail of the bracket and the locking pin can be prevented from being unlocked unexpectedly.
All peaks 28 of the bare stent 24 on the stent 40 are secured to the rear release mechanism 50, locking the head end of the stent 40 to the delivery system.
The stent 40 is compressed and inserted into the sheath 4 section by section starting from the last stent ring 25 until the entire stent 40 is inserted into the sheath 4. The nut 35 is tightened to fix the middle tube 9 and the sheath tube 4 together. The assembly of the stent 40 with the delivery system is thus completed.
As shown in fig. 8 a-10 b, the working principle of the invention is as follows:
1. Preoperatively, the vascular stent 40 and the delivery system are assembled together (as shown in fig. 8 a-8 c), wherein a plurality of guide wires 5 are sequentially connected with a third stent ring 253, a second stent ring 252, a first stent ring 251 and a bare stent 24 of the vascular stent 40, one end of each guide wire 5 is connected with the other end of the rear release mechanism 50, the other ends of the guide wires 5 are connected with the locking nails 7, the tail end of the vascular stent 40 is locked on the locking nails 7, the locking button 12 is locked on the small sealing handle 11, the bare stent 24 is locked on the rear release mechanism 50, and the vascular stent 40 is gradually compressed from the tail end and pushed into the sheath tube 4.
2. The superhard guidewire is delivered from the femoral incision into the thoracic aorta to the appropriate location.
3. The delivery system with the stent 40 mounted is advanced along the guidewire to the aortic arch and the position of the delivery system is adjusted by 4 visualization markers 37 around the pre-opened window on the stent 40 to align the window of the stent 40 with the left subclavian opening.
4. The nut 35 is unscrewed, the small handle 14 is fixed (at the moment, the bare stent 24 at the head end of the stent is fixed on the rear release mechanism 50, and the tail end of the stent is fixed on the locking nail 7), the back-withdrawn large handle 10 drives the sheath 4 to move backwards until the front three stent rings are completely separated from the sheath 4 and supported in the blood vessel (figure 10 a). At this point the pre-opening window 36 is fully extended and accurate determination of its alignment with the left subclavian artery opening can be made. When the two are not aligned, the position of the front 3-section stent ring 25 cannot be directly adjusted because the two are already supported in the blood vessel. The small handle 14 needs to be fixed, the large handle 10 is pushed forward, the front three sections of the support rings 25 and the bare frames 24 are compressed again under the guidance of the guide wires 5 and pulled back into the sheath tube 4, and the conveying system can be easily pumped and rotated at the moment, so that the position of the support pre-opening window 36 in the blood vessel can be adjusted. Once again, the sheath 4 is withdrawn to release the anterior 3-segment stent and if the pre-opening window 36 is not aligned with the left subclavian artery opening, the above procedure is repeated until the two are aligned to achieve accurate positioning of the vascular stent 40. The remainder of the stent within the sheath 4 is released.
5. Unlocking the lock knob 12 from the small sealing handle 11 and withdrawing the lock wire 8, the tail end of the vascular stent 40 is unlocked and separated from the lock nail 7.
6. Holding the small handle 14 still rotates the push nut 38 counterclockwise, opens the rear release mechanism 50, and releases the bare rack 24. To this end, the stent 40 is fully deployed.
7. Holding the large handle 10 still, withdrawing the small handle 14, separating the guide wire 5 from the vascular stent 40, and moving the middle tube 9, the lock pin 7, the guide wire 5, the double-layer core tube 6, the rear release mechanism 3 and the positioning guide head 1 together with the small handle 14 into the sheath tube 4.
8. After positioning the guide head 1 in engagement with the sheath 4, the nut 35 is locked.
9. The large handle 10 is held and retracted along the guide wire 5, the whole conveying system is withdrawn from the blood vessel, and the operation is completed.
In an alternative embodiment of the present invention, as shown in fig. 11-15 b. The number of the wire locking holes 19, the wire locking through holes 33, the rivets 13 and the lock buttons 12 is the same as that of the guide wires 5, the tail ends of the guide wires 5 sequentially penetrate through the wire locking holes 19, the wire locking through holes 33 to the rivet holes 23, and the tail ends of the guide wires 5 are extruded and fixed in the rivet holes 23 by the rivets and are fixedly connected with the lock buttons 12. In this embodiment, the number of guide wires is 3 to 8.
Preferably, the plurality of guide wires 5 include 5 guide wires, the 5 guide wires are respectively inserted into the bare rack 24 and the trough 29 of the bracket ring 25, the end disc 72 uniformly distributes 5 guide wire holes 18 with the same number as the bracket ring 25 along the circumferential direction, the 5 guide wires 5 are arranged through the 5 guide wire holes 18, the end disc 72 and the middle disc 73 are respectively provided with 5 wire locking holes 19 penetrating through the end disc 72 and the middle disc 73, 5 wire locking through holes 33 are penetrated through the middle tube, and 5 locking buttons 12 and 5 rivets 13 are respectively arranged. The tail ends of the 5 guide wires 5 sequentially pass through the guide wire holes 18, the wire locking holes 19 and the wire locking through holes 33 and are extruded into the rivet holes 23 through the rivets 13 to realize fixation, and are clamped into the limiting holes 31 through the matching of the lock buttons 12. Because 5 limit grooves 30 are formed in the concave manner on one side of the small sealing handle 11, 5 limit holes 31 are respectively formed in the 5 limit grooves 30, 5 lock buttons 12 and rivets 7 and 5 lock wires 8 are respectively fixed with 5 rivets 13 in the 5 limit holes 31. In this embodiment, the distal end of the lock wire 8 is fixed to the lock knob 12, and optionally, the distal end of the lock wire 8 is fixed to the center of the lock knob 12.
The sheath 4 is withdrawn by unlocking the first lock knob 12 from the small sealing handle 11 and withdrawing the first locking wire 8, thereby causing the portion of the first guidewire 5 attached to the vessel stent 40. When the vessel holder 40 is rotated or moved to adjust the pre-opening window 36, the pre-opening window 36 is made to correspond to the vessel. After the position of the stent 40 is accurately adjusted, the entire stent 40 is pushed out of the sheath 4. At this time, the rear release mechanism 50 at the proximal end of the vascular stent 40 is not opened, 5 guide wires are connected with the vascular stent 40 in a penetrating way, and the 5 guide wires 5 limit 1-5 wave troughs 29 of the last stent ring at the distal end of the vascular stent 40 on the locking nails 7. By withdrawing 5 guide wires 5 one by one, the guide wires 5 are separated from the vascular stent 40, and the guide wires 5 are contracted one by one, so that the vascular stent 40 has small contraction friction, the vascular stent 40 cannot move, and the vascular stent 40 has good adjusting effect. The last stent ring 25 at the distal end of the stent 40 is separated from the locking pins 7 one by the trough 29 limited on the locking pins 7 (the release mechanism 50 is still not opened at this time), and finally the pushing nut 38 is rotated anticlockwise by operating the small handle 14, the release mechanism 50 is opened, and the bare stent 24 and the stent ring 25 are sequentially released until the stent 40 is fully opened.
Compared with the prior art, the embodiment of the invention has the beneficial effects that:
The vascular stent 40 is delivered to the lesion site by a delivery system, the small handle is fixed, the large handle is withdrawn, the bare stent 24 of the vascular stent 40 and the front K (K is less than or equal to M) segment vascular stent 40 ring are released, and the front K segment vascular stent 40 is unfolded and supported in the blood vessel. If the intravascular position of the stent 40 is found to be inaccurate, the proximal breach may not be completely blocked, the branch vessel may not be blocked, and the pre-opening window 36 may not be aligned with the branch vessel. The fixed small handle 14 pushes the large handle 10 forward, the tail of the vascular stent 40 is fixed on the locking nail 7, the locking nail 7 is connected with the middle tube 9 through threads, so that the vascular stent 40 is fixed when the sheath tube 4 moves forward, and the vascular stent 40 is gradually compressed by the sheath tube 4 and is received in the sheath tube 4. When the trough 29 of the vessel stent 40 ring reaches the mouth of the sheath 4, the trough 29 is pressed by the guide wire 5, and the guide wire 5 smoothly guides the trough of the vessel stent 40 ring into the sheath, so that the trough is not blocked at the mouth of the sheath 4. Thus, the released part of the vascular stent 40 is retracted back into the sheath 4, so that the position of the vascular stent 40 in the blood vessel can be readjusted by adjusting the axial position and the circumferential position of the delivery system in the blood vessel, and the accurate positioning of the proximal end of the vascular stent 40 and the accurate positioning of the pre-opening window 36 are realized.
The tail end of the vascular stent 40 is limited on the locking nails 7, when the vascular distal end breach is blocked, the conveying system is pushed, so that the vascular stent 40 distal end is pushed to a proper position to effectively block the distal end breach, the small handle is fixed, the large handle 10 is withdrawn until the whole vascular stent 40 is separated from the sheath tube 4, and the vascular stent is supported and fixed on the vascular wall after being unfolded. The distal end of the vascular stent 40 is always locked and nailed on the locking nails 7 in the process, and the position is fixed, so that the precise positioning of the distal end of the vascular stent 40 is realized.
It should be noted that the above embodiments described above with reference to the drawings are only for illustrating the present invention and not for limiting the scope of the present invention, and it should be understood by those skilled in the art that modifications or equivalent substitutions to the present invention are intended to be included in the scope of the present invention without departing from the spirit and scope of the present invention. Furthermore, unless the context indicates otherwise, words occurring in the singular form include the plural form and vice versa. In addition, unless specifically stated, all or a portion of any embodiment may be used in combination with all or a portion of any other embodiment.