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WO2021135270A1 - Ancre intégrée et système d'ancrage - Google Patents

Ancre intégrée et système d'ancrage Download PDF

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Publication number
WO2021135270A1
WO2021135270A1 PCT/CN2020/110302 CN2020110302W WO2021135270A1 WO 2021135270 A1 WO2021135270 A1 WO 2021135270A1 CN 2020110302 W CN2020110302 W CN 2020110302W WO 2021135270 A1 WO2021135270 A1 WO 2021135270A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
base
lock
proximal end
distal end
Prior art date
Application number
PCT/CN2020/110302
Other languages
English (en)
Chinese (zh)
Inventor
黄桥
谢琦宗
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201922500885.2U external-priority patent/CN212346608U/zh
Priority claimed from CN201911424938.5A external-priority patent/CN113116427B/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2021135270A1 publication Critical patent/WO2021135270A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • the invention relates to the technical field of medical devices, in particular to an integrated anchoring piece and an anchoring system.
  • mitral regurgitation mitral regurgitation
  • MR mitral regurgitation
  • Traditional surgical procedures are traumatic and high-risk.
  • mitral regurgitation surgery there is a great demand for minimally invasive mitral regurgitation surgery in clinical practice.
  • Interventional minimally invasive treatment of mitral regurgitation has the advantages of less trauma and fewer complications.
  • Artificial chordal implantation is a kind of interventional mitral valve repair. The operating principle is: the suture is fed into the left ventricle through the catheter, so that one end of the suture is fixed to the mitral valve leaflet, and the other suture One end is connected with the left ventricular myocardial wall or papillary muscle through an anchor to form an artificial chordae.
  • the anchors used for artificial chordal implantation have a single function, and are generally only used to anchor the ventricular wall or papillary muscles. Later, additional instruments need to be introduced to lock the artificial chords and anchors. , And introduce additional equipment to cut the artificial tendon, that is, when the existing anchor is used for transcatheter tendon repair, the anchoring of the anchor, the locking of the artificial tendon and the anchor, and the cutting of the artificial tendon are respectively Separate instruments are required for implementation. Therefore, different instruments need to be replaced and introduced during the operation. The operation is more complicated, the number of instruments to be used is large, and the cost is higher.
  • one aspect of the present application provides an integrated anchor.
  • an integrated anchor including an anchor portion, a base fixedly connected to the proximal end of the anchor portion, and a lock core installed in the base;
  • the lock core includes two oppositely arranged elastic arms, and the two elastic arms are provided with a lock wire structure that cooperates with each other
  • the blade portion provided at the proximal end of the lock wire structure, the artificial tendon is inserted between the two elastic arms; the two elastic arms move distally relative to the diameter-changing section so that the diameter-changing section gradually squeezes
  • the wire locking structure gradually merges from its distal end to its proximal end to lock the artificial chords until the blade cuts the artificial chords.
  • Another aspect of the present application provides an anchoring system.
  • an anchoring system including the above-mentioned integrated anchor and a conveyor; the conveyor at least includes a torsion component, a release component, and a locking and cutting component; the torsion component and the release component
  • the torsion component is used to move axially relative to the release component so that the distal end of the release component is connected to the base of the integrated anchor or released from the base of the integrated anchor , And drive the release assembly and the base to rotate so that the integrated anchoring portion connected with the base is anchored into the target tissue
  • the locking and cutting assembly is movably installed in the release assembly and placed in the When the distal end of the release assembly is connected to the base of the integrated anchor, it is connected to the lock core of the integrated anchor, and the lock and cut assembly is used to drive the two elastic arms of the lock core relative to the The variable diameter section moves to the distal end to lock and cut the artificial chordae.
  • the integrated anchor provided by the present application is provided with an anchoring part, a base fixedly connected to the proximal end of the anchoring part, and a lock core installed in the base. Diameter section, the diameter of the variable diameter section gradually decreases from its proximal end to its distal end.
  • the two elastic arms on the lock cylinder are provided with a matching lock wire structure and a blade located at the proximal end of the lock wire structure.
  • the tendon is inserted between the two elastic arms; the two elastic arms move to the distal end relative to the variable diameter section, so that the variable diameter section gradually squeezes the two elastic arms, and the locking wire structure gradually merges from the distal end to the proximal end to lock the artificial tendon
  • the artificial tendon cord is cut up to the blade, that is, the integrated anchor of the present application integrates the functions of anchoring, locking and cutting the artificial tendon cord, while the conveyor in the anchoring system of the present application has a torsion component , Release component, and lock cutting component, the three cooperate with each other.
  • FIG. 1 is a schematic diagram of a three-dimensional structure of an integrated anchor provided by the first embodiment of the present invention.
  • Figure 2 is a side view of the integrated anchor in Figure 1.
  • Fig. 3 is a three-dimensional exploded view of the integrated anchor in Fig. 1.
  • Fig. 4 is a cross-sectional view of an integrated anchoring element wearing an artificial tendon cord provided by the first embodiment of the present invention.
  • Fig. 5 is a cross-sectional view of an integrated anchor locking and cutting artificial tendons according to the first embodiment of the present invention.
  • FIG. 6 is a schematic diagram of a three-dimensional structure of an integrated anchor provided by the second embodiment of the present invention.
  • Fig. 7 is a cross-sectional view of the integrated anchor in Fig. 6.
  • FIG. 8 is a schematic diagram of a three-dimensional structure of an anchoring system provided by an embodiment of the present invention.
  • Fig. 9 is a cross-sectional view of the conveyor in Fig. 8.
  • Fig. 10 is a partial enlarged view of part M in Fig. 9.
  • Fig. 11 is a perspective exploded view of the conveyor in Fig. 8.
  • Figure 12a is a structural schematic diagram of the lock buckle and the connecting position mating and docking.
  • Figure 12b is a schematic diagram of the structure where the lock buckle and the connection position are separated.
  • Fig. 12c is a schematic diagram of the structure when the sleeve protects the mating part of the base and the joint.
  • Fig. 13a is a schematic diagram of the structure of the first snap ring and the second snap ring separated.
  • Fig. 13b is a schematic diagram of the docking structure of the first snap ring and the second snap ring.
  • Fig. 14 is a schematic diagram of the three-dimensional structure of the handle part of the conveyor in Fig. 8.
  • Figure 15 is a schematic cross-sectional structure diagram of the integrated anchor installed in the conveyor.
  • Fig. 16 is a schematic diagram of the anchoring system in the embodiment of the present invention being introduced into the left ventricle along the artificial chordae.
  • Figure 17 is a schematic diagram of the anchoring system reaching the left ventricle in an embodiment of the present invention.
  • Fig. 18 is a schematic diagram of the integrated anchoring member in the anchoring system in the embodiment of the present invention being anchored into the ventricular wall and locking the artificial chordae.
  • Fig. 19 is a schematic diagram of the withdrawal of the transporter from the left ventricle in the anchoring system in the embodiment of the present invention.
  • orientation near the operator is usually defined as the proximal end, and the orientation far away from the operator is defined as the distal end.
  • the radial direction refers to the direction along the diameter or radius
  • the axial direction refers to the direction along the central axis.
  • the direction, the radial direction and the axial direction are perpendicular to each other
  • the circumferential direction refers to the circumferential direction around the central axis.
  • the first embodiment of the present invention provides an integrated anchor 100, which includes an anchor portion 110, a base 120 fixedly connected to the proximal end of the anchor portion 110, and a base 120 installed on the base.
  • the base 120 is a hollow structure, and the lock core 140 is installed in the inner cavity 121 of the base 120.
  • the base 120 is cylindrical.
  • the base 120 has a diameter-reducing section 160 (as shown in FIG. 4).
  • the diameter of the diameter-reducing section 160 gradually decreases from its proximal end J to its distal end Y.
  • the lock cylinder 140 includes two oppositely arranged elastic arms 142, two
  • the elastic arm 142 is provided with a lock line structure 144 that cooperates with each other and a blade 143 provided at the proximal end of the lock line structure 144, and the artificial tendon 30 is inserted between the two elastic arms 142 (as shown in Figure 4);
  • the elastic arm 142 moves to the distal end relative to the diameter-reducing section 160 so that the diameter-reducing section 160 gradually squeezes the two elastic arms 142, and the locking wire structure 144 gradually merges from its distal end to its proximal end to lock the artificial chord 30 until the blade
  • the part 143 cuts the artificial chord 30 (as shown in FIG. 5).
  • the diameter-reducing section 160 may be directly arranged on the inner surface of the base 120, or by adding a lock shell 130, the diameter-reducing section 160 may be provided in the lock shell 130.
  • the anchoring portion 110 is used for anchoring into the tissue.
  • the anchoring portion 110 is a spiral nail, and the proximal end of the anchoring portion 110 and the base 120 are fixed by laser welding.
  • the diameter reducing section 160 is preferably a truncated cone hole.
  • the artificial chord 30 is preferably a medical suture, and other wires, threads, ropes, etc. that can be used as artificial chords can also be used.
  • the integrated anchor 100 provided by the present invention integrates the functions of anchoring, locking and cutting the artificial tendon cord 30.
  • the anchoring, locking and cutting operations can be carried out by using the same conveyor, without the need to replace equipment, and the structure is simple and the operation is simple. Convenient, shorten the operation time and reduce the cost.
  • the integrated anchor 100 further includes a first snap ring 150, the first snap ring 150 is fixedly connected to the proximal end of the lock cylinder 140, and the first snap ring 150 includes a plurality of first centers arranged at intervals. 151 and a first bottom pointed groove 152 (as shown in FIG. 3) arranged between two adjacent first centers 151, the first center 151 faces the proximal end of the first snap ring 150, and the first bottom pointed groove 152 faces The distal end of the first snap ring 150.
  • the proximal end of the first retaining ring 150 and the lock cylinder 140 are fixed by laser welding.
  • the first snap ring 150 is used to connect with a driving device (such as the conveyor 200 described below). After the driving mechanism is connected to the first snap ring 150, the first snap ring 150 is driven to rotate and move to the distal end, thereby driving and The lock core 140 connected to the first snap ring 150 rotates and moves distally, so that the two elastic arms 142 of the lock core 140 move distally relative to the diameter reducing section 160 to realize the function of locking and cutting the artificial chord 30.
  • a driving device such as the conveyor 200 described below.
  • the anchor portion 110, the base 120, the lock core 140, and the first snap ring 150 are convenient for laser welding and can be used as implant materials, and they are all made of stainless steel.
  • the proximal end of the base 120 is provided with a connecting position 122 recessed into the base 120 and extending toward the distal end of the base 120 (as shown in FIG. 3).
  • the contour shape of the connecting portion 122 along the axis from the proximal end to the distal end thereof is substantially a "Z" shape.
  • the connecting position 122 can be formed by cutting the proximal end of the base 120, and the outline shape of the connecting position 122 is roughly a "Z" shape.
  • the driving mechanism is provided with a structure that is adapted to the connecting position 122. With this structure, when the driving mechanism is retracted backward, the connection with the connecting position 122 can be released without first moving in the direction perpendicular to the axial direction, and the operation is simple.
  • the base 120 also has a spiral section 170, the spiral section 170 is connected to the proximal end of the variable diameter section 160, the proximal end of the lock cylinder 140 is provided with a spiral seat 141, and the spiral seat 141 penetrates the spiral section 170.
  • the inner and spiral seat 141 is screwed to the spiral section 170; the rotation of the spiral seat 141 in the spiral section 170 causes the two elastic arms 142 to move distally relative to the diameter reducing section 160.
  • the lock core 140 rotates through the threads in the base 120 and moves to the distal end along the axial direction.
  • the integrated anchor 100 further includes a lock shell 130 (as shown in FIG. 1) fixedly inserted into the base 120, a variable diameter section 160 is provided at the distal end of the lock shell 130, and a spiral section 170 is opened in the lock housing 130 and communicates with the proximal end of the variable diameter section 160, and the minor diameter of the spiral section 170 is greater than or equal to the maximum diameter of the variable diameter section 160.
  • the minor diameter refers to the diameter of an imaginary cylinder tangent to the crest of the internal thread in the spiral section 170.
  • the minor diameter of the spiral section 170 is greater than or equal to the maximum diameter of the variable diameter section 160, so that when the elastic wall 142 does not enter the variable diameter
  • the diameter section 160 does not hinder the rotation and axial movement of the lock cylinder 140 in the spiral section 170.
  • the variable diameter section 160 and the spiral section 170 are opened in the lock housing 130.
  • the variable diameter section 160 and the spiral section 170 may be directly provided on the inner wall of the base 120.
  • the lock shell 130 and the base 120 are fixed by laser welding, and are made of materials that can be implanted in tissues, preferably stainless steel.
  • the distal ends of the two elastic arms 142 are provided with protrusions 145 protruding outwards.
  • the protrusions 145 and the inner wall of the diameter reducing section 160 Contact (as shown in Figure 5).
  • the outer diameter of the boss 145 is larger than the outer diameter of the two elastic arms 142, so that the boss 145 is squeezed when contacting the inner wall of the diameter reducing section 160, and the two elastic arms 142 The artificial tendon 30 is squeezed in the middle to lock and cut it.
  • the lock line structure 144 includes a plurality of smooth protrusions 1421 provided on one elastic wall 142 and a plurality of smooth protrusions 1421 provided on the other elastic wall 142, which are arranged opposite to and adapted to the plurality of protrusions 1421 Sleek depression 1422 (shown in Figure 3).
  • the blade 143 includes two blade tips arranged opposite to each other on the two elastic walls 142.
  • the anchoring portion 110 is a spiral nail.
  • the distal end of the spiral nail has a sharp tip 111 so that the spiral nail can be quickly anchored into the tissue.
  • the proximal end of the outer peripheral surface of the base 120 is provided with an external thread 123.
  • the external thread 123 is used to fit the driving device.
  • the operation process of the integrated anchor 100 in this embodiment is as follows:
  • the artificial tendon 30 is put on the integrated anchor 100.
  • the first snap ring 150 is rotated forward, and the lock core 140 rotates along the same time.
  • the boss 145 provided on the lock core 140 contacts the frustum-shaped diameter reducing section 160 provided on the lock shell 130.
  • the diameter reducing section The conical surface of 160 will gradually squeeze the boss 145, so that the two opposite elastic arms 142 provided on the lock cylinder 140 will be elastically deformed, so that the two elastic walls 142 of the lock cylinder 140 are provided with a wave-shaped sleek lock with embedding concaves and convexes.
  • the wire structure 144 and the opposite sharp blade 143 gradually squeeze the artificial tendon 30, thereby locking and cutting the artificial tendon 30. Because the blade 143 provided on the lock core 140 is set more than the lock wire structure 144 It is far away from the proximal end of the boss 145, so the thread locking structure 144 squeezes the suture before the blade 143. After the thread locking structure 144 bites and locks the artificial tendon 30, continue to rotate the first snap ring 150 and the lock core 140, The blade 143 only begins to squeeze the artificial tendon 30 and finally cut the artificial tendon 30. It can be seen that the integrated anchor 100 in the present application integrates the functions of anchoring into the tissue, locking the artificial tendon cord, and cutting the artificial tendon cord. The structure is simple, and the locking of the artificial tendon cord and the cutting of the artificial tendon cord can be performed simultaneously. The operation is convenient and quick.
  • the second embodiment of the present invention provides an integrated anchor 100a.
  • the anchor portion 110 in the integrated anchor 100a includes an anchor portion The main body 112 and the sub-anchor 113 arranged in the circumferential direction of the anchor body 112, and the distal end of the anchor body 112 is provided with a tip 111.
  • the sub-anchor 113 expands in the circumferential direction of the anchor body 112.
  • the integrated anchor 100a in this embodiment does not need to be rotated in the process of anchoring into the tissue, and can be directly pushed into the tissue distally.
  • an embodiment of the present invention also provides an anchoring system 10, which includes the integrated anchor 100 and the conveyor 200 described in any of the above embodiments.
  • the conveyor 200 includes at least a torsion component 203, a release component 202, and a locking and cutting component 201 (as shown in FIG. 11); the torsion component 203 cooperates with the release component 202, and the torsion component 203 is used for axial movement relative to the release component 202 So that the distal end of the release assembly 202 is connected to the base 120 of the integrated anchor 100 or released from the base 120 of the integrated anchor 100, and drives the release assembly 202 and the base 120 to rotate so as to connect with the base 120
  • the anchoring portion 110 of the anchor is anchored into the target tissue; the locking and cutting assembly 201 is movably installed in the release assembly 202, and is connected with the integrated anchor 100 when the distal end of the release assembly 202 is connected to the base 120 of the integrated anchor 100
  • the lock core 140 is connected, and the lock cutting assembly 201 is used to drive the two elastic arms 142 of the lock core 120 to move distally relative to the diameter reducing section 160 to lock and cut the artificial tendon 30.
  • the distal end of the release component 202 is connected to the base 120 of the integrated anchor 100.
  • the torsion component 203 is relative to the release component 202 along the After moving axially to the proximal end, the distal end of the release assembly 202 is released from the base 120 of the integrated anchor 100.
  • the release assembly 202 includes a release tube 230, and a joint 240 fixedly connected to the distal end of the release tube 230, and the joint 240 cooperates with the base 120 of the integrated anchor 100 (as shown in FIG. 12a);
  • the torsion assembly 203 includes a torsion tube 250 and a sleeve 260 fixedly connected to the distal end of the torsion tube 250; the release tube 230 is movably inserted in the torsion tube 250, the joint 240 is movably inserted in the sleeve 260, and the joint 240 and Limiting structures (243, 261) are provided between the sleeves 260 to limit the relative movement of the two in the axial direction; when the joint 240 is received in the sleeve 260, the joint 240 is connected to the base 120 of the integrated anchor 100, When the joint 240 is exposed to the outside of the sleeve 260, the joint 240 is released from the base 120 of the integrated anchor 100.
  • the release tube 230 adopts a metal hypotube, which has good compliance and can provide a good supporting force in the axial direction.
  • the torsion tube 250 adopts a metal hypotube, which has good compliance and torsion control. When the torsion tube 250 is rotated, the torsion force can be transmitted to the integrated anchor 100 at the maximum ratio, which improves the anchoring efficiency.
  • the joint 240 and the release tube 230 are both metal materials and can be fixed by laser welding.
  • the sleeve 260 and the torsion tube 250 are bonded and fixed by medical glue.
  • the connector 240 is a cylindrical hollow structure, and the distal end of the connector 240 is provided with a lock 241 recessed into the connector 240 and extending toward the proximal end of the connector 240.
  • the outline shape of the lock catch 241 from the proximal end to the distal end thereof in the axial direction is substantially a "Z" shape.
  • the shape of the lock 241 matches the shape of the connection site 122 at the proximal end of the base 120 in the integrated anchor 100 (as shown in FIG. 12a). With this structure, when the conveyor 200 is directed The connection between the lock catch 241 and the connecting position 122 can be released by retreating, without first moving in the direction perpendicular to the axial direction, and the operation is simple.
  • the lock catch 241 may be formed by cutting the distal end of the circumferential surface 242 of the joint 240.
  • the base 120 and the joint 240 are relatively fixed, and vice versa.
  • the joint 240 can be relatively movable.
  • the limiting structure includes a rib 243 (as shown in FIG. 11) extending along the axial direction of the release tube 230 provided on the outer peripheral surface of the joint 240, and an upper edge provided on the wall of the sleeve 260
  • the through groove 261 extending in the axial direction of the torsion tube 250 and the convex rib 243 are adapted to the through groove 261.
  • the limit structure makes the torsion tube 250 and the release tube 230 only maintain relative axial movement and cannot rotate relative to each other. When the torsion tube 250 rotates, the release tube 230 rotates with the torsion tube 250.
  • the locking and cutting assembly 201 includes a locking and cutting tube 210 and a second retaining ring 220 fixedly connected to the distal end of the locking and cutting tube 210, the locking and cutting tube 210 is inserted in the release tube 230; the joint 240 and the integrated
  • the second snap ring 220 is connected to the lock core 140 of the integrated anchor 100, and the rotation of the lock cutting tube 210 drives the second snap ring 220 and the lock core 140 to rotate to drive the lock
  • the two elastic arms 142 of the core 140 move distally relative to the diameter reducing section 160; when the joint 240 and the base 120 of the integrated anchor 100 are released, the second snap ring 220 and the lock core 140 are released.
  • the lock-cutting tube 210 adopts a metal hypotube, which has good compliance and torsion control. When the lock-cutting tube 210 is rotated, the torsion force can be transmitted to the integrated anchor 100 at the maximum ratio, which improves the locking reliability.
  • the distal end of the lock cylinder 140 is provided with a first snap ring 150, and the first snap ring 150 is adapted to the second snap ring 220.
  • the second snap ring 220 includes a plurality of second centers 222 arranged at intervals and a second bottom tip groove provided between two adjacent second centers 222 221, the second center 222 faces the distal end of the second snap ring 220, and the second bottom tip groove 221 faces the proximal end of the second snap ring 220.
  • the first center 151 and the second center 222 are respectively formed by the intersection of two inclined surfaces. The inclined surfaces have a guiding effect, so that the first center 151 can be smoothly inserted into the second bottom tip groove 221, and the second center 222 can be smoothly inserted into the second bottom groove 221.
  • a bottom tip groove 152 is respectively formed by the intersection of two inclined surfaces. The inclined surfaces have a guiding effect, so that the first center 151 can be smoothly inserted into the second bottom tip groove 221, and the second center 222 can be smoothly inserted into the second bottom groove 221.
  • the first snap ring 150 and the second snap ring 220 are separated and connected.
  • the first center 151 and the first bottom tip groove 152 are provided on the first snap ring 150
  • the second The second center point 222 and the second bottom point groove 221 provided on the snap ring 220 have the same index on the circumference and are adapted to each other. Due to the guiding effect of the first center point 151 and the second center point 222, the first snap ring The 150 and the second snap ring 220 can be docked and separated at any angle and position in the circumferential direction. There is no need to deliberately align during the docking, and the docking can be realized by blind push, which saves time and effort.
  • the first snap ring 150 can be driven to rotate by rotating the lock cutting tube 210. Since the first snap ring 150 and the lock cylinder 140 are fixedly connected, the lock cylinder can be controlled. The rotation of 140 realizes locking and cutting off the artificial chordae.
  • the integrated anchor 100 further includes a handle 300 (as shown in FIG. 11); the torsion assembly 203 also includes a torsion tube base 350 fixedly connected to the proximal end of the torsion tube 250, and the release assembly 202 also includes The release tube base 340 fixedly connected to the proximal end of the release tube 230, and the locking and cutting assembly 201 further includes a knob 330 fixedly connected to the proximal end of the locking and cutting tube 210.
  • the handle 300 is provided with an axial limit groove 360, the torsion tube base 350 is slidably connected to the axial limit groove 360; the knob 330 extends out of the proximal end of the handle 300, and the knob 330 rotates to connect to the handle 330
  • the release tube base 340 is fixed in the handle 300 and is located between the torsion tube base 350 and the knob 330.
  • the handle 300 includes a handle shell 320, and the axial limiting groove 360 is axially opened on the handle shell 320. Rotating the knob 330 can drive the lock cutting tube 210 to rotate, which in turn drives the second snap ring 220 to rotate.
  • an operating member 310 is further provided on the handle 300, the operating member 310 passes through the axial limiting groove 360 and is rotatably connected to the torsion tube base 350.
  • the torsion tube base 350 is provided with a pin hole 351 (as shown in FIG. 10), and the operating member 310 includes a connecting member 311 inserted into the pin hole 351, that is, the operating member 310 and the torsion tube base 350
  • the pin hole 351 and the connecting member 311 are rotationally connected.
  • the proximal end of the axial limiting groove 360 communicates with a vertical stopping groove 370 (as shown in FIG. 14); the movement of the operating member 310 along the axial limiting groove 360 drives the torsion tube base 350 to move in the axial direction, and the operating member 310 rotates into the stop groove 370 to define the axial position of the torsion tube base 350.
  • the torsion tube base 350 when the operating member 310 is moved proximally along the axial limit groove 360, the torsion tube base 350 can be driven to move proximally in the axial direction, and the torsion tube 250 and the sleeve 260 can be driven to move proximally.
  • the torsion tube base 350 can be driven to move to the distal end in the axial direction, thereby driving the torsion tube 250 and the sleeve 260 to the distal end Move to protect the joint 240 in the sleeve 260.
  • the operating member 310 is rotated into the stop groove 370 to define the axial position of the torsion tube base 350, so that the joint 240 is kept in the sleeve 260.
  • rotating the handle housing 320 can drive the torsion base 350 connected with the handle housing 320 to rotate, thereby driving the torsion tube 250 and the sleeve 260 to rotate. Since the sleeve 260 and the joint 240 have a limiting structure, The joint 240 can follow the sleeve 260 to rotate, and then can drive the integrated anchor 100 connected to the joint 240 to rotate, so that the anchor portion 110 of the integrated anchor 100 is screw anchored into the tissue to complete the anchoring operation.
  • the integrated anchor 100 further includes a support assembly 204 (as shown in FIG. 11).
  • the support assembly 204 includes a support tube 270, connected to the proximal end of the support tube 270 and movably sleeved on the distal end of the handle 300.
  • the reinforcing tube 360 on the end and the sheath 280 fixedly connected to the distal end of the support tube 270, the torsion tube 250 is movably inserted in the support tube 270 and the reinforcement tube 360, and the sleeve 260 is movably inserted in the sheath 280.
  • the support tube 270 adopts a polymer material composite tube with a braided mesh structure, which has good compliance performance and can be pushed freely in a tortuous lumen, and can provide a better supporting force in the axial direction.
  • the sheath 280 surrounds the tip of the spiral portion 110 of the integrated anchor 100, so that the integrated anchor 100 can be smoothly pushed along the outer sheath without scraping the inner wall of the outer sheath; the sheath 280 also It can protect the native chordae and avoid scratching or even cutting the chordae when the integrated anchor 100 is screwed into the myocardial tissue.
  • the sheath 280 is a rigid material, which can provide a good supporting force when the integrated anchor 100 penetrates the myocardial tissue, so as to improve the anchoring accuracy.
  • a limiting rib is provided between the proximal end of the reinforced tube 360 and the distal end of the handle 300, and the two limiting ribs partially overlap in the radial direction.
  • an internal thread 281 is provided in the sheath 280.
  • the internal thread 281 in the sheath 280 fits with the external thread 123 outside the base 120 in the integrated anchor 100 (as shown in FIG. 15).
  • the sheath 280 and the base 120 are screwed and transmitted, so that the conveyor 200 can stably support the integrated anchor 100.
  • the assembly process of the anchoring system 10 in this embodiment is as follows:
  • the integrated anchor 100 is first loaded into the conveyor 200, specifically, the reinforcing tube 360 is driven to move proximally to expose the sleeve 260, and then the operating member 310 is driven to move proximally.
  • the torsion component 203 moves proximally to expose the joint 240, and the joint 240 is docked with the base 120 of the integrated anchor 110, the first snap ring 150 and the second snap ring 220 are docked, and then push to the distal end in turn.
  • the member 310 drives the torsion assembly 203 to move distally so that the sleeve 260 covers the joint 240 and the base 120 of the integrated anchor 100, and the reinforcing tube 360 is driven distally so that the sheath 280 covers the integrated anchor 100
  • the distal end; finally, the free end of the artificial chord 30 (the artificial chord 30 has been sewn to the valve leaflet) extending out of the body is passed through the integrated anchor 100 and the lock cutting tube 210 in turn, until the proximal end of the knob 330 Pierce out.
  • the working process of the anchoring system 10 in this embodiment is as follows:
  • the transporter 200 is introduced into the left ventricle LV along the artificial chordae 30.
  • the handle housing 320 is first rotated and the torsion assembly 203 connected to the handle housing 320 rotates.
  • There is a sleeve 260 and a joint 240 between The axial limit structure makes the joint 240 rotate together with the sleeve 260, thereby rotating the integrated anchor 100 connected to the joint 240, so that the anchor portion 110 of the integrated anchor 100 is anchored during the rotation.
  • On the papillary muscle 40 (as shown in Figure 18).
  • the driving knob 330 is then rotated to make the integrated anchor member 100 lock the artificial tendon cord 30 and cut the artificial tendon cord 30.
  • the driving operating member 310 is moved back in the axial direction to expose the joint 240 from the sleeve 260.
  • the handle housing 320 and the support rod 360 are driven to withdraw the corresponding pipe bodies and the parts connected with the pipe bodies to the outside of the body.

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  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une ancre intégrée (100), comprenant une partie d'ancrage (110), une base (120) reliée de manière fixe à une extrémité proximale de la partie d'ancrage (110) et un cylindre de verrouillage (140) installé à l'intérieur de la base (120). Une section à diamètre variable (160) est disposée à l'intérieur de la base (120), le diamètre de la section à diamètre variable (160) diminue progressivement à partir d'une extrémité proximale (J) à une extrémité distale (Y) correspondante, le cylindre de verrouillage (140) comprend deux bras élastiques (142) disposés de manière opposée, les deux bras élastiques (142) sont pourvus d'une structure de fil de verrouillage (144) et d'une partie de bord de coupe (143) disposée en une extrémité proximale de la structure de fil de verrouillage (144) qui coopèrent l'une avec l'autre et un cordon artificiel (30) est monté entre les deux bras élastiques (142) d'une manière pénétrante. Les deux bras élastiques (142) se déplacent vers l'extrémité distale de la section à diamètre variable (160), de telle sorte que la section à diamètre variable (160) comprime progressivement les deux bras élastiques (142) et la structure de fil de verrouillage (144) est progressivement mise en prise à partir de l'extrémité distale à l'extrémité proximale correspondante pour verrouiller le cordon artificiel (30), jusqu'à ce que la partie de bord de coupe (143) coupe le cordage artificiel (30). L'ancre intégrée (100) intègre les fonctions d'ancrage, de verrouillage et de coupe du cordon artificiel (30). L'invention concerne en outre un système d'ancrage (10), comprenant l'ancre intégrée (100) et un transporteur (200).
PCT/CN2020/110302 2019-12-31 2020-08-20 Ancre intégrée et système d'ancrage WO2021135270A1 (fr)

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CN201922500885.2U CN212346608U (zh) 2019-12-31 2019-12-31 集成式锚定件及锚定系统
CN201911424938.5A CN113116427B (zh) 2019-12-31 2019-12-31 集成式锚定件及锚定系统

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WO2000060995A2 (fr) * 1999-04-09 2000-10-19 Evalve, Inc. Procede et dispositif de reparation de valvule cardiaque
WO2006135536A2 (fr) * 2005-06-09 2006-12-21 The University Of Miami Fixation aux muscles papillaires pour reduction ventriculaire gauche
CN102348419A (zh) * 2009-01-14 2012-02-08 詹姆斯·隆格里亚 人造腱索
US20180000587A1 (en) * 2010-04-27 2018-01-04 Medtronic, Inc. Prosthetic heart valve devices and methods of valve repair
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CN104367351A (zh) * 2014-12-03 2015-02-25 李鸿雁 一种人工腱索介入装置
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