WO2020134052A1 - Système de réduction d'anneau de valvule guidé par une fenêtre unique - Google Patents

Système de réduction d'anneau de valvule guidé par une fenêtre unique Download PDF

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Publication number
WO2020134052A1
WO2020134052A1 PCT/CN2019/097567 CN2019097567W WO2020134052A1 WO 2020134052 A1 WO2020134052 A1 WO 2020134052A1 CN 2019097567 W CN2019097567 W CN 2019097567W WO 2020134052 A1 WO2020134052 A1 WO 2020134052A1
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WO
WIPO (PCT)
Prior art keywords
tube
window
distal end
anchoring
guided valve
Prior art date
Application number
PCT/CN2019/097567
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English (en)
Chinese (zh)
Inventor
张庭超
谢琦宗
郭荣辉
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 CN201811641847.2A external-priority patent/CN111374799A/zh
Priority claimed from CN201822275151.4U external-priority patent/CN209916301U/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 WO2020134052A1 publication Critical patent/WO2020134052A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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 present invention relates to the field of medical equipment, and in particular to a single-window guided valve contraction system.
  • the human heart is composed of a left heart and a right heart.
  • the right heart includes the right ventricle (RV) and the right atrium (RA)
  • the left heart includes the left ventricle (LV) and the left atrium (LA).
  • the mitral valve is the "one-way valve" between the left atrium and the left ventricle, including the annulus (MVA), anterior lobe (AML), posterior lobe (PML), tendon cord (CT), and papillary muscle (PM).
  • the annulus is between the left atrium and the left ventricle.
  • the anterior and posterior lobes are connected to the annulus.
  • Mitral regurgitation is a common disease of heart valves. Mitral regurgitation can be divided into two categories: functional and organic (degenerative).
  • the present invention provides a valve annulus system that can effectively reduce the volume of the left ventricle and improve the therapeutic effect of functional mitral valve regurgitation.
  • the specific technical solution is as follows.
  • a single-window-guided valve contraction ring system includes a catheter positioning device, a delivery device, an anchoring device, and a tightening wire, and the anchoring device includes a plurality of anchoring pieces ;
  • the catheter positioning device includes a positioning tube.
  • the positioning tube is positioned on the targeting portion.
  • a window communicating with the inner cavity of the positioning tube is provided on the side wall of the distal end of the positioning tube. The positioning tube moves So that the window faces different positions of the targeting part;
  • the conveying device conveys the plurality of anchors along the positioning tube to different positions of the targeting portion via the window;
  • the anchoring device sequentially fixes the anchoring member passing through the window to different positions of the targeting portion
  • the tightening line is used to connect and tighten a plurality of the anchors fixed at different positions of the targeting portion, so as to reduce the circumference of the targeting portion.
  • the present invention has at least the following beneficial effects:
  • the single-window-guided valve contraction system provided by the present invention moves through the positioning tube in the catheter positioning device to make the window face different positions of the targeting portion, and then fix the anchoring member at different positions of the targeting portion, and then pass The tightening line tightens the targeting section, thereby achieving the effect of reducing the circumference of the targeting section.
  • the single-window-guided valvular contraction system provided by the present invention implants multiple anchors in sequence at the circumference of the myocardial wall of the left ventricle 0.5-2 cm below the mitral valve annulus, and multiple anchors Connecting in series and tightening and fixing can not only reduce the circumference of the mitral valve annulus, but also reduce the radial diameter of the left ventricle, thereby reducing the volume of the left ventricle, thereby improving the therapeutic effect of mitral valve regurgitation, especially suitable for Treatment of functional mitral regurgitation.
  • Figure 1 is a schematic diagram of the human heart structure.
  • FIG. 2 is a schematic structural diagram of a single-window guided valve contraction system provided by the first embodiment of the present invention.
  • FIG. 3 is a schematic structural diagram of a guide sheath provided by the present invention.
  • 4a is a schematic structural diagram of a rail catheter provided by the present invention.
  • 4b is a schematic structural diagram of another rail catheter provided by the present invention.
  • FIG. 5 is a schematic structural diagram of a catheter positioning device provided by the present invention.
  • FIG. 6 is a schematic perspective view of a positioning handle in a catheter positioning device provided in FIG. 5.
  • FIG. 7 is a front view of a positioning handle in a catheter positioning device provided in FIG. 5.
  • FIG. 8 is a cross-sectional view of FIG. 7 along B-B.
  • FIG. 9a is a partial structural schematic view of a positioning handle in a catheter positioning device provided in FIG. 5;
  • FIG. 9b is a cross-sectional view along A-A of FIG. 9a.
  • FIG. 10 is a schematic structural diagram of a delivery device provided by the present invention.
  • 11a is a schematic structural diagram of an anchoring device provided by the present invention.
  • 11b is a cross-sectional view of a partial structure of an anchoring device provided by the present invention.
  • FIG. 12 is a schematic structural diagram of a bending track catheter in a single-window-guided valve annulus system provided by a second embodiment of the present invention.
  • FIG. 13 is a schematic structural diagram of an anchoring device in a single-window guided valve contraction system provided by a third embodiment of the present invention.
  • FIG. 14 is a schematic structural diagram of an anchoring device in a single-window-guided valve annulus system provided by a fourth embodiment of the present invention.
  • 15 is a schematic structural diagram of an anchor in a single-window-guided valve contraction system provided by a fifth embodiment of the present invention.
  • FIG. 16 is a schematic structural diagram of an anchor in a single-window-guided valve annulus system according to a sixth embodiment of the present invention.
  • FIG. 17 is a schematic structural diagram of an anchor in a single-window-guided valve annulus system according to a seventh embodiment of the present invention.
  • FIG. 18 is a schematic structural view of the anchor portion of the anchor provided in FIG. 17 in a contracted state.
  • FIG. 19 is a schematic structural view of the anchor portion of the anchor provided in FIG. 17 in an expanded state.
  • FIG. 20 is a schematic diagram of the guiding device provided by the present invention is delivered through the apex of the valve leaflet.
  • 21 is a schematic diagram of an anchor provided by the present invention implanted in a wall of a ventricle.
  • FIG. 22 is a schematic diagram of a plurality of anchors provided by the present invention after being implanted in different positions of a ventricular wall.
  • FIG. 23 is a schematic diagram of the tightening wire provided by the present invention after tightening a plurality of anchors.
  • 24 is a schematic structural diagram of another catheter positioning device provided by the present invention.
  • 25 is a schematic structural diagram of another catheter positioning device provided by the present invention.
  • FIG. 26 is a schematic diagram of the guiding device provided by the present invention is fed into the left ventricle through the aortic pathway.
  • FIG. 27 is a schematic structural diagram of yet another catheter positioning device provided by the present invention.
  • FIG. 28 is a schematic diagram of the guiding device provided by the present invention is fed into the left ventricle via the interatrial septum path.
  • proximal and distal are defined herein as commonly used in the field of interventional medicine. Specifically, the “distal end” refers to the end away from the operator during the surgical operation, and the “proximal end” refers to the end near the operator during the surgical operation.
  • the first embodiment of the present invention provides a single-window guided valve contraction system 10, including a catheter positioning device 200, a delivery device 300, an anchoring device 400, and a tightening wire 500, anchored
  • the device 400 includes a plurality of anchors 440a.
  • the catheter positioning device 200 includes a positioning tube 210 (see FIG. 5) provided at the distal end, and the positioning tube 210 is positioned on the targeting portion.
  • a window 212 communicating with the inner cavity of the positioning tube 210 is opened on the side wall of the positioning tube 210.
  • the positioning tube 210 moves so that the window 212 faces different positions of the targeting portion. There is only one window 212 in the catheter positioning device 200.
  • the operator adjusts the distal position of the positioning tube 210 so that the window 212 faces different positions of the targeting portion, and then the multiple anchors 440a can be transported along the positioning tube 210 by the delivery device 300 to different locations of the targeting portion through the window 212
  • the anchoring device 400 fixes the anchors 440a passing through the window 212 to different positions of the targeting portion in sequence, and the tightening wire 500 is used to fix the plurality of anchors 440a fixed to different positions of the targeting portion Connect in series and tighten so that the perimeter of the targeting section is reduced.
  • the targeting portion is the mitral valve annulus or the left ventricular myocardial wall below the mitral valve annulus.
  • the targeting portion is the left ventricular myocardial wall below the mitral valve annulus, specifically, a plurality of anchors are sequentially implanted on the left ventricular myocardial wall 0.5-2 cm below the mitral valve annulus 440a, and a plurality of anchors 440a are connected in series and tightened and fixed, so as to complete the purpose of contracting the mitral valve and reducing the volume of the left ventricle, improving the therapeutic effect of mitral valve regurgitation, especially suitable for treatment Functional mitral regurgitation.
  • the catheter positioning device 200 further includes a positioning handle 230 (see FIG. 5) provided at the proximal end of the positioning tube 210.
  • the positioning handle 230 controls the distal end of the positioning tube 210 to advance or retreat along the surface of the targeting portion, so that the window 212 faces different positions of the targeting portion.
  • the positioning tube 210 and the positioning handle 230 are rigidly connected. In other embodiments, medical glue connection, welding, interference fit, etc. may be used.
  • the valve annulus system 10 further includes a guiding device 100 for establishing a trajectory from the outside of the patient to the target portion, and the catheter positioning device 200 reaches and passes through the inner cavity of the guiding device 100 It is positioned at the targeting section so that the window 212 faces the targeting section.
  • the catheter positioning device 200 is threaded in the lumen of the guiding device 100
  • the delivery device 300 is threaded in the lumen of the catheter positioning device 200
  • the anchoring device 400 passes through the lumen of the delivery device 300
  • the window 212 extends.
  • the guiding device 100 includes a guiding sheath 101 (see FIG. 3) and a rail catheter 102 (see FIG. 4a) installed in the guiding sheath 101,
  • the orbital catheter 102 extends from the distal end of the guide sheath 101 and is attached to the targeting portion, thereby establishing a track from the outside of the body to the targeting portion.
  • the lumen of the orbital catheter 102 is used to accommodate and pass the catheter positioning device 200.
  • the guide sheath 101 includes a sheath 130 having a certain axial length and a first traction member 104; the sheath 130 includes a first support section 131 near the proximal end and a near The first bending section 132 at the end, the distal end of the first traction member 104 is connected to the first bending section 132, the first traction member 104 moves along the axial direction of the sheath 130 to adjust the first bending section 132 to fit Target shape.
  • the sheath 130 is made of a polymer material selected from ABS, PE, PP, PEBAX, PC, PU, Nylon, PVC, PTFE, or PB, or a copolymer or mixture of several types . In this embodiment, PEBAX is selected, and the hardness is 40D.
  • the sheath tube 130 is a hollow multilayer tube body
  • the first traction member 104 includes a first traction wire 110, a first threading tube 120, and a first anchor ring 160, and the first threading tube 120 Opened axially in the inner wall of the sheath tube 130, the first pulling wire 110 is threaded in the first threading tube 120, the first anchor ring 160 is disposed at the distal end of the first threading tube 120, and the first anchor The ring 160 is located in the first bending section 132. The distal end of the first pulling wire 110 is connected to the first anchoring ring 160, and the first pulling wire 110 is pulled to drive the first bending section 132 to bend to fit the shape of the target portion.
  • first traction wire 110 is embedded in the inner wall of the sheath tube 130, and the first traction wire 110 is received in the first threading tube 120 to prevent the first traction wire 110 from bending.
  • the end extends to the distal end of the sheath 130 and is rigidly connected to the first anchor ring 160, thereby pulling the first pulling wire 110, thereby driving the first bending section 132 to bend, and realizing the bending function.
  • the first pulling wire 110 is made of 304 stainless steel, copper and other metals that can withstand a certain tensile force;
  • the first threading tube 120 can be made of 304 stainless steel;
  • the sheath tube 130 is composed of a multilayer polymer film and a metal reinforcement layer, such as The membrane is a PTFE tube, the middle layer is a 304 stainless steel braided mesh tube, the outer layer is a PEBAX tube, etc.;
  • the first anchor ring 160 is made of a metal material, such as 304 stainless steel.
  • the guide sheath 101 further includes a first bender 140 disposed at the proximal end of the sheath 130, and the proximal end of the first pulling wire 110 is connected to the first bender 140 by pulling the first The bender 140 pulls the first pulling wire 110, and then drives the first bending section 132 to bend.
  • the material of the first bend adjuster 140 is PC.
  • the guiding sheath 101 further includes a first handle 150, which is disposed between the first bender 140 and the sheath 130, or the first bender 140 is close to the sheath 130 The end is accommodated in the first handle 150, which is convenient for the operator to grasp and operate.
  • the distal end of the sheath 130 has a sharp end, preferably a conical structure.
  • the guiding sheath 101 may also be shaped in a tube shape, similar to the existing plastic delivery sheath, and will not be described here.
  • the rail duct 102 is a predetermined shaped rail duct 102a.
  • the shaped rail catheter 102a includes a rigidly connected second handle 110a and a shaped tube body 103a, and the second handle 110a is disposed at the proximal end of the shaped tube body 103a.
  • the shaped tube body 103a includes a first tube body 120a, a second tube body 130a and a third tube body 140a connected in this order from the proximal end to the distal end.
  • the extending direction of the third tube body 140a and the extending direction of the first tube body 120a The angle range between them is 0-180 degrees, and the third tube 140a and the first tube 120a smoothly transition through the second tube 130a.
  • a shaped rail catheter 112b with a better fit to the targeting portion including a first tube 1121b connected in sequence from the proximal end to the distal end.
  • Two tubes 1122b and a third tube 1123b, a first plane where the proximal ends of the first tube 1121b and the second tube 1122b are located, and a second plane where the distal ends of the third tube 1123b and the second tube 1122b are located The angle range is between 30-150 degrees.
  • the shaped tube body 103 a has an inner cavity 150 a capable of accommodating the catheter positioning device 200.
  • the shaped tube body 103a is a flexible tube with a certain hardness, which can be made of polymer materials such as PEEK, ABS, PE, PP, PEBAX, PC, PU, Nylon, PVC, PTFE or PB
  • One or more of the copolymers or mixtures can also be made of biocompatible metals such as nickel titanium alloys.
  • the shaped tube body 103a may be a single-layer tube; it may also be a multi-layer tube, such as a multi-layer tube body made of an inner film PTFE, an intermediate braided mesh tube, and an outer layer PEBAX tube into a flexible tube by heat fusion.
  • a PEBAX tube is used, and the entire tube body is shaped by heat setting or the like to closely fit the shape below the annulus (ie, the junction between the anterior and posterior leaflets and the myocardial wall).
  • the valve annulus system 10 further includes a guide wire 600 that is threaded in the rail catheter 102.
  • the guide wire 600 is used to provide the catheter positioning device 200, the delivery device 300, and the anchoring device 400 with directions to enter the targeting portion.
  • One end of the guide wire 600 is a flexible guide wire head, with a certain distance, it will not cause harm to human tissue when entering the human body, and the other end is a flexible wire made of a flexible metal material such as nickel titanium, preferably, the surface of the guide wire 600 PTFE film can be plated, the overall smoothness after coating is better, and the operability in the human body is improved.
  • the guide wire 600 is selected from a guide guide wire, a straight guide wire, a J-shaped guide wire, a loach guide wire, and the like. The dimensions are 0.014", 0.018", 0.035", 0.038", 0.046", etc.
  • the positioning tube 210 at least includes an axially penetrating guide wire cavity 215 and a delivery cavity 214 disposed parallel to the guide wire cavity 215; the window 212 communicates with the distal end of the delivery cavity 214 to provide the delivery device 300 and anchor
  • the device 400 provides positioning.
  • the window 212 is opened on the side wall 211 of the delivery cavity 214.
  • the shape of the window 212 may be a circle, an ellipse, a square, a diamond, a triangle, a trapezoid parallel, or a quadrangle.
  • the area of the window 212 ranges from 4 to 4000 mm 2 .
  • the positioning tube 210 may be an integrally formed double-lumen tube or a multi-lumen tube, or may be a form in which multiple individual tube bodies are sleeved together. In this embodiment, an integrally formed dual-lumen tube is used.
  • the distal end 224 of the delivery cavity 214 is an arc-shaped surface and smoothly transitions between the window 212, which is beneficial to the delivery device 300 smoothly extending through the window 212 along the distal end 224 of the delivery cavity 214 and reaching a predetermined position.
  • the tube body of the positioning tube 210 is composed of a polymer material, such as one or more copolymers or mixtures of ABS, PE, PP, PEBAX, PC, PU, Nylon, PVC, PTFE, or PB.
  • the inner diameter of the positioning tube 210 ranges from 0.3 to 15 mm, preferably from 1.5 to 10 mm.
  • a developing member is embedded in the positioning tube 210 to indicate the position of the tube.
  • the developing member is made of a metal material that does not transmit X-rays, such as one or more of iron, copper, gold, platinum, titanium, nickel, and iridium.
  • the catheter positioning device 200 further includes a steering head 220, which is disposed at the distal end of the positioning tube 210, the steering head 220 is made of a flexible material, and the guide wire cavity 215 is connected to the inner cavity of the steering head 220 Generally, the steering head 220 has an inclined surface 221 facing the targeting portion. When the catheter positioning device 200 is placed in the left ventricle, the inclined surface 221 of the steering head 220 faces the ventricular wall to further fit the ventricular wall.
  • the positioning handle 230 includes a regulating mechanism 201, a handle housing 202, and a sheath connector 235; the regulating mechanism 201 cooperates with the handle housing 202 to control the positioning tube 210 in the axial direction Go forward or backward.
  • the window 212 at the distal end of the positioning tube 210 is controlled to different positions of the targeting portion.
  • the sheath connector 235 communicates with the positioning tube 210 (see FIG. 8 ), and the sheath connector 235 is provided with an axially through hole 236 for the delivery device 300 to pass through. In other words, the delivery device 300 sequentially enters the through hole 236 and the positioning tube 210 in the sheath connector 235, and then protrudes from the window 212.
  • the positioning handle 230 further includes a locking head 231, and the proximal end of the sheath connecting piece 235 and the locking head 231 are detachably connected by a screw connection or the like.
  • a locking portion 233 is provided at the proximal end of the sheath connector 235, and the locking portion 233 is sleeved on the outside of the locking head 231 by a thread, and a seal is provided at the connection between the locking portion 233 and the locking head 231
  • the pad 234 and the sealing pad 234 have an axial cavity for the delivery device 400 to pass through.
  • the sealing pad 234 is preferably made of a medical polymer material with elasticity, such as silicone.
  • the adjustment mechanism 201 includes an adjustment knob 241 and an adjustment screw 244.
  • the adjusting screw 244 is movably sleeved on the distal end of the sheath connector 235; the adjusting knob 241 and the handle housing 202 can be relatively rotatably connected, and the adjusting knob 241 is threadedly connected to the outside of the adjusting screw 244, and from the handle The housing 202 radially penetrates the outer surface of the handle housing 202.
  • the adjusting knob 241 advances or retreats axially on the adjusting screw 244, so that the handle housing 202 and the adjusting screw 244 move relatively, thereby driving the positioning tube 210 connected to the sheath connector 235 along Advance or retreat axially so that the window 212 faces different positions of the targeting portion.
  • the adjusting screw 244 is movably sleeved on the distal end of the sheath connecting piece 235, the adjusting screw 244 is a hollow tube body with a closed distal end, and the adjusting screw 244 is provided with threads outside.
  • the adjusting knob 241 is internally provided with threads to match with the adjusting screw 244.
  • the adjusting knob 241 is advanced or retreated on the adjusting screw 244 in the axial direction, thereby achieving the connection with the adjusting knob 244
  • the relative movement between the adjustment handle housing 202 and the adjustment screw 244 drives the positioning tube 210 connected to the sheath connector 235 to move forward or backward in the axial direction, so that the window 212 faces different positions of the targeting portion.
  • the regulating mechanism 201 further includes a stopper 239 and a locking member 232; the locking member 232 is disposed on the sheath connecting member 235, and the stopper 239 penetrates the outside of the handle housing 202 and extends along the positioning handle 230 Radially extending, the stopper 239 is used to abut the retaining member 232 to control the distance the sheath connector 235 moves. That is, when the operator rotates the adjustment knob 241, the adjustment screw 244 moves proximally with respect to the handle housing 202, and pushes the locking member 232 of the sheath connector 235 to move proximally, when the sheath connector 235 is locked The position piece 232 cannot continue to move after contacting the limiter 239. At this time, the position piece 232 is fixed between the limiter 239 and the proximal end of the adjusting screw 244, thereby limiting and locking the position of the distal end of the positioning tube 210.
  • the handle housing 202 is provided with a guide groove 260 and a plurality of limit grooves 261 (see FIG. 7) communicating with the guide groove 260 in the axial direction, and the limiter 239 is provided in the limit groove 261 and It can move axially along the guide groove 260.
  • the stopper 239 snaps into the stopper groove 261
  • the distance between two adjacent limiting slots 261 is the minimum distance for each movement of the limiter 239. In operation, the distance of the stopper 239 can be moved according to the actual situation.
  • the handle housing 202 includes an adjustment handle 238 located at the proximal end, a protective sleeve 245 located at the distal end, and a front shell 242 and a rear shell 240 disposed therebetween; wherein the proximal end of the adjustment knob 241 is The rear case 240 is connected, and the distal end of the adjusting knob 241 is connected to the front case 242.
  • the rigid connection between the rear shell 240 and the adjusting handle 238 is achieved through a tightly fitted snap structure, and the front shell 242 and the protective cover 245 are rigidly connected through a tightly fitted snap structure.
  • Relatively rotatable movable connection between the adjusting knob 241 and the handle housing 202 Relatively rotatable movable connection between the adjusting knob 241 and the handle housing 202.
  • the front casing 242 and the distal end of the adjusting knob 241 realize a relatively rotatable movable connection through a gap-fitting snap structure
  • the rear casing 240 is connected to the adjusting
  • a movable connection with relative rotation is realized through a snap-fit structure of a gap fit. That is to say, the adjustment knob 241 is relatively rotatably connected with the front case 242 and the rear case 240 to realize the relative rotation between the adjustment knob 241 and the handle housing 202.
  • the positioning handle 230 further includes a support rod 237 (see FIG. 8 ).
  • the support rod 237 is disposed around the sheath connector 235 and passes through the locking member 232 on the sheath connector 235.
  • the distal end is connected to the distal end of the handle housing 202.
  • the support rod 237 is connected to the protective sleeve 245 at the distal end of the handle housing 202, and respectively passes through the closed end of the adjusting screw 244, thereby connecting the protective sleeve 245, the adjusting screw 244, and the sheath connector 235 together.
  • the operator When using the positioning handle 230, the operator first moves the limiter 239 to the proximal end by a certain distance, correspondingly snaps the limiter 239 into the limit slot 261 with a corresponding distance, wherein the distance moved by the limiter 239 is The implantation distance between every two anchors 440a. Then, the adjustment knob 241 is rotated, so that the adjustment screw 244 moves in the axial direction relative to the handle housing 202, which in turn drives the sheath connecting member 235 to move in the axial direction. When the locking member 232 abuts the stopper 239, it cannot continue to move.
  • the locking member 232 is fixed between the stopper 239 and the proximal end of the adjusting screw 244, thereby limiting and locking the position of the distal end of the positioning tube 210, that is, defining the window 212 of the positioning tube 210 and the ventricular wall Relative position, so as to adjust the implantation distance between the two anchors 440a in vitro.
  • the stopper 239 is unscrewed from the limit groove 261, and moved proximally to the next limit groove 261, screwed in and fixed, Then rotate the adjustment knob 241, so that the adjustment screw 244 moves proximally relative to the handle housing 202, the adjustment screw 244 drives the sheath connector 235 to move synchronously to the proximal end, and when the adjustment screw 244 is withdrawn to a certain distance (two implant anchors)
  • the proximal end of the adjusting screw 244 and the clamping member 234 will push against the stopper 239, and cannot continue to move to the proximal end.
  • the operator can also fix it by pulling the limiter 239 directly into the nearest limit slot 261, and then drive the positioning tube 210 through the proximal end of the sheath withdrawal connector 235 Move backward, and determine the moving distance according to the patient's condition combined with medical influence, so as to control the number of anchors 440a to be implanted and the distance between the anchors 440a in real time.
  • the entire positioning handle 230 can be injection molded or machined using polymer materials, such as medical grade polymer materials such as ABS, PC, nylon, etc.
  • the support rod 237 and the stopper 239 are preferably made of stainless steel or other metals Material to improve smoothness during operation.
  • the delivery device 300 is used to reach the targeting portion along the guide wire 600 and the catheter positioning device 200, extend through the window 212 of the catheter positioning device 200, and provide a delivery channel for the anchor 440a in the anchor device 400.
  • the delivery device 300 includes a delivery tube 330 and a third traction member 106.
  • the delivery tube 330 includes a second support section 331 near the proximal end and a second bending section 332 near the distal end
  • the third traction member 106 moves along the axial direction of the delivery tube 330 to adjust the second bending section 332 to a shape matching the catheter positioning device 200 so that the distal end of the delivery tube 330 reaches the window 212.
  • the delivery tube 330 is a hollow tube body, which may be a single-layer tube made of a polymer material, such as PEEK, PI, ABS, PE, PP, PEBAX, PC, PU, Nylon, PVC, PTFE Or one or several copolymers or mixtures of PB, can also be a multilayer tube.
  • a multi-layer polymer body composed of a multi-layer polymer film and a metal is used.
  • the inner film is a PTFE tube
  • the middle layer is a stainless steel 304 braided mesh tube
  • the outer layer is a PEBAX tube.
  • the second bending section 332 can be arbitrarily bent in the same plane direction, and the bending angle is 0-360 degrees.
  • the delivery tube 330 is a hollow multi-layer tube
  • the third traction member 106 includes a third traction wire 340, a third threading tube 350, and a third anchor ring 360.
  • the third threading tube 350 is axially opened in the inner wall of the delivery tube 330
  • the third pulling wire 340 is threaded in the third threading tube 350
  • the third anchor ring 360 is disposed at the distal end of the third threading tube 350
  • the third anchoring ring 360 is located in the second bending section 332; the distal end of the third pulling wire 340 is connected to the third anchoring ring 360, by pulling the third pulling wire 340, and thereby driving the second bending section 332 bends to a shape that fits with catheter positioning device 200 so that the distal end of delivery tube 330 reaches window 212.
  • the delivery device 300 further includes a third bender 310 disposed at the proximal end of the delivery tube 330, and the proximal end of the third pulling wire 340 is connected to the third bender 310 by pulling the third bender The device 310 pulls the third pulling wire 340 to drive the second bending section 332 to bend.
  • the delivery device 300 further includes a fourth handle 320 disposed between the third bender 310 and the delivery tube 330, or the third bender 310 and the delivery tube 330 are received at the proximal end
  • the fourth handle 320 is convenient for the operator to grasp and operate.
  • the third bend adjuster 310 is made of polymer materials such as ABS or metal materials such as 304 stainless steel and 316 stainless steel
  • the fourth handle 320 is made of metals or polymers such as 304 stainless steel, ABS and PC.
  • the pulling wire 340 may be 304 stainless steel wire, iron wire, copper wire, nickel-titanium wire, etc., or a polymer pulling wire such as nylon rope, polypropylene rope, polyurethane rope, and fiber rope.
  • the third threading tube 350 may be a 304 stainless steel tube.
  • the third anchor ring 360 is made of metal material, such as 304 stainless steel.
  • a developing member may be embedded in the tube body of the conveying tube 330 to indicate the position of the tube body, the developing member is made of a metal material that does not transmit X-rays, such as iron, copper, gold, platinum, titanium, nickel Or one or more of iridium.
  • the anchoring device 400 reaches the annulus through the lumen of the delivery device 300, and implants a plurality of anchors 440a at different locations of the targeting portion (eg, myocardial wall).
  • the targeting portion eg, myocardial wall
  • the anchoring device 400 further includes a release controller 410a, and a push rod 420a disposed between the release controller 410a and the anchor 440a, the push rod 420a and the anchor
  • the anchor 440a is detachably connected, and the release controller 410a controls the anchor 440a to be released at the targeting portion. It can be understood that the release controller 410a can rotate the anchor 440a by twisting until the anchor 440a is implanted into a target portion of the patient's tissue, such as the myocardial wall near the annulus.
  • the pushing rod 420a may be a solid thin rod or a hollow thin tube of metal or polymer material with a certain axial length, and the metal material is selected from one of iron, steel, copper, titanium, nickel or chromium Or several.
  • the polymer material is selected from one or more of ABS, PE, PP, PEBAX, PC, PU, Nylon, PVC, PTFE or PB. It can be a single rod/strand bar or tube, or it can be wound/woven from multiple rods/strand bar or tube or wire. In this embodiment, a steel cable twisted by a plurality of steel wires is used as the push rod 420a.
  • the anchoring device 400 further includes a connection mechanism 430a, the proximal end of the connection mechanism 430a is rigidly connected to the distal end of the push rod 420a, and the push rod 420a is detachable between the distal end of the connection mechanism 430a and the anchor 440a Connection; the release controller 410a controls the connection mechanism 430a to open to release the anchor 440a. It can be understood that the release controller 410a further includes controlling actions of the anchor 440a, such as forward, backward, twist, rotation, slide, move, swing, and the like.
  • the detachable connection includes one of screw connection, snap connection or clip connection. It can be understood that, in this embodiment, the detachable connection between the distal end of the connection mechanism 430a and the anchor 440a is a threaded connection.
  • the tube body of the connecting mechanism 430a near the distal end is provided with threads and is threadedly engaged with the anchor 440a.
  • the most distal end 431a of the connection mechanism 430a has no thread, so as to prevent the threaded engagement with the anchor 440a from being locked, which is difficult to be released later.
  • the anchor 440a includes a connection portion 441a and an anchor portion 442a, and the anchor portion 442a is detachably connected to the push rod 420a through the connection portion 441a.
  • the anchor portion 442a is detachably connected to the distal end of the connection mechanism 430a through the connection portion 441a.
  • the connecting portion 441a and the anchoring portion 442a are rigidly connected or integrally formed.
  • the connecting portion 441a is provided with threads inside to cooperate with the distal tube body 432a of the connecting mechanism 430a, the anchoring portion 442a is used for anchoring in human tissue, and the distal end of the anchoring portion 442a It has a sharp needle shape to facilitate the penetration of the anchor portion 442a into human tissue.
  • the anchor portion 442a includes at least one spiral structure. After the tip of the spiral structure of the anchoring portion 442a penetrates into the tissue, the specific surface area of the anchoring portion 442a in contact with the tissue of the targeting portion can be greatly increased, thereby being firmly fixed inside the tissue, avoiding the inability of the prior art flexible anchoring portion It is stable and maintains the expanded shape and deforms, which is easy to be pulled off.
  • the anchoring portion 442a has a continuously same/or variable cross-section (that is, a spiral shape).
  • the anchor portion 442a has a length ranging from 4 mm to 16 mm, a diameter ranging from 0.2 mm to 5 mm, and a penetration depth ranging from 2 to 10 mm.
  • the connecting portion 441a is rigidly connected to the proximal end of the anchoring portion 442a, and the connecting portion 441a has a cross-sectional diameter significantly larger than that of the anchoring portion 442a for limiting the anchoring portion 442a to control the anchoring
  • the portion 442a punctures the target tissue into a predetermined depth to prevent the excessive puncture from damaging the target tissue.
  • the connecting portion 441a is made of a material with good rigidity, such as stainless steel, POM, PEEK, and the like.
  • the spiral structure of the anchor portion 442a is made of a rigid biocompatible metal material or a material with a shape memory function.
  • the rigid biocompatible metal material is selected from one or more alloys of iron, steel, copper, titanium, nickel, and chromium. In this embodiment, stainless steel is used.
  • implants used for mitral annuloplasty are usually made of shape memory metal with high flexibility. Such implants have low rigidity and are used to retract the annulus during pulling the rope. It is easy to pull off the implant and cause serious damage to the heart. In this embodiment, it is made of rigid materials such as stainless steel, which can effectively prevent the implant from being pulled off.
  • the connecting portion 441a is provided with a connecting hole 443a, and the connecting hole 443a is used for tightening the wire 500 to pass through.
  • the tightening wire 500 connects the plurality of anchors 440a in series through the hole on the connecting hole 443a.
  • the tightening wire 500 is a flexible wire with a certain length, which is a single-strand/multi-strand cable/wire rope, which can be a conventional medical tightening wire or a flexible clue of other medical grades.
  • the tightening wire 500 is made of a biocompatible metal/polymer material, and the metal material is selected from one or more of iron, steel, copper, titanium, nickel, or chromium.
  • the polymer material is selected from one or more of ABS, PE, PP, PEBAX, PC, PU, Nylon, PVC, PTFE or PB.
  • a second embodiment of the present invention provides a single-window guided valve contraction system 10a.
  • the orbital catheter 102 may be capable of real-time The shape-adjusting curved rail duct 102b.
  • the bending track catheter 102b includes a bending tube 103b and a second traction member 105.
  • the bending tube 103b includes a fourth tube 130b near the proximal end and a fifth tube 140b near the distal end.
  • the second traction member 105 bends along the curve The axial direction of the tube 103b moves to adjust the fifth tube body 140b to fit the shape of the target portion.
  • the bending tube 103b is a hollow multilayer tube body
  • the second traction member 105 further includes a second traction wire 133b, a second threading tube 132b, and a second anchor ring 131b, the second threading
  • the tube 132b is opened in the inner wall of the bending tube 103b, the second pulling wire 133b is threaded in the second threading tube 132b; the second anchor ring 131b is disposed at the distal end of the second threading tube 132b, and the second anchor
  • the fixed ring 131b is located in the fifth tube 140b; the distal end of the second pulling wire 133b is connected to the second anchor ring 131b, which can pull the second pulling wire 133b, thereby driving the fifth tube 140b to bend to fit the target
  • the shape of the part realizes the function of bending.
  • the bending track catheter 102b further includes a second bender 110b disposed at the proximal end of the bending tube 103b.
  • the proximal end of the second pulling wire 133b is connected to the second bender 110b.
  • the second bender 110b pulls the second pulling wire 133b, thereby driving the fifth tube 140b to bend.
  • the bending rail conduit 102b further includes a third handle 120b disposed between the second bender 110b and the bend tube 103b, or the second bender 110b and the bend tube The proximal end of 103b is accommodated in the third handle 120b, which is convenient for the operator to grasp and operate.
  • the bending tube 103b is made of a polymer material, such as ABS, PE, PP, PEBAX, PC, PU, Nylon, PVC, PTFE or PB copolymer or mixture of several or more .
  • a third embodiment of the present invention provides a single-window guided valve contraction system 10b.
  • the push in the anchoring device 400b The rod 420b is detachably connected to the anchor 440b.
  • the push rod 420b is directly connected to the anchor 440b with no other connecting mechanism in between.
  • the manner in which the distal end of the push rod 420b is detachably connected to the anchor 440b includes one of a screw connection, a snap connection, or a clip connection.
  • the pipe body of the push rod 420b near the distal end is provided with threads and is threadedly engaged with the anchor 440b.
  • the most distal end of the push rod 420b is not threaded, so as to prevent the threaded engagement with the anchor 440b from being locked, which is difficult to be released later.
  • the fourth embodiment of the present invention provides a single-window guided valve contraction system 10c.
  • the anchoring device 400c further includes a The five handles 460c and the release tube 450c.
  • the fifth handle 460c is disposed at the proximal end of the release tube 450c.
  • the push rod 420c passes through the fifth handle 460c.
  • the distal end of the push rod 420c and the connection mechanism 430c pass through the release tube 450c.
  • connection mechanism 430c cooperates with the release tube 450c to make the connection mechanism 430c clamp the anchor 440c; when the release controller 410c pulls the push rod 420c to move to the distal end
  • the connection mechanism 430c cooperates with the release tube 450c to release the anchor 440c.
  • connection mechanism 430c includes multiple sets of connecting rods 432 and multiple pins 431, the multiple sets of connecting rods 432 are movably connected by multiple pins 431, and the closest set of connecting rods 432 among the multiple sets of connecting rods 432 pass pins 431 is connected to the push rod 420c, and the end of the most distal set of connecting rods 432 of the plurality of connecting rods 432 is provided with a clamping portion 434c, which is used to clamp and release the anchor 440c.
  • the connecting rod 432 and the pin 431 can be metal materials or high density polymer materials, such as stainless steel, POM, etc.
  • the connecting mechanism 430c cooperates with the release tube 450c to make the clamping portion 434c clamp the anchor 440c, and when the release controller 410c pulls the push rod 420c to move to the distal end At this time, the connection mechanism 430c cooperates with the release tube 450c to cause the clamping portion 434c to release the anchor 440c.
  • the push rod 420c and the first group of connecting rods 432c are movably connected through the first pin 431c, and the first group of connecting rods 432c are respectively movable with the second group of connecting rods 433c through two second pins 436c
  • the second group of connecting rods 433c is in turn connected to the distal end of the release tube 450c through a third pin 435c, and the third pin 435c is rigidly connected to the release tube 450c.
  • the distal end of the connecting rod 433c of the second group is bent toward the axial direction of the push rod 420c and extends to form a clamping portion 434c.
  • the release controller 410c is rigidly connected to the push rod 420c, and the push rod 420c sequentially passes through the inner cavity of the fifth handle 460c and the release tube 450c.
  • the tension 420c is tightened by the release controller 410c, due to the action of the first pin 431c, the first group of connecting rods 432c is stretched to move proximally, thereby driving the second group of connecting rods 433c to move proximally through the second pin 436c
  • the second group of connecting rods 433c since the second group of connecting rods 433c is connected to the release tube 450c through the third pin 435c, the second group of connecting rods 433c will not move to the proximal end, causing the proximal end of the second group of connecting rods 433c connected to the second pin 436c to move closer to the midline, In this way, the second group of connecting rods 433c is rotated through the third pin 435c, so that the distal end 434c of the
  • the fifth embodiment of the present invention provides a single-window guided valve contraction system 10d.
  • another anchor 440d is provided in the valve contraction system 10d.
  • the anchor portion 442d includes two spiral structures 4421 and 4422.
  • the anchor portion 442d is two spiral structures 4421 and 4422, the two spiral structures have the same size or the difference in size is smaller than the first preset range.
  • the angle between the starting points of the two sets of spiral structures 4421 and 4422 is 180°. This structure increases the contact area between the anchoring portion 442d and the human tissue. After the anchoring portion 442d is implanted into the human tissue, a larger The anchoring force is more firm and prevents falling off.
  • the sixth embodiment of the present invention provides a single-window guided valve contraction system 10e.
  • another anchor 440e is provided in the valve contraction system 10e
  • the difference between the dimensions of the two spiral structures 4423 and 4424 is greater than the second preset range.
  • this structure also makes the entire anchor 440e more flexible, lighter in weight, and more harmful to the patient. small.
  • the seventh embodiment of the present invention provides a single-window-guided valve contraction system 10f. Unlike the first embodiment, another anchor is provided in the valve contraction system 10f The stator 440f and the anchor portion 442f in the anchor 440f are connected to the push rod 420f through the connection portion 441f.
  • the anchoring portion 442f includes a connecting ring 4425 near the proximal end, an anchoring needle 4426 near the distal end, and a binding portion 4427 sleeved on the outside of the connecting ring 4425 and the anchoring needle 4426; the anchoring needle 4426 has expansion in a natural state The shape (see FIG. 19) and the contracted shape constrained by the delivery device 300 (see FIG. 18).
  • the anchor portion 442f has a length ranging from 4mm to 16mm, a diameter ranging from 0.2mm to 5mm, and a penetration depth ranging from 2 to 10mm.
  • the anchoring portion 442f is made of a material with a shape memory function, and is compressed in the delivery device 300 when contracting the shape.
  • the anchoring needle 4426 When released from the delivery device 300, its tip can penetrate into the deep part of the targeted tissue and be fixed inside the tissue completely Return to the expanded shape in its natural state.
  • the anchoring needle 4426 includes two branches 4426a and 4426b, which are disposed away from each other.
  • the proximal ends of the branches 4426a and 4426b are formed by intersecting and extending the distal ends of the connecting rings 4425, and the distal ends of the branches 4426a and 4426b are formed.
  • Reversely extending, that is, the branches 4426a and 4426b respectively have two symmetrically arranged openings directed toward the proximal hook-shaped structure.
  • the restraining portion 4427 is sleeved at the distal stagger of the connecting ring 4425, thereby restricting the relative position between the two branches of the anchoring portion, and preventing the two hook-shaped structures from completely bouncing off due to their own elasticity in a natural state.
  • the push rod 420f when in use, the push rod 420f is pulled proximally until the entire anchor 440f is received at the distal end of the lumen of the delivery device 300. At this time, the two branches 4426a of the anchor needle 4426 And 4426b are constrained to be parallel to the axial direction of the push rod 42Of.
  • the push rod 420f is pushed to the distal end until the anchor needle 4426 protrudes from the delivery tube 330, and the anchor needle 4426 restores the hook-like structure in its natural state, as shown in FIG. 19, the entire anchor needle 4426 has a double hook shape, that is, the state of the anchor 440f after implantation.
  • the anchor 440f having an expanded shape and a contracted shape expands to the expanded shape as the tip penetrates the target tissue to a predetermined depth during the contracted shape, because the expanded shape has a cross section that is significantly larger than the contracted shape, and the anchor 440f is rigid, which ensures that the anchor 440f stably maintains the expanded shape without any denaturation, thereby the anchor 440f can be firmly fixed inside the tissue, thereby avoiding that the prior art flexible anchor cannot be stably maintained
  • the shape is expanded and deformed, which is easy to be pulled off.
  • the tightening wire 500 passes through the connecting ring 4425 to tighten the plurality of anchors 44Of.
  • the anchor piece 440f is detachably connected to the push rod 420f through the connecting portion 441f, specifically referring to the detachable connection between the anchor piece 440f and the connecting portion 441f.
  • the release controller controls the connecting portion 441f to release the anchor portion 442f, leaving only the anchor portion 442f on the targeting portion.
  • the following uses the seventh embodiment as an example to describe the use of the single-window-guided valve annulus system 10f provided by the present invention in a surgical procedure for treating mitral valve regurgitation.
  • Surgical operations can have a variety of paths, such as: 1 Transapical; 2 Transfemoral artery-abdominal artery-thoracic artery-aortic arch-left ventricle; 3 Transfemoral artery-abdominal artery-vena cava-right atrium-left atrium-right ventricle .
  • the first surgical route is transapical, with the following steps:
  • the first step surgical operation, an incision is made at the apex of the heart, the guiding sheath 101 of the guiding device 100 is sent through the apex to the position below the PML of the valve leaflet, and the position is adjusted;
  • the second step adjust the distal end of the sheath of the guiding sheath 101 so that the first bending section 132 faces the myocardial wall LVPW;
  • the third step the rail catheter (plastic rail catheter or adjustable curved rail catheter) is fed into the inner cavity of the sheath 130.
  • the plastic rail catheter will automatically extend during the process of extending from the distal end of the guiding sheath 101 Gradually fit under the annulus; the bending track catheter is first pushed out from the distal end of the guiding sheath 101, and then the bending degree of the adjusting track catheter is adjusted to make it fit under the valve annulus;
  • Step 4 As shown in FIG. 20, the guide wire 600 is fed through the lumen of the track catheter, and then the track catheter is withdrawn. At this time, the track from the outside body to the body is established; then the guide wire 600 is sent into the catheter positioning device 200, Until the catheter positioning device 200 reaches the predetermined position smoothly, it fits the myocardial wall and is close to the lower part of the annulus MVA, while ensuring that the window 212 faces the myocardial wall LVPW side, which is conducive to providing positioning for the subsequent implantation of the anchor 442f;
  • Step 5 As shown in FIG. 21, the delivery device 300 and the anchor device 400 assembled therewith are sent. After the anchor 440f passes out of the window 212, the anchor needle of the anchor portion 442f pierces the myocardial wall and anchors The anchor 440f is restored to its expanded state due to its own elasticity. When the anchor 440f is unable to continue to deform due to the tissue of the ventricular wall, it indicates that the anchor is completed and the connection between the tightening wire 500 and the restraining ring 4427 is locked;
  • Step 6 At this time, the delivery device 300 and the anchoring device 400 without the anchoring piece 440f are withdrawn, the tightening wire 500 is passed through the second anchoring piece 440f, and then the second anchoring piece 440f and the anchor
  • the distal end of the fixing device 400 is connected to the conveying device 300, and the limiter 239 is unscrewed from the limit groove 261, and moves backward to the next limit groove 261, and after screwing in, it is fixed and then rotated Adjust the knob 241 until the rotation is subjected to a large resistance.
  • the position of the second anchor 440f to be implanted has been found. You can implant the second anchor 440f according to the fifth step, and then implant Into the subsequent anchor 440f.
  • Step 7 As shown in FIG. 22, after implanting all the anchors 440f, the catheter positioning device 200, the delivery device 300 and the anchoring device 400 are withdrawn, leaving only a plurality of anchors 440f and more A tightening wire 500 with two anchors 440f connected in series, as shown in FIG. 23, tighten the tightening wire 500 to reduce the volume of the entire left ventricle and at the same time achieve the purpose of shrinking the annulus, after which the tightening can be tightened The wire 500 is knotted and cut to complete the operation.
  • a predetermined-type catheter positioning device 200a is provided, and the positioning tube of the catheter positioning device 200a is provided with a curved section 201a at its distal end by heat setting or other setting methods to make it After reaching the annulus, the distal body of the positioning tube can be close to the annulus MVA and fit the myocardial wall.
  • the orbit can be directly established during the transapical operation, and There is no need to use the track catheter 102 and the guide wire 600 to assist in establishing the track.
  • the second surgical path is the trans-aortic path.
  • the difference from the trans-apical path is that all the instruments in the operation are the path through the femoral artery-abdominal artery-thoracic artery-aortic arch-left ventricle.
  • a predetermined-type catheter positioning device 200b is provided, and the positioning tube of the catheter positioning device 200a is heat-set or otherwise shaped so that its distal end has two curved sections 201b and 202b, after the positioning tube is fed into the left ventricle, the distal tube body of the positioning tube can fit the myocardial wall well.
  • the catheter positioning device 200b can directly establish the rail from the outside of the body to the target portion.
  • the third surgical path is the trans-atrial septal path, which is different from the trans-apical path in that all instruments in the operation are via the femoral artery—abdominal artery—caval vein—right atrium—left atrium—left ventricle, and From the right atrium to the left atrium, it is necessary to puncture the oval foramen with the interatrial septum puncture device, and from the left atrium to the left ventricle through the mitral valve orifice. The remaining operations are the same as the transapical path.
  • a predetermined-type catheter positioning device 200c is provided, and the positioning tube of the catheter positioning device 200c is heat-set or otherwise shaped so that its distal end has three curved sections 201c, 202c And 203c, after the positioning tube is fed into the left ventricle, the distal tube body of the positioning tube can fit well with the myocardial wall and be close to the annulus.
  • the catheter positioning device 200c can directly establish the rail from the outside of the body to the target portion.
  • the second path and the third path use pure intervention, resulting in less surgical damage to the patient, faster recovery of the patient, lower risk of complications, and higher acceptance.
  • the single-window-guided valve repair system 10 can also directly position the catheter positioning device 200 on the annulus of the mitral valve, and then implant multiple anchors 440f into the annulus in sequence At different positions, tighten the wire 500 to tighten and fix the multiple anchors 440f, so as to achieve the purpose of reducing the annulus, and because the connection part 441f defines the implant depth of the anchor 440f, the anchor can be avoided
  • the stator 440f is implanted too deep, damaging the valve leaflets.

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Abstract

La présente invention concerne un système de réduction d'anneau de valvule guidé par une fenêtre unique, comprenant un dispositif de positionnement de cathéter, un dispositif d'administration, un dispositif d'ancrage et une ligne de serrage. Le dispositif d'ancrage comprend une pluralité d'éléments d'ancrage. Le dispositif de positionnement de cathéter comprend un tube de positionnement ayant la paroi latérale sur son extrémité distale pourvue d'une fenêtre communiquant avec la cavité interne du tube de positionnement. Le tube de positionnement se déplace de telle sorte que la fenêtre est orientée vers différentes positions d'une partie ciblée. Le dispositif d'administration délivre, le long du tube de positionnement, la pluralité d'éléments d'ancrage aux différentes positions de la partie ciblée au moyen de la fenêtre. Le dispositif d'ancrage fixe séquentiellement les éléments d'ancrage passant à travers la fenêtre aux différentes positions de la partie ciblée. La ligne de serrage est utilisée pour connecter la pluralité d'éléments d'ancrage fixés aux différentes positions de la partie ciblée en série et la serrer pour diminuer le périmètre de la partie ciblée. Le système de réduction d'anneau de valvule guidé par une fenêtre unique selon la présente invention permet à la fenêtre de correspondre aux différentes positions de la partie ciblée au moyen du mouvement du tube de positionnement, puis fixe les éléments d'ancrage aux différentes positions de la partie ciblée, puis serre la partie ciblée au moyen de la ligne de serrage, ce qui permet de mettre en œuvre l'effet de diminution du périmètre de la partie ciblée.
PCT/CN2019/097567 2018-12-29 2019-07-24 Système de réduction d'anneau de valvule guidé par une fenêtre unique WO2020134052A1 (fr)

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CN201811641847.2 2018-12-29
CN201811641847.2A CN111374799A (zh) 2018-12-29 2018-12-29 一种单窗导引的瓣膜缩环系统
CN201822275151.4 2018-12-29
CN201822275151.4U CN209916301U (zh) 2018-12-29 2018-12-29 一种单窗导引的瓣膜缩环系统

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