WO2020134052A1 - Single window-guided valve annulus reduction system - Google Patents

Single window-guided valve annulus reduction system 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
Other languages
French (fr)
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 CN201822275151.4U external-priority patent/CN209916301U/en
Priority claimed from CN201811641847.2A external-priority patent/CN111374799A/en
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/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • 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 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

The present invention provides a single window-guided valve annulus reduction system, comprising a catheter positioning device, a delivery device, an anchoring device, and a tightening line. The anchoring device comprises a plurality of anchoring members. The catheter positioning device comprises a positioning tube having the side wall on the distal end thereof provided with a window communicating with the inner cavity of the positioning tube. The positioning tube moves such that the window is oriented to different positions of a targeted part. The delivery device delivers, along the positioning tube, the plurality of anchoring members to the different positions of the targeted part by means of the window. The anchoring device sequentially fixes the anchoring members passing through the window at the different positions of the targeted part. The tightening line is used for connecting the plurality of anchoring members fixed at the different positions of the targeted part in series and tightening same to decrease the perimeter of the targeted part. The single window-guided valve annulus reduction system provided by the present invention makes the window to correspond to the different positions of the targeted part by means of the movement of the positioning tube, then fixes the anchoring members at the different positions of the targeted part, and then tightens the targeted part by means of the tightening line, thereby implementing the effect of decrease the perimeter of the targeted part.

Description

一种单窗导引的瓣膜缩环***Single-window guided valve ring shrinkage system 技术领域Technical field
本发明涉及医疗器械领域，具体涉及一种单窗导引的瓣膜缩环***。The present invention relates to the field of medical equipment, and in particular to a single-window guided valve contraction system.
背景技术Background technique
如图1所示，人体心脏由左心和右心组成，右心包括右心室(RV)和右心房(RA)，左心包括左心室(LV)和左心房(LA)。二尖瓣是左心房和左心室之间的“单向阀门”，包括瓣环(MVA)、前叶(AML)、后叶(PML)、腱索(CT)及***肌(PM)。瓣环介于左心房和左心室之间，前叶与后叶与瓣环相连，两个瓣叶上面有多根腱索(CT)，腱索另一端与***肌相连。在心脏跳动过程中，正常的二尖瓣的前叶与后叶处于开放和闭合的循环运动中，从而保证血液循环由左心房定向向左心室流动和通过一定流量。当二尖瓣的瓣叶、瓣环、***肌、腱索等部件发生器质性或功能性改变造成二尖瓣前、后叶吻合不良，就会导致血液反流，称为二尖瓣反流(简称：MR)。二尖瓣反流是一种常见的心脏瓣膜疾病。二尖瓣反流从病因学上可分为功能性及器质性(退行性)两大类。对于二尖瓣反流，临床试验显示药物治疗只能改善患者症状，而不能延长患者生存或手术时机。传统的标准治疗方法为外科手术，主要为外科手术瓣膜修复或置换。但外科手术创伤大，愈合难，并发症多，手术风险较高。介入方法的经皮二尖瓣瓣环成形术是最常用的二尖瓣成形方法之一，其长期治疗效果较好。然而，现有技术在功能性二尖瓣反流并伴有心脏衰竭左心室扩大的患者中，由于仅针对瓣环进行缩环，无法对左心室进行有效的减容，治疗效果不理想。As shown in Figure 1, 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), and 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. There are multiple tendons (CT) on the two lobes. The other end of the tendon is connected to the papillary muscles. During the beating of the heart, the anterior and posterior lobes of the normal mitral valve are in open and closed circulatory motion, thereby ensuring that the blood circulation flows from the left atrium to the left ventricle and passes a certain amount of flow. When the mitral valve leaflets, annulus, papillary muscles, chordae and other components are qualitatively or functionally modified to cause anastomosis of the anterior and posterior leaves of the mitral valve, blood regurgitation can occur, which is called mitral valve regurgitation Stream (abbreviation: MR). Mitral regurgitation is a common disease of heart valves. Mitral regurgitation can be divided into two categories: functional and organic (degenerative). For mitral regurgitation, clinical trials have shown that drug treatment can only improve the patient's symptoms, but not prolong the patient's survival or the timing of surgery. The traditional standard treatment method is surgery, which is mainly surgical valve repair or replacement. However, surgical operations are traumatized, difficult to heal, have many complications, and have a high risk of surgery. Interventional percutaneous mitral annuloplasty is one of the most commonly used mitral angioplasty methods, and its long-term treatment effect is better. However, in the prior art, in patients with functional mitral regurgitation and left ventricular enlargement accompanied by heart failure, since only the annulus is contracted, the left ventricle cannot be effectively reduced, and the treatment effect is not ideal.
发明内容Summary of the invention
有鉴于此，本发明提供一种能够对左心室进行有效减容的瓣膜缩环***，改善功能性二尖瓣反流的治疗效果。具体技术方案如下。In view of this, 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.
一种单窗导引的瓣膜缩环***，所述单窗导引的瓣膜缩环***包括导管定位装置、输送装置、锚定装置以及收紧线，所述锚定装置包括多个锚定件；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 ;
所述导管定位装置包括定位管，所述定位管定位于靶向部上，所述定位管远端的侧壁上开设有与所述定位管的内腔连通的一窗口，所述定位管移动以使所述窗口朝向所述靶向部的不同位置；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;
所述输送装置沿所述定位管将多个所述锚定件经由所述窗口输送至所述靶向部的不同位置；The conveying device conveys the plurality of anchors along the positioning tube to different positions of the targeting portion via the window;
所述锚定装置将穿过所述窗口的锚定件依次固定在所述靶向部的不同位置上；The anchoring device sequentially fixes the anchoring member passing through the window to different positions of the targeting portion;
所述收紧线用于将固定在所述靶向部的不同位置上的多个所述锚定件串联并收紧，以使靶向部的周长缩小。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.
本发明与现有技术相比，至少具有以下有益效果：Compared with the prior art, the present invention has at least the following beneficial effects:
本发明提供的单窗导引的瓣膜缩环***通过导管定位装置中的定位管移动以使窗口朝 向靶向部的不同位置，进而将锚定件固定在靶向部不同的位置上，再通过收紧线将靶向部收紧，从而实现缩小靶向部周长的效果。例如，本发明提供的单窗导引的瓣膜缩环***在二尖瓣瓣环下方0.5-2cm的左心室的心肌壁圆周处，依次植入多个锚定件，并将多个锚定件串联并拉紧、固定，不仅可以缩小二尖瓣瓣环的周长，还可以减小左心室径向直径，进而减小左心室容积，从而提高二尖瓣反流的治疗效果，尤其适用于治疗功能性二尖瓣反流。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. For example, 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.
附图说明BRIEF DESCRIPTION
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。In order to more clearly explain the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings required in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without paying any creative work, other drawings can be obtained based on these drawings.
图1为人体心脏结构示意图。Figure 1 is a schematic diagram of the human heart structure.
图2为本发明第一实施例提供的一种单窗导引的瓣膜缩环***的结构示意图。FIG. 2 is a schematic structural diagram of a single-window guided valve contraction system provided by the first embodiment of the present invention.
图3为本发明提供的一种导引鞘管的结构示意图。3 is a schematic structural diagram of a guide sheath provided by the present invention.
图4a为本发明提供的一种轨道导管的结构示意图。4a is a schematic structural diagram of a rail catheter provided by the present invention.
图4b为本发明提供的另一种轨道导管的结构示意图。4b is a schematic structural diagram of another rail catheter provided by the present invention.
图5为本发明提供的一种导管定位装置的结构示意图。5 is a schematic structural diagram of a catheter positioning device provided by the present invention.
图6为图5中提供的一种导管定位装置中的定位手柄的立体结构示意图。6 is a schematic perspective view of a positioning handle in a catheter positioning device provided in FIG. 5.
图7为图5中提供的一种导管定位装置中的定位手柄的主视图。7 is a front view of a positioning handle in a catheter positioning device provided in FIG. 5.
图8为图7沿B-B的剖视图。8 is a cross-sectional view of FIG. 7 along B-B.
图9a图为图5中提供的一种导管定位装置中的定位手柄的局部结构示意图；图9b图为图9a沿A-A的剖视图。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.
图10为本发明提供的一种输送装置的结构示意图。10 is a schematic structural diagram of a delivery device provided by the present invention.
图11a为本发明提供的一种锚定装置的结构示意图。11a is a schematic structural diagram of an anchoring device provided by the present invention.
图11b为本发明提供的一种锚定装置的局部结构的剖视图。11b is a cross-sectional view of a partial structure of an anchoring device provided by the present invention.
图12为本发明第二实施例提供的一种单窗导引的瓣膜缩环***中的调弯轨道导管的结构示意图。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.
图13为本发明第三实施例提供的一种单窗导引的瓣膜缩环***中的锚定装置的结构示意图。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.
图14为本发明第四实施例提供的一种单窗导引的瓣膜缩环***中的锚定装置的结构示意图。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.
图15为本发明第五实施例提供的一种单窗导引的瓣膜缩环***中的锚定件的结构示意图。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.
图16为本发明第六实施例提供的一种单窗导引的瓣膜缩环***中的锚定件的结构示意图。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.
图17为本发明第七实施例提供的一种单窗导引的瓣膜缩环***中的锚定件的结构示意图。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.
图18为图17中提供的锚定件中的锚定部在收缩状态下的结构示意图。FIG. 18 is a schematic structural view of the anchor portion of the anchor provided in FIG. 17 in a contracted state.
图19为图17中提供的锚定件中的锚定部在扩展状态下的结构示意图。FIG. 19 is a schematic structural view of the anchor portion of the anchor provided in FIG. 17 in an expanded state.
图20为本发明提供的导引装置经心尖送入瓣叶下方的示意图。FIG. 20 is a schematic diagram of the guiding device provided by the present invention is delivered through the apex of the valve leaflet.
图21为本发明提供的锚定件植入心室壁的示意图。21 is a schematic diagram of an anchor provided by the present invention implanted in a wall of a ventricle.
图22为本发明提供的多个锚定件植入心室壁不同位置后的示意图。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.
图23为本发明提供的收紧线将多个锚定件收紧后的示意图。23 is a schematic diagram of the tightening wire provided by the present invention after tightening a plurality of anchors.
图24为本发明提供的另一种导管定位装置的结构示意图。24 is a schematic structural diagram of another catheter positioning device provided by the present invention.
图25为本发明提供的又一种导管定位装置的结构示意图。25 is a schematic structural diagram of another catheter positioning device provided by the present invention.
图26为本发明提供的导引装置经主动脉路径送入左心室的示意图。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.
图27为本发明提供的再一种导管定位装置的结构示意图。FIG. 27 is a schematic structural diagram of yet another catheter positioning device provided by the present invention.
图28为本发明提供的导引装置经房间隔路径送入左心室的示意图。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.
具体实施方式detailed description
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。The technical solutions in the embodiments of the present application will be described clearly and completely in combination with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, but not all the embodiments. Based on the embodiments in this application, all other embodiments obtained by a person of ordinary skill in the art without making creative work fall within the scope of protection of this application.
需要说明的是，在本发明实施例中使用的术语是仅仅出于描述特定实施例的目的，而非旨在限制本发明。在本发明实施例和所附权利要求书中所使用的单数形式的“一种”、“所述”和“该”也旨在包括多数形式，除非上下文清楚地表示其他含义。还应当理解，本文中使用的术语“和/或”是指并包含一个或多个相关联的列出项目的任何或所有可能组合。It should be noted that the terms used in the embodiments of the present invention are only for the purpose of describing specific embodiments, and are not intended to limit the present invention. The singular forms "a", "said" and "the" used in the embodiments of the present invention and the appended claims are also intended to include the majority forms unless the context clearly indicates other meanings. It should also be understood that the term "and/or" as used herein refers to and encompasses any or all possible combinations of one or more associated listed items.
为了更加清楚地描述单窗导引的瓣膜缩环***的结构，此处限定术语“近端”及“远端”为介入医疗领域惯用术语。具体而言，“远端”表示手术操作过程中远离操作人员的一端，“近端”表示手术操作过程中靠近操作人员的一端。In order to more clearly describe the structure of the single-window-guided valve loop system, the terms "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.
请参阅图2和图5，本发明第一实施例提供一种单窗导引的瓣膜缩环***10，包括导管定位装置200、输送装置300、锚定装置400以及收紧线500，锚定装置400包括多个锚定件440a。2 and 5, 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.
导管定位装置200包括设于远端的定位管210(参阅图5)，定位管210定位于靶向部上。定位管210远端的侧壁上开设有与定位管210的内腔连通的一窗口212，定位管210移动以使窗口212朝向靶向部的不同位置。其中导管定位装置200中的窗口212只有1个。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.
操作者调整定位管210的远端位置，以使窗口212朝向靶向部的不同位置，进而可通过输送装置300沿定位管210将多个锚定件440a经由窗口212输送至靶向部的不同位置，锚定装置400将穿过窗口212的锚定件440a依次固定在靶向部的不同位置上，收紧线500用于将固定在靶向部的不同位置上的多个锚定件440a串联并收紧，以使靶向部的周长缩小。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.
在进一步的实施例中，靶向部为二尖瓣瓣环或者二尖瓣瓣环下方的左心室心肌壁。In a further embodiment, the targeting portion is the mitral valve annulus or the left ventricular myocardial wall below the mitral valve annulus.
在进一步的实施例中，靶向部为二尖瓣瓣环下方的左心室心肌壁，具体是在二尖瓣瓣环下方0.5-2cm的左心室的心肌壁上，依次植入多个锚定件440a，并将多个锚定件440a串联并拉紧、固定，从而完成对二尖瓣缩环、同时对左心室减容的目的，改善二尖瓣反流的治疗效果，尤其适用于治疗功能性二尖瓣反流。In a further embodiment, 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.
在进一步的实施例中，导管定位装置200还包括设置于定位管210近端的定位手柄230(参阅图5)。定位手柄230控制定位管210远端沿靶向部的表面前进或后退，以使窗口212朝向靶向部的不同位置。定位管210与定位手柄230刚性连接，在其他实施例中，可以通过医用胶水连接、焊接、过盈配合等方式。In a further embodiment, 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.
在进一步的实施例中，瓣膜缩环***10还包括导引装置100，导引装置100用于建立从患者体外到靶向部的轨道，导管定位装置200通过导引装置100的内腔达到并定位在靶向部，以使窗口212朝向靶向部。可以理解的是，所述导管定位装置200穿装在导引装置100的内腔中，输送装置300穿装在导管定位装置200的内腔中，锚定装置400通过输送装置300的内腔自窗口212伸出。In a further embodiment, 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. It can be understood that 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, and the anchoring device 400 passes through the lumen of the delivery device 300 The window 212 extends.
请参阅图3和图4a，在进一步的实施例中，导引装置100包括导引鞘管101(参阅图3)及穿装在导引鞘管101中的轨道导管102(参阅图4a)，轨道导管102自导引鞘管101的远端伸出，并贴合在靶向部，进而建立从体外到靶向部的轨道，轨道导管102的内腔用于容纳并通过导管定位装置200。Please refer to FIGS. 3 and 4a. In a further embodiment, 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.
请参阅图3，在进一步的实施例中，导引鞘管101包括具有一定轴向长度的鞘管130和第一牵引件104；鞘管130包括靠近近端的第一支撑段131和靠近远端的第一调弯段132，第一牵引件104的远端连接第一调弯段132，第一牵引件104沿鞘管130的轴向移动以将第一调弯段132调整至贴合靶向部的形状。鞘管130由高分子聚合物材料制成，所述高分子材料选自ABS、PE、PP、PEBAX、PC、PU、Nylon、PVC、PTFE或PB中的一种或几种的共聚物或混合物。本实施例中选用PEBAX，硬度为40D。3, in a further embodiment, 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.
在进一步的实施例中，鞘管130为中空的多层管体，第一牵引件104包括第一牵引丝110、第一穿丝管120和第一锚定环160，第一穿丝管120轴向开设在鞘管130的内壁中，第一牵引丝110穿设在第一穿丝管120中，第一锚定环160设置在第一穿丝管120的远端，且第一锚定环160位于第一调弯段132中。第一牵引丝110的远端与第一锚定环160连接，通过牵拉第一牵引丝110，进而带动第一调弯段132弯曲至贴合靶向部的形状。可以理解的是，第一牵引丝110嵌入鞘管130的内壁中，且第一牵引丝110收容在第一穿丝管120中以防止第一牵引丝110弯折，第一牵引丝110的远端延伸至鞘管130的远端并与第一锚定环160刚性连接，由此，通过牵拉第一牵引丝110，从而带动第一调弯段132弯曲，实现调弯功能。第一牵引丝110由304不锈钢、铜等能承受一定拉力的金属制成；第一穿丝管120可以由304不锈钢制成；鞘管130由多层高分子膜及金属加强层组成，如内膜为PTFE管、中层为304不锈钢编织网管、外层为PEBAX管等；第一锚定环160由金属材料制成，如304不锈钢。In a further embodiment, the sheath tube 130 is a hollow multilayer tube body, and 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. It can be understood that the 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.
在进一步的实施例中，导引鞘管101还包括设置在鞘管130近端的第一调弯器140， 第一牵引丝110的近端与第一调弯器140连接，通过拉动第一调弯器140，牵拉第一牵引丝110，进而带动第一调弯段132弯曲。第一调弯器140材料为PC。In a further embodiment, 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.
在进一步的实施例中，导引鞘管101还包括第一手柄150，第一手柄150设置在第一调弯器140与鞘管130之间，或者第一调弯器140与鞘管130近端收容在第一手柄150中，便于操作者抓持及操作使用。In a further embodiment, 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.
在其他实施例中，在鞘管130远端具有尖锐的端部，优选为圆锥形结构。In other embodiments, the distal end of the sheath 130 has a sharp end, preferably a conical structure.
可以理解的是，在其他实施例中，导引鞘管101也可以采用塑形管体的方式，类似现有的塑形输送鞘管，在此不再赘述。It can be understood that, in other embodiments, 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.
请参阅图4a，在进一步的实施例中，轨道导管102为预定型的塑形轨道导管102a。塑形轨道导管102a包括刚性连接的第二手柄110a和塑形管体103a，第二手柄110a设置在塑形管体103a的近端。塑形管体103a包括由近端至远端依次相连的第一管体120a、第二管体130a及第三管体140a，第三管体140a的延伸方向与第一管体120a的延伸方向之间的角度范围为0-180度，且第三管体140a与第一管体120a之间通过第二管体130a平滑过渡。Please refer to FIG. 4a. In a further embodiment, 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.
请参阅图4b，在进一步的实施例中，提供了一种与靶向部的贴合性较好的塑形轨道导管112b，包括由近端至远端依次相连的第一管体1121b，第二管体1122b及第三管体1123b，第一管体1121b与第二管体1122b的近端所在的第一平面和第三管体1123b与第二管体1122b的远端所在的第二平面之间的角度范围为30-150度。Please refer to FIG. 4b. In a further embodiment, a shaped rail catheter 112b with a better fit to the targeting portion is provided, 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.
可以理解的是，塑形管体103a中具有能够容纳导管定位装置200的内腔150a。It can be understood that the shaped tube body 103 a has an inner cavity 150 a capable of accommodating the catheter positioning device 200.
可以理解的是，塑形管体103a为具有一定硬度的柔性管，可以由高分子聚合物材料制成，如PEEK、ABS、PE、PP、PEBAX、PC、PU、Nylon、PVC、PTFE或PB中的一种或几种的共聚物或混合物，也可以由生物相容性金属如镍钛合金制成。塑形管体103a可以是单层管；也可以是多层管，如由内膜PTFE、中间编织网管、外层PEBAX管通过热熔成为一个柔性管件的多层管体。本实施例中采用PEBAX管，整个管体通过热定型等方式塑形至紧密贴合瓣环下方(即，前瓣叶和后瓣叶与心肌壁的连接处)的形状。It can be understood that 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. In this embodiment, 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).
请再次参阅图2，瓣膜缩环***10还包括导丝600，导丝600穿设在轨道导管102中。导丝600用于为导管定位装置200、输送装置300和锚定装置400提供进入靶向部的方向指引。导丝600的一端为柔性的导丝头，有一定的距离，进入人体时不会对人体组织造成伤害，另一端为柔性丝，材质为镍钛等柔性金属材料，优选的，导丝600表面可以镀PTFE膜，镀膜后整体的光滑性更好，提升在人体内的可操作性。导丝600选自导引导丝，直形导丝，J形导丝，泥鳅导丝等。尺寸为0.014”、0.018”、0.035”、0.038”、0.046”等。Referring again to FIG. 2, 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.
请参阅图5，定位管210至少包括轴向贯通的导丝腔215及与导丝腔215平行设置的输送腔214；窗口212与输送腔214的远端连通，从而为输送装置300及锚定装置400提供定位。也就是说，窗口212开设在输送腔214的侧壁211上。窗口212形状可以是圆形、椭圆形、方形、菱形、三角形、梯形平行或四边形。窗口212的面积范围为4～4000mm 2。定位管210可以采用一体成型的双腔管或多腔管，也可以采用多根单独的管体套装在一起的形式，本实施例中采用一体成型的双腔管。 Referring to FIG. 5, 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. In other words, 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.
优选地，输送腔214的远端224为一弧形面，与窗口212之间平滑过渡，有利于输送装置300沿输送腔214的远端224顺滑地经窗口212伸出并到达预定位置。定位管210的管体由高分子聚合物材料组成，如ABS、PE、PP、PEBAX、PC、PU、Nylon、PVC、PTFE或PB中的一种或几种的共聚物或混合物。定位管210的内径范围为0.3～15mm，优选为1.5～10mm。定位管210的管体内埋设显影件以指示管***置。显影件由不透射X射线的金属材料制成，如，铁、铜、黄金、铂金、钛、镍、铱中的一种或几种。Preferably, 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.
在进一步的实施例中，导管定位装置200还包括转向头220，转向头220设置在定位管210的远端，转向头220由柔性材料制成，导丝腔215与转向头220的内腔相连通，转向头220具有朝向靶向部的倾斜面221。当导管定位装置200置于左心室中时，该转向头220的倾斜面221朝向心室壁，以进一步贴合心室壁。In a further embodiment, 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.
请参阅图6至图9b，在进一步的实施例中，定位手柄230包括调控机构201、手柄外壳202和鞘管连接件235；调控机构201与手柄外壳202配合作用以控制定位管210沿轴向前进或后退。进而控制定位管210远端的窗口212朝向靶向部的不同位置。鞘管连接件235与定位管210连通(参阅图8)，且鞘管连接件235内部设有轴向贯通的通孔236，以用于输送装置300通过。也就是说输送装置300依次进入鞘管连接件235中的通孔236和定位管210，再自窗口212伸出。Please refer to FIGS. 6 to 9b. In a further embodiment, 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. In turn, 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.
在进一步的实施例中，定位手柄230还包括锁紧头231，鞘管连接件235的近端与锁紧头231之间通过螺纹连接等方式可拆卸连接。具体的，在鞘管连接件235的近端设有锁紧部233，锁紧部233通过螺纹套设在锁紧头231的外部，在锁紧部233与锁紧头231连接处设有密封垫234，密封垫234具有轴向内腔以供输送装置400通过，密封垫234优选为具有弹性的医用高分子材料，如硅胶制成。In a further embodiment, 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. Specifically, 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.
在进一步的实施例中，调控机构201包括调节旋钮241及调节螺杆244。In a further embodiment, the adjustment mechanism 201 includes an adjustment knob 241 and an adjustment screw 244.
调节螺杆244活动地套设在鞘管连接件235的远端；调节旋钮241与手柄外壳202之间可相对旋转的活动连接，且调节旋钮241通过螺纹连接在调节螺杆244的外部，并自手柄外壳202径向穿出手柄外壳202外表面。通过旋转调节旋钮241，使得调节旋钮241在调节螺杆244上沿轴向前进或后退，从而使手柄外壳202与调节螺杆244之间相对运动，进而带动与鞘管连接件235连接的定位管210沿轴向前进或后退，以使窗口212朝向靶向部的不同位置。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. By rotating the adjusting knob 241, 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.
具体的，调节螺杆244活动地套设在鞘管连接件235的远端，调节螺杆244为中空、远端封闭的管体，调节螺杆244外部设有螺纹。调节旋钮241的内部设有螺纹以与调节螺杆244相适配，由此，通过旋转调节旋钮241，使得调节旋钮241在调节螺杆244上沿轴向前进或后退，从而实现与调节旋钮244相连的调节手柄外壳202与调节螺杆244之间的相对运动，进而带动与鞘管连接件235连接的定位管210沿轴向前进或后退，以使窗口212朝向靶向部的不同位置。Specifically, 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. Therefore, by rotating the adjusting knob 241, 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.
在进一步的实施例中，调控机构201还包括限位器239以及卡位件232；卡位件232设置在鞘管连接件235上，限位器239贯穿手柄外壳202外部，并沿定位手柄230径向延 伸，限位器239用于抵接卡位件232以控制鞘管连接件235移动的距离。也就是说，当操作者旋转调节旋钮241，调节螺杆244相对于手柄外壳202向近端移动，并推动鞘管连接件235的卡位件232向近端移动，当鞘管连接件235的卡位件232抵接限位器239后无法继续移动，此时卡位件232被固定在限位器239与调节螺杆244的近端之间，从而限制并锁定定位管210远端的位置。In a further embodiment, 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.
在进一步的实施例中，手柄外壳202上沿轴向设有导向槽260及多个与导向槽260连通的限位槽261(参阅图7)，限位器239设在限位槽261中并可沿导向槽260轴向移动，当限位器239卡入限位槽261，限位器239与手柄外壳202之间的位置相对固定。其中相邻两个限位槽261之间的距离，即为限位器239每次移动的最小距离。在操作中，可根据实际情况来移动限位器239的距离。In a further embodiment, 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. When the stopper 239 snaps into the stopper groove 261, the position between the stopper 239 and the handle housing 202 is relatively fixed. 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.
在进一步的实施例中，手柄外壳202包括位于近端的调节手柄238、位于远端的保护套245以及设于二者之间的前壳242和后壳240；其中调节旋钮241的近端与后壳240连接，调节旋钮241的远端与前壳242连接。In a further embodiment, 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.
其中，后壳240与调节手柄238之间通过紧密配合的卡扣结构实现刚性连接，前壳242与保护套245之间通过紧密配合的卡扣结构实现刚性连接。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.
调节旋钮241与手柄外壳202之间可相对旋转的活动连接，具体的，前壳242与调节旋钮241远端之间通过间隙配合的卡扣结构实现可相对旋转的活动连接，后壳240与调节旋钮241近端之间通过间隙配合的卡扣结构实现可相对旋转的活动连接。也就是说调节旋钮241通过与前壳242和后壳240之间可相对旋转的活动连接，来实现调节旋钮241与手柄外壳202之间可相对旋转的活动连接。Relatively rotatable movable connection between the adjusting knob 241 and the handle housing 202. Specifically, 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, and the rear casing 240 is connected to the adjusting Between the proximal ends of the knob 241, 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.
在进一步的实施例中，定位手柄230还包括支撑棒237(参阅图8)，支撑棒237围绕鞘管连接件235设置并穿过鞘管连接件235上的卡位件232，支撑棒237的远端与手柄外壳202的远端连接。具体的，支撑棒237与手柄外壳202远端的保护套245连接，并分别穿过调节螺杆244的封闭端，从而将保护套245、调节螺杆244及鞘管连接件235连接在一起。In a further embodiment, 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. Specifically, 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.
操作者在使用定位手柄230时，先向近端移动限位器239一定距离时，对应将限位器239卡入具有相应距离的限位槽261中，其中限位器239移动的距离即为每两个锚定件440a之间的植入间距。然后旋转调节旋钮241，从而使得调节螺杆244相对于手柄外壳202沿轴向移动，进而带动鞘管连接件235沿轴向移动，当卡位件232抵接限位器239时无法继续移动，此时卡位件232被固定在限位器239与调节螺杆244的近端之间，从而限制并锁定定位管210远端的位置，即，限定了定位管210的窗口212与心室壁之间的相对位置，从而实现在体外调节两个锚定件440a之间的植入间距。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.
在实际操作中，当需要植入下一个锚定件440a时，将限位器239从限位槽261中旋出，并向近端移动到下一个限位槽261中，旋入后固定，然后旋转调节旋钮241，使得调节螺杆244相对于手柄外壳202向近端移动，调节螺杆244带动鞘管连接件235向近端同步运动，当调节螺杆244后撤到一定距离(两个植入锚定件440a的间距)时，调节螺杆244 近端及卡位件234就会顶到限位器239，无法继续向近端移动。In actual operation, when the next anchor 440a needs to be implanted, 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) When the distance between the stator 440a), 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.
另外，实际操作中，如果病人情况不同，操作者也可以通过将限位器239直接拉到最近端的限位槽261内固定，然后通过后撤鞘管连接件235的近端，带动定位管210向后移动，并根据患者情况结合医学影响确定移动距离，从而实时控制需要植入的锚定件440a数量和锚定件440a之间的距离。In addition, in actual operation, if the patient's condition is different, 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.
可以理解的是，整个定位手柄230均可使用高分子材料注塑或者机加工而成，材料如：ABS、PC、尼龙等医疗级高分子材料，支撑棒237和限位器239优选用不锈钢等金属材质以提升操作时的顺滑性。It can be understood that 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.
输送装置300用于沿着导丝600和导管定位装置200到达靶向部，经由导管定位装置200的窗口212伸出，为锚定装置400中的锚定件440a提供输送通道。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.
请参阅图10，在进一步的实施例中，输送装置300包括输送管330和第三牵引件106，输送管330包括靠近近端的第二支撑段331和靠近远端的第二调弯段332，第三牵引件106沿输送管330的轴向移动以将第二调弯段332调整至与导管定位装置200相配合的形状，使得输送管330的远端到达窗口212。可以理解的是，输送管330为中空管体，可以是高分子聚合物材料制成的单层管，如PEEK、PI、ABS、PE、PP、PEBAX、PC、PU、Nylon、PVC、PTFE或PB中的一种或几种的共聚物或混合物制成，也可以是多层管体。本实施例中采用多层高分子膜及金属构成的多层管体，内膜为PTFE管、中层为不锈钢304编织网管、外层为PEBAX管。可以理解的是，第二调弯段332可在同一平面方向任意调弯，调弯角度为0～360度。Referring to FIG. 10, in a further embodiment, 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. It can be understood that 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. In this embodiment, 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, and the outer layer is a PEBAX tube. It can be understood that the second bending section 332 can be arbitrarily bent in the same plane direction, and the bending angle is 0-360 degrees.
在进一步的实施例中，输送管330为中空的多层管体，第三牵引件106包括第三牵引丝340、第三穿丝管350以及第三锚定环360。第三穿丝管350轴向开设在输送管330的内壁中，第三牵引丝340穿设在第三穿丝管350中，第三锚定环360设置在第三穿丝管350的远端，且第三锚定环360位于第二调弯段332中；第三牵引丝340的远端与第三锚定环360连接，通过牵拉第三牵引丝340，进而带动第二调弯段332弯曲至与导管定位装置200相配合的形状，使得输送管330的远端到达窗口212。In a further embodiment, the delivery tube 330 is a hollow multi-layer tube, and 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, and the third anchor ring 360 is disposed at the distal end of the third threading tube 350 , And 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.
在进一步的实施例中，输送装置300还包括设置在输送管330近端的第三调弯器310，第三牵引丝340的近端与第三调弯器310连接，通过拉动第三调弯器310，牵拉第三牵引丝340，进而带动第二调弯段332弯曲。In a further embodiment, 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.
在进一步的实施例中，输送装置300还包括第四手柄320，第四手柄320设置在第三调弯器310与输送管330之间，或者第三调弯器310与输送管330近端收容在第四手柄320中，便于操作者抓持及操作使用。In a further embodiment, 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.
可以理解的是，第三调弯器310由ABS等高分子材料或者304不锈钢、316不锈钢等金属材料制成，第四手柄320材料为金属或者高分子，如304不锈钢、ABS、PC等。牵引丝340可以是304不锈钢丝、铁丝、铜丝、镍钛丝等，或者是尼龙绳、聚丙烯绳、聚氨酯绳、纤维绳等高分子牵引绳。第三穿丝管350可以为304不锈钢管。第三锚定环360为金属材料制成，如304不锈钢等。It can be understood that 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, and 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.
在进一步的实施例中，输送管330的管体中可埋设显影件以指示管***置，显影件由不透射X射线的金属材料制成，如，铁、铜、黄金、铂金、钛、镍或铱中的一种或几种。In a further embodiment, 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.
锚定装置400通过输送装置300的内腔到达瓣环，并将多个锚定件440a植入在靶向部(如，心肌壁)的不同位置。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).
请参阅图11a及图11b，在进一步的实施例中，锚定装置400还包括释放控制器410a，以及设置在释放控制器410a与锚定件440a之间的推送杆420a，推送杆420a与锚定件440a之间可拆卸连接，释放控制器410a控制锚定件440a释放在靶向部。可以理解的是，释放控制器410a可通过扭转来带动锚定件440a旋转直至锚定件440a植入患者组织的靶向部，如瓣环附近的心肌壁。11A and 11B, in a further embodiment, 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.
可以理解的是，推送杆420a可以是具有一定轴向长度的金属或高分子材质的实心细杆或空心细管，金属材质选自，铁、钢、铜、钛、镍或铬中的一种或几种。高分子材质选自ABS、PE、PP、PEBAX、PC、PU、Nylon、PVC、PTFE或PB中的一种或几种。可以为单根/股的棒材或管材，或由多根/股棒材或管材或线材缠绕/编织而成。本实施例中采用多根钢丝捻制而成的钢缆作为推送杆420a。It can be understood that 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.
在进一步的实施例中，锚定装置400还包括连接机构430a，连接机构430a近端与推送杆420a的远端刚性连接，推送杆420a通过连接机构430a远端与锚定件440a之间可拆卸连接；释放控制器410a控制连接机构430a打开，以释放锚定件440a。可以理解的是，释放控制器410a还包括控制锚定件440a的动作，如，前进、后退、扭转、旋转、滑动、移动、摆动等。In a further embodiment, 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.
在进一步的实施例中，可拆卸连接的方式包括螺纹连接、卡扣连接或者夹合连接中的一种。可以理解的是，在该实施例中，连接机构430a远端与锚定件440a可拆卸连接的方式为螺纹连接。In a further embodiment, 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.
在进一步的实施例中，当采用螺纹连接时，连接机构430a靠近远端的管体设有螺纹，且与锚定件440a之间螺纹配合。连接机构430a的最远端431a无螺纹，以防止与锚定件440a之间的螺纹配合锁死，后续难以解脱。In a further embodiment, when a threaded connection is used, 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.
在进一步的实施例中，锚定件440a包括连接部441a与锚定部442a，锚定部442a通过连接部441a与推送杆420a之间可拆卸连接。在该实施例中，锚定部442a通过连接部441a与连接机构430a远端可拆卸连接。其中连接部441a与锚定部442a二者之间刚性连接或一体成型。可以理解的是，在该实施例中，连接部441a内部设有螺纹与连接机构430a的远端管体432a配合，锚定部442a用于锚定在人体组织中，锚定部442a的远端为尖锐的针状以利于锚定部442a刺入人体组织。In a further embodiment, 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. In this embodiment, 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. It can be understood that, in this embodiment, 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.
在进一步的实施例中，锚定部442a包括至少一个螺旋结构。锚定部442a的螺旋结构的尖端刺入组织内部后，可大大增加锚定部442a与靶向部组织接触的比表面积，从而牢牢固定在组织内部，避免现有技术的柔性锚定部无法稳定保持扩展形状而发生变形，易被拉脱的问题。In a further embodiment, 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.
可以理解的是，锚定部442a具有一个可连续相同/或变化的横截面(即为螺旋状)。 锚定部442a的长度范围为4mm-16mm，直径范围为0.2mm-5mm，刺入深度范围为2-10mm。在该实施例中，连接部441a与锚定部442a的近端刚性连接，连接部441a具有明显大于锚定部442a的横截面直径，用于对锚定部442a的限位，以控制锚定部442a穿刺靶向组织进入预定的深度，防止过度穿刺对靶向组织造成损伤。It can be understood that 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. In this embodiment, 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.
可以理解的是，连接部441a由刚性较好的材料制成，如不锈钢、POM、PEEK等。锚定部442a的螺旋结构为具有刚性的生物相容性金属材质或者具有形状记忆功能的材料制成。具有刚性的生物相容性金属材质选自，铁、钢、铜、钛、镍、铬中的一种或几种的合金，本实施例中采用不锈钢。现有技术中，二尖瓣瓣环成形术使用的植入物通常由柔性较高的形状记忆金属制成，这类植入件的刚性较低的，在牵拉绳索收缩瓣环的过程中，很容易将植入件拉脱，进而对心脏造成严重的损伤，本实施例中采用不锈钢等刚性材料制成，可有效避免植入件被拉脱。It can be understood that 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. In the prior art, 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.
在进一步的实施例中，连接部441a上设有连线孔443a，连线孔443a用于收紧线500通过。In a further embodiment, 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.
可以理解的是，收紧线500通过连线孔443a上的孔将多个锚定件440a串联连接。收紧线500为具有一定长度的柔性线，为单股/多股缆绳/线绳，可以是常规医用收紧线，也可以是其他医疗级别的柔性线索。收紧线500由生物相容性的金属/高分子材料制成，金属材料选自，铁、钢、铜、钛、镍或铬中的一种或几种。高分子材料选自ABS、PE、PP、PEBAX、PC、PU、Nylon、PVC、PTFE或PB中的一种或几种。It can be understood that 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.
请参阅图12，本发明第二实施例提供一种单窗导引的瓣膜缩环***10a，与第一实施例中不同的是，在瓣膜缩环***10a中，轨道导管102可以为能够实时调节形状的调弯轨道导管102b。调弯轨道导管102b包括调弯管103b和第二牵引件105，调弯管103b包括靠近近端的第四管体130b及靠近远端的第五管体140b，第二牵引件105沿调弯管103b的轴向移动以将第五管体140b调整至贴合靶向部的形状。Referring to FIG. 12, a second embodiment of the present invention provides a single-window guided valve contraction system 10a. Unlike the first embodiment, in the 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.
在进一步的实施例中，调弯管103b为中空的多层管体，第二牵引件105还包括第二牵引丝133b、第二穿丝管132b和第二锚定环131b，第二穿丝管132b开设在调弯管103b的内壁中，第二牵引丝133b穿设在第二穿丝管132b中；第二锚定环131b设置在第二穿丝管132b的远端，且第二锚定环131b位于第五管体140b中；第二牵引丝133b的远端与第二锚定环131b连接，可牵拉第二牵引丝133b，从而带动第五管体140b弯曲至贴合靶向部的形状，实现调弯功能。In a further embodiment, the bending tube 103b is a hollow multilayer tube body, and 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.
在进一步的实施例中，调弯轨道导管102b还包括设置在调弯管103b近端的第二调弯器110b，第二牵引丝133b的近端与第二调弯器110b连接，通过拉动第二调弯器110b，牵拉第二牵引丝133b，进而带动第五管体140b弯曲。In a further embodiment, 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.
在进一步的实施例中，调弯轨道导管102b还包括第三手柄120b，第三手柄120b设置在第二调弯器110b与调弯管103b之间，或者第二调弯器110b与调弯管103b近端收容在第三手柄120b中，便于操作者抓持及操作使用。In a further embodiment, 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.
可以理解的是，调弯管103b由高分子聚合物材料制成，如ABS、PE、PP、PEBAX、 PC、PU、Nylon、PVC、PTFE或PB中的一种或几种的共聚物或混合物。It can be understood that 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 .
请参阅图13，本发明第三实施例提供一种单窗导引的瓣膜缩环***10b，与第一实施例中不同的是，在瓣膜缩环***10b中，锚定装置400b中的推送杆420b与锚定件440b之间可拆卸连接。也就是说，推送杆420b与锚定件440b直接相连，中间没有其他连接机构。Referring to FIG. 13, a third embodiment of the present invention provides a single-window guided valve contraction system 10b. Unlike the first embodiment, in the valve contraction system 10b, the push in the anchoring device 400b The rod 420b is detachably connected to the anchor 440b. In other words, the push rod 420b is directly connected to the anchor 440b with no other connecting mechanism in between.
可以理解的是，推送杆420b远端与锚定件440b可拆卸连接的方式包括螺纹连接、卡扣连接或者夹合连接中的一种。当推送杆420b远端与锚定件440b可拆卸连接的方式采用螺纹连接时，推送杆420b靠近远端的管体设有螺纹，且与锚定件440b之间螺纹配合。推送杆420b的最远端无螺纹，以防止与锚定件440b之间的螺纹配合锁死，后续难以解脱。It can be understood that 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. When the distal end of the push rod 420b and the anchor 440b are detachably connected by a screw 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.
请参阅图14，本发明第四实施例提供一种单窗导引的瓣膜缩环***10c，与第一实施例中不同的是，在瓣膜缩环***10c中，锚定装置400c还包括第五手柄460c和释放管450c，第五手柄460c设置在释放管450c的近端，推送杆420c穿过第五手柄460c，推送杆420c的远端和连接机构430c穿装在释放管450c中。Referring to FIG. 14, the fourth embodiment of the present invention provides a single-window guided valve contraction system 10c. Unlike the first embodiment, in the 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.
当释放控制器410c拉动推送杆420c向近端移动时，连接机构430c与释放管450c配合作用以使连接机构430c夹紧锚定件440c；当释放控制器410c拉动推送杆420c向远端移动时，连接机构430c与释放管450c配合作用以使连接机构430c释放锚定件440c。When the release controller 410c pulls the push rod 420c to move to the proximal end, the 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.
在进一步的实施例中，连接机构430c包括多组连接杆432和多个销钉431，多组连接杆432通过多个销钉431活动连接，多组连接杆432中最近端的一组连接杆432通过销钉431与推送杆420c连接，多组连接杆432中最远端的一组连接杆432的端部设有夹紧部434c，夹紧部434c用于夹紧和释放锚定件440c。连接杆432和销钉431可以是金属材料或者密度比较大的高分子材料，如不锈钢、POM等，In a further embodiment, the 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.
当释放控制器410c拉动推送杆420c向近端移动时，连接机构430c与释放管450c配合作用以使夹紧部434c夹紧锚定件440c，当释放控制器410c拉动推送杆420c向远端移动时，连接机构430c与释放管450c配合作用以使夹紧部434c释放锚定件440c。When the release controller 410c pulls the push rod 420c to move to the proximal end, 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.
具体的，如图14所示，推送杆420c与第一组连接杆432c通过第一销钉431c活动连接，第一组连接杆432c又通过两个第二销钉436c分别与第二组连接杆433c活动连接，第二组连接杆433c又通过第三销钉435c与释放管450c的远端连接，且第三销钉435c与释放管450c刚性连接。第二组连接杆433c的远端朝向推送杆420c的轴向弯曲并延伸形成夹紧部434c。释放控制器410c与推送杆420c刚性连接，推送杆420c依次穿过第五手柄460c和释放管450c的内腔。当通过释放控制器410c拉紧420c时，由于第一销钉431c的作用，第一组连接杆432c受到拉伸向近端移动，从而通过第二销钉436c带动第二组连接杆433c向近端移动，但是由于第二组连接杆433c通过第三销钉435c与释放管450c连接，所以第二组连接杆433c不会向近端运动，从而导致其与第二销钉436c连接的近端向中线靠拢，以此带动第二组连接杆433c通过第三销钉435c旋转运动，从而，第二组连接杆433c的远端部434c向中间靠拢并夹紧锚定件440c的连接部441c，反之，当向远端推动推送杆420c即可实现解脱与锚定件440c之间的连接脱离功能，从而实现整个组件带动锚定件440c运动又可实现远距离脱离的操作。Specifically, as shown in FIG. 14, 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 In connection, 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. When 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 However, 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 second group of connecting rods 433c moves closer to the middle and clamps the connecting part 441c of the anchor 440c. Pushing the push rod 420c at the end can realize the connection and disconnection function between the release and the anchor 440c, so as to realize the operation that the entire assembly drives the anchor 440c to move and realize the remote detachment.
请参阅图15，本发明第五实施例提供一种单窗导引的瓣膜缩环***10d，与第一实施例中不同的是，在瓣膜缩环***10d中提供另一种锚定件440d，在锚定件440d中，锚定部442d包括两个螺旋结构4421和4422。当锚定部442d为两个螺旋结构4421和4422时，两个螺旋结构的尺寸相同或者尺寸之差小于第一预设范围。优选为两组螺旋结构4421和4422的起始点之间的夹角为180°，此结构增加了锚定部442d与人体组织的接触面积，锚定部442d植入人体组织后能够实现更大的锚定力，更加牢固，防止脱落。Referring to FIG. 15, the fifth embodiment of the present invention provides a single-window guided valve contraction system 10d. Unlike the first embodiment, another anchor 440d is provided in the valve contraction system 10d. In the anchor 440d, the anchor portion 442d includes two spiral structures 4421 and 4422. When 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. Preferably, 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.
请参阅图16，本发明第六实施例提供一种单窗导引的瓣膜缩环***10e，与第一实施例中不同的是，在瓣膜缩环***10e中提供又一种锚定件440e，当锚定部442e包括两个螺旋结构4423和4424时，两个螺旋结构4423和4424的尺寸之差大于第二预设范围。也就是说，是由两组尺寸不同的内外螺旋结构4423和4424组成，这种结构，除了增加锚定力，还使得整个锚定件440e的柔性更好，质量更轻，对患者的损伤更小。Referring to FIG. 16, the sixth embodiment of the present invention provides a single-window guided valve contraction system 10e. Unlike the first embodiment, another anchor 440e is provided in the valve contraction system 10e When the anchor portion 442e includes two spiral structures 4423 and 4424, the difference between the dimensions of the two spiral structures 4423 and 4424 is greater than the second preset range. In other words, it is composed of two sets of internal and external spiral structures 4423 and 4424 with different sizes. In addition to increasing the anchoring force, this structure also makes the entire anchor 440e more flexible, lighter in weight, and more harmful to the patient. small.
请参阅图17至图19，本发明第七实施例提供一种单窗导引的瓣膜缩环***10f，与第一实施例中不同的是，在瓣膜缩环***10f中提供再一种锚定件440f，锚定件440f中的锚定部442f通过连接部441f与推送杆420f连接。Referring to FIGS. 17-19, 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.
锚定部442f包括靠近近端的连接环4425、靠近远端的锚定针4426及套设在连接环4425和锚定针4426外部的束缚部4427；锚定针4426具有在自然状态下的扩展形状(参阅图19)和被输送装置300约束的收缩形状(参阅图18)。锚定部442f的长度范围为4mm-16mm，直径范围为0.2mm-5mm，刺入深度范围为2-10mm。锚定部442f为形状记忆功能的材料制成，在收缩形状时被压缩于输送装置300中，当从输送装置300中释放后其尖端可刺入靶向组织深部，并固定在组织内部后完全恢复至自然状态下的扩展形状。本实施例中，锚定针4426包括两个背向设置的分支4426a和4426b，分支4426a和4426b的近端部分分别由连接环4425的远端交错并延伸形成，分支4426a和4426b的远端部分反向延伸，即，分支4426a和4426b分别具有的两个对称设置的开口指向近端的钩状结构。束缚部4427套设在连接环4425的远端交错处，从而限制锚定部的两个分支之间的相对位置，防止自然状态下，两个钩状结构由于自身弹性完全弹开。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. 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. In this embodiment, 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.
如图17和图18所示，使用的时候，向近端拉动推送杆420f，直至整个锚定件440f收容在输送装置300内腔的远端，此时，锚定针4426的两个分支4426a和4426b被约束至平行于推送杆420f的轴向。当到达预定位置后，向远端推送推送杆420f，直至锚定针4426从输送管330中伸出，锚定针4426恢复自然状态下的钩状结构，如图19所示，整个锚定针4426呈双弯钩状，也就是植入后的锚定件440f的状态。这种具有扩展形状和收缩形状的锚定件440f，在收缩形状时随着尖端刺入靶向组织预定深度，展开至扩展形状，由于扩展形状具有明显大于收缩形状的横截面，同时锚定件440f是刚性的，这确保锚定件440f稳定的保持扩展形状不发生任何变性，由此可牢牢的将锚定件440f固定在组织内部，从而避免现有技术的柔性锚定件无法稳定保持扩展形状而发生变形，易被拉脱的问题。As shown in FIGS. 17 and 18, 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. When the predetermined position is reached, 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.
可以理解的是，收紧线500穿过连接环4425以将多个锚定件440f收紧。还可以理解的是，在该实施例中，锚定件440f通过连接部441f与推送杆420f之间可拆卸连接，具体 是指锚定件440f与连接部441f之间可拆卸连接。在锚定件440f中的锚定部442f植入靶向部后，释放控制器控制连接部441f释放锚定部442f，只留锚定部442f在靶向部上。It can be understood that the tightening wire 500 passes through the connecting ring 4425 to tighten the plurality of anchors 44Of. It can also be understood that, in this embodiment, 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. After the anchor portion 442f in the anchor 440f is implanted into the targeting portion, the release controller controls the connecting portion 441f to release the anchor portion 442f, leaving only the anchor portion 442f on the targeting portion.
下面以第七实施例为例来说明本发明提供的单窗导引的瓣膜缩环***10f在治疗二尖瓣反流的手术过程中的使用方法。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.
手术操作可有多种路径，如：①经心尖；②经股动脉—腹动脉—胸动脉—主动脉弓—左心室；③经股动脉——腹动脉—腔静脉—右心房—左心房—右心室。以下分别详细描述：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 following are detailed descriptions:
第一种手术路径为经心尖，操作步骤如下：The first surgical route is transapical, with the following steps:
第一步：外科手术，在心尖处开切口，将导引装置100的导引鞘管101经心尖送入瓣叶PML下方并调整位置；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;
第二步：调整导引鞘管101的鞘管远端，使第一调弯段132朝向心肌壁LVPW；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;
第三步：通过鞘管130的内腔送入轨道导管(塑形轨道导管或者可调弯轨道导管)，塑形轨道导管在自导引鞘管101的远端伸出的过程中，会自动逐渐与瓣环下方贴合；调弯轨道导管先自导引鞘管101的远端推出，再调整调弯轨道导管的弯曲程度，使其与瓣环下方贴合；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;
第四步：如图20所示，通过轨道导管的内腔送入导丝600，然后撤出轨道导管，此时建立从体外至体内的轨道；再沿导丝600送入导管定位装置200，直至导管定位装置200顺利到达预定位置，与心肌壁贴合，并靠近瓣环MVA的下方，同时保证窗口212朝向心肌壁LVPW一侧，利于为后续锚定件442f的植入提供定位；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;
第五步：如图21所示，送入输送装置300及与其装配好的锚定装置400，锚定件440f从窗口212传出后，锚定部442f的锚定针刺入心肌壁，锚定件440f由于自身弹性恢复扩展状态，当锚定件440f受到心室壁组织作用无法继续变形时，说明锚定完成，收紧线500与束缚环4427之间的连接锁死；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;
第六步：此时撤出输送装置300和不含锚定件440f的锚定装置400，将收紧线500穿过第二个锚定件440f，再将第二个锚定件440f与锚定装置400的远端连接，装入输送装置300内，将限位器239从限位槽261中旋出，并向后移动到下一个限位槽261，并旋入后实现固定，然后旋转调节旋钮241，直到旋转受到较大阻力，此时，第二个需要植入的锚定件440f的位置已经找准，可按照第五步植入第二个锚定件440f，然后，依次植入后续锚定件440f。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. At this time, 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.
第七步：如图22所示，植入所有锚定件440f后，撤出导管定位装置200、输送装置300及锚定装置400，左心室内只留下多个锚定件440f和将多个锚定件440f串联在一起的收紧线500，如图23所示，拉紧收紧线500，以减小整个左心室的容积，同时达到缩小瓣环的目的，之后即可将收紧线500打结并切断，完成手术。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.
参阅图24，在进一步的实施方式中，提供一种预定型的导管定位装置200a，将导管定位装置200a的定位管通过热定型或者其他定型方式，在其远端设置一个弯曲段201a，使其在到达瓣环后，定位管的远端管体能够靠近瓣环MVA下方，并贴合心肌壁，通过使用这种预定型的导管定位装置200a，在经心尖的操作过程可以直接建立轨道，而无需使用轨道 导管102和导丝600辅助建立轨道。Referring to FIG. 24, in a further embodiment, 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. By using this predetermined type of catheter positioning device 200a, 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.
第二种手术路径为经主动脉路径，与经心尖路径的不同之处在于，手术中所有器械均是经股动脉—腹动脉—胸动脉—主动脉弓—左心室的路径。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.
参阅图25，在这种手术路径中，提供一种预定型的导管定位装置200b，将将导管定位装置200a的定位管通过热定型或者其他定型方式，使得其远端具有两个弯曲段201b和202b，在定位管送入左心室后，定位管的远端管体能够与心肌壁良好的贴合。如图26所示，无需使用轨道导管102和导丝600辅助建立轨道，即可由导管定位装置200b直接建立体外到靶向部的轨道。Referring to FIG. 25, in this surgical path, 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. As shown in FIG. 26, without using the rail catheter 102 and the guide wire 600 to assist in establishing the rail, the catheter positioning device 200b can directly establish the rail from the outside of the body to the target portion.
第三种手术路径为经房间隔路径，与经心尖路径的不同之处在于，手术中所有器械均是经股动脉——腹动脉—腔静脉—右心房—左心房—左心室的路径，并且在从右心房到左心房时需要配合房间隔穿刺装置穿刺卵圆孔，从左心房到左心室时通过二尖瓣口，其余操作与经心尖路径相同。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.
参阅图27，在这种手术路径中，提供一种预定型的导管定位装置200c，将导管定位装置200c的定位管通过热定型或者其他定型方式，使得其远端具有三个弯曲段201c、202c和203c，在定位管送入左心室后，定位管的远端管体能够与心肌壁良好的贴合，并靠近瓣环下方。如图28所示，无需使用轨道导管102和导丝600辅助建立轨道，即可由导管定位装置200c直接建立体外到靶向部的轨道。Referring to FIG. 27, in this surgical 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. As shown in FIG. 28, without using the rail catheter 102 and the guide wire 600 to assist in establishing the rail, the catheter positioning device 200c can directly establish the rail from the outside of the body to the target portion.
第二种路径和第三种路径采用纯介入的方式，对病人造成的外科伤害更小，病人恢复更快，并发症风险较低，接受程度较高。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.
可以理解的是，本发明提供的单窗导引的瓣膜修复***10，也可以将导管定位装置200直接定位在二尖瓣的瓣环上，然后将多个锚定件440f依次植入瓣环的不同位置，再通过收紧线500将多个锚定件440f收紧并固定，从而达到缩小瓣环的目的，并且由于通过连接部441f限定了锚定件440f的植入深度，可避免锚定件440f植入过深，损伤瓣叶。It can be understood that the single-window-guided valve repair system 10 provided by the present invention 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.
以上对本申请实施例进行了详细介绍，本文中应用了具体个例对本申请的原理及实施例进行了阐述，以上实施例的说明只是用于帮助理解本申请的方法及其核心思想；同时，对于本领的一般技术人员，依据本申请的思想，在具体实施例及应用范围上均会有改变之处，综上所述，本说明书内容不应理解为对本申请的限制。The embodiments of the present application have been described in detail above, and specific examples are used in this article to explain the principles and embodiments of the present application. The descriptions of the above embodiments are only used to help understand the method and the core idea of the present application; A person of ordinary skill in the art, according to the ideas of the present application, may have changes in specific embodiments and application scopes. In summary, the content of this specification should not be construed as limiting the present application.

Claims (35)

  1. 一种单窗导引的瓣膜缩环***，其特征在于，所述单窗导引的瓣膜缩环***包括导管定位装置、输送装置、锚定装置以及收紧线，所述锚定装置包括多个锚定件；A single-window-guided valve ring shrinkage system, characterized in that the single-window-guided valve ring shrinkage system includes a catheter positioning device, a delivery device, an anchoring device, and a tightening wire. The anchoring device includes multiple Anchors
    所述导管定位装置包括定位管，所述定位管定位于靶向部上，所述定位管远端的侧壁上开设有与所述定位管的内腔连通的一窗口，所述定位管移动以使所述窗口朝向所述靶向部的不同位置；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;
    所述输送装置沿所述定位管将多个所述锚定件经由所述窗口输送至所述靶向部的不同位置；The conveying device conveys the plurality of anchors along the positioning tube to different positions of the targeting portion via the window;
    所述锚定装置将穿过所述窗口的锚定件依次固定在所述靶向部的不同位置上；The anchoring device sequentially fixes the anchoring member passing through the window to different positions of the targeting portion;
    所述收紧线用于将固定在所述靶向部的不同位置上的多个所述锚定件串联并收紧，以使靶向部缩小。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 shrink the targeting portion.
  2. 如权利要求1所述的单窗导引的瓣膜缩环***，其特征在于，所述定位管至少包括轴向贯通的导丝腔及与所述导丝腔平行设置的输送腔；所述窗口与所述输送腔的远端连通。The single-window-guided valve annulus system according to claim 1, wherein the positioning tube includes at least an axially penetrating guide wire lumen and a delivery lumen parallel to the guide wire lumen; the window Communicate with the distal end of the delivery cavity.
  3. 如权利要求2所述的单窗导引的瓣膜缩环***，其特征在于，所述导管定位装置还包括转向头，所述转向头设置在所述定位管的远端，所述转向头由柔性材料制成，所述导丝腔与所述转向头的内腔相连通，所述转向头的远端设有朝向靶向部的倾斜面。The single-window-guided valve annulus system according to claim 2, wherein the catheter positioning device further includes a steering head, the steering head is disposed at a distal end of the positioning tube, and the steering head is Made of flexible material, the guide wire cavity communicates with the inner cavity of the steering head, and the distal end of the steering head is provided with an inclined surface toward the targeting portion.
  4. 如权利要求1所述的单窗导引的瓣膜缩环***，其特征在于，所述导管定位装置还包括设置于所述定位管近端的定位手柄，所述定位手柄控制所述定位管远端沿所述靶向部的表面前进或后退，以使所述窗口朝向所述靶向部的不同位置。The single-window-guided valve annulus system according to claim 1, wherein the catheter positioning device further comprises a positioning handle provided at the proximal end of the positioning tube, and the positioning handle controls the positioning tube to The end advances or retreats along the surface of the targeting portion, so that the window faces different positions of the targeting portion.
  5. 如权利要求4所述的单窗导引的瓣膜缩环***，其特征在于，所述定位手柄包括调控机构、手柄外壳及鞘管连接件；所述调控机构与所述手柄外壳配合作用以控制所述定位管沿轴向前进或后退；所述鞘管连接件与所述定位管连通，且所述鞘管连接件内部设有轴向贯通的通孔，以供所述输送装置通过。The single window guided valve contraction ring system according to claim 4, wherein the positioning handle includes a regulating mechanism, a handle housing and a sheath connector; the regulating mechanism cooperates with the handle housing to control The positioning tube advances or retreats in the axial direction; the sheath tube connector communicates with the positioning tube, and the sheath tube connector is provided with an axially penetrating through hole for the delivery device to pass through.
  6. 如权利要求5所述的单窗导引的瓣膜缩环***，其特征在于，所述调控机构包括调节旋钮及调节螺杆；The single window guided valve contraction ring system according to claim 5, wherein the adjustment mechanism includes an adjustment knob and an adjustment screw;
    所述调节螺杆活动地套设在鞘管连接件的远端；The adjusting screw is movably sleeved on the distal end of the sheath connector;
    所述调节旋钮与所述手柄外壳之间可相对旋转的活动连接，且所述调节旋钮通过螺纹连接在所述调节螺杆的外部，并自所述手柄外壳径向穿出所述手柄外壳外表面；A relatively rotatable movable connection between the adjusting knob and the handle housing, and the adjusting knob is connected to the outside of the adjusting screw through a thread, and penetrates the outer surface of the handle housing radially from the handle housing ;
    通过旋转所述调节旋钮，使得所述调节旋钮在所述调节螺杆上沿轴向前进或后退，从而使所述手柄外壳与所述调节螺杆之间相对运动，进而带动与所述鞘管连接件连接的定位管沿轴向前进或后退，以使所述窗口朝向靶向部的不同位置。By rotating the adjustment knob, the adjustment knob advances or retreats on the adjustment screw in the axial direction, so that the handle housing and the adjustment screw move relative to each other, thereby driving the connection piece with the sheath tube The connected positioning tubes are advanced or retreated in the axial direction so that the window faces different positions of the targeting portion.
  7. 如权利要求6所述的单窗导引的瓣膜缩环***，其特征在于，所述调控机构还包括限位器以及卡位件；The single window guided valve contraction ring system according to claim 6, wherein the regulating mechanism further includes a stopper and a clamping member;
    所述卡位件设置在所述鞘管连接件上，所述限位器贯穿所述手柄外壳外部，并沿所述定位手柄径向延伸，所述限位器用于抵接所述卡位件以控制所述鞘管连接件移动的距离。The locking piece is arranged on the sheath connecting piece, the stopper penetrates the outside of the handle housing and extends radially along the positioning handle, and the stopper is used to abut the locking piece To control the distance the sheath connector moves.
  8. 如权利要求7所述的单窗导引的瓣膜缩环***，其特征在于，所述手柄外壳上沿轴向设有导向槽及多个与所述导向槽连通的限位槽，所述限位器设在所述限位槽中并可沿所述导向槽轴向移动，当所述限位器卡入所述限位槽，所述限位器与所述手柄外壳之间的位置相对固定。The single-window guided valve contraction ring system according to claim 7, wherein the handle housing is provided with a guide groove and a plurality of limit grooves communicating with the guide groove in the axial direction. The stopper is set in the limit slot and can move axially along the guide slot. When the limiter snaps into the limit slot, the position between the limiter and the handle housing is opposite fixed.
  9. 如权利要求7所述的单窗导引的瓣膜缩环***，其特征在于，所述定位手柄还包括支撑棒，所述支撑棒围绕所述鞘管连接件设置并穿过所述鞘管连接件上的卡位件，所述支撑棒的远端与所述手柄外壳的远端连接。The single-window-guided valve annulus system according to claim 7, wherein the positioning handle further comprises a support rod, the support rod is disposed around the sheath connector and is connected through the sheath The locking member on the component, the distal end of the support rod is connected to the distal end of the handle housing.
  10. 如权利要求6所述的单窗导引的瓣膜缩环***，其特征在于，所述手柄外壳包括位于近端的调节手柄、位于远端的保护套以及设于二者之间的前壳和后壳；其中所述调节旋钮的近端与所述后壳连接，所述调节旋钮的远端与所述前壳连接。The single-window-guided valve contraction ring system according to claim 6, wherein the handle housing includes an adjustment handle at the proximal end, a protective sleeve at the distal end, and a front shell disposed between the two Rear shell; wherein the proximal end of the adjustment knob is connected to the rear shell, and the distal end of the adjustment knob is connected to the front shell.
  11. 如权利要求1-10任一项所述的单窗导引的瓣膜缩环***，其特征在于，所述瓣膜缩环***还包括导引装置，所述导引装置用于建立从体外到靶向部的轨道；所述导管定位装置通过所述导引装置的内腔到达并定位在所述靶向部，以使所述窗口朝向所述靶向部。The single window guided valve contraction ring system according to any one of claims 1-10, wherein the valve contraction ring system further comprises a guiding device, the guiding device is used to establish The track of the direction part; the catheter positioning device reaches and is positioned at the targeting part through the lumen of the guiding device so that the window faces the targeting part.
  12. 如权利要求11所述的单窗导引的瓣膜缩环***，其特征在于，所述导引装置包括导引鞘管及穿装在所述导引鞘管中的轨道导管，所述轨道导管自所述导引鞘管的远端伸出，并贴合在靶向部，进而建立从体外到靶向部的轨道；The single-window-guided valve annulus system according to claim 11, wherein the guiding device includes a guiding sheath tube and a rail catheter threaded in the guiding sheath tube, the rail catheter Extending from the distal end of the guiding sheath and fitting to the targeting part, thereby establishing a track from outside the body to the targeting part;
    所述轨道导管的内腔用于容纳并通过所述导管定位装置。The lumen of the rail catheter is used to receive and pass through the catheter positioning device.
  13. 如权利要求12所述的单窗导引的瓣膜缩环***，其特征在于，所述导引鞘管包括具有一定轴向长度的鞘管和第一牵引件，所述鞘管包括靠近近端的第一支撑段和靠近远端的第一调弯段，所述第一牵引件的远端连接所述第一调弯段，所述第一牵引件沿所述鞘管的轴向移动以将所述第一调弯段调整至贴合靶向部的形状。The single-window-guided valve annulus system according to claim 12, wherein the guide sheath includes a sheath having a certain axial length and a first traction member, the sheath includes a proximal end The first support section and the first bending section near the distal end, the distal end of the first traction member is connected to the first bending section, the first traction member moves along the axial direction of the sheath tube to The first bending section is adjusted to fit the shape of the target portion.
  14. 如权利要求13所述的单窗导引的瓣膜缩环***，其特征在于，所述鞘管为中空的多层管体，所述第一牵引件包括第一牵引丝、第一穿丝管和第一锚定环，所述第一穿丝管轴向开设在所述鞘管的内壁中，所述第一牵引丝穿设在所述第一穿丝管中，所述第一锚定环设置在所述第一穿丝管的远端，且所述第一锚定环位于所述第一调弯段中；The single-window-guided valve annulus system according to claim 13, wherein the sheath tube is a hollow multilayer tube body, and the first traction member includes a first traction wire and a first threading tube And a first anchoring ring, the first threading tube is axially opened in the inner wall of the sheath tube, the first pulling wire is threaded in the first threading tube, and the first anchoring A ring is provided at the distal end of the first threading tube, and the first anchoring ring is located in the first bending section;
    所述第一牵引丝的远端与所述第一锚定环连接，通过牵拉所述第一牵引丝，进而带动所述第一调弯段弯曲至贴合靶向部的形状。The distal end of the first traction wire is connected to the first anchoring ring, and the first flexing wire is pulled to bend the first bending section to fit the shape of the targeting portion.
  15. 如权利要求14所述的单窗导引的瓣膜缩环***，其特征在于，所述导引鞘管还包括设置在所述鞘管近端的第一调弯器，所述第一牵引丝的近端与所述第一调弯器连接，通过拉动所述第一调弯器，牵拉所述第一牵引丝，进而带动所述第一调弯段弯曲。The single-window-guided valve annulus system according to claim 14, wherein the guiding sheath further includes a first bender disposed at a proximal end of the sheath, the first pulling wire The proximal end of is connected to the first bender, and by pulling the first bender, the first pulling wire is pulled, thereby driving the first bending section to bend.
  16. 如权利要求13所述的单窗导引的瓣膜缩环***，其特征在于，所述轨道导管为塑形轨道导管，所述塑形轨道导管包括刚性连接的第二手柄和塑形管体，所述第二手柄设置在所述塑形管体的近端；The single-window-guided valve annulus system according to claim 13, wherein the rail catheter is a plastic rail catheter, and the plastic rail catheter includes a rigidly connected second handle and a plastic tube body, The second handle is disposed at the proximal end of the shaped tube body;
    所述塑形管体包括由近端至远端依次相连的第一管体、第二管体及第三管体，所述第三管体的延伸方向与第一管体的延伸方向之间的角度范围为0-180度，且第三管体与第一管体之间通过第二管体平滑过渡。The shaped tube body includes a first tube body, a second tube body and a third tube body sequentially connected from the proximal end to the distal end, and the extending direction of the third tube body is between the extending direction of the first tube body The angle range is 0-180 degrees, and the third pipe body and the first pipe body smoothly transition through the second pipe body.
  17. 如权利要求13所述的单窗导引的瓣膜缩环***，其特征在于，所述轨道导管为调弯轨道导管，所述调弯轨道导管包括调弯管和第二牵引件，所述调弯管包括靠近近端的第四管体及靠近远端的第五管体，所述第二牵引件沿所述调弯管的轴向移动以将所述第五管体调整至贴合靶向部的形状。The single-window-guided valve annulus system according to claim 13, wherein the rail catheter is a curved rail catheter, the curved rail catheter includes a curved tube and a second traction member, and the The elbow includes a fourth tube near the proximal end and a fifth tube near the distal end, and the second traction member moves along the axial direction of the bending tube to adjust the fifth tube to fit the target The shape of the direction.
  18. 如权利要求17所述的单窗导引的瓣膜缩环***，其特征在于，所述调弯管为中空的多层管体，所述第二牵引件包括第二牵引丝、第二穿丝管和第二锚定环，所述第二穿丝管轴向开设在所述调弯管的内壁中，所述第二牵引丝穿设在所述第二穿丝管中，所述第二锚定环设置在所述第二穿丝管的远端，且所述第二锚定环位于所述第五管体中；The single-window-guided valve contraction ring system according to claim 17, wherein the bending tube is a hollow multilayer tube body, and the second traction member includes a second traction wire and a second threading wire Tube and a second anchor ring, the second threading tube is axially opened in the inner wall of the bending tube, the second pulling wire is threaded in the second threading tube, the second An anchor ring is provided at the distal end of the second threading tube, and the second anchor ring is located in the fifth tube body;
    所述第二牵引丝的远端与所述第二锚定环连接，通过牵拉所述第二牵引丝，进而带动所述第五管体弯曲至贴合靶向部的形状。The distal end of the second pulling wire is connected to the second anchoring ring, and by pulling the second pulling wire, the fifth tube is bent to fit the shape of the target portion.
  19. 如权利要求18所述的单窗导引的瓣膜缩环***，其特征在于，所述调弯轨道导管还包括设置在所述调弯管近端的第二调弯器，所述第二牵引丝的近端与所述第二调弯器连接，通过拉动所述第二调弯器，牵拉所述第二牵引丝，进而带动所述第五管体弯曲。The single-window-guided valve contraction ring system according to claim 18, wherein the bending track catheter further includes a second bender disposed at a proximal end of the bending tube, the second traction The proximal end of the wire is connected to the second bender, and by pulling the second bender, the second pulling wire is pulled, thereby driving the fifth tube to bend.
  20. 如权利要求1-10任一项所述的单窗导引的瓣膜缩环***，其特征在于，所述输送装置包括输送管和第三牵引件，所述输送管包括靠近近端的第二支撑段和靠近远端的第二调弯段，所述第三牵引件沿所述输送管的轴向移动以将所述第二调弯段调整至与所述导管定位装置相配合的形状，使得所述输送管的远端到达所述窗口。The single window guided valve annulus system according to any one of claims 1-10, wherein the delivery device includes a delivery tube and a third traction member, and the delivery tube includes a second proximal end A supporting section and a second bending section near the distal end, the third traction member moves along the axial direction of the delivery tube to adjust the second bending section to a shape matching the catheter positioning device, The distal end of the delivery tube is allowed to reach the window.
  21. 如权利要求20所述的单窗导引的瓣膜缩环***，其特征在于，所述输送管为中空的多层管体，所述第三牵引件包括第三牵引丝、第三穿丝管和第三锚定环，所述第三穿丝管轴向开设在所述输送管的内壁中，所述第三牵引丝穿设在所述第三穿丝管中，所述第三锚定环设置在所述第三穿丝管的远端，且所述第三锚定环位于所述第二调弯段中；The single-window guided valve contraction system according to claim 20, wherein the delivery tube is a hollow multi-layer tube body, and the third traction member includes a third traction wire and a third threading tube And a third anchor ring, the third threading tube is axially opened in the inner wall of the conveying tube, the third pulling wire is threaded in the third threading tube, and the third anchoring A ring is provided at the distal end of the third threading tube, and the third anchoring ring is located in the second bending section;
    所述第三牵引丝的远端与所述第三锚定环连接，通过牵拉所述第三牵引丝，进而带动所述第二调弯段弯曲至与所述导管定位装置相配合的形状，使得所述输送管的远端到达所述窗口。The distal end of the third traction wire is connected to the third anchoring ring, and by pulling the third traction wire, the second bending section is bent to a shape matching the catheter positioning device , So that the distal end of the delivery tube reaches the window.
  22. 如权利要求21所述的单窗导引的瓣膜缩环***，其特征在于，所述输送装置还包括设置在所述输送管近端的第三调弯器，所述第三牵引丝的近端与所述第三调弯器连接，通过拉动所述第三调弯器，牵拉所述第三牵引丝，进而带动所述第二调弯段弯曲。The single-window guided valve annulus system according to claim 21, wherein the delivery device further includes a third bender disposed at the proximal end of the delivery tube, The end is connected to the third bend adjuster, and the third bend wire is pulled by pulling the third bend adjuster, thereby driving the second bend section to bend.
  23. 如权利要求1-10任一项所述的单窗导引的瓣膜缩环***，其特征在于，所述锚定装置还包括释放控制器以及设置在所述释放控制器与所述锚定件之间的推送杆，所述推送杆与所述锚定件之间可拆卸连接，所述释放控制器控制所述锚定件释放在靶向部。The single-window-guided valve annulus system according to any one of claims 1 to 10, wherein the anchoring device further includes a release controller and the release controller and the anchor Between the push rod and the detachable connection between the push rod and the anchor, the release controller controls the anchor to be released at the targeting portion.
  24. 如权利要求23所述的单窗导引的瓣膜缩环***，其特征在于，所述锚定装置还包括连接机构，所述连接机构近端与所述推送杆的远端刚性连接，所述推送杆通过所述连接机构远端与所述锚定件之间可拆卸连接；所述释放控制器控制所述连接结构打开，以释放所述锚定件。The single-window-guided valve annulus system according to claim 23, wherein the anchoring device further comprises a connecting mechanism, the proximal end of the connecting mechanism is rigidly connected to the distal end of the push rod, the The push rod is detachably connected to the anchor through the distal end of the connection mechanism; the release controller controls the connection structure to open to release the anchor.
  25. 如权利要求24所述的单窗导引的瓣膜缩环***，其特征在于，所述可拆卸连接的方式包括螺纹连接、卡扣连接或者夹合连接。The single window guided valve contraction ring system according to claim 24, wherein the detachable connection includes screw connection, snap connection or clip connection.
  26. 如权利要求25所述的瓣膜缩环***，其特征在于，当采用螺纹连接时，所述连接机构靠近远端的管体设有螺纹，且与所述锚定件之间螺纹配合，所述连接机构的最远端无螺纹。The valve annulus system according to claim 25, wherein when a threaded connection is used, the tube body of the connecting mechanism near the distal end is provided with a thread and is threadedly engaged with the anchoring member, the The most distal end of the connection mechanism has no threads.
  27. 如权利要求24所述的单窗导引的瓣膜缩环***，其特征在于，所述锚定装置还包括第五手柄和释放管，所述第五手柄设置在所述释放管的近端，所述推送杆穿过所述第五手柄，所述推送杆的远端和所述连接机构穿装在所述释放管中；The single-window-guided valve annulus system according to claim 24, wherein the anchoring device further includes a fifth handle and a release tube, the fifth handle is disposed at a proximal end of the release tube, The push rod passes through the fifth handle, and the distal end of the push rod and the connection mechanism are threaded into the release tube;
    当所述释放控制器拉动所述推送杆向近端移动时，所述连接机构与所述释放管配合作用以使所述连接机构夹紧所述锚定件；当所述释放控制器拉动所述推送杆向远端移动时，所述连接机构与所述释放管配合作用以使所述连接机构释放所述锚定件。When the release controller pulls the push rod to move to the proximal end, the connection mechanism cooperates with the release tube to make the connection mechanism clamp the anchor; when the release controller pulls the push rod When the push rod moves to the distal end, the connection mechanism cooperates with the release tube to cause the connection mechanism to release the anchor.
  28. 如权利要求27所述的单窗导引的瓣膜缩环***，其特征在于，所述连接机构包括多组连接杆和多个销钉，多组所述连接杆通过多个销钉活动连接，多组所述连接杆中最近端的一组所述连接杆通过销钉与所述推送杆连接，多组所述连接杆中最远端的一组所述连接杆的端部设有夹紧部，所述夹紧部用于夹紧和释放所述锚定件。The single-window-guided valve annulus system according to claim 27, wherein the connection mechanism includes a plurality of sets of connecting rods and a plurality of pins, and a plurality of sets of the connecting rods are movably connected by a plurality of pins. The group of connecting rods at the closest end of the connecting rods are connected to the push rod by pins, and the end of the group of connecting rods at the farthest end of the group of connecting rods is provided with a clamping part, The clamping part is used to clamp and release the anchor.
  29. 如权利要求23所述的单窗导引的瓣膜缩环***，其特征在于，所述锚定件包括连接部与锚定部，所述锚定部通过所述连接部与所述推送杆之间可拆卸连接。The single-window-guided valve annulus system according to claim 23, wherein the anchoring member includes a connecting portion and an anchoring portion, and the anchoring portion passes through the connecting portion and the push rod Detachable connection.
  30. 如权利要求29所述的单窗导引的瓣膜缩环***，其特征在于，所述连接部上设有连线孔，所述连线孔用于收紧线通过。The single-window guided valve contraction ring system according to claim 29, wherein the connecting portion is provided with a connecting hole, and the connecting hole is used for tightening the wire through.
  31. 如权利要求29所述的单窗导引的瓣膜缩环***，其特征在于，所述锚定部包括至少一个螺旋结构。The single-window-guided valve annulus system of claim 29, wherein the anchor portion includes at least one spiral structure.
  32. 如权利要求31所述的单窗导引的瓣膜缩环***，其特征在于，所述锚定部包括两个螺旋结构，两个所述螺旋结构的尺寸相同或者尺寸之差小于第一预设范围。The single-window-guided valve contraction ring system according to claim 31, wherein the anchoring portion includes two spiral structures, and the two spiral structures have the same size or the size difference is smaller than the first preset range.
  33. 如权利要求31所述的单窗导引的瓣膜缩环***，其特征在于，所述锚定部包括两个螺旋结构，两个所述螺旋结构的尺寸之差大于第二预设范围。The single-window guided valve contraction system according to claim 31, wherein the anchoring portion includes two helical structures, and a difference in size between the two helical structures is greater than a second predetermined range.
  34. 如权利要求29所述的单窗导引的瓣膜缩环***，其特征在于，所述锚定部包括靠近近端的连接环、靠近远端的锚定针及套设在所述连接环和所述锚定针外部的束缚部；所述锚定针具有在自然状态下的扩展形状和被输送装置约束的收缩形状。The single-window guided valve contraction ring system of claim 29, wherein the anchoring portion includes a connecting ring near the proximal end, an anchoring pin near the distal end, and a sleeve on the connecting ring and The restraining portion outside the anchor needle; the anchor needle has an expanded shape in a natural state and a contracted shape constrained by the delivery device.
  35. 如权利要求1所述的单窗导引的瓣膜缩环***，其特征在于，所述靶向部为二尖瓣瓣环或者二尖瓣瓣环下方的左心室心肌壁。The single window guided valve annulus system according to claim 1, wherein the targeting portion is a mitral valve annulus or a left ventricular myocardial wall below the mitral valve annulus.
PCT/CN2019/097567 2018-12-29 2019-07-24 Single window-guided valve annulus reduction system WO2020134052A1 (en)

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CN201822275151.4U CN209916301U (en) 2018-12-29 2018-12-29 Single-window guided valve ring-contracting system
CN201811641847.2A CN111374799A (en) 2018-12-29 2018-12-29 Single-window guided valve ring-contracting system
CN201811641847.2 2018-12-29
CN201822275151.4 2018-12-29

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