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WO2020134053A1 - Valve annulus shrinkage system - Google Patents

Valve annulus shrinkage system Download PDF

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Publication number
WO2020134053A1
WO2020134053A1 PCT/CN2019/097569 CN2019097569W WO2020134053A1 WO 2020134053 A1 WO2020134053 A1 WO 2020134053A1 CN 2019097569 W CN2019097569 W CN 2019097569W WO 2020134053 A1 WO2020134053 A1 WO 2020134053A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
anchoring
valve annulus
distal end
anchor
Prior art date
Application number
PCT/CN2019/097569
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 CN201811646655.0A external-priority patent/CN111374800A/en
Priority claimed from CN201822270742.2U external-priority patent/CN209966663U/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 WO2020134053A1 publication Critical patent/WO2020134053A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • the invention relates to the field of medical instruments, and in particular to a valve ring 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 valve regurgitation is a common disease of heart valves. Mitral regurgitation can be divided into two categories: functional and organic (also called 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.
  • valve ring contraction system includes a positioning device, a delivery device, an anchoring device, and a tightening wire
  • the anchoring device includes a plurality of anchoring pieces
  • the positioning device is provided with a plurality of windows arranged in an axial direction, the positioning device is positioned on the targeting portion, and the plurality of windows face different positions of the targeting portion;
  • the conveying device conveys the plurality of anchors along the positioning device to different positions of the targeting portion via the plurality of windows, respectively;
  • the anchoring device sequentially fixes the anchoring member passing through each window to different positions of the targeting portion
  • the tightening line is used to connect and tighten a plurality of 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 valve contraction ring system provided by the present invention protrudes the anchoring device from different windows to fix the anchoring member at different positions of the targeting portion, and then tightens the targeting portion by tightening the wire, thereby achieving shrinkage
  • the effect of the perimeter of the targeting section is achieved.
  • the valvular annulus 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 annulus, and connects and tightens the multiple anchors in series.
  • Fixation 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 regurgitation, especially suitable for the treatment of functional mitral Petal reflux.
  • Figure 1 is a schematic diagram of the human heart structure.
  • FIG. 2 is a schematic structural diagram of a valve contraction ring system according to a 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 tube of a catheter positioning device provided in FIG. 5.
  • FIG. 7 is a cross-sectional view of a partial structure of a conveying device provided by the present invention.
  • FIG 8a is a schematic structural view of an anchoring device provided by the present invention.
  • 8b is a cross-sectional view of a partial structure of an anchoring device provided by the present invention.
  • FIG. 9 is a schematic structural diagram of a bending track catheter in a valve ring contraction system according to a second embodiment of the present invention.
  • FIG. 10 is a schematic structural diagram of an anchoring device in a valve contraction ring system according to a third embodiment of the present invention.
  • FIG. 11 is a schematic structural diagram of an anchoring device in a valve contraction ring system according to a fourth embodiment of the present invention.
  • FIG. 12 is a schematic structural diagram of an anchor in a valve contraction ring system according to a fifth embodiment of the present invention.
  • FIG. 13 is a schematic structural diagram of an anchor in a valve contraction ring system according to a sixth embodiment of the present invention.
  • FIG. 14 is a schematic structural diagram of an anchor in a valve contraction ring system according to a seventh embodiment of the present invention.
  • FIG. 15 is a schematic structural view of the anchor provided in FIG. 14 in a contracted state.
  • FIG. 16 is a schematic structural view of the anchor provided in FIG. 14 in an expanded state.
  • 17 is a schematic view of the catheter positioning device provided by the present invention and the ventricular wall fit.
  • FIG. 18 is a schematic diagram of the guide device provided by the present invention is sent through the apex below the valve leaflet.
  • FIG. 19 is a schematic diagram of an anchor provided by the present invention implanted in a ventricular wall.
  • FIG. 20 is a schematic diagram of multiple anchors provided by the present invention after being implanted in different positions of a ventricular wall.
  • FIG. 21 is a schematic diagram of the tightening wire provided by the present invention after tightening a plurality of anchors.
  • 22 is a schematic diagram of the guide device provided by the present invention is sent into the left ventricle through the aortic pathway.
  • 23 is a schematic diagram of the guide device provided by the present invention is sent into the left ventricle through 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 valve annulus system 10, which includes a positioning device 20, a delivery device 300, an anchoring device 400, and a tightening wire 500.
  • the anchoring device 400 includes a plurality of anchors 440a .
  • the positioning device 20 is provided with a plurality of windows 231 arranged axially, the positioning device 20 is positioned on the targeting portion, and the multiple windows 231 face different positions of the targeting portion; the conveying device 300 anchors the plurality of anchors along the positioning device 20 440a is delivered to different positions of the targeting portion through a plurality of windows 231; the anchoring device 400 sequentially fixes the anchor 440a passing through each window 231 at different positions of the targeting portion; the tightening wire 500 is used to A plurality of anchors 440a fixed at different positions of the targeting portion are connected in series and tightened to reduce the circumference of the targeting portion.
  • 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 positioning device 20 includes a guiding device 100 and a catheter positioning device 200.
  • the guiding device 100 is used to establish a track from a patient's body to a target portion in the body.
  • the catheter positioning device 200 is provided with multiple windows 231, the catheter positioning device 200 reaches and is positioned at the targeting portion through the lumen of the guiding device 100, so that each window 231 faces a different position of the targeting portion. It can be understood that the catheter positioning device 200 is threaded into the lumen of the guiding device 100, the delivery device 300 is threaded into the lumen of the catheter positioning device 200, and the anchoring device 400 passes through the lumen of the delivery device 300 The anchor 440a extends from different windows 231.
  • 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 between them ranges from 0 to 180 degrees, and the third tube 140a and the first tube 120a smoothly transition through the second tube 130a.
  • a shaped rail catheter 200b with better fit to the targeting portion including a first tube body 201b connected in sequence from the proximal end to the distal end.
  • 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 is shaped by heat setting or the like to closely fit the shape below the annulus (i.e., 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 catheter positioning device 200 includes a fourth handle 210 and a positioning tube 230.
  • the fourth handle 210 is provided at the proximal end of the positioning tube 230, and the distal end of the positioning tube 230 is provided with a plurality of windows along the axial direction 231, multiple windows 231 all penetrate the same side tube wall of the positioning tube 230, and the multiple windows 231 face different positions of the targeting portion.
  • the windows 231 in different positions are aligned with different positions of the left ventricular wall (targeting portion) to provide the positioning function for the delivery device 300 and the anchoring device 400.
  • the number of windows 231 is preferably 3 to 15, and further preferably 10.
  • the shape of the window 231 may be one or more of a circle, an ellipse, a square, a diamond, a triangle, and a polygon. In this embodiment, a rectangle is used, and the four corners of the rectangle are preferably curved to prevent the conveyor 300 from being scratched. Anchoring device 400 or human tissue.
  • the area of the window 231 is 4 to 4000 mm 2 .
  • two adjacent windows 231 communicate with each other through a notch 233, the notch 233 penetrates the same side wall of the positioning tube 230, and the distal end of the window 231 at the most distal end of the positioning tube 230 is closed and located at The proximal end of the window 231 at the closest end of the positioning tube 230 is closed.
  • the window 231 penetrates the side wall of the positioning tube 230 so that each window 231 communicates with the inner cavity of the positioning tube 230.
  • the multiple windows 231 communicating through the notch 233 can improve the flexibility of the tube body of the positioning tube 230 near the distal end, and can be smoothly turned in the rail catheter 102 to fit the shape of the target portion (eg, the ventricular wall).
  • two adjacent windows 231 are axially spaced apart by a convex portion 232, and a notch 233 is opened in the middle of the convex portion 232.
  • the catheter positioning device 200 further includes a steering head 220 disposed at the distal end of the positioning tube 230, the steering head 220 is made of a flexible material, and the distal end of the steering head 220 is provided with a targeting portion ⁇ 221.
  • the inclined surface 221 of the steering head 220 faces the ventricular wall to further fit the ventricular wall.
  • the tube body of the positioning tube 230 is composed of a polymer material, such as one or more copolymers of ABS, PE, PP, PEBAX, PC, PU, Nylon, PVC, PTFE or PB or mixture. In this embodiment, PE pipes are used.
  • the inner diameter of the positioning tube 230 ranges from 0.3 to 15 mm, preferably from 1.5 to 10 mm.
  • the developing member is embedded in the positioning tube 230 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 delivery device 300 is used to reach the targeting portion along the guide wire 600 and the catheter positioning device 200, and sequentially extend through the multiple windows 231 of the catheter positioning device 200 to provide a delivery channel for the multiple anchors 440a of the anchoring device 400, respectively .
  • 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 positioning device 20 so that the distal end of the delivery tube 330 reaches the window 231.
  • 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 matching the positioning device 20 so that the distal end of the delivery tube 330 reaches the window 231.
  • 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 fifth 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 fifth 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 fifth 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 pieces 440a are detachably connected, and the release controller 410a controls the anchor piece 440a to be released at the targeting portion.
  • 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 area of the anchoring portion 442a in contact with the tissue of the targeting portion can be greatly increased, so as to be firmly fixed inside the tissue, avoiding the instability of the prior art flexible anchoring portion There is a problem of being deformed by maintaining the expanded shape and being easily 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 valve contraction ring system 10a.
  • the orbital catheter 102 is a curved orbit that can adjust the shape in real time.
  • 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 includes a second traction wire 133b, a second threading tube 132b, and a second anchor ring 131b
  • the second threading 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 positioned at the distal end of the second threading tube 132b
  • the second anchor The ring 131b is located in the fifth tube 140b
  • the distal end of the second pulling wire 133b is connected to the second anchoring ring 131b, which can pull the second pulling wire 133b, thereby driving the fifth tube 140b to bend to fit the target portion Shape to realize 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 .
  • a third embodiment of the present invention provides a valve contraction ring system 10b. Unlike the first embodiment, in the valve contraction ring system 10b, the push rod 420b and the anchor in the anchoring device 400b The piece 440b is detachably connected. In other words, 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.
  • a threaded connection is adopted, the tube body near the distal end of the push rod 420b is provided with a thread, and is threadably 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.
  • a fourth embodiment of the present invention provides a valve contraction ring system 10c.
  • the anchoring device 400c further includes a sixth handle 460c and a release
  • the tube 450c and the sixth handle 460c are disposed at the proximal end of the release tube 450c.
  • the push rod 420c passes through the sixth handle 460c.
  • the distal end of the push rod 420c and the connection mechanism 430c are inserted into 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 sixth 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
  • a fifth embodiment of the present invention provides a valve contraction ring system 10d, which is different from the first embodiment in that another anchor 440d is provided in the valve contraction ring 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.
  • a sixth embodiment of the present invention provides a valve contraction ring system 10e.
  • another anchor 440e is provided in the valve contraction ring system 10e.
  • the anchoring portion When 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.
  • the seventh embodiment of the present invention provides a valve annulus system 10f. Unlike the first embodiment, an additional anchor 440f is provided in the valve annulus system 10f.
  • the anchor The fixed member 440f is connected to the push rod 420f through a connecting member 441f.
  • the anchor portion 442f in the anchor 440f includes a connection ring 4425 near the proximal end, an anchor needle 4426 near the distal end, and a binding portion 4427 sleeved outside the connection ring 4425 and the anchor needle 4426; the anchor needle 4426 has The expanded shape in a natural state (see FIG. 16) and the contracted shape constrained by the conveying device 300 (see FIG. 15).
  • 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 it is contracted in shape.
  • the anchoring needle 4426 When it is released from the delivery device 300, its tip can penetrate into the deep part of the targeted tissue, and After being fixed inside the tissue, it will fully return to its expanded state under natural conditions.
  • the anchoring needle 4426 includes two branches 4426a and 4426b.
  • the proximal ends of the branches 4426a and 4426b are formed by intersecting and extending the distal ends of the connecting rings 4425, respectively, and the distal ends of the branches 4426a and 4426b extend in reverse. That is, the branches 4426a and 4426b respectively have two symmetrically arranged openings pointing to the proximal hook-shaped structure.
  • the binding portion 4427 is sleeved at the distal stagger of the connecting ring 4425, thereby restricting the relative position between the two branches 4426a and 4426b of the anchoring needle 4426, 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. 16, 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, since the expanded shape has a cross section that is significantly larger than the contracted shape, and the anchor
  • the 440f is rigid, which ensures that the anchor 440f stably maintains the expanded shape without any deformation, thereby the anchor 440f can be firmly fixed inside the tissue, thereby preventing the prior art flexible anchor from being unable to 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 440f.
  • the anchor portion 442f and the connecting member 441f are detachably connected. After the anchor member 440f is implanted into the targeting portion, the release controller controls the connecting member 441f to release the anchor portion 442f, leaving only the anchor portion 442f is in the targeting section.
  • the following uses the first embodiment as an example to describe a method of using the valve annulus system 10 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;
  • Step 2 Adjust the distal end of the sheath 130 guiding the 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. 18, 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 successfully, the positioning is completed. As shown in FIG. 17, after the catheter positioning device 200 is positioned, it completely fits the wall of the ventricle, which is convenient for providing positioning for subsequent implantation of the anchor 440a;
  • Step 5 As shown in FIG. 19, outside the body, first pass one end of the tightening wire 500 through the connecting hole 443a of the first anchor 440a and tie the knot, and then pass the guide wire 600 and the catheter positioning device 200 Feed the conveying device 300 and the anchoring device 400.
  • the anchoring device 440a When the first anchoring piece 440a of the anchoring device 400 reaches a predetermined position, the anchoring device 440a is rotated by the release controller 410a of the rotating anchoring device 400 until the first An anchor 440a penetrates into the wall of the ventricle; then the delivery device 300 is withdrawn from the first window 231 of the catheter positioning device 200, and the delivery device 300 is sent into the second window 231 again for the second anchor Piece 440a provides positioning.
  • Step 6 After passing the other end of the tightening wire 500 through the connecting hole 443a of the second anchor 440a, the second anchor 440a is introduced into the patient's body along the guide wire 600 and the delivery device 300 and implanted The ventricular wall, and then the end of the tightening wire 500 is sequentially passed through the subsequent multiple anchors 440a, and the multiple anchors 440a are sequentially fed into the patient's body along the guide wire 600, and are sequentially screwed into the ventricular wall along the annulus Different locations.
  • Step 7 As shown in FIG. 20, after implanting all the anchors 440a, the catheter positioning device 200, the delivery device 300 and the anchoring device 400 are withdrawn, leaving only a plurality of anchors 440a and more A tightening wire 500 with two anchors 440a connected in series, as shown in FIG. 21, 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.
  • the second surgical path is the trans-aortic path, which differs from the trans-apical path in that all instruments in the surgery are via the femoral artery-abdominal artery-thoracic artery-aortic arch-left ventricle, The rest of the operation is the same as the transapical path.
  • the third surgical path is the transatrial septal path, which is different from the transapical path in that all instruments are operated through the femoral artery—abdominal artery—caval vein—right atrium—left atrium—left
  • the second and third paths use pure intervention, resulting in less surgical damage to the patient, faster recovery of the patient, lower risk of complications, and higher acceptance.
  • valve repair system 10 can also directly position the catheter positioning device 200 on the annulus of the mitral valve, and then implant a plurality of anchors 440a in different positions of the annulus in turn, and then The multiple anchors 440a are tightened and fixed by tightening the wire 500, so as to achieve the purpose of reducing the annulus.

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Abstract

A valve annulus shrinkage system, comprising a positioning device (10), a transport device (300), an anchoring device (400), and a tightening wire (500). The anchoring device (400) comprises multiple anchoring pieces (440a); the positioning device (10) is provided with multiple windows (231) arranged axially, the positioning device (10) is positioned on a targeting portion, and the multiple windows (231) face different positions of the targeting portion; the transport device (300) transports the multiple anchoring pieces (440a) along the positioning device (10) to the different positions of the targeting portion respectively by means of the multiple windows (231); the anchoring device (100) sequentially fixes the anchoring pieces (440a) passing through the windows (231) at the different positions of the targeting portion; the tightening wire (500) is used for connecting in series and tightening the multiple anchoring pieces (440a) fixed at the different positions of the targeting portion, so that the circumference of the targeting portion is reduced. According to the valve annulus shrinkage system, the anchoring device (440a) is extended out from the different windows (231) to fix the anchoring pieces (440a) at different positions of the targeting portion, and then the targeting portion is tightened by means of the tightening wire (500); thus, the effect of reducing the circumference of the targeting portion is achieved.

Description

一种瓣膜缩环系统Valve contraction ring system 技术领域Technical field
本发明涉及医疗器械领域,具体涉及一种瓣膜缩环系统。The invention relates to the field of medical instruments, and in particular to a valve ring 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)及乳头肌(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),腱索另一端与乳头肌相连。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、乳头肌、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(也称退行性)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 (also called 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系统,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.
一种瓣膜缩环系统,所述瓣膜缩环系统包括定位装置、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 valve ring contraction system, the valve ring contraction system includes a positioning device, a delivery device, an anchoring device, and a tightening wire, the anchoring device includes a plurality of anchoring pieces;
所述定位装置中设有轴向排列的多个窗口,所述定位装置定位于靶向部上,多个所述窗口朝向所述靶向部的不同位置;The positioning device is provided with a plurality of windows arranged in an axial direction, the positioning device is positioned on the targeting portion, and the plurality of windows face different positions of the targeting portion;
所述输送装置沿所述定位装置将多个所述锚定件分别经由多个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 device to different positions of the targeting portion via the plurality of windows, respectively;
所述锚定装置将穿过每一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 each 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 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:
本发明提供的瓣膜缩环系统通过将锚定装置自不同的窗口伸出,以将锚定件固定在靶 向部的不同位置上,进而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,本发明提供的瓣膜缩环系统在二尖瓣瓣环下方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 valve contraction ring system provided by the present invention protrudes the anchoring device from different windows to fix the anchoring member at different positions of the targeting portion, and then tightens the targeting portion by tightening the wire, thereby achieving shrinkage The effect of the perimeter of the targeting section. For example, the valvular annulus 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 annulus, and connects and tightens the multiple anchors in series. Fixation 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 regurgitation, especially suitable for the treatment of functional mitral Petal reflux.
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瓣膜缩环系统的结构示意图。2 is a schematic structural diagram of a valve contraction ring system according to a 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的定位管的立体结构示意图。6 is a schematic perspective view of a positioning tube of a catheter positioning device provided in FIG. 5.
图7为本发明提供的一种输送装置的部分结构剖视图。7 is a cross-sectional view of a partial structure of a conveying device provided by the present invention.
图8a为本发明提供的一种锚定装置的结构示意视图。8a is a schematic structural view of an anchoring device provided by the present invention.
图8b为本发明提供的一种锚定装置的部分结构剖视图。8b is a cross-sectional view of a partial structure of an anchoring device provided by the present invention.
图9为本发明第二实施例提供的一种瓣膜缩环系统中的调弯轨道导管的结构示意图。9 is a schematic structural diagram of a bending track catheter in a valve ring contraction system according to a second embodiment of the present invention.
图10为本发明第三实施例提供的一种瓣膜缩环系统中的锚定装置的结构示意图。10 is a schematic structural diagram of an anchoring device in a valve contraction ring system according to a third embodiment of the present invention.
图11为本发明第四实施例提供的一种瓣膜缩环系统中的锚定装置的结构示意图。11 is a schematic structural diagram of an anchoring device in a valve contraction ring system according to a fourth embodiment of the present invention.
图12为本发明第五实施例提供的一种瓣膜缩环系统中的锚定件的结构示意图。12 is a schematic structural diagram of an anchor in a valve contraction ring system according to a fifth embodiment of the present invention.
图13为本发明第六实施例提供的一种瓣膜缩环系统中的锚定件的结构示意图。13 is a schematic structural diagram of an anchor in a valve contraction ring system according to a sixth embodiment of the present invention.
图14为本发明第七实施例提供的一种瓣膜缩环系统中的锚定件的结构示意图。14 is a schematic structural diagram of an anchor in a valve contraction ring system according to a seventh embodiment of the present invention.
图15为图14中提供的锚定件在收缩状态下的结构示意图。15 is a schematic structural view of the anchor provided in FIG. 14 in a contracted state.
图16为图14中提供的锚定件在扩展状态下的结构示意图。16 is a schematic structural view of the anchor provided in FIG. 14 in an expanded state.
图17为本发明提供的导管定位装置与心室壁贴合的示意图。17 is a schematic view of the catheter positioning device provided by the present invention and the ventricular wall fit.
图18为本发明提供的导引装置经心尖送入瓣叶下方的示意图。18 is a schematic diagram of the guide device provided by the present invention is sent through the apex below the valve leaflet.
图19为本发明提供的锚定件植入心室壁的示意图。FIG. 19 is a schematic diagram of an anchor provided by the present invention implanted in a ventricular wall.
图20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. 20 is a schematic diagram of multiple anchors provided by the present invention after being implanted in different positions of a ventricular wall.
图21为本发明提供的收紧线将多个锚定件收紧后的示意图。FIG. 21 is a schematic diagram of the tightening wire provided by the present invention after tightening a plurality of anchors.
图22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。22 is a schematic diagram of the guide device provided by the present invention is sent into the left ventricle through the aortic pathway.
图23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。23 is a schematic diagram of the guide device provided by the present invention is sent into the left ventricle through 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.
为了更加清楚地描述瓣膜缩环系统的结构,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 valvuloplasty 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,本发明第一实施例提供一种瓣膜缩环系统10,包括定位装置20、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。定位装置20中设有轴向排列的多个窗口231,定位装置20定位于靶向部上,多个窗口231朝向靶向部的不同位置;输送装置300沿定位装置20将多个锚定件440a分别经由多个窗口231输送至靶向部的不同位置;锚定装置400将穿过每一窗口231的锚定件440a依次固定在靶向部不同的位置上;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。Referring to FIG. 2, the first embodiment of the present invention provides a valve annulus system 10, which includes a positioning device 20, a delivery device 300, an anchoring device 400, and a tightening wire 500. The anchoring device 400 includes a plurality of anchors 440a . The positioning device 20 is provided with a plurality of windows 231 arranged axially, the positioning device 20 is positioned on the targeting portion, and the multiple windows 231 face different positions of the targeting portion; the conveying device 300 anchors the plurality of anchors along the positioning device 20 440a is delivered to different positions of the targeting portion through a plurality of windows 231; the anchoring device 400 sequentially fixes the anchor 440a passing through each window 231 at different positions of the targeting portion; the tightening wire 500 is used to A plurality of anchors 440a fixed at different positions of the targeting portion are connected in series and tightened to reduce the circumference of the targeting portion.
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,定位装置20包括导引装置100和导管定位装置200,导引装置100用于建立从患者体外到体内的靶向部的轨道,导管定位装置200中设有多个窗口231,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,以使每个窗口231朝向靶向部的不同位置。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的内腔将锚定件440a自不同的窗口231伸出。In a further embodiment, the positioning device 20 includes a guiding device 100 and a catheter positioning device 200. The guiding device 100 is used to establish a track from a patient's body to a target portion in the body. The catheter positioning device 200 is provided with multiple windows 231, the catheter positioning device 200 reaches and is positioned at the targeting portion through the lumen of the guiding device 100, so that each window 231 faces a different position of the targeting portion. It can be understood that the catheter positioning device 200 is threaded into the lumen of the guiding device 100, the delivery device 300 is threaded into the lumen of the catheter positioning device 200, and the anchoring device 400 passes through the lumen of the delivery device 300 The anchor 440a extends from different windows 231.
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,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和第一管体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 between them ranges from 0 to 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200b,包括由近端至远端依次相连的第一管体201b,第二管体203b及第三管体202b,第一管体201b与第二管体203b的近端所在的第一平面和第三管体202b与第二管体203b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 200b with better fit to the targeting portion is provided, including a first tube body 201b connected in sequence from the proximal end to the distal end. Two tube bodies 203b and a third tube body 202b, a first plane where the proximal ends of the first tube body 201b and the second tube body 203b are located, and a second plane where the distal ends of the third tube body 202b and the second tube body 203b 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 is shaped by heat setting or the like to closely fit the shape below the annulus (i.e., the junction between the anterior and posterior leaflets and the myocardial wall).
请再次参阅图2,瓣膜缩环系统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和图6,导管定位装置200包括第四手柄210和定位管230,第四手柄210设置在定位管230的近端,定位管230的远端管体沿轴向设置多个窗口231,多个窗口231均贯穿定位管230的同一侧管壁,且多个窗口231朝向靶向部的不同位置。可以理解的是,在进一步的实施例中,不同位置的窗口231对准左心室壁(靶向部)的不同位置,为输送装置300及锚定装置400提供定位功能。窗口231的数量优选为3至15个,进一步地优选为10个。窗口231的形状可以是圆形、椭圆形、方形、菱形、三角形、多边形中的一种或几种,本实施例中采用矩形,且矩形的四角优选为弧形以防止刮伤输送装置300、锚定装置400或人体组织。窗口231的面积范围为4~4000mm 25 and 6, the catheter positioning device 200 includes a fourth handle 210 and a positioning tube 230. The fourth handle 210 is provided at the proximal end of the positioning tube 230, and the distal end of the positioning tube 230 is provided with a plurality of windows along the axial direction 231, multiple windows 231 all penetrate the same side tube wall of the positioning tube 230, and the multiple windows 231 face different positions of the targeting portion. It can be understood that, in a further embodiment, the windows 231 in different positions are aligned with different positions of the left ventricular wall (targeting portion) to provide the positioning function for the delivery device 300 and the anchoring device 400. The number of windows 231 is preferably 3 to 15, and further preferably 10. The shape of the window 231 may be one or more of a circle, an ellipse, a square, a diamond, a triangle, and a polygon. In this embodiment, a rectangle is used, and the four corners of the rectangle are preferably curved to prevent the conveyor 300 from being scratched. Anchoring device 400 or human tissue. The area of the window 231 is 4 to 4000 mm 2 .
在进一步的实施例中,相邻两个窗口231之间通过槽口233连通,槽口233贯穿定位管230的同一侧管壁,位于定位管230最远端的窗口231的远端封闭,位于定位管230最近端的窗口231的近端封闭。可以理解的是,窗口231贯穿定位管230的一侧管壁使每个窗口231均与定位管230的内腔相连通,由此,当输送装置300经过定位管230的内腔输送至体内,可经由每个窗口231伸出,从而为锚定装置400提供定位作用。多个窗口231通过槽口233连通则可提高定位管230靠近远端的管体的柔顺性,可在轨道导管102中顺利地转向,以贴合靶向部(如,心室壁)的形状。In a further embodiment, two adjacent windows 231 communicate with each other through a notch 233, the notch 233 penetrates the same side wall of the positioning tube 230, and the distal end of the window 231 at the most distal end of the positioning tube 230 is closed and located at The proximal end of the window 231 at the closest end of the positioning tube 230 is closed. It can be understood that the window 231 penetrates the side wall of the positioning tube 230 so that each window 231 communicates with the inner cavity of the positioning tube 230. Thus, when the delivery device 300 is delivered into the body through the inner cavity of the positioning tube 230, It can be extended through each window 231 to provide the anchoring device 400 with a positioning effect. The multiple windows 231 communicating through the notch 233 can improve the flexibility of the tube body of the positioning tube 230 near the distal end, and can be smoothly turned in the rail catheter 102 to fit the shape of the target portion (eg, the ventricular wall).
在进一步的实施例中,相邻两个窗口231的轴向之间通过凸部232间隔,槽口233开设在凸部232中间。In a further embodiment, two adjacent windows 231 are axially spaced apart by a convex portion 232, and a notch 233 is opened in the middle of the convex portion 232.
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230的远端,转向头220由柔性材料制成,转向头220的远端设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 disposed at the distal end of the positioning tube 230, the steering head 220 is made of a flexible material, and the distal end of the steering head 220 is provided with a targeting portion的斜面221. 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.
可以理解的是,定位管230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。本实施例中采用PE管。定位管230的内径范围为0.3~15mm,优选为1.5~10mm。定位管230的管体内埋设显影件以指示管体位置。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。It can be understood that the tube body of the positioning tube 230 is composed of a polymer material, such as one or more copolymers of ABS, PE, PP, PEBAX, PC, PU, Nylon, PVC, PTFE or PB or mixture. In this embodiment, PE pipes are used. The inner diameter of the positioning tube 230 ranges from 0.3 to 15 mm, preferably from 1.5 to 10 mm. The developing member is embedded in the positioning tube 230 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.
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,依次经由导管定位装置200的多个窗口231伸出,为锚定装置400的多个锚定件440a分别提供输送通道。The delivery device 300 is used to reach the targeting portion along the guide wire 600 and the catheter positioning device 200, and sequentially extend through the multiple windows 231 of the catheter positioning device 200 to provide a delivery channel for the multiple anchors 440a of the anchoring device 400, respectively .
请参阅图7,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调整至与定位装置20相配合的形状,使得输送管330的远端到达窗口231。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. 7, 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 positioning device 20 so that the distal end of the delivery tube 330 reaches the window 231. 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弯曲至与定位装置20相配合的形状,使得输送管330的远端到达窗口231。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 matching the positioning device 20 so that the distal end of the delivery tube 330 reaches the window 231.
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还包括第五手柄320,第五手柄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近端收容在第五手柄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 fifth 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 fifth 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,第五手柄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 fifth 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体位置,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8a及图8b,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。8a and 8b, 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 pieces 440a are detachably connected, and the release controller 410a controls the anchor piece 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远端之间可拆卸连接。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 area of the anchoring portion 442a in contact with the tissue of the targeting portion can be greatly increased, so as to be firmly fixed inside the tissue, avoiding the instability of the prior art flexible anchoring portion There is a problem of being deformed by maintaining the expanded shape and being easily 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9,本发明第二实施例提供一种瓣膜缩环系统10a,与第一实施例中不同的是,在瓣膜缩环系统10a中,轨道导管102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. 9, a second embodiment of the present invention provides a valve contraction ring system 10a. The difference from the first embodiment is that in the valve contraction ring system 10a, the orbital catheter 102 is a curved orbit that can adjust the shape in real time. The catheter 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 includes a second traction wire 133b, a second threading tube 132b, and a second anchor ring 131b, and the second threading 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 positioned at the distal end of the second threading tube 132b, and the second anchor The ring 131b is located in the fifth tube 140b; the distal end of the second pulling wire 133b is connected to the second anchoring ring 131b, which can pull the second pulling wire 133b, thereby driving the fifth tube 140b to bend to fit the target portion Shape to realize 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 .
请参阅图10,本发明第三实施例提供一种瓣膜缩环系统10b,与第一实施例中不同的是,在瓣膜缩环系统10b中,锚定装置400b中的推送杆420b与锚定件440b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. 10, a third embodiment of the present invention provides a valve contraction ring system 10b. Unlike the first embodiment, in the valve contraction ring system 10b, the push rod 420b and the anchor in the anchoring device 400b The piece 440b is detachably connected. 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 a threaded connection is adopted, the tube body near the distal end of the push rod 420b is provided with a thread, and is threadably 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11,本发明第四实施例提供一种瓣膜缩环系统10c,与第一实施例中不同的是,在瓣膜缩环系统10c中,锚定装置400c还包括第六手柄460c和释放管450c,第六手柄460c设置在释放管450c的近端,推送杆420c穿过第六手柄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. 11, a fourth embodiment of the present invention provides a valve contraction ring system 10c. Unlike the first embodiment, in the valve contraction ring system 10c, the anchoring device 400c further includes a sixth handle 460c and a release The tube 450c and the sixth handle 460c are disposed at the proximal end of the release tube 450c. The push rod 420c passes through the sixth handle 460c. The distal end of the push rod 420c and the connection mechanism 430c are inserted into 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11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依次穿过第六手柄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. 11, 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 sixth 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 whole assembly drives the anchor 440c to move and can realize the remote detachment.
请参阅图12,本发明第五实施例提供一种瓣膜缩环系统10d,与第一实施例中不同的是,在瓣膜缩环系统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. 12, a fifth embodiment of the present invention provides a valve contraction ring system 10d, which is different from the first embodiment in that another anchor 440d is provided in the valve contraction ring system 10d. In 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13,本发明第六实施例提供一种瓣膜缩环系统10e,与第一实施例中不同的是,在瓣膜缩环系统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. 13, a sixth embodiment of the present invention provides a valve contraction ring system 10e. Unlike the first embodiment, another anchor 440e is provided in the valve contraction ring system 10e. When the anchoring portion When 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14至图16,本发明第七实施例提供一种瓣膜缩环系统10f,与第一实施例中不同的是,在瓣膜缩环系统10f中提供再一种锚定件440f,锚定件440f通过连接件441f与推送杆420f连接。Referring to FIGS. 14 to 16, the seventh embodiment of the present invention provides a valve annulus system 10f. Unlike the first embodiment, an additional anchor 440f is provided in the valve annulus system 10f. The anchor The fixed member 440f is connected to the push rod 420f through a connecting member 441f.
锚定件440f中的锚定部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16)和被输送装置300约束的收缩形状(参阅图15)。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。本实施例中,锚定部442f为具有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,从而限制锚定针4426的两个分支4426a和4426b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 anchor portion 442f in the anchor 440f includes a connection ring 4425 near the proximal end, an anchor needle 4426 near the distal end, and a binding portion 4427 sleeved outside the connection ring 4425 and the anchor needle 4426; the anchor needle 4426 has The expanded shape in a natural state (see FIG. 16) and the contracted shape constrained by the conveying device 300 (see FIG. 15). 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. In this embodiment, the anchoring portion 442f is made of a material with a shape memory function, and is compressed in the delivery device 300 when it is contracted in shape. When it is released from the delivery device 300, its tip can penetrate into the deep part of the targeted tissue, and After being fixed inside the tissue, it will fully return to its expanded state under natural conditions. In this embodiment, the anchoring needle 4426 includes two branches 4426a and 4426b. The proximal ends of the branches 4426a and 4426b are formed by intersecting and extending the distal ends of the connecting rings 4425, respectively, and the distal ends of the branches 4426a and 4426b extend in reverse. That is, the branches 4426a and 4426b respectively have two symmetrically arranged openings pointing to the proximal hook-shaped structure. The binding portion 4427 is sleeved at the distal stagger of the connecting ring 4425, thereby restricting the relative position between the two branches 4426a and 4426b of the anchoring needle 4426, and preventing the two hook-shaped structures from completely bouncing off due to their own elasticity in a natural state .
如图14和图15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16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稳定地保持扩展形状不发生任何变形,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. 14 and 15, 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. 16, 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, since the expanded shape has a cross section that is significantly larger than the contracted shape, and the anchor The 440f is rigid, which ensures that the anchor 440f stably maintains the expanded shape without any deformation, thereby the anchor 440f can be firmly fixed inside the tissue, thereby preventing the prior art flexible anchor from being unable to be stably maintained The shape is expanded and deformed, which is easy to be pulled off.
可以理解的是,在该实施例中,收紧线500穿过连接环4425以将多个锚定件440f收紧。在其他实施例中,锚定部442f与连接件441f之间可拆卸连接,当锚定件440f植入靶向部后,释放控制器控制连接件441f释放锚定部442f,只留锚定部442f在靶向部中。It can be understood that in this embodiment, the tightening wire 500 passes through the connecting ring 4425 to tighten the plurality of anchors 440f. In other embodiments, the anchor portion 442f and the connecting member 441f are detachably connected. After the anchor member 440f is implanted into the targeting portion, the release controller controls the connecting member 441f to release the anchor portion 442f, leaving only the anchor portion 442f is in the targeting section.
下面以第一实施例为例来说明本发明提供的瓣膜缩环系统10在治疗二尖瓣反流的手术过程中的使用方法。The following uses the first embodiment as an example to describe a method of using the valve annulus system 10 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130远端,使第一调弯段132朝向心肌壁LVPW;Step 2: Adjust the distal end of the sheath 130 guiding the 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18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,完成定位,如图17所示,导管定位装置200定位后与心室壁完全贴合,方便为后续的锚定件440a植入提供定位;Step 4: As shown in FIG. 18, 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 successfully, the positioning is completed. As shown in FIG. 17, after the catheter positioning device 200 is positioned, it completely fits the wall of the ventricle, which is convenient for providing positioning for subsequent implantation of the anchor 440a;
第五步:如图19所示,在体外,先将收紧线500的一端穿过第一个锚定件440a的连线孔443a并打死结,然后通过导丝600和导管定位装置200送入输送装置300和锚定装置400,当锚定装置400的第一个锚定件440a到达预定位置后,通过旋转锚定装置400的释放控制器410a,带动锚定件440a旋转,直至第一个锚定件440a刺入心室壁中;然后将输送装置300从导管定位装置200的第一个窗口231中撤回,将输送装置300再送入第二个窗口231中,为第二个锚定件440a提供定位。Step 5: As shown in FIG. 19, outside the body, first pass one end of the tightening wire 500 through the connecting hole 443a of the first anchor 440a and tie the knot, and then pass the guide wire 600 and the catheter positioning device 200 Feed the conveying device 300 and the anchoring device 400. When the first anchoring piece 440a of the anchoring device 400 reaches a predetermined position, the anchoring device 440a is rotated by the release controller 410a of the rotating anchoring device 400 until the first An anchor 440a penetrates into the wall of the ventricle; then the delivery device 300 is withdrawn from the first window 231 of the catheter positioning device 200, and the delivery device 300 is sent into the second window 231 again for the second anchor Piece 440a provides positioning.
第六步:将收紧线500的另一端穿过第二个锚定件440a的连线孔443a后将第二个锚定件440a沿导丝600和输送装置300送入患者体内并植入心室壁,然后将收紧线500的末端依次穿过后续的多个锚定件440a,并将多个锚定件440a依次沿导丝600送入患者体内,并沿瓣环依次旋入心室壁的不同位置。Step 6: After passing the other end of the tightening wire 500 through the connecting hole 443a of the second anchor 440a, the second anchor 440a is introduced into the patient's body along the guide wire 600 and the delivery device 300 and implanted The ventricular wall, and then the end of the tightening wire 500 is sequentially passed through the subsequent multiple anchors 440a, and the multiple anchors 440a are sequentially fed into the patient's body along the guide wire 600, and are sequentially screwed into the ventricular wall along the annulus Different locations.
第七步:如图20所示,植入所有锚定件440a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440a和将多个锚定件440a串联在一起的收紧线500,如图21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. 20, after implanting all the anchors 440a, the catheter positioning device 200, the delivery device 300 and the anchoring device 400 are withdrawn, leaving only a plurality of anchors 440a and more A tightening wire 500 with two anchors 440a connected in series, as shown in FIG. 21, 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.
如图22所示,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由股动脉—腹动脉—胸动脉—主动脉弓—左心室的路径,其余操作均与经心尖路径相同。As shown in Figure 22, the second surgical path is the trans-aortic path, which differs from the trans-apical path in that all instruments in the surgery are via the femoral artery-abdominal artery-thoracic artery-aortic arch-left ventricle, The rest of the operation is the same as the transapical path.
如图23所示,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由股动脉—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。As shown in FIG. 23, the third surgical path is the transatrial septal path, which is different from the transapical path in that all instruments are operated through the femoral artery—abdominal artery—caval vein—right atrium—left atrium—left The path of the ventricle, and from the right atrium to the left atrium, need to cooperate with the interatrial septal puncture device to puncture the oval hole, from the left atrium to the left ventricle through the mitral valve orifice, and the remaining operations are the same as the transapical path.
第二种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 and third paths 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,本发明提供的瓣膜修复系统10,也可以直接将导管定位装置200定位在二尖瓣的瓣环上,然后将多个锚定件440a依次植入瓣环的不同位置,再通过收紧线500将多个锚定件440a收紧并固定,从而达到缩小瓣环的目的。It can be understood that the 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 a plurality of anchors 440a in different positions of the annulus in turn, and then The multiple anchors 440a are tightened and fixed by tightening the wire 500, so as to achieve the purpose of reducing the annulus.
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 (30)

  1. 一种瓣膜缩环系统,其特征在于,所述瓣膜缩环系统包括定位装置、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 valve ring contraction system, characterized in that the valve ring contraction system includes a positioning device, a delivery device, an anchoring device, and a tightening wire, and the anchoring device includes a plurality of anchoring members;
    所述定位装置中设有轴向排列的多个窗口,所述定位装置定位于靶向部上,多个所述窗口朝向所述靶向部的不同位置;The positioning device is provided with a plurality of windows arranged in an axial direction, the positioning device is positioned on the targeting portion, and the plurality of windows face different positions of the targeting portion;
    所述输送装置沿所述定位装置将多个所述锚定件分别经由多个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 device to different positions of the targeting portion via the plurality of windows, respectively;
    所述锚定装置将穿过每一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 each 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 anchors fixed at different positions of the targeting portion, so as to reduce the circumference of the targeting portion.
  2. 如权利要求1所述的瓣膜缩环系统,其特征在于,所述定位装置包括导引装置和导管定位装置;The valve annulus system according to claim 1, wherein the positioning device includes a guiding device and a catheter positioning device;
    所述导引装置用于建立从体外到靶向部的轨道;The guiding device is used to establish a track from outside the body to the targeting part;
    所述导管定位装置中设有多个所述窗口,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,以使每个所述窗口朝向所述靶向部的不同位置。A plurality of the windows are provided in the catheter positioning device, and the catheter positioning device reaches and is positioned at the targeting portion through the lumen of the guiding device so that each of the windows faces the targeting Different locations of the Ministry.
  3. 如权利要求2所述的瓣膜缩环系统,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,贴合在靶向部,进而建立从体外到靶向部的轨道;The valve annulus contraction system according to claim 2, wherein the guiding device includes a guiding sheath and a rail catheter installed in the guiding sheath, and the rail catheter is guided from the guiding The distal end of the sheath tube is extended and attached to the target part, thereby establishing a track from the outside of the body to the target 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.
  4. 如权利要求3所述的瓣膜缩环系统,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 valve annulus system of claim 3, wherein the guide sheath includes a sheath having a certain axial length and a first traction member; the sheath includes a first support section near the proximal end And a 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 move the first bending section The bending section is adjusted to fit the shape of the target part.
  5. 如权利要求4所述的瓣膜缩环系统,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 valve annulus contraction system according to claim 4, wherein the sheath tube is a hollow multilayer tube body, and the first traction member includes a first traction wire, a first threading tube, and a first anchor A 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 ring is positioned in the A 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.
  6. 如权利要求5所述的瓣膜缩环系统,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 valve annulus system according to claim 5, wherein the guide sheath further comprises a first bender disposed at a proximal end of the sheath, and the proximal end of the first pulling wire is The first bender is connected, and by pulling the first bender, the first pulling wire is pulled, thereby driving the first bending section to bend.
  7. 如权利要求3所述的瓣膜缩环系统,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 valve annulus contraction system of claim 3, wherein the orbit catheter is a shaped orbit catheter, and the orbit catheter includes a rigidly connected second handle and a shaped tube body, and the second handle Placed 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.
  8. 如权利要求7所述的瓣膜缩环系统,其特征在于,所述第一管体与所述第二管体的近端所在的第一平面和所述第三管体与所述第二管体的远端所在的第二平面之间的角度范围为30-150度。The valve annulus system according to claim 7, wherein the first plane where the proximal ends of the first tube and the second tube are located and the third tube and the second tube The angle range between the second plane where the distal end of the body is located is 30-150 degrees.
  9. 如权利要求3所述的瓣膜缩环系统,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 valve annulus contraction system according to claim 3, wherein the orbital catheter is a curved orbital catheter, the curved orbital catheter includes a curved tube and a second traction member, and the curved tube includes a close proximity The fourth tube body at the end and the fifth tube body near the distal end, the second traction member moves along the axial direction of the bending tube to adjust the fifth tube body to fit the shape of the targeting portion.
  10. 如权利要求9所述的瓣膜缩环系统,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 valve annulus system according to claim 9, wherein the bending tube is a hollow multi-layer tube, and the second traction member includes a second traction wire, a second threading tube, and a second anchor A fixed 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, and the second anchoring ring is positioned at A distal end of the second threading tube, and the second anchoring 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.
  11. 如权利要求10所述的瓣膜缩环系统,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 valve annulus system according to claim 10, wherein the bending track catheter further comprises a second bender disposed at the proximal end of the bending tube, and the proximal end of the second traction wire is The second bender is connected, and by pulling the second bender, the second pulling wire is pulled, thereby driving the fifth tube to bend.
  12. 如权利要求2所述的瓣膜缩环系统,其特征在于,所述导管定位装置包括第四手柄和定位管,所述第四手柄设置在所述定位管的近端,所述定位管的远端管体沿轴向设置多个所述窗口,所述多个窗口均贯穿所述定位管的同一侧管壁,且所述多个窗口朝向所述靶向部的不同位置。The valve annulus system according to claim 2, wherein the catheter positioning device includes a fourth handle and a positioning tube, the fourth handle is disposed at a proximal end of the positioning tube, and the distal end of the positioning tube The end tube body is provided with a plurality of the windows along the axial direction, all of the windows penetrate the same side tube wall of the positioning tube, and the plurality of windows face different positions of the targeting portion.
  13. 如权利要求12所述的瓣膜缩环系统,其特征在于,相邻两个所述窗口之间通过槽口连通,所述槽口贯穿所述定位管的同一侧管壁,位于所述定位管最远端的窗口的远端封闭,位于所述定位管最近端的窗口的近端封闭。The valve annulus system according to claim 12, wherein two adjacent windows are communicated through a notch, the notch penetrates the same side tube wall of the positioning tube and is located in the positioning tube The distal end of the most distal window is closed, and the proximal end of the window located at the closest end of the positioning tube is closed.
  14. 如权利要求12所述的瓣膜缩环系统,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,所述转向头的远端设有朝向靶向部的倾斜面。The valve annulus system according to claim 12, 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 a flexible material. The distal end of the steering head is provided with an inclined surface toward the targeting portion.
  15. 如权利要求2-14任一项所述的瓣膜缩环系统,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 valve annulus system according to any one of claims 2-14, wherein the delivery device includes a delivery tube and a third traction member, and the delivery tube includes a second support section near the proximal end and a near-end The second bending section at the end, the third traction member moves along the axial direction of the delivery pipe to adjust the second bending section to a shape matching the positioning device, so that the delivery pipe The far end reaches the window.
  16. 如权利要求15所述的瓣膜缩环系统,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 valve annulus contraction system according to claim 15, wherein the delivery tube is a hollow multilayer tube body, and the third traction member includes a third traction wire, a third threading tube, and a third anchor A 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 ring is positioned in the A 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 pulling wire is connected to the third anchoring ring, and by pulling the third pulling wire, the second bending section is driven to bend to a shape matching the positioning device, The distal end of the delivery tube is allowed to reach the window.
  17. 如权利要求16所述的瓣膜缩环系统,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 valve annulus contraction system according to claim 16, wherein the delivery device further includes a third bender disposed at the proximal end of the delivery tube, and the proximal end of the third traction wire and the first Three benders are connected, and by pulling the third bender, the third pulling wire is pulled, thereby driving the second bending section to bend.
  18. 如权利要求1所述的瓣膜缩环系统,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 valve annulus contraction system of claim 1, wherein the anchoring device further comprises a release controller and a push rod provided between the release controller and the anchor, the push rod A detachable connection with the anchor, the release controller controls the anchor to be released at the targeting portion.
  19. 如权利要求18所述的瓣膜缩环系统,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 valve annulus contraction system of claim 18, wherein the anchoring device further comprises a connection mechanism, the proximal end of the connection mechanism is rigidly connected to the distal end of the push rod, and the push rod passes through the The distal end of the connection mechanism is detachably connected to the anchor; the release controller controls the opening of the connection structure to release the anchor.
  20. 如权利要求19所述的瓣膜缩环系统,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 valve annulus system of claim 19, wherein the detachable connection includes screw connection, snap connection, or clip connection.
  21. 如权利要求20所述的瓣膜缩环系统,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 contraction system according to claim 20, characterized in that, when a threaded connection is adopted, 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.
  22. 如权利要求19所述的瓣膜缩环系统,其特征在于,所述锚定装置还包括第六手柄和释放管,所述第六手柄设置在所述释放管的近端,所述推送杆穿过所述第六手柄,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 valve annulus system of claim 19, wherein the anchoring device further includes a sixth handle and a release tube, the sixth handle is disposed at a proximal end of the release tube, and the push rod passes through After the sixth handle, 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.
  23. 如权利要求22所述的瓣膜缩环系统,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 valve annulus contraction system according to claim 22, wherein the connecting mechanism includes multiple sets of connecting rods and multiple pins, multiple sets of the connecting rods are movably connected by multiple pins, and multiple sets of the connecting rods The most recent set of the connecting rods is connected to the push rod by pins, and the end of the most distal set of the connecting rods of the plurality of sets of connecting rods is provided with a clamping part, the clamping part is used for Clamp and release the anchor.
  24. 如权利要求18-23任一项所述的瓣膜缩环系统,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 valve annulus system according to any one of claims 18 to 23, wherein the anchoring member includes a connecting portion and an anchoring portion, and the anchoring portion passes between the connecting portion and the push rod Detachable connection.
  25. 如权利要求24所述的瓣膜缩环系统,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 valve annulus system according to claim 24, wherein the connecting portion is provided with a connecting hole, and the connecting hole is used for tightening the wire through.
  26. 如权利要求24所述的瓣膜缩环系统,其特征在于,所述锚定部包括至少一个螺旋结构。The valve annulus system of claim 24, wherein the anchor portion includes at least one helical structure.
  27. 如权利要求26所述的瓣膜缩环系统,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 valve annulus contraction system according to claim 26, 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.
  28. 如权利要求26所述的瓣膜缩环系统,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 valve annulus system according to claim 26, 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.
  29. 如权利要求24所述的瓣膜缩环系统,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 valve annulus contraction system of claim 24, wherein the anchoring portion includes a connecting ring near the proximal end, an anchoring pin near the distal end, and the sleeve and the anchoring needle sleeved on the connecting ring External restraint; the anchor needle has an expanded shape in its natural state and a contracted shape constrained by the delivery device.
  30. 如权利要求1所述的瓣膜缩环系统,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 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/CN2019/097569 2018-12-29 2019-07-24 Valve annulus shrinkage system WO2020134053A1 (en)

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CN201822270742.2 2018-12-29
CN201811646655.0 2018-12-29
CN201811646655.0A CN111374800A (en) 2018-12-29 2018-12-29 Valve ring-contracting system
CN201822270742.2U CN209966663U (en) 2018-12-29 2018-12-29 Valve ring-contracting system

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