WO2020134053A1 - Système de retrait d'anneau de valve - Google Patents

Système de retrait d'anneau de valve 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
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WO
WIPO (PCT)
Prior art keywords
tube
anchoring
valve annulus
distal end
anchor
Prior art date
Application number
PCT/CN2019/097569
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English (en)
Chinese (zh)
Inventor
张庭超
谢琦宗
郭荣辉
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201811646655.0A external-priority patent/CN111374800A/zh
Priority claimed from CN201822270742.2U external-priority patent/CN209966663U/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2020134053A1 publication Critical patent/WO2020134053A1/fr

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

Definitions

  • the invention relates to the 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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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un système de retrait d'anneau de valve, comprenant un dispositif de positionnement (10), un dispositif de transport (300), un dispositif d'ancrage (400) et un fil de serrage (500). Le dispositif d'ancrage (400) comprend de multiples pièces d'ancrage (440a) ; le dispositif de positionnement (10) est pourvu de multiples fenêtres (231) agencées axialement, le dispositif de positionnement (10) est positionné sur une partie de ciblage, et les multiples fenêtres (231) font face à différentes positions de la partie de ciblage ; le dispositif de transport (300) transporte les multiples pièces d'ancrage (440a) le long du dispositif de positionnement (10) vers les différentes positions de la partie de ciblage respectivement au moyen des multiples fenêtres (231) ; le dispositif d'ancrage (100) fixe séquentiellement les pièces d'ancrage (440a) passant à travers les fenêtres (231) aux différentes positions de la partie de ciblage ; le fil de serrage (500) est utilisé pour connecter en série et serrer les multiples pièces d'ancrage (440a) fixées aux différentes positions de la partie de ciblage, de telle sorte que la circonférence de la partie de ciblage est réduite. Selon le système de retrait d'anneau de valve, le dispositif d'ancrage (440a) est étendu hors des différentes fenêtres (231) pour fixer les pièces d'ancrage (440a) à différentes positions de la partie de ciblage, puis la partie de ciblage est serrée au moyen du fil de serrage (500) ; ainsi, l'effet de réduction de la circonférence de la partie de ciblage est obtenu.
PCT/CN2019/097569 2018-12-29 2019-07-24 Système de retrait d'anneau de valve WO2020134053A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201811646655.0A CN111374800A (zh) 2018-12-29 2018-12-29 一种瓣膜缩环系统
CN201811646655.0 2018-12-29
CN201822270742.2 2018-12-29
CN201822270742.2U CN209966663U (zh) 2018-12-29 2018-12-29 一种瓣膜缩环系统

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US11672661B2 (en) 2019-08-22 2023-06-13 Silara Medtech Inc. Annuloplasty systems and methods

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US20130103055A1 (en) * 2005-04-22 2013-04-25 Benvenue Medical, Inc. Catheter-based tissue remodeling devices and methods
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WO2010128503A2 (fr) * 2009-05-04 2010-11-11 Valtech Cardio, Ltd. Techniques de déploiement d'anneau d'annuloplastie et outil de rotation sur fil
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