A single-window guided valve shrinking ring system

Abstract

The present invention provides a single-window guided valve shrink ring system, comprising a catheter positioning device, a conveying device, an anchoring device and a tightening line, wherein the anchoring device comprises a plurality of anchors; the catheter positioning device comprises a positioning tube, a window communicating with its inner cavity is provided on the side wall at the distal end, and the positioning tube moves so that the window faces different positions of the targeting portion; the conveying device conveys the plurality of anchors to different positions of the targeting portion through the window along the positioning tube; the anchoring device sequentially fixes the anchors passing through the window at different positions of the targeting portion; the tightening line is used to connect and tighten the plurality of anchors fixed at different positions of the targeting portion in series, so as to reduce the circumference of the targeting portion. The single-window guided valve shrink ring system provided by the present invention moves the positioning tube so that the window corresponds to different positions of the targeting portion, and then fixes the anchors at different positions of the targeting portion, and then tightens the targeting portion through the tightening line, thereby achieving the effect of reducing the circumference of the targeting portion.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a single-window guided valve shrink ring system. Background Art

[0002] like Figure 1 As shown in the figure, the human heart consists 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 a "one-way valve" between the left atrium and the left ventricle, including the valve ring (MVA), the anterior leaflet (AML), the posterior leaflet (PML), the chordae tendineae (CT) and the papillary muscles (PM). The valve ring is between the left atrium and the left ventricle. The anterior leaflet and the posterior leaflet are connected to the valve ring. There are multiple chordae tendineae (CT) on the two leaflets, and the other end of the chordae tendineae is connected to the papillary muscles. During the beating of the heart, the anterior leaflet and the posterior leaflet of the normal mitral valve are in an open and closed cycle, thereby ensuring that the blood circulation flows from the left atrium to the left ventricle in a certain direction and passes a certain flow rate. When the leaflets, annulus, papillary muscles, chordae tendineae and other components of the mitral valve undergo organic or functional changes, resulting in poor anastomosis between the anterior and posterior leaflets of the mitral valve, blood reflux will occur, which is called mitral valve regurgitation (abbreviated as: MR). Mitral regurgitation is a common heart valve disease. Mitral regurgitation can be divided into two categories from the perspective of etiology: functional and organic (degenerative). For mitral regurgitation, clinical trials have shown that drug therapy can only improve patient symptoms, but cannot prolong patient survival or the timing of surgery. The traditional standard treatment method is surgery, mainly surgical valve repair or replacement. However, surgery is traumatic, difficult to heal, has many complications, and has a high surgical risk. The interventional method of percutaneous mitral annuloplasty is one of the most commonly used mitral valve shaping methods, and its long-term treatment effect is good. However, in patients with functional mitral regurgitation and left ventricular enlargement due to heart failure, the existing technology only shrinks the valve ring and cannot effectively reduce the volume of the left ventricle, resulting in unsatisfactory treatment effects. Summary of the invention

[0003] In view of this, the present invention provides a valve shrinking ring system that can effectively reduce the volume of the left ventricle and improve the treatment effect of functional mitral regurgitation. The specific technical solution is as follows.

[0004] A single-window guided valve shrink ring system, the single-window guided valve shrink ring system comprising a catheter positioning device, a delivery device, an anchoring device and a tightening line, wherein the anchoring device comprises a plurality of anchoring members;

[0005] The catheter positioning device comprises a positioning tube, the positioning tube is positioned on the targeting portion, a window communicating with the inner cavity of the positioning tube is provided on the side wall at the distal end of the positioning tube, and the positioning tube moves so that the window faces different positions of the targeting portion;

[0006] The delivery device delivers the plurality of anchors along the positioning tube through the window to different positions of the targeting portion;

[0007] The anchoring device sequentially fixes the anchoring member passing through the window at different positions of the targeting portion;

[0008] The tightening line is used to connect in series and tighten a plurality of the anchors fixed at different positions of the targeting portion, so as to reduce the circumference of the targeting portion.

[0009] Compared with the prior art, the present invention has at least the following beneficial effects:

[0010] The single-window guided valve shrink ring system provided by the present invention moves the positioning tube in the catheter positioning device so that the window faces different positions of the target part, and then fixes the anchor at different positions of the target part, and then tightens the target part through the tightening line, so as to achieve the effect of reducing the circumference of the target part. For example, the single-window guided valve shrink ring system provided by the present invention sequentially implants multiple anchors at the circumference of the myocardial wall of the left ventricle 0.5-2cm below the mitral valve ring, and connects the multiple anchors in series and tightens and fixes them, which can not only reduce the circumference of the mitral valve ring, but also reduce the radial diameter of the left ventricle, thereby reducing the volume of the left ventricle, thereby improving the treatment effect of mitral valve regurgitation, and is particularly suitable for treating functional mitral valve regurgitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 Schematic diagram of the human heart structure.

[0012] Figure 2 A schematic structural diagram of a single-window guided valve shrink ring system provided in the first embodiment of the present invention.

[0013] Figure 3 The present invention is a schematic structural diagram of a guide sheath provided by the present invention.

[0014] Figure 4a A schematic structural diagram of a track guide tube provided by the present invention.

[0015] Figure 4b A schematic structural diagram of another track guide tube provided by the present invention.

[0016] Figure 5 A schematic structural diagram of a catheter positioning device provided by the present invention.

[0017] Figure 6 for Figure 5 A schematic diagram of the three-dimensional structure of a positioning handle in a catheter positioning device provided in the invention.

[0018] Figure 7 for Figure 5A front view of a positioning handle in a catheter positioning device provided in the present invention.

[0019] Figure 8 for Figure 7 Section view along BB.

[0020] Fig. 9 Figure a in the figure is Figure 5 A schematic diagram of the local structure of a positioning handle in a catheter positioning device provided in FIG; FIG b is a cross-sectional view along AA of FIG a.

[0021] Fig.10 A schematic structural diagram of a conveying device provided by the present invention.

[0022] Fig.11 A schematic structural diagram of an anchoring device provided by the present invention.

[0023] Fig.12 A schematic structural diagram of a bend-adjusting track catheter in a single-window guided valve contraction ring system provided in the second embodiment of the present invention.

[0024] Fig.13 A schematic structural diagram of an anchoring device in a single-window guided valve contraction ring system provided in the third embodiment of the present invention.

[0025] Fig.14 A schematic structural diagram of an anchoring device in a single-window guided valve contraction ring system provided in the fourth embodiment of the present invention.

[0026] Fig.15 A schematic structural diagram of an anchoring member in a single-window guided valve contraction ring system provided in the fifth embodiment of the present invention.

[0027] Fig.16 A schematic structural diagram of an anchoring member in a single-window guided valve contraction ring system provided in the sixth embodiment of the present invention.

[0028] Fig.17 A schematic structural diagram of an anchoring member in a single-window guided valve contraction ring system provided in the seventh embodiment of the present invention.

[0029] Fig.18 for Fig.17 A schematic structural diagram of the anchoring portion in the anchoring member provided in the embodiment of the present invention is provided in the embodiment of the present invention.

[0030] Fig.19 for Fig.17 A schematic structural diagram of the anchor portion of the anchor member provided in the expanded state.

[0031] Fig. 20 A schematic diagram of the guide device provided by the present invention being delivered to the underside of the valve leaflet through the apex of the heart.

[0032] Fig.21 This is a schematic diagram of the anchor provided by the present invention being implanted into the ventricular wall.

[0033] Fig. 22 This is a schematic diagram of multiple anchors provided by the present invention implanted in different locations on the ventricular wall.

[0034] Fig.23 This is a schematic diagram of a tightening line provided by the present invention after tightening multiple anchoring members.

[0035] Fig.24 A schematic structural diagram of another catheter positioning device provided by the present invention.

[0036] Fig.25 This is a schematic structural diagram of another catheter positioning device provided by the present invention.

[0037] Fig.26 A schematic diagram of the guide device provided by the present invention being delivered into the left ventricle via the aorta.

[0038] Fig. 27 The present invention is a schematic structural diagram of another catheter positioning device provided by the present invention.

[0039] Fig.28 A schematic diagram of the guide device provided by the present invention being delivered into the left ventricle via the atrial septum pathway. DETAILED DESCRIPTION

[0040] The following is a preferred embodiment of the present invention. It should be noted that a person skilled in the art may make several improvements and modifications without departing from the principle of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

[0041] In order to more clearly describe the structure of the single-window guided valve ring system, the terms "proximal end" and "distal end" are defined as conventional terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation, and "proximal end" refers to the end close to the operator during the surgical operation.

[0042] See also Figure 2 and Figure 5 The first embodiment of the present invention provides a single-window guided valve shrink ring system 10, including a catheter positioning device 200, a delivery device 300, an anchoring device 400 and a tightening wire 500, wherein the anchoring device 400 includes a plurality of anchoring members 440a.

[0043] The catheter positioning device 200 includes a positioning tube 210 (see Figure 5), the positioning tube 210 is positioned on the target portion. A window 212 is provided on the side wall at the distal end of the positioning tube 210 and is connected to the inner cavity of the positioning tube 210. The positioning tube 210 moves so that the window 212 faces different positions of the target portion. There is only one window 212 in the catheter positioning device 200.

[0044] The operator adjusts the distal position of the positioning tube 210 so that the window 212 faces different positions of the targeting portion, and then can use the conveying device 300 to convey multiple anchors 440a along the positioning tube 210 through the window 212 to different positions of the targeting portion. The anchoring device 400 fixes the anchors 440a passing through the window 212 at different positions of the targeting portion in sequence, and the tightening line 500 is used to connect and tighten the multiple anchors 440a fixed at different positions of the targeting portion in series to reduce the circumference of the targeting portion.

[0045] In a further embodiment, the target portion is the mitral valve annulus or the left ventricular myocardial wall below the mitral valve annulus.

[0046] In a further embodiment, the target portion is the left ventricular myocardial wall below the mitral valve annulus, specifically, on the left ventricular myocardial wall 0.5-2 cm below the mitral valve annulus. A plurality of anchors 440a are implanted in sequence, and the plurality of anchors 440a are connected in series, tightened, and fixed, thereby achieving the purpose of shrinking the mitral valve annulus and reducing the volume of the left ventricle, thereby improving the treatment effect of mitral regurgitation, and is particularly suitable for treating functional mitral regurgitation.

[0047] In a further embodiment, the catheter positioning device 200 further includes a positioning handle 230 (see FIG. Figure 5 The positioning handle 230 controls the distal end of the positioning tube 210 to advance or retreat along the surface of the target portion so that the window 212 faces different positions of the target portion. The positioning tube 210 is rigidly connected to the positioning handle 230. In other embodiments, the positioning tube 210 can be connected by medical glue, welding, interference fit, etc.

[0048] In a further embodiment, the valve shrink ring system 10 further includes a guide device 100, the guide device 100 is used to establish a track from the outside of the patient to the target portion, and the catheter positioning device 200 reaches and is positioned at the target portion through the inner cavity of the guide device 100, so that the window 212 faces the target portion. It can be understood that the catheter positioning device 200 is installed in the inner cavity of the guide device 100, the delivery device 300 is installed in the inner cavity of the catheter positioning device 200, and the anchoring device 400 extends from the window 212 through the inner cavity of the delivery device 300.

[0049] See also Figure 3 and Figure 4aIn a further embodiment, the guiding device 100 comprises a guiding sheath 101 (see Figure 3 ) and the track catheter 102 (see Figure 4a ), the track catheter 102 extends from the distal end of the guide sheath 101 and fits on the targeting portion, thereby establishing a track from the outside of the body to the targeting portion. The inner cavity of the track catheter 102 is used to accommodate and pass the catheter positioning device 200.

[0050] See also Figure 3 In a further embodiment, the guide sheath 101 includes a sheath 130 with 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 first bending section 132 near the distal end, the distal end of the first traction member 104 is connected to the first bending section 132, and the first traction member 104 moves along the axial direction of the sheath 130 to adjust the first bending section 132 to fit the shape of the target portion. The sheath 130 is made of a polymer material, and the polymer material is selected from one or more copolymers or mixtures of ABS, PE, PP, PEBAX, PC, PU, ​​Nylon, PVC, PTFE or PB. In this embodiment, PEBAX is selected with a hardness of 40D.

[0051] In a further embodiment, the sheath 130 is a hollow multi-layer tube, and the first traction member 104 includes a first traction wire 110, a first wire threading tube 120, and a first anchoring ring 160. The first wire threading tube 120 is axially opened in the inner wall of the sheath 130, the first traction wire 110 is inserted in the first wire threading tube 120, the first anchoring ring 160 is arranged at the distal end of the first wire threading tube 120, and the first anchoring ring 160 is located in the first bending section 132. The distal end of the first traction wire 110 is connected to the first anchoring ring 160, and by pulling the first traction wire 110, the first bending section 132 is driven to bend to a shape that fits the target portion. It can be understood that the first traction wire 110 is embedded in the inner wall of the sheath 130, and the first traction wire 110 is contained in the first wire threading tube 120 to prevent the first traction wire 110 from bending. The distal end of the first traction wire 110 extends to the distal end of the sheath 130 and is rigidly connected to the first anchoring ring 160. Thus, by pulling the first traction wire 110, the first bending adjustment section 132 is driven to bend, thereby realizing the bending adjustment function. The first traction wire 110 is made of 304 stainless steel, copper and other metals that can withstand a certain tension; the first wire threading tube 120 can be made of 304 stainless steel; the sheath 130 is composed of multiple layers of polymer film and metal reinforcement layer, such as the inner film is PTFE tube, the middle layer is 304 stainless steel braided mesh tube, the outer layer is PEBAX tube, etc.; the first anchoring ring 160 is made of metal material, such as 304 stainless steel.

[0052] In a further embodiment, the guide sheath 101 further comprises a first bend adjuster 140 disposed at the proximal end of the sheath 130, the proximal end of the first traction wire 110 is connected to the first bend adjuster 140, and by pulling the first bend adjuster 140, the first traction wire 110 is pulled, thereby driving the first bending section 132 to bend. The material of the first bend adjuster 140 is PC.

[0053] In a further embodiment, the guide sheath 101 further comprises a first handle 150, which is disposed between the first bender 140 and the sheath 130, or the first bender 140 and the proximal end of the sheath 130 are accommodated in the first handle 150, so as to facilitate the operator to grasp and operate.

[0054] In other embodiments, the distal end of the sheath tube 130 has a sharp tip, preferably a conical structure.

[0055] It is understandable that in other embodiments, the guide sheath 101 may also adopt a shaped tube body, similar to the existing shaped delivery sheath, which will not be described in detail here.

[0056] See also Figure 4a In a further embodiment, the track catheter 102 is a pre-shaped track catheter 102a. The shaped track catheter 102a includes a second handle 110a and a shaped tube body 103a that are rigidly connected, and the second handle 110a is arranged 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 that are sequentially connected from the proximal end to the distal end, and the angle between the extension direction of the third tube body 140a and the extension direction of the first tube body 120a is in the range of 0-180 degrees, and the third tube body 140a and the first tube body 120a are smoothly transitioned through the second tube body 130a.

[0057] See also Figure 4b In a further embodiment, a shaped track catheter 112b with good fit with the targeting portion is provided, comprising a first tube body 1121b, a second tube body 1122b and a third tube body 1123b connected in sequence from the proximal end to the distal end, and an angle range between a first plane where the proximal ends of the first tube body 1121b and the second tube body 1122b are located and a second plane where the distal ends of the third tube body 1123b and the second tube body 1122b are located is 30-150 degrees.

[0058] It is understandable that the shaped tube body 103 a has an inner cavity 150 a capable of accommodating the catheter positioning device 200 .

[0059] It is understandable that the shaping tube body 103a is a flexible tube with a certain hardness, which can be made of a high molecular polymer material, such as a copolymer or mixture of one or more of PEEK, ABS, PE, PP, PEBAX, PC, PU, ​​Nylon, PVC, PTFE or PB, or a biocompatible metal such as nickel-titanium alloy. The shaping tube body 103a can be a single-layer tube; it can also be a multi-layer tube, such as a multi-layer tube body formed by hot melting an inner membrane PTFE, an intermediate braided mesh tube, and an outer layer PEBAX tube into a flexible tube. In this embodiment, a PEBAX tube is used, and the entire tube body is shaped by heat setting and the like to fit closely to the shape below the valve ring (i.e., the connection between the anterior leaflet and the posterior leaflet and the myocardial wall).

[0060] Please refer again Figure 2 The valve contraction ring system 10 also includes a guide wire 600, which is inserted into the track catheter 102. The guide wire 600 is used to provide direction guidance for the catheter positioning device 200, the conveying device 300 and the anchoring device 400 to enter the target part. One end of the guide wire 600 is a flexible guide wire head with a certain distance, which will not cause damage to human tissue when entering the human body. The other end is a flexible wire made of flexible metal materials such as nickel titanium. Preferably, the surface of the guide wire 600 can be coated with PTFE film, and the overall smoothness after coating is better, which improves the operability in the human body. The guide wire 600 is selected from a guide wire, a straight guide wire, a J-shaped guide wire, a loach guide wire, etc. The size is 0.014", 0.018", 0.035", 0.038", 0.046", etc.

[0061] See also Figure 5 The positioning tube 210 at least includes an axially penetrating guidewire cavity 215 and a delivery cavity 214 arranged parallel to the guidewire cavity 215; the window 212 is connected to the distal end of the delivery cavity 214, thereby providing positioning for the delivery device 300 and the anchoring device 400. In other words, the window 212 is opened on the side wall 211 of the delivery cavity 214. The shape of the window 212 can be circular, elliptical, square, diamond, triangle, trapezoidal parallel or quadrilateral. The area range of the window 212 is 4 to 4000 mm 2 The positioning tube 210 may be an integrally formed double-lumen tube or multi-lumen tube, or may be a plurality of separate tubes sheathed together. In this embodiment, an integrally formed double-lumen tube is used.

[0062] Preferably, the distal end 224 of the delivery cavity 214 is an arc-shaped surface, which smoothly transitions with the window 212, which is conducive to the delivery device 300 extending smoothly through the window 212 along the distal end 224 of the delivery cavity 214 and reaching the predetermined position. The tube body of the positioning tube 210 is composed of a high molecular polymer material, such as a copolymer or mixture of one or more of ABS, PE, PP, PEBAX, PC, PU, ​​Nylon, PVC, PTFE or PB. The inner diameter range of the positioning tube 210 is 0.3 to 15 mm, preferably 1.5 to 10 mm. A developing component is buried in the tube body of the positioning tube 210 to indicate the position of the tube body. The developing component 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.

[0063] In a further embodiment, the catheter positioning device 200 further includes a steering head 220, which is disposed at the distal end of the positioning tube 210, and is made of a flexible material. The guidewire cavity 215 is connected to the inner cavity of the steering head 220, and the steering head 220 has an inclined surface 221 facing the targeting portion. When the catheter positioning device 200 is placed in the left ventricle, the inclined surface 221 of the steering head 220 faces the ventricular wall to further fit the ventricular wall.

[0064] See also Figures 6 to 9 In a further embodiment, the positioning handle 230 includes a regulating mechanism 201, a handle housing 202 and a sheath connector 235; the regulating mechanism 201 cooperates with the handle housing 202 to control the positioning tube 210 to move forward or backward along the axial direction. This controls the window 212 at the distal end of the positioning tube 210 to face different positions of the target portion. The sheath connector 235 is connected to the positioning tube 210 (see Figure 8 ), and the sheath connector 235 is provided with an axially penetrating through hole 236 for the delivery device 300 to pass through. That is to say, the delivery device 300 sequentially enters the through hole 236 and the positioning tube 210 in the sheath connector 235, and then extends out from the window 212.

[0065] In a further embodiment, the positioning handle 230 further includes a locking head 231, and the proximal end of the sheath connector 235 is detachably connected to the locking head 231 by means of threaded connection or the like. Specifically, a locking portion 233 is provided at the proximal end of the sheath connector 235, and the locking portion 233 is threadedly sleeved on the outside of the locking head 231, and a sealing gasket 234 is provided at the connection between the locking portion 233 and the locking head 231, and the sealing gasket 234 has an axial inner cavity for the conveying device 300 to pass through, and the sealing gasket 234 is preferably made of an elastic medical polymer material, such as silicone.

[0066] In a further embodiment, the regulating mechanism 201 includes an adjusting knob 241 and an adjusting screw 244 .

[0067] The adjusting screw 244 is movably sleeved on the distal end of the sheath connector 235; the adjusting knob 241 is movably connected to the handle housing 202 so as to be relatively rotatable, and the adjusting knob 241 is threadedly connected to the outside of the adjusting screw 244 and radially passes through the outer surface of the handle housing 202 from the handle housing 202. By rotating the adjusting knob 241, the adjusting knob 241 is moved forward or backward along the axial direction on the adjusting screw 244, so that the handle housing 202 and the adjusting screw 244 move relative to each other, thereby driving the positioning tube 210 connected to the sheath connector 235 to move forward or backward along the axial direction, so that the window 212 faces different positions of the target portion.

[0068] Specifically, the adjusting screw 244 is movably sleeved on the distal end of the sheath connector 235, and the adjusting screw 244 is a hollow tube body with a closed distal end, and a thread is provided on the outside of the adjusting screw 244. The inside of the adjusting knob 241 is provided with a thread to match the adjusting screw 244, and thus, by rotating the adjusting knob 241, the adjusting knob 241 is moved forward or backward along the axial direction on the adjusting screw 244, thereby realizing the relative movement between the adjusting handle housing 202 connected to the adjusting knob 241 and the adjusting screw 244, and then driving the positioning tube 210 connected to the sheath connector 235 to move forward or backward along the axial direction, so that the window 212 faces different positions of the target portion.

[0069] In a further embodiment, the regulating mechanism 201 further includes a stopper 239 and a stopper 232; the stopper 232 is arranged on the sheath connector 235, the stopper 239 penetrates the outside of the handle housing 202 and extends radially along the positioning handle 230, and the stopper 239 is used to abut the stopper 232 to control the moving distance of the sheath connector 235. That is, when the operator rotates the adjusting knob 241, the adjusting screw 244 moves toward the proximal end relative to the handle housing 202, and pushes the stopper 232 of the sheath connector 235 to move toward the proximal end, and when the stopper 232 of the sheath connector 235 abuts the stopper 239 and cannot move further, the stopper 232 is fixed between the stopper 239 and the proximal end of the adjusting screw 244, thereby limiting and locking the position of the distal end of the positioning tube 210.

[0070] In a further embodiment, the handle housing 202 is provided with a guide groove 260 and a plurality of limit grooves 261 communicating with the guide groove 260 along the axial direction (see Figure 7 ), the stopper 239 is arranged in the stopper groove 261 and can move axially along the guide groove 260. When the stopper 239 is inserted into the stopper groove 261, the position between the stopper 239 and the handle housing 202 is relatively fixed. The distance between two adjacent stopper grooves 261 is the minimum distance that the stopper 239 moves each time. In operation, the distance of the stopper 239 can be moved according to actual conditions.

[0071] In a further embodiment, the handle housing 202 includes an adjustment handle 238 located at the proximal end, a protective cover 245 located at the distal end, and a front shell 242 and a rear shell 240 disposed therebetween; wherein the proximal end of the adjustment knob 241 is connected to the rear shell 240, and the distal end of the adjustment knob 241 is connected to the front shell 242.

[0072] Among them, the rear shell 240 and the adjustment handle 238 are rigidly connected through a tightly fitting snap-fit ​​structure, and the front shell 242 and the protective cover 245 are rigidly connected through a tightly fitting snap-fit ​​structure.

[0073] The adjusting knob 241 is rotatably connected to the handle housing 202. Specifically, the front housing 242 and the distal end of the adjusting knob 241 are connected to each other via a snap-fit ​​structure with clearance, and the rear housing 240 and the proximal end of the adjusting knob 241 are connected to each other via a snap-fit ​​structure with clearance. That is, the adjusting knob 241 is connected to the handle housing 202 via a rotatable connection with the front housing 242 and the rear housing 240.

[0074] In a further embodiment, the positioning handle 230 further includes a support rod 237 (see Figure 8 ), the support rod 237 is arranged around the sheath connector 235 and passes through the retaining piece 232 on the sheath connector 235, and the distal end of the support rod 237 is connected to the distal end of the handle housing 202. Specifically, the support rod 237 is connected to the protective cover 245 at the distal end of the handle housing 202, and passes through the closed end of the adjusting screw 244 respectively, so as to connect the protective cover 245, the adjusting screw 244 and the sheath connector 235 together.

[0075] When the operator uses the positioning handle 230, he first moves the stopper 239 to the proximal end by a certain distance, and then correspondingly inserts the stopper 239 into the stopper groove 261 with a corresponding distance, wherein the distance moved by the stopper 239 is the implantation spacing between each two anchors 440a. Then, the adjusting knob 241 is rotated, so that the adjusting screw 244 moves axially relative to the handle housing 202, thereby driving the sheath tube connector 235 to move axially. When the clamping member 232 abuts against the stopper 239, it cannot move further. At this time, the clamping member 232 is fixed between the stopper 239 and the proximal end of the adjusting screw 244, thereby limiting and locking the position of the distal end of the positioning tube 210, that is, limiting the relative position between the window 212 of the positioning tube 210 and the ventricular wall, thereby realizing the in vitro adjustment of the implantation spacing between the two anchors 440a.

[0076] In actual operation, when the next anchor 440a needs to be implanted, the limiter 239 is unscrewed from the limit slot 261 and moved proximally to the next limit slot 261, screwed in and fixed, and then the adjusting knob 241 is rotated to make the adjusting screw 244 move proximally relative to the handle housing 202, and the adjusting screw 244 drives the sheath connector 235 to move proximally synchronously. When the adjusting screw 244 is withdrawn to a certain distance (the distance between the two implanted anchors 440a), the proximal end of the adjusting screw 244 and the locking member 232 will hit the limiter 239 and cannot continue to move proximally.

[0077] In addition, in actual operation, if the patient's condition is different, the operator can also pull the limiter 239 directly into the nearest limit groove 261 for fixation, and then withdraw the proximal end of the sheath connector 235 to drive the positioning tube 210 to move backward, and determine the moving distance based on the patient's condition and medical influence, thereby controlling the number of anchors 440a that need to be implanted and the distance between the anchors 440a in real time.

[0078] It is understandable that the entire positioning handle 230 can be made of injection molding or machining of polymer materials, such as medical-grade polymer materials such as ABS, PC, nylon, etc. The support rod 237 and the limiter 239 are preferably made of metal materials such as stainless steel to improve smoothness during operation.

[0079] The delivery device 300 is used to reach the target portion along the guide wire 600 and the catheter positioning device 200 , extend through the window 212 of the catheter positioning device 200 , and provide a delivery channel for the anchor 440 a in the anchor device 400 .

[0080] See also Fig.10 In a further embodiment, the delivery device 300 includes a delivery tube 330 and a third traction member 106, the delivery tube 330 includes a second support section 331 near the proximal end and a second bending section 332 near the distal end, and 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 that matches the catheter positioning device 200, so that the distal end of the delivery tube 330 reaches the window 212. It can be understood that the delivery tube 330 is a hollow tube body, which can be a single-layer tube made of a polymer material, such as a copolymer or a mixture of one or more of PEEK, PI, ABS, PE, PP, PEBAX, PC, PU, ​​Nylon, PVC, PTFE or PB, or a multi-layer tube body. In this embodiment, a multi-layer tube body composed of multiple polymer films and metals 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 bent arbitrarily in the same plane direction, and the bending angle is 0 to 360 degrees.

[0081] In a further embodiment, the delivery tube 330 is a hollow multi-layer tube body, and the third traction member 106 includes a third traction wire 340, a third wire threading tube 350, and a third anchoring ring 360. The third wire threading tube 350 is axially opened in the inner wall of the delivery tube 330, the third traction wire 340 is inserted in the third wire threading tube 350, the third anchoring ring 360 is arranged at the distal end of the third wire threading tube 350, and the third anchoring ring 360 is located in the second bending section 332; the distal end of the third traction wire 340 is connected to the third anchoring ring 360, and by pulling the third traction wire 340, the second bending section 332 is driven to bend to a shape that matches the catheter positioning device 200, so that the distal end of the delivery tube 330 reaches the window 212.

[0082] In a further embodiment, the conveying device 300 also includes a third bender 310 arranged at the proximal end of the conveying tube 330, and the proximal end of the third traction wire 340 is connected to the third bender 310. By pulling the third bender 310, the third traction wire 340 is pulled, thereby driving the second bending section 332 to bend.

[0083] In a further embodiment, the delivery device 300 also includes a fourth handle 320, which is disposed between the third bender 310 and the delivery tube 330, or the proximal ends of the third bender 310 and the delivery tube 330 are accommodated in the fourth handle 320, so as to facilitate the operator to grasp and operate.

[0084] It is understandable that the third bender 310 is made of polymer materials such as ABS or metal materials such as 304 stainless steel, 316 stainless steel, and the fourth handle 320 is made of metal or polymer, such as 304 stainless steel, ABS, PC, etc. The traction wire 340 can be 304 stainless steel wire, iron wire, copper wire, nickel titanium wire, etc., or a polymer traction rope such as nylon rope, polypropylene rope, polyurethane rope, fiber rope, etc. The third threading tube 350 can be a 304 stainless steel tube. The third anchoring ring 360 is made of metal materials, such as 304 stainless steel, etc.

[0085] In a further embodiment, a developing component may be embedded in the tube body of the delivery tube 330 to indicate the position of the tube body, and the developing component is made of a metal material that does not transmit X-rays, such as one or more of iron, copper, gold, platinum, titanium, nickel or iridium.

[0086] The anchoring device 400 reaches the valve annulus through the inner cavity of the delivery device 300, and implants a plurality of anchoring elements 440a at different locations of the target part (eg, the myocardial wall).

[0087] See also Fig.11In 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 440a are detachably connected, and the release controller 410a controls the anchor 440a to be released at the target portion. It is understandable that the release controller 410a can drive the anchor 440a to rotate by twisting until the anchor 440a is implanted into the target portion of the patient's tissue, such as the myocardial wall near the valve annulus.

[0088] It is understandable that the push rod 420a can be a solid thin rod or hollow thin tube of metal or polymer material with a certain axial length, 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. It can be a single rod or tube, or a plurality of rods or tubes or wires wound / woven. In this embodiment, a steel cable made of twisted multiple steel wires is used as the push rod 420a.

[0089] In a further embodiment, the anchoring device 400 further includes a connecting mechanism 430a, the proximal end of the connecting mechanism 430a is rigidly connected to the distal end of the push rod 420a, and the push rod 420a is detachably connected to the anchor 440a through the distal end of the connecting mechanism 430a; the release controller 410a controls the connecting mechanism 430a to open to release the anchor 440a. It is understandable that the release controller 410a also includes controlling the actions of the anchor 440a, such as forward, backward, twisting, rotating, sliding, moving, swinging, etc.

[0090] In a further embodiment, the detachable connection includes one of a threaded connection, a snap connection or a clamping connection. It is understood that in this embodiment, the detachable connection between the distal end of the connecting mechanism 430a and the anchor 440a is a threaded connection.

[0091] In a further embodiment, when threaded connection is adopted, the tube body of the connection mechanism 430a near the distal end is provided with threads, and the threads are engaged with the anchor 440a. The distal end 431a of the connection mechanism 430a is not threaded to prevent the threads from being locked with the anchor 440a, which makes it difficult to release later.

[0092] In a further embodiment, the anchor 440a includes a connecting portion 441a and an anchoring portion 442a, and the anchoring portion 442a is detachably connected to the push rod 420a through the connecting portion 441a. In this embodiment, the anchoring portion 442a is detachably connected to the distal end of the connecting mechanism 430a through the connecting 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 a thread inside to cooperate with the distal end tube 432a of the connecting mechanism 430a, and the anchoring portion 442a is used to anchor in human tissue, and the distal end of the anchoring portion 442a is sharp and needle-shaped to facilitate the anchoring portion 442a to penetrate into human tissue.

[0093] In a further embodiment, the anchoring portion 442a includes at least one spiral structure. After the tip of the spiral structure of the anchoring portion 442a penetrates into the tissue, the specific surface area of ​​the anchoring portion 442a in contact with the tissue of the targeting portion can be greatly increased, thereby firmly fixing the anchoring portion 442a in the tissue, thereby avoiding the problem that the flexible anchoring portion of the prior art cannot stably maintain the expanded shape and is deformed and easily pulled off.

[0094] It is understandable that the anchoring portion 442a has a cross-section that is continuously the same or variable (i.e., a spiral shape). The length range of the anchoring portion 442a is 4 mm-16 mm, the diameter range is 0.2 mm-5 mm, and the penetration depth range is 2-10 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 that is significantly larger than the anchoring portion 442a, which is used to limit the anchoring portion 442a, so as to control the anchoring portion 442a to puncture the target tissue into a predetermined depth, and prevent excessive puncture from causing damage to the target tissue.

[0095] It is understandable that the connecting portion 441a is made of a material with good rigidity, such as stainless steel, POM, PEEK, etc. The spiral structure of the anchoring portion 442a is made of a rigid biocompatible metal material or a material with shape memory function. The rigid biocompatible metal material is selected from one or more alloys of iron, steel, copper, titanium, nickel, and chromium. Stainless steel is used in this embodiment. In the prior art, the implants used in mitral annuloplasty are usually made of shape memory metals with high flexibility. The rigidity of such implants is low. In the process of pulling the rope to contract the valve ring, it is easy to pull the implant off, thereby causing 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.

[0096] In a further embodiment, a connection hole 443a is provided on the connection portion 441a, and the connection hole 443a is used for the tightening wire 500 to pass through.

[0097] It is understandable that the tightening line 500 connects multiple anchors 440a in series through the holes on the connection hole 443a. The tightening line 500 is a flexible line with a certain length, which is a single-strand / multi-strand cable / cord, and can be a conventional medical tightening line or other medical-grade flexible lines. The tightening line 500 is made of biocompatible metal / polymer materials, 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.

[0098] See also Fig.12 The second embodiment of the present invention provides a single-window guided valve shrink ring system 10a. Different from the first embodiment, in the valve shrink ring system 10a, the track catheter 102 can be a bend-adjusting track catheter 102b that can adjust its shape in real time. The bend-adjusting track catheter 102b includes a bend-adjusting tube 103b and a second traction member 105. The bend-adjusting tube 103b includes a fourth tube body 130b near the proximal end and a fifth tube body 140b near the distal end. The second traction member 105 moves along the axial direction of the bend-adjusting tube 103b to adjust the fifth tube body 140b to a shape that fits the target portion.

[0099] In a further embodiment, the bending adjustment tube 103b is a hollow multi-layer tube body, and the second traction member 105 also includes a second traction wire 133b, a second wire threading tube 132b and a second anchoring ring 131b. The second wire threading tube 132b is opened in the inner wall of the bending adjustment tube 103b, and the second traction wire 133b is passed through the second wire threading tube 132b; the second anchoring ring 131b is arranged at the distal end of the second wire threading tube 132b, and the second anchoring ring 131b is located in the fifth tube body 140b; the distal end of the second traction wire 133b is connected to the second anchoring ring 131b, which can pull the second traction wire 133b, thereby driving the fifth tube body 140b to bend to a shape that fits the targeting portion, thereby realizing the bending adjustment function.

[0100] In a further embodiment, the bending track catheter 102b also includes a second bend adjuster 110b arranged at the proximal end of the bending adjustment tube 103b, and the proximal end of the second traction wire 133b is connected to the second bend adjuster 110b. By pulling the second bend adjuster 110b, the second traction wire 133b is pulled, thereby driving the fifth tube body 140b to bend.

[0101] In a further embodiment, the bending track catheter 102b also includes a third handle 120b, which is arranged between the second bend adjuster 110b and the bending adjustment tube 103b, or the proximal ends of the second bend adjuster 110b and the bending adjustment tube 103b are accommodated in the third handle 120b, which is convenient for the operator to grasp and operate.

[0102] It is understandable that the bending adjustment tube 103b is made of a high molecular polymer material, such as a copolymer or a mixture of one or more of ABS, PE, PP, PEBAX, PC, PU, ​​Nylon, PVC, PTFE or PB.

[0103] See also Fig.13 The third embodiment of the present invention provides a single window guided valve shrink ring system 10b. Different from the first embodiment, in the valve shrink ring system 10b, the push rod 420b and the anchor 440b in the anchor device 400b are detachably connected. That is, the push rod 420b is directly connected to the anchor 440b without any other connection mechanism in between.

[0104] It is understandable that the manner in which the distal end of the push rod 420b is detachably connected to the anchor 440b includes one of a threaded connection, a snap connection, or a clamp connection. When the manner in which the distal end of the push rod 420b is detachably connected to the anchor 440b is a threaded connection, the tube body of the push rod 420b near the distal end is provided with threads, and the threads are matched with the anchor 440b. The farthest end of the push rod 420b is not threaded to prevent the threads from being locked with the anchor 440b, which makes it difficult to release it later.

[0105] See also Fig.14 The fourth embodiment of the present invention provides a single-window guided valve shrink ring system 10c. Different from the first embodiment, in the valve shrink ring system 10c, the anchoring device 400c also includes a fifth handle 460c and a release tube 450c. The fifth handle 460c is arranged at the proximal end of the release tube 450c, and the push rod 420c passes through the fifth handle 460c. The distal end of the push rod 420c and the connecting mechanism 430c are installed in the release tube 450c.

[0106] When the release controller 410c pulls the push rod 420c to move toward the proximal end, the connecting mechanism 430c cooperates with the release tube 450c to enable the connecting mechanism 430c to clamp the anchor 440c; when the release controller 410c pulls the push rod 420c to move toward the distal end, the connecting mechanism 430c cooperates with the release tube 450c to enable the connecting mechanism 430c to release the anchor 440c.

[0107] In a further embodiment, the connection mechanism 430c includes multiple groups of connection rods 432 and multiple pins 431, the multiple groups of connection rods 432 are movably connected through the multiple pins 431, the group of connection rods 432 at the closest end of the multiple groups of connection rods 432 is connected to the push rod 420c through the pin 431, and the end of the group of connection rods 432 at the farthest end of the multiple groups of connection rods 432 is provided with a clamping part 434c, and the clamping part 434c is used to clamp and release the anchor 440c. The connection rods 432 and the pins 431 can be made of metal materials or high-density polymer materials, such as stainless steel, POM, etc.

[0108] When the release controller 410c pulls the push rod 420c to move toward the proximal end, the connecting mechanism 430c cooperates with the release tube 450c to make the clamping part 434c clamp the anchor 440c. When the release controller 410c pulls the push rod 420c to move toward the distal end, the connecting mechanism 430c cooperates with the release tube 450c to make the clamping part 434c release the anchor 440c.

[0109] Specifically, Fig.14 As shown, the push rod 420c is movably connected to the first group of connecting rods 432c through the first pin 431c, and the first group of connecting rods 432c is movably connected to the second group of connecting rods 433c through two second pins 436c, respectively, and the second group of connecting rods 433c is connected to the distal end of the release tube 450c through the third pin 435c, and the third pin 435c is rigidly connected to the release tube 450c. The distal end of the second group of connecting rods 433c 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 passes through the inner cavity of the fifth handle 460c and the release tube 450c in sequence. When 420c is tightened by the release controller 410c, due to the action of the first pin 431c, the first group of connecting rods 432c are stretched and moved 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 are connected to the release tube 450c through the third pin 435c, the second group of connecting rods 433c will not move proximally, thereby causing the proximal end connected to the second pin 436c to move closer to the midline, thereby driving the second group of connecting rods 433c to rotate through the third pin 435c, so that the distal end of the second group of connecting rods 433c moves closer to the middle and clamps the connecting portion 441c of the anchor 440c. Conversely, when the push rod 420c is pushed toward the distal end, the function of releasing the connection with the anchor 440c can be realized, thereby realizing the operation of the entire assembly driving the anchor 440c to move and realizing long-distance detachment.

[0110] See also Fig.15The fifth embodiment of the present invention provides a single-window guided valve shrink ring system 10d. Different from the first embodiment, another anchoring member 440d is provided in the valve shrink ring system 10d. In the anchoring member 440d, the anchoring portion 442d includes two spiral structures 4421 and 4422. When the anchoring portion 442d is two spiral structures 4421 and 4422, the sizes of the two spiral structures are the same or the size difference is less than the first preset range. Preferably, the angle between the starting points of the two groups 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 in the human tissue, it can achieve a greater anchoring force, be more firm, and prevent falling off.

[0111] See also Fig.16 The sixth embodiment of the present invention provides a single-window guided valve shrink ring system 10e. Different from the first embodiment, another anchor 440e is provided in the valve shrink ring system 10e. When the anchor part 442e includes two spiral structures 4423 and 4424, the size difference between the two spiral structures 4423 and 4424 is greater than the second preset range. In other words, it is composed of two sets of inner and outer spiral structures 4423 and 4424 of different sizes. This structure, in addition to increasing the anchoring force, also makes the entire anchor 440e more flexible, lighter, and less damaging to the patient.

[0112] See also Figures 17 to 19 The seventh embodiment of the present invention provides a single-window guided valve shrink ring system 10f. Different from the first embodiment, another anchoring member 440f is provided in the valve shrink ring system 10f, and the anchoring portion 442f in the anchoring member 440f is connected to the pushing rod 420f through the connecting portion 441f.

[0113] The anchoring portion 442f includes a connecting ring 4425 near the proximal end, an anchoring needle 4426 near the distal end, and a binding portion 4427 sleeved outside the connecting ring 4425 and the anchoring needle 4426; the anchoring needle 4426 has an expanded shape in a natural state (see Fig.19 ) and the contracted shape constrained by the conveying device 300 (see Fig.18). The length range of the anchoring portion 442f is 4mm-16mm, the diameter range is 0.2mm-5mm, and the penetration depth range is 2-10mm. The anchoring portion 442f is made of a material with a shape memory function, and is compressed in the delivery device 300 when in a contracted shape. When released from the delivery device 300, its tip can penetrate deep into the targeted tissue, and after being fixed inside the tissue, it can fully recover to its expanded shape in a natural state. In this embodiment, the anchoring needle 4426 includes two back-to-back branches 4426a and 4426b, and the proximal portions of the branches 4426a and 4426b are respectively formed by staggering and extending the distal ends of the connecting ring 4425, and the distal portions of the branches 4426a and 4426b extend in the opposite direction, that is, the branches 4426a and 4426b respectively have two symmetrically arranged openings pointing to the proximal hook-shaped structures. The binding portion 4427 is sleeved at the distal intersection of the connecting ring 4425, thereby limiting the relative position between the two branches of the anchoring portion and preventing the two hook structures from completely popping open due to their own elasticity in a natural state.

[0114] like Fig.17 and Fig.18 As shown, when in use, the push rod 420f is pulled proximally until the entire anchor 440f is accommodated in the distal end of the inner cavity of the delivery device 300. At this time, the two branches 4426a and 4426b of the anchor needle 4426 are constrained to be parallel to the axial direction of the push rod 420f. When reaching the predetermined position, the push rod 420f is pushed distally until the anchor needle 4426 extends out of the delivery tube 330, and the anchor needle 4426 restores the hook structure in the natural state, as shown in FIG. Fig.19 As shown, the entire anchor needle 4426 is in a double hook shape, which is the state of the anchor 440f after implantation. This anchor 440f with an extended shape and a contracted shape, when in the contracted shape, expands to an extended shape as the tip penetrates the target tissue to a predetermined depth. Since the extended shape has a cross-section that is significantly larger than the contracted shape, and the anchor 440f is rigid, this ensures that the anchor 440f stably maintains the extended shape without any degeneration, thereby firmly fixing the anchor 440f inside the tissue, thereby avoiding the problem that the flexible anchor in the prior art cannot stably maintain the extended shape and is deformed and easily pulled off.

[0115] It is understood that the tightening line 500 passes through the connecting ring 4425 to tighten the plurality of anchors 440f. It is also understood that in this embodiment, the anchor 440f is detachably connected to the push rod 420f through the connecting portion 441f, specifically, the anchor 440f is detachably connected to the connecting portion 441f. After the anchor 442f in the anchor 440f is implanted in the targeting portion, the release controller controls the connecting portion 441f to release the anchor 442f, leaving only the anchor 442f on the targeting portion.

[0116] The seventh embodiment is taken as an example to illustrate the method of using the single-window guided valve shrink ring system 10f provided by the present invention in the surgical process of treating mitral regurgitation.

[0117] There are many routes for surgical operation, such as: ① through the apex; ② through the femoral artery - abdominal artery - thoracic artery - aortic arch - left ventricle; ③ through the femoral artery - abdominal artery - vena cava - right atrium - left atrium - right ventricle. The following are detailed descriptions:

[0118] The first surgical approach is transapical and involves the following steps:

[0119] Step 1: surgical operation, making an incision at the apex of the heart, inserting the guiding sheath 101 of the guiding device 100 through the apex of the heart to the bottom of the valve leaflet PML and adjusting the position;

[0120] Step 2: Adjust the distal end of the guiding sheath 101 so that the first bending section 132 faces the myocardial wall LVPW;

[0121] Step 3: insert the orbital catheter (shaped orbital catheter or adjustable orbital catheter) through the inner cavity of the sheath tube 130. The shaped orbital catheter will automatically and gradually fit under the valve annulus during the process of extending from the distal end of the guide sheath tube 101. The adjustable orbital catheter is first pushed out from the distal end of the guide sheath tube 101, and then the degree of curvature of the adjustable orbital catheter is adjusted to fit under the valve annulus.

[0122] Step 4: If Fig. 20 As shown, the guide wire 600 is inserted through the inner cavity of the track catheter, and then the track catheter is withdrawn, at this time, a track from the outside of the body to the inside of the body is established; then the catheter positioning device 200 is inserted along the guide wire 600 until the catheter positioning device 200 successfully reaches the predetermined position, fits with the myocardial wall, and is close to the bottom of the valve ring MVA, while ensuring that the window 212 faces the side of the myocardial wall LVPW, which is conducive to providing positioning for the subsequent implantation of the anchoring part 442f;

[0123] Step 5: If Fig.21 As shown, the delivery device 300 and the anchoring device 400 assembled therewith are delivered, and after the anchoring member 440f is transmitted from the window 212, the anchoring needle of the anchoring portion 442f pierces the myocardial wall, and the anchoring member 440f recovers the expanded state due to its own elasticity. When the anchoring member 440f cannot continue to deform due to the action of the ventricular wall tissue, it means that the anchoring is completed, and the connection between the tightening line 500 and the restraining ring 4427 is locked;

[0124] Step 6: At this time, withdraw the delivery device 300 and the anchor device 400 without the anchor 440f, pass the tightening line 500 through the second anchor 440f, and then connect the second anchor 440f to the distal end of the anchor device 400, and install it into the delivery device 300, unscrew the limiter 239 from the limit groove 261, and move it backward to the next limit groove 261, and fix it after screwing it in, and then rotate the adjustment knob 241 until the rotation encounters greater resistance. At this time, the position of the second anchor 440f to be implanted has been found, and the second anchor 440f can be implanted according to the fifth step, and then the subsequent anchors 440f are implanted in sequence.

[0125] Step 7: Fig. 22 As shown, after all anchoring members 440f are implanted, the catheter positioning device 200, the delivery device 300 and the anchoring device 400 are withdrawn, and only a plurality of anchoring members 440f and a tightening wire 500 connecting the plurality of anchoring members 440f in series are left in the left ventricle. Fig.23 As shown, the tightening wire 500 is tightened to reduce the volume of the entire left ventricle and simultaneously achieve the purpose of reducing the valve ring. Afterwards, the tightening wire 500 can be knotted and cut to complete the operation.

[0126] See also Fig.24 In a further embodiment, a pre-shaped catheter positioning device 200a is provided, and the positioning tube of the catheter positioning device 200a is heat-formed or otherwise formed, and a curved section 201a is provided at its distal end, so that after reaching the valve annulus, the distal end of the positioning tube can be close to the bottom of the valve annulus MVA and fit the myocardial wall. By using this pre-shaped catheter positioning device 200a, a track can be directly established during the transapical operation without the need to use the track catheter 102 and the guide wire 600 to assist in establishing the track.

[0127] The second surgical route is the transaortic route. The difference from the transapical route is that all instruments in the operation are inserted through the femoral artery-abdominal artery-thoracic artery-aortic arch-left ventricle route.

[0128] See also Fig.25 In this surgical procedure, a pre-shaped catheter positioning device 200b is provided. The positioning tube of the catheter positioning device 200a is heat-set or otherwise set so that its distal end has two curved sections 201b and 202b. After the positioning tube is delivered into the left ventricle, the distal end of the positioning tube can be well fitted with the myocardial wall. Fig.26 As shown, the catheter positioning device 200b can directly establish a track from outside the body to the target part without using the track catheter 102 and the guide wire 600 to assist in establishing the track.

[0129] The third surgical route is the transseptal route, which is different from the transapical route in that all instruments in the operation are through the femoral artery-abdominal artery-vena cava-right atrium-left atrium-left ventricle route, and when going from the right atrium to the left atrium, the atrial septal puncture device is required to puncture the foramen ovale, and when going from the left atrium to the left ventricle, the mitral valve orifice is passed. The rest of the operations are the same as the transapical route.

[0130] See also Fig. 27 In this surgical procedure, a pre-shaped catheter positioning device 200c is provided. The positioning tube of the catheter positioning device 200c is heat-formed or otherwise formed so that its distal end has three curved sections 201c, 202c and 203c. After the positioning tube is delivered into the left ventricle, the distal end of the positioning tube can be well fitted with the myocardial wall and close to the lower part of the valve ring. Fig.28 As shown, the catheter positioning device 200c can directly establish a track from outside the body to the target part without using the track catheter 102 and the guide wire 600 to assist in establishing the track.

[0131] The second and third pathways use a purely interventional approach, which causes less surgical damage to patients, leads to faster patient recovery, lower risk of complications, and higher acceptance.

[0132] It can be understood that the single-window guided valve ring shrinkage system 10 provided by the present invention can also position the catheter positioning device 200 directly on the valve ring of the mitral valve, and then implant multiple anchors 440f in different positions of the valve ring in turn, and then tighten and fix the multiple anchors 440f through the tightening line 500, so as to achieve the purpose of shrinking the valve ring, and because the implantation depth of the anchor 440f is limited by the connecting part 441f, it can be avoided that the anchor 440f is implanted too deeply and damages the valve leaflet.

[0133] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A single-window guided valve ring system, characterized in that: The single-window guided valve shrink ring system comprises a catheter positioning device, a delivery device, an anchoring device and a tightening wire, wherein the anchoring device comprises a plurality of anchoring members; The catheter positioning device comprises a positioning tube, the positioning tube is positioned on the targeting portion, a window communicating with the inner cavity of the positioning tube is provided on the side wall at the distal end of the positioning tube, and the positioning tube moves so that the window faces different positions of the targeting portion; The delivery device delivers the plurality of anchors along the positioning tube through the window to different positions of the targeting portion; The anchoring device sequentially fixes the anchoring member passing through the window at different positions of the targeting portion; The tightening line is used to connect and tighten the plurality of anchors fixed at different positions of the targeting portion in series, so as to shrink the targeting portion; The catheter positioning device also includes a positioning handle disposed at the proximal end of the positioning tube, the positioning handle including a regulating mechanism, a handle housing and a sheath tube connector; the regulating mechanism cooperates with the handle housing to control the positioning tube to advance or retreat axially, and the sheath tube connector is in communication with the positioning tube; The regulating mechanism includes a limiter and a clamping member; the clamping member is arranged on the sheath tube connector, and the limiter is used to abut against the clamping member to control the moving distance of the sheath tube connector; The handle shell is axially provided with a guide groove and a plurality of limit grooves connected with the guide groove. The limiter is arranged in the limit groove and can move axially along the guide groove. When the limiter is inserted into the limit groove, the position between the limiter and the handle shell is relatively fixed. The distance that the limiter moves between the limit grooves is the implantation spacing between the two anchors.

2. The single-window guided valve shrink ring system according to claim 1, characterized in that: The positioning tube at least comprises an axially penetrating guidewire cavity and a delivery cavity arranged parallel to the guidewire cavity; the window is communicated with the distal end of the delivery cavity.

3. The single-window guided valve shrink ring system according to claim 2, characterized in that: The catheter positioning device also includes a steering head, which is arranged at the distal end of the positioning tube and is made of a flexible material. The guidewire cavity is connected to the inner cavity of the steering head, and the distal end of the steering head is provided with an inclined surface facing the targeting portion.

4. The single-window guided valve shrink ring system according to claim 1, characterized in that: An axially penetrating through hole is provided inside the sheath tube connector to allow the conveying device to pass through.

5. The single-window guided valve shrink ring system according to claim 4, characterized in that: The regulating mechanism includes an adjusting knob and an adjusting screw; The adjusting screw is movably sleeved on the distal end of the sheath tube connector; The adjusting knob is movably connected to the handle housing so as to be relatively rotatable, and the adjusting knob is threadedly connected to the outside of the adjusting screw and radially passes through the outer surface of the handle housing; By rotating the adjusting knob, the adjusting knob is moved forward or backward axially on the adjusting screw, thereby causing relative movement between the handle housing and the adjusting screw, thereby driving the positioning tube connected to the sheath connector to move forward or backward axially, so that the window faces different positions of the targeting portion.

6. The single-window guided valve shrink ring system according to claim 5, characterized in that: The limiter passes through the outside of the handle shell and extends radially along the positioning handle.

7. The single-window guided valve shrink ring system according to claim 6, characterized in that: The positioning handle also includes a support rod, which is arranged around the sheath tube connector and passes through a locking piece on the sheath tube connector. The distal end of the support rod is connected to the distal end of the handle housing.

8. The single-window guided valve shrink ring system according to claim 5, characterized in that: The handle housing comprises an adjusting handle at a proximal end, a protective cover at a distal end, and a front shell and a rear shell arranged therebetween; wherein the proximal end of the adjusting knob is connected to the rear shell, and the distal end of the adjusting knob is connected to the front shell.

9. The single-window guided valve shrink ring system according to any one of claims 1 to 8, characterized in that: The valve contraction ring system also includes a guide device, which is used to establish a track from outside the body to the targeting portion; the catheter positioning device reaches and is positioned at the targeting portion through the inner cavity of the guide device, so that the window faces the targeting portion.

10. The single-window guided valve shrink ring system according to claim 9, characterized in that: The guiding device includes a guiding sheath and a track catheter inserted in the guiding sheath, wherein the track catheter extends from the distal end of the guiding sheath and fits on the target portion, thereby establishing a track from the outside of the body to the target portion; The inner cavity of the track catheter is used to accommodate and pass the catheter positioning device.

11. The single-window guided valve shrink ring system according to claim 10, characterized in that: The guide sheath includes a sheath with a certain axial length and a first traction member, the sheath includes a first supporting section near the proximal end and a first bending adjustment section near the distal end, the distal end of the first traction member is connected to the first bending adjustment section, and the first traction member moves along the axial direction of the sheath to adjust the first bending adjustment section to a shape that fits the targeting portion.

12. The single-window guided valve shrink ring system according to claim 11, characterized in that: The sheath is a hollow multi-layer tube, the first traction member comprises a first traction wire, a first wire threading tube and a first anchoring ring, the first wire threading tube is axially opened in the inner wall of the sheath, the first traction wire is inserted in the first wire threading tube, the first anchoring ring is arranged at the distal end of the first wire threading tube, and the first anchoring ring is located in the first bending adjustment section; The distal end of the first traction wire is connected to the first anchoring ring, and the first traction wire is pulled to drive the first bending section to bend to a shape that fits the targeting portion.

13. The single window guided valve shrink ring system according to claim 12, characterized in that: The guide sheath also includes a first bend adjuster arranged at the proximal end of the sheath, and the proximal end of the first traction wire is connected to the first bend adjuster. By pulling the first bend adjuster, the first traction wire is pulled, thereby driving the first bending section to bend.

14. The single-window guided valve shrink ring system according to claim 11, characterized in that: The track catheter is a shaping track catheter, and the shaping track catheter comprises a second handle and a shaping tube body that are rigidly connected, and the second handle is arranged at the proximal end of the shaping tube body; The shaping tube body includes a first tube body, a second tube body and a third tube body which are sequentially connected from the proximal end to the distal end. The angle between the extension direction of the third tube body and the extension direction of the first tube body is in the range of 0-180 degrees, and the third tube body and the first tube body are smoothly transitioned through the second tube body.

15. The single window guided valve shrink ring system according to claim 11, characterized in that: The track catheter is a bend-adjustable track catheter, which includes a bend-adjustable tube and a second traction member. The bend-adjustable tube includes a fourth tube body near the proximal end and a fifth tube body near the distal end. The second traction member moves axially along the bend-adjustable tube to adjust the fifth tube body to a shape that fits the targeting portion.

16. The single-window guided valve shrink ring system according to claim 15, characterized in that: The bending adjustment tube is a hollow multi-layer tube body, the second traction member includes a second traction wire, a second wire threading tube and a second anchoring ring, the second wire threading tube is axially opened in the inner wall of the bending adjustment tube, the second traction wire is inserted in the second wire threading tube, the second anchoring ring is arranged at the distal end of the second wire threading tube, and the second anchoring ring is located in the fifth tube body; The distal end of the second traction wire is connected to the second anchoring ring, and the second traction wire is pulled to drive the fifth tube to bend to a shape that fits the targeting portion.

17. The single-window guided valve shrink ring system according to claim 16, characterized in that: The bending track catheter also includes a second bend adjuster arranged at the proximal end of the bending tube, and the proximal end of the second traction wire is connected to the second bend adjuster. By pulling the second bend adjuster, the second traction wire is pulled, thereby driving the fifth tube body to bend.

18. The single-window guided valve shrink ring system according to any one of claims 1 to 8, characterized in that: The delivery device includes a delivery tube and a third traction member, the delivery tube includes a second support section near the proximal end and a second bending adjustment section near the distal end, the third traction member moves axially along the delivery tube to adjust the second bending adjustment section to a shape that matches the catheter positioning device, so that the distal end of the delivery tube reaches the window.

19. The single window guided valve shrink ring system according to claim 18, characterized in that: The delivery tube is a hollow multi-layer tube body, and the third traction member includes a third traction wire, a third wire threading tube and a third anchoring ring. The third wire threading tube is axially opened in the inner wall of the delivery tube, the third traction wire is inserted in the third wire threading tube, the third anchoring ring is arranged at the distal end of the third wire threading tube, and the third anchoring ring is located in the second bending adjustment section; The distal end of the third traction wire is connected to the third anchoring ring. By pulling the third traction wire, the second bending section is driven to bend to a shape that matches the catheter positioning device, so that the distal end of the delivery tube reaches the window.

20. The single window guided valve shrink ring system according to claim 19, characterized in that: The conveying device also includes a third bend adjuster arranged at the proximal end of the conveying tube. The proximal end of the third traction wire is connected to the third bend adjuster. By pulling the third bend adjuster, the third traction wire is pulled, thereby driving the second bending section to bend.

21. The single-window guided valve shrink ring system according to any one of claims 1 to 8, characterized in that: The anchoring device further comprises a release controller and a push rod arranged between the release controller and the anchoring member, the push rod and the anchoring member are detachably connected, and the release controller controls the anchoring member to be released at the targeting portion.

22. The single-window guided valve shrink ring system according to claim 21, characterized in that: The anchoring device also includes a connecting mechanism, the proximal end of the connecting mechanism is rigidly connected to the distal end of the pushing rod, and the pushing rod is detachably connected to the anchoring member through the distal end of the connecting mechanism; the release controller controls the connecting mechanism to open to release the anchoring member.

23. The single window guided valve shrink ring system according to claim 22, characterized in that: The detachable connection method includes a threaded connection, a snap connection or a clamp connection.

24. The valve shrink ring system according to claim 23, characterized in that: When threaded connection is adopted, the tube body of the connection mechanism close to the distal end is provided with threads, and the threads are matched with the anchoring member, and the distal end of the connection mechanism has no threads.

25. The single window guided valve shrink ring system according to claim 22, characterized in that: The anchoring device further comprises a fifth handle and a release tube, wherein the fifth handle is arranged at the proximal end of the release tube, the push rod passes through the fifth handle, and the distal end of the push rod and the connecting mechanism are installed in the release tube; When the release controller pulls the push rod to move toward the proximal end, the connecting mechanism cooperates with the release tube to enable the connecting mechanism to clamp the anchor; when the release controller pulls the push rod to move toward the distal end, the connecting mechanism cooperates with the release tube to enable the connecting mechanism to release the anchor.

26. The single window guided valve shrink ring system according to claim 25, characterized in that: The connecting mechanism includes multiple groups of connecting rods and multiple pins, the multiple groups of connecting rods are movably connected by multiple pins, the group of connecting rods at the closest end of the multiple groups of connecting rods is connected to the pushing rods by pins, and the end of the group of connecting rods at the farthest end of the multiple groups of connecting rods is provided with a clamping part, and the clamping part is used to clamp and release the anchor.

27. The single window guided valve shrink ring system according to claim 21, characterized in that: The anchoring member comprises a connecting portion and an anchoring portion, and the anchoring portion is detachably connected to the pushing rod through the connecting portion.

28. The single window guided valve shrink ring system according to claim 27, characterized in that: The connecting portion is provided with a wire connection hole, and the wire connection hole is used for the tightening wire to pass through.

29. The single window guided valve shrink ring system according to claim 27, characterized in that: The anchoring portion includes at least one helical structure.

30. The single window guided valve shrink ring system according to claim 29, characterized in that: The anchoring portion includes two spiral structures, and the sizes of the two spiral structures are the same or the size difference between them is less than a first preset range.

31. The single window guided valve shrink ring system according to claim 29, characterized in that: The anchoring portion includes two spiral structures, and a size difference between the two spiral structures is greater than a second preset range.

32. The single window guided valve shrink ring system according to claim 27, characterized in that: The anchoring part includes a connecting ring near the proximal end, an anchoring needle near the distal end, and a restraining part sleeved outside the connecting ring and the anchoring needle; the anchoring needle has an expanded shape in a natural state and a contracted shape constrained by a conveying device.

33. The single window guided valve shrink ring system according to claim 1, characterized in that: The target portion is the mitral valve annulus or the left ventricular myocardial wall below the mitral valve annulus.

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