WO2019105073A1 - 双侧人工腱索植入系统 - Google Patents

双侧人工腱索植入系统 Download PDF

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Publication number
WO2019105073A1
WO2019105073A1 PCT/CN2018/102166 CN2018102166W WO2019105073A1 WO 2019105073 A1 WO2019105073 A1 WO 2019105073A1 CN 2018102166 W CN2018102166 W CN 2018102166W WO 2019105073 A1 WO2019105073 A1 WO 2019105073A1
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WIPO (PCT)
Prior art keywords
clamping
artificial
chord
implantation system
distal
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PCT/CN2018/102166
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English (en)
French (fr)
Inventor
张庭超
张伟伟
潘湘斌
孟旭
Original Assignee
杭州德晋医疗科技有限公司
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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 WO2019105073A1 publication Critical patent/WO2019105073A1/zh

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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 belongs to the technical field of medical instruments, and relates to a device for repairing heart valve defects, in particular to a bilateral artificial chordae implantation system.
  • the mitral valve is a one-way "valve" between the left atrium (abbreviation: LA) and the left ventricle (abbreviation: LV), which ensures blood flow from the left atrium to the left ventricle.
  • LA left atrium
  • LV left ventricle
  • a normal healthy mitral valve has multiple chordae.
  • the leaflets of the mitral valve are divided into the anterior and posterior lobe.
  • the two When the left ventricle is in the diastolic state, the two are in an open state, and the blood flows from the left atrium to the left ventricle; when the left ventricle is in the contracted state, the tendon is stretched to ensure The leaflets are not rushed to the atrial side by the blood flow, and the anterior and posterior leaves are well closed, thereby ensuring blood flow from the left ventricle through the aortic valve (abbreviation: AV) to the aorta.
  • AV aortic valve
  • mitral valve repair refers to suturing the prolapsed mitral valve leaflets with the corresponding anterior or posterior lobes to form a mitral valve with a "double-pored" structure.
  • chordae repair technique refers to the treatment of chordae lesions by surgical implantation of artificial chordae. It requires invasive thoracotomy and general anesthesia and moderate hypothermic cardiopulmonary bypass as auxiliary support. Such surgical procedures have the defects of complicated surgical procedure, high surgical cost, high degree of patient trauma, high risk of complications, long hospital stay, and painful recovery process.
  • the instrument for implanting the artificial chord in a minimally invasive manner comprises a handle assembly, a capture assembly and a needle assembly; after the leaflet is captured by the closable capture component, the needle blade is pierced by the needle, and then the hook is taken Artificial search.
  • This device can only be implanted with artificial chordae on one of the anterior or posterior lobes of the mitral valve for each operation, which is less efficient and takes longer.
  • the technical problem to be solved by the present invention is to provide a bilateral artificial chordae implantation system capable of simultaneously implanting artificial chordae in the anterior and posterior lobes of the mitral valve in view of the above-mentioned drawbacks in the prior art.
  • a double-sided artificial chordae implantation system includes a clamping device, a puncturing device and a pushing device.
  • the push device includes a pusher catheter.
  • the clamping device includes a clamping pusher and a distal collet and a proximal collet for mating the clamping leaflets.
  • the proximal collet is disposed at a distal end of the push catheter.
  • the distal collet is disposed at a distal end of the clamping pusher.
  • the clamp pusher is movably mounted at a substantially central axis of the pusher catheter.
  • the puncture device includes at least one pair of puncture push rods and a puncture needle respectively disposed at a distal end of the puncture push rod.
  • the piercing pusher is movably mounted in the pusher catheter and is symmetrically disposed about the pinch pusher.
  • the double-sided artificial chordae implantation system of the present invention has at least the following beneficial effects: the clamping push rod is disposed at a substantially central axis of the push catheter, and at least one pair of puncturing push rods are disposed in the push catheter and The clamping push rod is symmetrically arranged, so that the front and rear leaves of the mitral valve can be simultaneously clamped by the relative movement between the proximal collet and the distal collet, and at least one of the two sides of the gripping push rod
  • the puncture push rod drives the puncture needle to puncture the anterior and posterior lobe of the mitral valve respectively, thereby realizing bilateral artificial chordae implantation, which greatly shortens the operation time and improves the operation efficiency.
  • Figure 1 is a schematic view of a normal chordae in the heart
  • Figure 2 is a schematic view of the chordae rupture in the heart
  • FIG. 3 is a schematic structural view of a double-sided artificial chordae implantation system according to Embodiment 1 of the present invention.
  • FIG. 4 is a schematic structural view showing a clamping device of a double-sided artificial chordae implantation system according to a first embodiment of the present invention
  • FIG. 5 is a schematic structural view of a first embodiment of a manual chord of a bilateral artificial chordae implantation system according to Embodiment 1 of the present invention
  • FIG. 6 is a schematic structural view of a second embodiment of a manual chord of a bilateral artificial chordae implantation system according to Embodiment 1 of the present invention.
  • FIG. 7 is a schematic structural view of a third embodiment of a manual chord of a double-sided artificial chordae implantation system according to Embodiment 1 of the present invention.
  • FIG. 8 is a schematic structural view showing a connection between a fixing member and a puncture needle of a double-sided artificial chordae implantation system according to Embodiment 1 of the present invention
  • FIG. 9 is a schematic structural view of a clamping push rod and a distal collet of a clamping device of a double-sided artificial chordae implantation system according to Embodiment 1 of the present invention.
  • FIG. 10 is a schematic structural view of a first embodiment of a distal collet of a bilateral artificial chordae implantation system according to Embodiment 1 of the present invention.
  • Figure 11 is a cross-sectional view taken along line A-A of Figure 10;
  • Figure 12a is a schematic view showing a second embodiment of the distal collet of the bilateral artificial chordae implantation system according to the first embodiment of the present invention
  • Figure 12b is a cross-sectional view taken along line A-A of Figure 12a;
  • Figure 12c is a cross-sectional view taken along line B-B of Figure 12a;
  • Figure 13 is an exploded view of the bilateral artificial chordae implantation system of the second embodiment of the present invention.
  • Figure 14 is a radial cross-sectional view of the push catheter of the bilateral artificial chordae implantation system of the second embodiment of the present invention.
  • FIG. 15 is a schematic structural view of a proximal end surface of a distal collet of a double-sided artificial chordae implantation system according to a second embodiment of the present invention.
  • Figure 16 is a cross-sectional view taken along line A-A of Figure 15;
  • Figure 17 is a cross-sectional view taken along line B-B of Figure 15;
  • Figure 18 is an exploded view of the bilateral artificial chordae implantation system of the third embodiment of the present invention.
  • FIG. 19 is an axial cross-sectional view of a push catheter of a bilateral artificial chordae implantation system according to a third embodiment of the present invention.
  • FIG. 20 and FIG. 21 are schematic diagrams showing the clamping aid of the double-sided artificial chordae implantation system according to the third embodiment of the present invention.
  • FIG. 22 is a schematic structural view of a first embodiment of a clamping assist device for a double-sided artificial chordae implantation system according to a third embodiment of the present invention.
  • FIG. 23 is a schematic structural view of a second embodiment of a clamping assist device of a double-sided artificial chordae implantation system according to a third embodiment of the present invention.
  • FIG. 24 is a schematic structural view of a third embodiment of a clamping assist device for a double-sided artificial chordae implantation system according to a third embodiment of the present invention.
  • FIG. 25 is a schematic structural view of a fourth embodiment of a clamping assist device for a double-sided artificial chordae implantation system according to a third embodiment of the present invention.
  • 26 to 32 are schematic views showing the process of implanting a artificial chord with a bilateral artificial chordae implantation system according to a third embodiment of the present invention.
  • the orientation near the operator is defined as the proximal end, and the orientation away from the operator is defined as the distal end.
  • the bilateral artificial chordae implantation system of the present invention is used to implant the artificial chordae 100 into the patient's heart, replacing the anterior and posterior mitral mitral valves. Lesion of the lesion.
  • the bilateral artificial chordae implantation system includes a clamping device 300, a puncturing device 400, and a pushing device 200.
  • the push device 200 includes a push conduit 210.
  • the pusher catheter 210 is provided with a plurality of through lumens in the axial direction.
  • the clamping device 300 includes a clamping pusher 330 and a distal collet 310 and a proximal collet 320 for matingly gripping the leaflets.
  • the proximal collet 320 is disposed at a distal end of the push catheter 210, and the distal collet 310 is disposed at a distal end of the clamp pusher 330.
  • the clamping pusher 330 is movably worn at a substantially central axis of the pusher catheter 210.
  • the lancing device 400 includes at least one pair of puncture push rods 420 and a puncture needle head 410 respectively disposed at the distal end of the puncture push rod 420.
  • the piercing push rod 420 is movably worn in the pusher catheter 210 and is symmetrically disposed about the pinch pusher 330.
  • the clamping device 300 of the bilateral artificial chordae implantation system of the present invention can simultaneously clamp the anterior and posterior lobes of the mitral valve, and then at least one pair of puncturing pushers on either side of the clamping pusher 330.
  • the 420 pushes the puncture needle 410 to puncture the anterior and posterior lobes of the mitral valve, respectively, thereby achieving bilateral artificial chordae implantation.
  • the double artificial chordae implantation system of the first embodiment includes a pair of artificial chords 100.
  • Each artificial chord 100 includes a length of chord body 110 that is flexible.
  • the chord body 110 is used to implant into the heart, replacing the lesion chordae within the heart.
  • the chord body 110 has opposing first and second ends.
  • a fixing member 120 is coupled to the first end and/or the second end. The fixing member 120 is used for non-detachable connection or detachable connection with the lancing device 400.
  • the chord body 110 can be secured between the leaflets and the ventricular wall (or the mastoid muscles, etc.) to replace the diseased chordae, maintaining tension between the leaflets and the ventricular wall.
  • the flexibility of the chord body 110 means that it can be arbitrarily bent without stretching in the axial direction, and generally the chord body 110 is in the form of a flexible wire.
  • the material of the chord body 110 may be a polymer material compatible with the human body or a relatively soft metal material. It is preferably a polymer material such as PTFE.
  • the first end and the second end of the chord body 110 have no difference in direction, importance, and the like.
  • the fixing member 120 may be provided only at one end of the chord body 110, or may be disposed at both ends of the chord body 110 as shown in FIG.
  • the fixing member 120 is disposed only at the first end of the chord body 110.
  • the cable body 110 and the fixing member 120 may be fixedly connected by knotting, winding, welding, bonding or snapping.
  • the first end of the chord body 110 can be knotted out of the fixture 120 to form a larger diameter coil; or the end can be welded to a larger diameter ball; or a positioning rod can be placed at the end. .
  • the positioning rods are different from the axial direction of the chord body 110 and the fixing member 120.
  • the positioning rod After the first end of the positioning rod and the chord body 110 is passed through the fixing member 120, the positioning rod returns to the natural state, and the card is locked on the back surface of the fixing member 120, thereby fixing the first end of the chord body 110 to the fixed position.
  • the second end of the chord body 110 since the second end of the chord body 110 is not provided with the fixing member 120, the second end of the chord body 110 should be knotted, wound, or provided with a spherical end, a disc-shaped end, etc., so that the second The cross-sectional dimension of the end is greater than the cross-sectional dimension of the chord body 110 to secure the second end of the chord body 110 to the upper surface of the leaflet.
  • the fixing member 120 is configured to form a detachable fixed connection or a non-detachable fixed connection with the puncture needle 410 of the lancing device 400, and the shape is matched with different connection manners.
  • the outer portion of the fixing member 120 is generally cylindrical, and the cross-sectional shape may be various shapes such as a circle, an ellipse, a polygon, or the like, preferably a circular shape or an elliptical shape.
  • a screw connection for example, a screw connection, a bonding, a rough surface friction connection, an interference fit or a snap connection.
  • a snap-fit connection is adopted.
  • a receiving cavity 121 is disposed in the axial direction of the fixing member 1200 .
  • the inner wall of the receiving cavity 121 is provided with three grooves or holes 125 in the radial direction.
  • the puncture needle 410 is correspondingly provided with a convex edge 411 or a protrusion to be engaged with the groove or the hole 125.
  • the three recesses or holes 125 ensure the stability of the connection between the fixing member 120 and the puncture needle 410, reduce the amplitude of the shaking of the puncture needle 410 after the connection, and do not additionally increase the diameter of the puncture needle 410, resulting in an increase in the diameter of the puncture point. .
  • the contact is increased to reduce the risk of the artificial chord 100 tearing the leaflets.
  • the chord body 110 is sleeved.
  • the slip preventing member 130 is slidable in the axial direction of the chord body 110. Since the anti-slip member 130 is previously disposed on the chord body 110, after the puncture needle 410 is punctured and fixedly coupled with the chord body 110, the anti-slip member 130 can be driven to the puncture point and fixed together with the chord body 110. On the leaf.
  • the specific arrangement of the anti-slip member 130 on the artificial chord 100 is that the anti-slip member 130 is provided with a through hole 131 through which the chord body 110 passes.
  • the number of the through holes 131 is related to the manner in which the slip preventing member 130 is fixed.
  • One way is to provide a through hole 131 through the anti-slip member 130, through which the chord body 110 passes (as shown in FIG. 5).
  • Another way is to provide at least two through holes 131 on the anti-slip member 130.
  • the first end and the second end of one of the chord bodies 110 respectively pass through different through holes 131 (as shown in FIG. 6).
  • the cross-sectional dimension of the through hole 131 is smaller than the sectional size of the fixing member 120.
  • the second end should be knotted or provided with a spherical end, a disc-shaped end, etc.
  • the cross-sectional dimension of the two ends is larger than the cross-sectional dimension of the through hole 131 on the anti-skid member 130 (as shown in FIG. 5).
  • the anti-slip member 130 In order to disperse the force of the chordae body 110 against the leaflets as far as possible to the contact surface between the anti-slip member 130 and the leaflets, the anti-slip member 130 needs to be attached to the leaflets as much as possible, so that the anti-slip member 130 is provided to fit the leaflets. Fit surface 132.
  • the specific structure of the anti-slip member 130 is not limited, and may have various structures such as a sheet shape having a certain area, a disk shape or a spherical shape, or even an irregular shape, and preferably a sheet shape.
  • the anti-slip member 130 may be a non-porous structure, or may be a mesh structure, a bar-like structure, or the like.
  • the anti-slip member 130 should be made of a biocompatible material, and may be made of an elastic material or a non-elastic material. Specifically, the anti-slip member 130 is selected from at least one of an elastic spacer, a heart patch, a felt sheet, a mesh structure, a disc-like structure, or a double disc-like structure.
  • the structure of the anti-slip member 130 having a disc-like structure or a double disc-like structure is similar to the occluder in the prior art, and will not be described herein.
  • the anti-slip member 130 having a disc-like structure or a double disc-like structure should be made of a shape memory material.
  • the sling body 110 may not be provided with the anti-slip member 130. As long as the fixing member 120 and the puncturing needle 410 form a fixed connection, the chord body 110 may be fixed to the leaflet and the ventricular wall or the mastoid. Replace the lesion with the chordae between the muscles.
  • the pusher catheter 210 of the push device 200 is a tubular body or rod having a certain axial length, preferably circular in cross section, and having a circular diameter ranging from 10 mm to 12 mm.
  • the push duct 210 is provided with a plurality of mutually separated inner cavities passing through both ends of the push duct 210 in the axial direction.
  • the pusher catheter 210 can be an integrally formed multi-lumen tube, or the outer tube and the inner tube set can be secured together to form a unitary push channel 210.
  • the pusher catheter 210 can be made of a biocompatible polymer material (for example, polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or Polyurethane PU), metal material (for example, stainless steel or nickel titanium alloy) or metal-polymer composite material.
  • a biocompatible polymer material for example, polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or Polyurethane PU
  • metal material for example, stainless steel or nickel titanium alloy
  • the proximal end of the push catheter 210 is provided with a first handle 201 for manipulating the push catheter 210 to push distally or to withdraw proximally.
  • the puncture device 400 is movably worn in the lumen of the push catheter 210.
  • the puncturing device 400 includes at least one pair of puncturing push rods 420 and a puncture needle head 410 respectively disposed at the distal end of the puncturing push rod 420.
  • Each of the piercing push rods 420 has a certain axial length, and the two piercing push rods 420 are symmetrically disposed with respect to the pinch push rods 330 (ie, the central axis of the push duct 210).
  • the puncture needle 410 can be coupled to the fixation member 120 of the artificial chord 100 after puncturing the leaflets to pull the chordae body 100 toward the proximal end.
  • the distal end of the puncture needle 410 is a tapered straight tip to facilitate puncture of the leaflets and reduce the diameter of the puncture point formed on the leaflets.
  • a needle having a hook-shaped head end is used to pass through the leaflet, and a suture as an artificial chordae is taken, and then the needle is pulled back to drive the artificial chord through the leaflet, and then the artificial chord is fixed on the ventricular wall.
  • the needle with the hook-shaped head end has a large puncture point formed on the leaflet, and the damage to the leaflet is large, which not only affects the recovery process of the patient, but also increases the risk of the leaflet being torn.
  • the tapered tip of the cone forms a small puncture point on the leaflets, which is beneficial to the patient's postoperative healing.
  • the double-sided artificial chordae implantation system of the present embodiment has a single puncture point formed on each leaflet having a diameter ranging from 0.3 mm to 1.5 mm. Further, by selecting the shape and diameter of the appropriate puncture needle 410, the puncture point The diameter can be controlled to be about 0.7 mm.
  • the distal end portion of the puncture needle 410 is provided with at least one convex tooth or at least one ring projection 411 for forming an interference fit or a snap connection with the fixing member 120. It can be understood that in other embodiments, the puncture needle 410 can also form a non-removable or detachable connection with the fixing member 120 of the artificial chord 100 by means of threading, bonding, frictional connection or the like.
  • a puncture push rod 420 is coupled to the proximal end of the puncture needle 410, and the puncture push rod 420 is movably worn in the inner cavity of the push catheter 210.
  • the proximal end of the puncture pusher 420 is passed through the proximal end of the pusher catheter 210 and is coupled to the third handle 401.
  • the axial movement of the third handle 401 can drive the puncturing push rod 420 to move along the axial direction of the push catheter 210, thereby driving the puncture needle 410 to puncture distally or retrace to the proximal end.
  • the puncture needle 410 can be driven by the third handle 401 to pierce the leaflet and connect with the fixing member 120 of the artificial chord 100, and the puncture needle 410 and the artificial sling 100 are fixed.
  • the pieces 120 are connected as a whole.
  • the prior art needle with a hook-shaped head end has a lower probability of picking up the artificial chordae, resulting in a lower surgical success rate and prolonging the operation time; and after the needle is hooked by the artificial chordae, only the needle and the artificial chord are only Through the weak frictional connection, during the process of withdrawing the needle, due to the blood flow of the patient or the movement of the operator, the artificial chord is easily detached from the needle, prolonging the operation time, and even causing the operation failure.
  • the puncture needle 410 of the present embodiment and the chord body 110 of the artificial chord 100 form a stable and reliable indirect connection through the fixing member 120, so that the artificial chord 100 is not easily detached from the puncture needle 410, and the operator can conveniently and quickly smash the sputum.
  • One or both ends of the cable 100 connected to the fixture 120 are pulled to a predetermined position of the ventricular wall or the mastoid muscle.
  • the clamping device 300 can simultaneously clamp the anterior and posterior lobes of the mitral valve.
  • the proximal end of the clamping pusher 330 of the clamping device 300 is threaded out of the proximal end of the push catheter 210 and a second handle 301 is provided. Thereby, the second handle 301 is pushed distally, and the clamping push rod 330 is moved to the distal end, so that the distal collet 310 is away from the proximal collet 320, forming the open state of the clamping device 300, at this time
  • a hollow cylindrical leaflet receiving space is formed between the end collet 310 and the proximal collet 320 to accommodate both the anterior and posterior mitral lobes.
  • the operator can adjust the distal end of the artificial chord implant system such that the anterior and posterior lobes of the mitral valve simultaneously enter the leaflet accommodation space between the distal collet 310 and the proximal collet 320, and then withdraw proximally
  • the second handle 301 drives the clamping pusher 330 to move proximally, so that the distal collet 310 approaches the proximal collet 320 to form a clamping state of the clamping device 300, as shown in FIG.
  • the anterior and posterior lobes of the mitral valve are both clamped and fixed by the gripping device 300.
  • the shape of the proximal collet 320 and the distal collet 310 conforms to the shape of the push catheter 210, and the distal collet 310 and the proximal collet 320 should form a smooth overall after closure to facilitate pushing and reducing the patient Damage to the wound.
  • the foregoing state of pushing the second handle 301 distally such that the distal collet 310 is away from the proximal collet 320 can also be achieved by withdrawing the first handle 201 and the push catheter 210 toward the proximal end;
  • the proximal withdrawal of the second handle 301 to bring the distal collet 310 closer to the proximal collet 320 can also be achieved by pushing the first handle 201 and the push catheter 210 distally.
  • the gripping surface of the proximal collet 320 ie, the distal end face of the proximal collet 320
  • the gripping surface of the distal collet 310 ie, the proximal end of the distal collet 310
  • the end faces should conform to each other and have a large leaflet contact area, respectively.
  • the proximal end surface of the distal collet 310 serves as a gripping surface in contact with the leaflets, preferably as a conical surface projecting proximally from the distal end; and the distal end surface of the proximal collet 320 is in contact with the leaflets
  • the gripping surface is preferably provided as a conical surface recessed from the distal end to the proximal end and shaped to cooperate with the conical surface of the proximal end surface of the distal collet 310.
  • the gripping faces of the distal collet 310 and/or the proximal collet 320 are provided with gripping reinforcements for enhancing the gripping force.
  • the clamping reinforcement is preferably at least one of a projection, a rib, a groove or a recess, and the shape of the clamping reinforcement provided on the proximal end surface of the distal collet 310 (ie, the clamping surface) should be
  • the shape of the gripping reinforcement provided at the distal end face (i.e., the gripping surface) of the proximal collet 320 is mated such that there is no gap between the closed distal collet 310 and the proximal collet 320.
  • the clamping faces of the distal collet 310 and the clamping faces of the proximal collet 320 are respectively provided with a plurality of parallel ribs as clamping reinforcements, when the distal collet 310 and the proximal collet After 320 is closed, there is no gap between the two.
  • the clamping pusher 330 is a tubular body or a hollow rod-shaped body having a certain axial length, and the cross section is preferably elliptical or circular, and the clamping pusher 330 is provided with an artificial jaw in the axial direction. Cable channel 331.
  • the distal collet 310 is provided with two artificial sling receiving cavities 315 and 315a respectively communicating with the artificial chord passage 331, and the artificial chord receiving cavities 315 and 315a are both penetrated to the far end.
  • the proximal end face of the end collet 310, and the artificial chord receiving cavities 315 and 315a are symmetrically disposed with respect to the gripping pusher 330 (i.e., the central axis of the pusher catheter 210). That is, the distal end of the artificial chord passage 331 is branched into a Y shape, and the two branches of the Y-shaped bifurcation serve as artificial chord receiving chambers 315 and 315a, respectively.
  • the sling body 110 of one manual chord 100 is received in the artificial chord passage 331 and the artificial chord receiving cavity 315, and the chord body 110 of the other artificial chord 100 is received in the artificial chord passage 331 and the artificial chord The receiving cavity 315a.
  • the proximal end surface of the distal collet 310 is provided with two fixing cavities 313 and 313a for accommodating the fixing members 120 of the two artificial chords 100, respectively, and the fixing cavities 313 and 313a are related to the clamping push rod 330 (ie, The central axis of the pusher catheter 210 is symmetrically disposed.
  • the fixed cavity 313 is in axial communication with the artificial cable receiving cavity 315; the fixed cavity 313a is in axial communication with the artificial cable receiving cavity 315a.
  • the positions of the two fixed cavities 313 and 313a correspond to the positions of the two puncture needles 420, respectively.
  • the two fixing members 120 of the two artificial chords 100 are respectively received in the distal collet 310, and the proximal ends of each of the fixing members 120 correspond to one puncture needle 410, respectively.
  • the proximal end face of the distal collet 310 is elliptical, and both of the fixed lumens 313 and 313' are located on the major axis of the ellipse to accommodate the shape of the two leaflets of the mitral valve when closed.
  • the fixed cavities 313 and 313a may also be located at other positions of the ellipse as long as the two fixed cavities 313 and 313a are symmetrically disposed, as shown in FIGS. 12a to 12c.
  • the prior art exposes the artificial chordae to the outside of the artificial chordae implantation system, so that the external surface of the artificial chordae implantation system is not smooth, causing frictional damage to the tissue when the device enters the human body, and at the same time, blood leakage occurs, thereby increasing patient production.
  • the fixed cavity 313 of the present embodiment can place and fix the artificial chordae 100 inside the artificial chordae implantation system, thereby avoiding the aforementioned problems.
  • the artificial chord implanted by means of a U-shaped loop sleeve combined with a hook-shaped needle causes wrinkles of the leaflet flap edge, so that the edge of the leaflet leaf forms an artificial gap, and the opposite edge cannot be formed, which is easy to cause The mitral regurgitation is not satisfactory.
  • the distance between the fixed cavity 313 and the clamping push rod 330 is the distance between the artificial chord and the edge of the leaflet after implantation, which can effectively prevent the edge of the leaflet from being folded. Increased surgical results.
  • the proximal end surface of the distal collet 310 is provided with two receiving grooves 314 and 314a for accommodating the anti-slip members 130 of the two artificial slings 100, respectively, and is received.
  • the slots 314 and 314a are symmetrically disposed with respect to the clamping pusher 330 (ie, the central axis of the push catheter 210).
  • the receiving groove 314 is in radial communication with the artificial cable receiving cavity 315, and the receiving groove 314a is in radial communication with the artificial cable receiving cavity 315a.
  • the receiving groove 314 is in radial communication with the fixed cavity 313.
  • the receiving groove 314a is in radial communication with the fixed cavity 313a.
  • the two puncture needles 410 can be driven by respectively withdrawing a pair of puncture push rods 420 toward the proximal end.
  • the anti-slip member 130 fits over the upper surface of the anterior leaflet of the mitral valve, while the puncture needle 410, the fixation member 120 and the tendon body 110 on the other side pass through the mitral valve in turn.
  • the leaf, the anti-slip member 130 is attached to the upper surface of the posterior lobe of the mitral valve to complete the artificial chordae implantation of the bilateral lobes of the mitral valve.
  • the fixing cavity and the receiving groove are arranged to pull the chord body 110 and the anti-slip member 130 to the leaflets without loosening the distal collet 310 and the proximal collet 320, so that the clamping device 300 is closed.
  • the chordae body 110 does not come into contact with the leaflets alone, thereby avoiding the linear cutting effect of the chordae body 110 from damaging the lobed leaflets. .
  • the fixing cavity 313 is sized such that the fixing member 120 of the artificial chord 100 can be fixed in the fixing cavity 313, and can be smoothly pulled out from the fixing cavity 313 after the fixing member 120 is pulled by an external force. Therefore, the shape of the fixed cavity 313 is matched with the shape of the fixing member 120, and the diameter of the inscribed circle of the fixed cavity 313 is larger than the diameter of the circumcircle of the artificial cable receiving cavity 315.
  • the ratio of the diameter of the circumcircle of the artificial chord receiving cavity 315 to the diameter of the inscribed circle of the fixed cavity 313 is (0.2 to 0.4):1.
  • the diameter of the inscribed circle of the fixed cavity 313 is the diameter of the circular cross section of the fixed cavity 313, and the external connection of the artificial cable receiving cavity 315
  • the diameter of the circle is the diameter of the circular cross section of the artificial chord receiving cavity 315.
  • the fixed cavity 313 has a circular cross section and a diameter D1.
  • the artificial chord receiving cavity 315 has a circular cross section with a diameter D2 and D2 is 30% of D1.
  • the purpose of the setting is that if the D2 is too large, the puncture needle 410 is engaged with the fixing member 120 of the artificial chord 100 under the pushing of the puncturing push rod 420, the fixing member 120 may be due to the distal thrust of the puncturing push rod 420.
  • the puncturing needle 410 and the fixing member 120 of the artificial chord 100 can not be successfully connected at one time, prolonging the operation time; if the D2 is too small, the artificial sling 100
  • the chord body 110 cannot pass smoothly through the artificial chord receiving cavity 315, and after the puncture needle 410 is connected with the fixing member 120 of the artificial chord 100, the artificial chord 100 cannot be smoothly pulled out of the clamping surface of the distal collet 310. .
  • the cross section of the fixed cavity 313 and the artificial cable receiving cavity 315 may also be elliptical, triangular, quadrangular, polygonal, or the like, as long as the shape of the fixed cavity 313 and the fixing member 120 are The shapes cooperate with each other, and the shape of the artificial chord receiving cavity 315 does not affect the sling body 110 passing therethrough smoothly.
  • the fixed cavity 313 and the receiving groove 314 are in radial communication.
  • the width D3 of the communicating portion between the fixed cavity 313 and the receiving groove 314 is 20%-50% of D1, and the purpose of the setting is that if the D3 is too large, the fixing member 120 of the artificial chord 100 cannot be firmly fixed.
  • the fixing cavity 313a, the receiving groove 314a and the artificial cable receiving cavity 315a on the other side of the clamping pusher 330 are disposed in the same size as the aforementioned fixing cavity 313, the receiving groove 314 and the artificial cable receiving cavity 315.
  • the size settings are exactly the same and will not be described here.
  • the puncture needle adopts a tapered structure with a straight tip.
  • the diameter of the puncture needle is small, and the puncture point formed on the leaflet is small, the damage to the leaflet is reduced, and the postoperative healing process of the patient is accelerated;
  • the puncture needle and the artificial chord can form a stable and reliable indirect connection, so that the artificial chord is not easily separated from the puncture needle, and the artificial sling is conveniently and quickly pulled to a predetermined position;
  • the clamping push rod is disposed at a substantially central axis of the pushing catheter, and at least one pair of puncture push rods are symmetrically arranged with respect to the clamping push rod, and can be clamped by the relative movement between the proximal collet and the distal collet
  • the anterior and posterior mitral mitral and the artificial chordae are implanted in the anterior and posterior mitral mitral, which greatly shortens the operation time and improves the operation efficiency.
  • the structure of the bilateral artificial chordae implantation system of the second embodiment is basically the same as that of the bilateral artificial chordae implantation system of the first embodiment, and the difference is that the two-sided artificial chordae implantation system of the second embodiment is
  • the puncture device comprises two pairs of puncture push rods and puncture needles respectively disposed at the distal ends of the puncture push rods, and the structure of the artificial tendons is different from the structure of the artificial tendons of the first embodiment.
  • the puncturing device 400 includes two pairs of puncturing push rods 420 and a puncture needle 410 disposed at the distal end of each puncturing push rod 420.
  • the two artificial slings 100 are respectively received in the clamping pusher 330, and each of the artificial slings 100 is in the form of FIG. 6, that is, the fixing body 120 is provided at both ends of the chord body 110.
  • each of the two puncture pushers 420 is a pair, and is provided on one side of the push duct 210 (hereinafter referred to as "first side"), and the other two are used as the other pair, and are provided on the push duct 210 and the first.
  • the other side of the side opposite side hereinafter referred to as "second side", and the two puncture push rods 420 in each pair are symmetrically disposed with respect to the central axis of the push duct 210.
  • the proximal ends of the two puncture pushers 420 in each pair are connected to the same handle 401.
  • the clamping pusher 330 is movably mounted within the clamping pusher passage 203 of the push conduit 210 and is located at a substantially central axis, whereby the four piercing push rods 420 are symmetrically disposed about the clamping pusher 330.
  • a manual cable passage 331 is disposed in the axial direction inside the clamp pusher 330. Both artificial chords 100 are received in the artificial chord passage 331 of the clamp pusher 330.
  • Four fasteners 120 are disposed in the distal collet 310 and correspond to the four puncture needles 410 at the distal end of the four puncture pushers 420, respectively.
  • the distal collet 310 is provided with four artificial chord receiving cavities 315 respectively penetrating to the clamping faces of the distal collet 310, and four artificial chord receiving cavities 315 are clamped.
  • the push rod 330 ie, the central axis of the push catheter 210) is symmetrically disposed, that is, four artificial chord receiving chambers 315, each of which is a pair, disposed on one side of the distal collet 310 (hereinafter referred to as The "first side") and the other two are the other pair disposed on the other side of the distal chuck 310 opposite to the first side (hereinafter referred to as "second side").
  • each artificial chord receiving cavity 315 is in axial communication with a fixed cavity 313.
  • the ratio of the diameter D2 of each artificial chord receiving cavity 315 to the diameter D1 of the fixed cavity 313 connected thereto is in the range of 0.2 to 0.4. ): 1.
  • the two fixed cavities 313 on the first side are in radial communication with each other, and the two fixed cavities 313 on the second side are in radial communication.
  • the two artificial chord receiving cavities 315 on the first side are in radial communication with each other, and the two artificial chord receiving cavities 315 on the second side are in radial communication.
  • the chord body 110 of one artificial chord 100 is received in the artificial chord passage 331 and the two artificial chord receiving cavities 315 on the first side of the distal collet 310, and the chord body of the other artificial chord 100
  • the 110 is housed in the artificial slinging passage 331 and the two artificial sling receiving cavities 315 on the second side of the distal collet 310.
  • each of the chord bodies 110 are pierced through the artificial chord passages 331 and respectively passed through two artificial chord receiving cavities 315 on the same side of the distal collet 310 and respectively respectively respectively
  • the fixing members 120 housed in the fixed cavity 313 are connected.
  • the four puncture needles 410 located at the distal ends of the four puncture push rods 420 respectively puncture the anterior and posterior leaves of the mitral valve, and are located on the first side.
  • the two puncture needles 410 are respectively connected to the two fixing members 120 on the first side, and the two puncture needles 410 on the second side are respectively connected with the two fixing members 120 on the second side, so that one of the cable bodies 110 is provided.
  • two fixing members 120 and two puncture needles 410 disposed at two ends of the chord body 110 form a U-shaped structure
  • another chord body 110 and two fixing members 120 disposed at two ends of the chord body 110 and The two puncture needles 410 also form a U-shaped structure, after which the operator withdraws the four puncture push rods 420 toward the proximal end, and the two chord body 110 can be pulled out from the proximal end surface of the distal collet 310, respectively.
  • chord body 110 A portion of the chord body 110 is respectively attached to the upper surface of the anterior and posterior lobes of the mitral valve, and the remainder of the chord body 110 follows the fixation member 120 and the puncturing needle 410 through the anterior and posterior leaves respectively until reaching The predetermined location of the ventricular wall or mastoid muscle. Therefore, the bilateral artificial chordae implantation system of the present embodiment can quickly and conveniently implant four artificial chordae 100 between the anterior and posterior mitral mitral and ventricular wall or mastoid muscle, respectively, and avoid sputum. The vertical cutting effect of the cord body 110 on the leaflets results in leaflet damage.
  • the artificial chord 100 in this embodiment is further provided with a slip preventing member 130.
  • a slip preventing member 130 Referring again to FIG. 6, at least two through holes 131 are provided in the sheet-shaped anti-slip member 130, and the first end and the second end of the chord main body 110 of one artificial chord 100 pass through one of the through holes 131 of the anti-slip member 130, respectively. It is then connected to a fixing member 120. Thereby, the chord body 110 and the slip preventing member 130 form an annular closed state before the puncturing. After the puncture, the cleat 130, the tendon body 110, the two fixtures 120, and the two puncture needles 410 form an open-loop U-shaped state.
  • the sling body 110 presses the anti-slip member 130 to make the anti-slip member 130 abut against the upper surface of the leaflet, and the relative position between the chord body 110 and the anti-slip member 130 and the leaflet is substantially fixed, so as to avoid the implanted chord body 110. Causes tearing of the leaflets.
  • the proximal end surface of the distal collet 310 is further provided with two receiving slots 314 for receiving the anti-slip members 130 .
  • the two receiving slots 314 are opposite to the clamping push rods 330 (ie, the push ducts 210 ).
  • the center axis) is symmetrically set.
  • the two fixing cavities 313 on the first side of the distal collet 310 are respectively in radial communication with the receiving slots 314 on the side, and the two fixing cavities 313 on the second side of the distal collet 310 are respectively located
  • the receiving grooves 314 on the side are in radial communication.
  • the chord body 110, the two fixing members 120, and the anti-slip member 130 on the same side can be pulled out together at the proximal end surface of the distal collet 310.
  • the width D3 of the communicating portion between the fixed cavity 313 and the receiving groove 314 on each side is 20%-50% of the diameter D1 of the fixed cavity 313.
  • the bilateral artificial chordae implantation system of the second embodiment has at least the following beneficial effects:
  • the main body of the chord is attached to the upper surface of the leaflet, and the fixing manner between the main body and the anti-slip member and the leaflet is relatively firm and reliable, thereby effectively avoiding tearing of the leaflet or the main body of the chord and the anti-slip member.
  • the risk of detachment of the leaf surface is better.
  • the structure of the bilateral artificial chordae implantation system of the third embodiment is basically the same as that of the two-sided artificial chordae implantation system of the second embodiment, and the difference is that the double artificial chordae implantation system of the third embodiment is Also included is a clamping aid.
  • the bilateral artificial chordae implantation system includes a clamping device 300, a puncturing device 400, a pushing device 200, and a clamping aid 500.
  • the clamping pusher 330 of the clamping device 300 is located at a substantially central axis of the pusher catheter 210.
  • the gripping aid 500 includes at least one pair of gripping auxiliary arms 520 that are movably inserted into the pusher catheter 210 and gripping aids 510 that are respectively disposed at the distal ends of the gripping arm 520.
  • Each pair of gripping auxiliary arms 520 is symmetrically disposed with respect to the gripping pusher 330 (ie, the central axis of the pusher catheter 210).
  • a fourth handle 501 may be disposed at the proximal end of the clamp auxiliary arm 520.
  • a pair of clamping auxiliary arms 520 are provided.
  • the two clamping auxiliary arms 520 are movably worn in the pushing duct 210 and symmetrically disposed with respect to the clamping push rod 330, each of the clamping auxiliary arms 520 being far away.
  • a clamping aid 510 is provided at the end.
  • an auxiliary arm housing chamber 250 is provided in the pushing duct 210 in the axial direction. Prior to the puncture, both the grip aid 510 and the grip auxiliary arm 520 are housed in the auxiliary arm receiving chamber 250. On the distal end face of the proximal collet 320, the side wall of the pusher catheter 210 or the side wall of the proximal collet 320 is provided with an opening 260 that extends through the auxiliary arm receiving cavity 250.
  • the clamping auxiliary arm 520 can be driven to push the clamping aid 510 out of the opening 260 to support the lower surface of the leaflet, stabilize the beating leaflets, and reduce the flap. The extent of movement of the leaf cooperates with the gripping device 300 to grip and secure the leaflets.
  • the angle between the axial direction of the distal end portion of the auxiliary arm receiving chamber 250 and the axial direction of the pushing duct 210 ranges from 120 to 150°.
  • the reason for this arrangement is that before the puncture, the clamping pusher 330 is in contact with the edge of the leaflet, and the distal collet 310 and the proximal collet 320 can only clamp part of the leaflets, in order to keep the beating leaflets as stable as possible.
  • the lower surface of the opposite side of the leaflet edge is necessary to have a certain angle between the clamping aid 510 and the pushing catheter 210 to support each leaflet.
  • the grip aid 510 is supported on the lower surface of the leaflet and cooperates with the gripping device 300 to retain the leaflets.
  • the grip aid 510 is made of an elastic and/or flexible material to accommodate the anatomy of the leaflets and the amplitude of movement of the leaflets and to avoid damage to the leaflets.
  • the elastic material is preferably a shape memory material.
  • the clamping aid 510 can be made of a metallic material, a polymeric material, or a metal-polymer composite.
  • the clamping aid 510 is a rod-shaped body.
  • the rod-shaped body may be a solid or hollow structure of a single-layer or multi-layer composite structure, or may be wound from a single wire or a plurality of wires.
  • the cross section of the rod may be a regular circular or elliptical shape, a crescent shape, a semicircular shape, a polygonal shape or the like.
  • the clamping aid 510 has a smooth shape, and the distal end is formed by laser spot welding to form a smooth round head without defects such as burrs, edges or corners.
  • the clamping aid 510 is made of an elastic nickel-titanium alloy having a shape memory function and has a circular cross section.
  • the clamp auxiliary arm 520 is rod-shaped or tubular having a certain axial length and has a certain hardness or rigidity to provide support and pushability.
  • the clamping auxiliary arm 520 may be made of a metal rod or a polymer rod of a hollow or solid structure of a single layer or a multi-layer composite structure, or may be wound by a single wire or a plurality of wires.
  • the cross section of the clamping auxiliary arm 520 may be a regular circular or elliptical shape, a crescent shape, a semicircular shape, a polygonal shape, or a ring shape.
  • the clamp auxiliary arm 520 may be made of a metal material, a polymer material, or a metal-polymer composite material. In this embodiment, the clamping auxiliary arm 520 is made of an elastic material with a memory function and has a circular cross section.
  • the support of the gripping auxiliary arm 520 and the softness of the gripping aid 510 can be achieved by separately forming the gripping aid 510 and the gripping auxiliary arm 520 using different materials. That is, the clamp auxiliary arm 520 is made of a hard material; the clamp aid 510 is made of an elastic and/or flexible material. It can be understood that the clamping auxiliary arm 520 and the clamping aid 510 can also be made of the same material first, and then a material with a higher hardness is added to the outside and/or inside of the clamping auxiliary arm 520 as a reinforcing tube or hardened. The wire is lining to ensure the support of the clamping auxiliary arm 520. As shown in FIG. 23, the clamp auxiliary arm 520 is composed of a softer inner tube 521 and a harder outer tube 522.
  • the grip aid 510 is made of a non-transmissive X-ray material.
  • the relative position between the instrument and the leaflets cannot be judged by a lower level of operation such as X-ray operation, and the precise ultrasonic guidance must be relied upon to clamp the device.
  • Ultrasound has high requirements for doctor's operation technology and analysis of cardiac ultrasound images, resulting in increased surgical costs, increased difficulty in surgery, and increased operation time.
  • the clamping aid 510 of the present embodiment is made of a non-transmissive X-ray material, after the clamping aid 510 is in contact with the leaflets, the flexible and/or elastic clamping aid 510 is associated with the amplitude of movement of the leaflets.
  • the swinging therefore, the operator can quickly and accurately determine the position of the leaflets by X-rays before the clamping device 300 holds the leaflets, thereby operating the clamping device 300 more quickly and accurately to clamp the leaflets, reducing the cost of surgery And difficulty, shorten the operation time and improve the success rate of surgery.
  • the clamping aid 510 may also be a deformed structure composed of a plurality of rod-shaped bodies. After the deformation structure is contracted and deformed, it is housed in the push duct 210 together with the clamp auxiliary arm 520.
  • the deformed structure is an open bifurcated structure or an umbrella-like structure composed of a plurality of rod-shaped bodies.
  • the gripping aid 510 has a stretched state in a compressed state and a natural state.
  • the clamping aid 510 When the clamping aid 510 is in the compressed state, it can be received in the auxiliary arm receiving cavity 250 of the pushing catheter 210 and pushed; when the clamping aid 510 is provided by the clamping surface of the proximal collet 320, the pushing catheter 210 After the side wall or the opening 260 of the side wall of the proximal collet 320 is extended, it is transformed into an extended state, which can be supported on the lower surface of the leaflet to stabilize the beating leaflets.
  • the contact surface of the larger diameter clamping aid 510 and the leaflet is the plane in which the clamping aid 510 is located. Therefore, the contact area between the clamping aid 500 and the leaflets is larger, which can be better.
  • the leaflets are attached to improve the support of the leaflets by the clamping aid 500.
  • the ends of the bifurcated or umbrella-shaped gripping aid 510 can be rolled in the proximal direction of the gripping auxiliary arm 520, and the plurality of gripping aids 510 form a recessed area. , as shown in Figure 24. At this time, since the ends of each of the gripping aids 510 are turned inwardly and directed toward the proximal end of the gripping auxiliary arm 520, the end of the support rod of the gripping aid 510 can be prevented from stabbing the leaflets or the ventricular wall.
  • the deformed structure may also be a closed loop structure composed of a plurality of support rods, which may be circular, diamond, elliptical, pear-shaped, polygonal or other irregularities but may be formed.
  • the shape of the closed structure is shown in Figure 25.
  • at least one connecting rod having flexibility and/or elasticity may be disposed between the support rods of the closed-loop structure to improve the self-stability of the closed-loop structure, and further enhance the clamping aid. 510 support force on the leaflets.
  • the closed loop structure when a plurality of support bars and connecting rods are disposed in the closed loop structure, the closed loop structure may also form a sheet structure or a mesh structure. It can also be understood that, in other embodiments, the mesh structure may be heat set to form a network structure to form a stretchable deformable disk structure (similar to a single disk occluder in the prior art). The disc-shaped structure can be further heat-set to form a columnar, nested, oblate, or the like structure.
  • the clamping aid 510 is made of a shape memory material, it can be received in the auxiliary arm receiving cavity 250 of the push catheter 210 and transported, and then extended through the opening 260 to return to the natural unfolded state, in contact with the lower surface of the leaflet. And provide support for the leaflets.
  • the bilateral artificial chordae implantation system is advanced through the mitral valve into the left ventricle;
  • the second step continues to advance the bilateral artificial chordae implantation system until the distal collet 310 and the proximal collet 320 are both located in the left atrium, and the second handle 301 is pushed distally, and the second handle 301 is driven.
  • the clamping pusher 330 moves distally relative to the push catheter 210, and the distal collet 310 at the distal end of the clamping pusher 330 is separated from the proximal collet 320 at the distal end of the push catheter 210, at which point the proximal collet Forming a hollow cylindrical leaflet receiving space between the 320 and the distal collet 310;
  • the fourth handle 501 is pushed distally, and the fourth handle 501 drives the clamping auxiliary arm 520 to push the clamping aid 510 out through the opening 260.
  • the two clamping assistants 510 respectively Supporting the anterior and posterior lobe of the mitral valve to assist in stabilizing the beating leaflets, maintaining the relative position between the first handle 201 and the second handle 301, and slowly moving the entire artificial tendon implant proximally The system, until the anterior and posterior lobes of the mitral valve enter the leaflet receiving space between the proximal collet 320 and the distal collet 310, at which point the two clamping aids 510 can be placed against the mitral valve
  • the leaves and the back leaves provide a certain supporting force respectively;
  • the distal end of the bilateral artificial chordae implantation system is fine-tuned until the edges of the anterior and posterior lobes of the mitral valve are in contact with the clamping push rod 330, and the proximal end is retracted.
  • the two handles 301 drive the distal collet 310 to move toward the proximal collet 320 until the two are closed, and the anterior and posterior mitral valves are clamped;
  • the third handle 401 is pushed distally, and the four puncture needles 410 are driven to move along the axial direction of the push catheter 210 to the distal collet 310, respectively, until the four puncture needles 410 pass through the anterior lobe of the mitral valve, respectively.
  • a rear leaf and respectively forming a fixed connection with the four fixing members 120 disposed in the distal collet 310;
  • the third handle 401 is retracted, so that the puncture needle 410 drives the fixing member 120, the chord body 110 connected to the fixing member 120 passes through the leaflets in sequence, and the anti-slip member 130 also passes from the distal collet 310.
  • the proximal end face is pulled out, and the abutting faces 132 (ie, the lower faces) of the two non-slip members 130 are in contact with the upper surfaces of the anterior and posterior lobes of the mitral valve, respectively, while each of the chordae bodies 110 are respectively pressed
  • the upper surfaces of the two anti-slip members 130 are respectively attached to the anterior and posterior lobes of the mitral valve (as shown in FIG. 31).
  • the point contact between the artificial chord 100 and the leaflets is converted into a non-slip member.
  • the surface contact between the 130 and the leaflets can effectively reduce the risk of tearing of the leaflets 900;
  • the seventh step continues to withdraw the third handle 401 until the fixing member 120 is withdrawn from the proximal end of the pushing catheter 210, and the fourth handle 501 is withdrawn, and the clamping aid 510 is retracted to the auxiliary arm receiving cavity 250.
  • the entire bilateral artificial chordae implantation system is withdrawn, and the length of the chordae body 110 remaining in the heart is adjusted, and the two ends of the chordae body 110 are respectively fixed at predetermined positions of the ventricular wall or the mastoid muscle, such as Figure 32 shows the completion of bilateral artificial chordae implantation of the anterior and posterior mitral mitral valves.
  • the relative position of the distal collet 310 and the proximal collet 320 can be finely adjusted to make a certain distance between the two, and then the clamping push is adjusted.
  • the relative position between the rod 330 and the leaflets, the clamping device 300 is operated again to clamp the leaflets, and the surgical operation of the fifth step is performed.
  • the clamping aid 500 under the leaflets has a certain supporting effect on the leaflets, the leaflets can be prevented from slipping out of the clamping device 300.
  • the two sets of artificial chordae can be fixed together, thereby pulling the anterior and posterior lobe to each other, shortening two.
  • the gap between the two makes the mitral valve form a "double-pored" structure, and the "edge-to-edge” repair of the mitral valve is achieved.
  • the bilateral artificial chordae implantation system of the present invention has a clamping push rod disposed at a substantially central axis of the push catheter, and at least one pair of puncturing push rods are disposed in the push catheter and symmetric about the clamping push rod The setting, so that the relative movement between the proximal collet and the distal collet can simultaneously clamp the anterior and posterior lobes of the mitral valve, thereby simultaneously implanting the artificial chordae in the anterior and posterior lobes of the mitral valve.
  • the two sets of artificial chordae can be fixed together, thereby pulling the anterior and posterior lobes toward each other, shortening the gap between the two, and making the apex
  • the flap forms a "double-pored" structure that achieves the "edge-to-edge” repair of the mitral valve.

Abstract

一种双侧人工腱索植入系统，包括夹持装置（300）、穿刺装置（400）和推送装置（200）。推送装置（200）包括推送导管（210）。夹持装置（300）包括夹持推杆（330）及用于配合夹持瓣叶的远端夹头（310）和近端夹头（320）。近端夹头（320）设置在推送导管（210）的远端，远端夹头（310）设置在夹持推杆（330）的远端。所述夹持推杆（330）活动地在推送导管（210）的大致中心轴处。穿刺装置（400）包括至少一对穿刺推杆（420）及分别设于穿刺推杆（420）远端的穿刺针头（410）。穿刺推杆（420）活动地穿装在推送导管（210）中且关于夹持推杆（330）呈对称设置。该双侧人工腱索植入系统可同时夹持二尖瓣的前叶和后叶，进而同时在二尖瓣的前叶和后叶植入人工腱索，大大缩短手术时间，提高手术效率。

Description

双侧人工腱索植入系统 技术领域
本发明属于医疗器械技术领域，涉及一种修复心脏瓣膜缺陷的器械，尤其涉及一种双侧人工腱索植入系统。
背景技术
二尖瓣为左心房(简称：LA)和左心室(简称：LV)之间的单向“阀门”，可以保证血液从左心房流向左心室。请参见图1，正常健康的二尖瓣具有多根腱索。二尖瓣的瓣叶分为前叶和后叶，左心室处于舒张状态时，两者处于张开状态，血液从左心房流向左心室；左心室处于收缩状态时，腱索被拉伸，保证瓣叶不会被血流冲到心房侧，前、后叶闭合良好，从而保证血液从左心室经过主动脉瓣(简称：AV)流向主动脉。若腱索或乳头肌出现病变，例如图2所示的前叶腱索及后叶腱索断裂，当左心室处于收缩状态时，二尖瓣不能像正常状态时恢复至关闭状态，血流的冲力会进一步导致瓣叶脱入左心房，造成血液返流。目前通常采用外科手术治疗二尖瓣返流，常见的二尖瓣瓣膜修复术包括“缘对缘”瓣膜修复术、腱索修复术、瓣环成形术等。“缘对缘”瓣膜修复术是指将脱垂的二尖瓣瓣叶与对应的前叶或后叶缝合起来，形成具有“双孔化”结构的二尖瓣。
腱索修复术是指采用外科手术植入人工腱索的方式治疗腱索病变，需要采用侵入性开胸技术，并实行全麻、中度低温体外循环作为辅助支持。这类外科手术存在手术过程复杂、手术成本高、病人创伤程度高、并发症风险高、住院时间长以及患者恢复过程痛苦等缺陷。
另一种治疗方式是通过微创方式植入人工腱索。现有技术中，微创方式植入人工腱索采用的器械包含手柄组件、俘获组件和针头等组件；通过可闭合的俘获组件将瓣叶俘获后，再利用针头刺穿瓣叶，然后勾取人工腱索。这种器械每次操作仅能在二尖瓣的前叶或者后叶中的一侧植入人工腱索，手术效率较低，耗时较长。
发明内容
本发明要解决的技术问题在于，针对现有技术中的上述缺陷，提供一种可同时在二尖瓣的前叶和后叶植入人工腱索的双侧人工腱索植入系统。
本发明解决其技术问题所采用的技术方案是：
一种双侧人工腱索植入系统，包括夹持装置、穿刺装置和推送装置。所述推送装置包括推送导管。所述夹持装置包括夹持推杆及用于配合夹持瓣叶的远端夹头和近端夹头。所 述近端夹头设置在所述推送导管的远端。所述远端夹头设置在所述夹持推杆的远端。所述夹持推杆活动地穿装在所述推送导管的大致中心轴处。所述穿刺装置包括至少一对穿刺推杆及分别设于所述穿刺推杆远端的穿刺针头。所述穿刺推杆活动地穿装在所述推送导管中且关于所述夹持推杆呈对称设置。
本发明的双侧人工腱索植入系统与现有技术相比，至少具有以下有益效果：夹持推杆设置在推送导管的大致中心轴处，至少一对穿刺推杆设置在推送导管中且关于夹持推杆对称设置，因此通过近端夹头与远端夹头之间的相对运动可同时夹持二尖瓣的前叶和后叶，进而由位于夹持推杆两侧的至少一对穿刺推杆带动穿刺针头分别穿刺二尖瓣的前叶和后叶，进而实现双侧的人工腱索植入，大大缩短手术时间，提高手术效率。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1是心脏中正常腱索的示意图；
图2是心脏中腱索断裂的示意图；
图3是本发明实施例一的双侧人工腱索植入系统的结构示意图；
图4是本发明实施例一的双侧人工腱索植入系统的夹持装置闭合时的结构示意图；
图5是本发明实施例一的双侧人工腱索植入系统的人工腱索的第一种实施方式的结构示意图；
图6是本发明实施例一的双侧人工腱索植入系统的人工腱索的第二种实施方式的结构示意图；
图7是本发明实施例一的双侧人工腱索植入系统的人工腱索的第三种实施方式的结构示意图；
图8是本发明实施例一的双侧人工腱索植入系统的固定件与穿刺针头连接的结构示意图；
图9是本发明实施例一的双侧人工腱索植入系统的夹持装置的夹持推杆及远端夹头的结构示意图；
图10是本发明实施例一的双侧人工腱索植入系统的远端夹头的第一种实施方式的结构示意图；
图11是图10沿A-A线的剖视图；
图12a是本发明实施例一的双侧人工腱索植入系统的远端夹头的第二种实施方式的示意图；
图12b是图12a沿A-A线的剖视图；
图12c是图12a沿B-B线的剖视图；
图13是本发明实施例二的双侧人工腱索植入系统的爆炸图；
图14是本发明实施例二的双侧人工腱索植入系统的推送导管的径向剖视图；
图15是本发明实施例二的双侧人工腱索植入系统的远端夹头的近端面的结构示意图；
图16是图15沿A-A线的剖视图；
图17是图15沿B-B线的剖视图；
图18是本发明实施例三的双侧人工腱索植入系统的爆炸图；
图19是本发明实施例三的双侧人工腱索植入系统的推送导管的轴向剖视图；
图20及图21是本发明实施例三的双侧人工腱索植入系统的夹持辅助件自推送导管伸出的示意图；
图22是本发明实施例三的双侧人工腱索植入系统的夹持辅助装置的第一种实施方式的结构示意图；
图23是本发明实施例三的双侧人工腱索植入系统的夹持辅助装置的第二种实施方式的结构示意图；
图24是本发明实施例三的双侧人工腱索植入系统的夹持辅助装置的第三种实施方式的结构示意图；
图25是本发明实施例三的双侧人工腱索植入系统的夹持辅助装置的第四种实施方式的结构示意图；
图26至图32是利用本发明实施例三的双侧人工腱索植入系统植入人工腱索的过程示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
以下为了描述方便，将靠近操作者的方位定义为近端，远离操作者的方位定义为远端。
实施例一
如图3至图11及图12a至图12c所示，本发明的双侧人工腱索植入系统用于将人工腱索100植入患者心脏内，替换二尖瓣的前叶和后叶的病变腱索。双侧人工腱索植入系统包括夹持装置300、穿刺装置400和推送装置200。推送装置200包括推送导管210。推送导管210沿轴向设有多个贯通的内腔。夹持装置300包括夹持推杆330及用于配合夹持瓣叶 的远端夹头310和近端夹头320。近端夹头320设置在推送导管210的远端，远端夹头310设置在夹持推杆330的远端。夹持推杆330活动地穿装在推送导管210的大致中心轴处。穿刺装置400包括至少一对穿刺推杆420及分别设于穿刺推杆420远端的穿刺针头410。穿刺推杆420活动地穿装在推送导管210中且关于夹持推杆330呈对称设置。由此，本发明的双侧人工腱索植入系统的夹持装置300可同时夹持二尖瓣的前叶和后叶，然后由位于夹持推杆330两侧的至少一对穿刺推杆420带动穿刺针头410分别穿刺二尖瓣的前叶和后叶，进而实现双侧的人工腱索植入。
实施例一的双侧人工腱索植入系统中包括一对人工腱索100。每根人工腱索100均包括一段具有柔性的腱索主体110。腱索主体110用于植入心脏内，替代心脏内的病变腱索。腱索主体110具有相对的第一端和第二端。第一端和/或第二端连接有固定件120。固定件120用于与穿刺装置400不可拆卸连接或可拆卸连接。
腱索主体110可以固定在瓣叶和心室壁(或者乳突肌等部位)之间，以替代病变的腱索，维持瓣叶与心室壁之间的张力。腱索主体110具有柔性是指其在轴向无拉伸可以任意弯曲，一般腱索主体110采用柔性线的形式。腱索主体110的材料可以是与人体相容的高分子材料或者较为柔软的金属材料等。优选为PTFE等高分子材料。
腱索主体110的第一端和第二端并没有方向、重要程度等区别。如图5所示，固定件120可以仅设置在腱索主体110的一端，也可以如图6所示设置在腱索主体110的两端。
本实施例中，固定件120仅设置在腱索主体110的第一端。腱索主体110与固定件120之间可以采用打结、缠绕、焊接、粘接或卡接等方式固定连接。例如，可以将腱索主体110的第一端穿出固定件120之后打结形成一个直径较大的线团；或者将末端焊接为一个直径较大的圆球；或者在末端再设置一个定位杆。在自然状态下，定位杆与腱索主体110及固定件120的轴向均不相同。将定位杆及腱索主体110的第一端穿过固定件120后，定位杆恢复自然状态，即可卡挡在固定件120的背面，由此将腱索主体110的第一端固定在固定件120上。如图5所示，由于腱索主体110的第二端没有设置固定件120，腱索主体110的第二端应当通过打结、缠绕、或者设置球状末端、盘状末端等方式，使得第二端的截面尺寸大于腱索主体110的截面尺寸，以将腱索主体110的第二端固定在瓣叶的上表面。
固定件120用于与穿刺装置400的穿刺针头410形成可拆卸固定连接或不可拆卸固定连接，其形状配合不同的连接方式。固定件120的外部通常为柱形，横截面形状可以是圆形、椭圆形、多边形等各种形状，优选圆形或椭圆形。
固定件120与穿刺针头410之间的连接方式有多种，例如，螺纹连接、粘接、粗糙面摩擦连接、过盈配合或者卡扣连接。如图8所示，本实施例中，采用卡扣连接，具体地， 在固定件1200沿轴向设置一容置腔121，容置腔121的内壁沿径向设有三个凹槽或孔125，穿刺针头410上对应设置凸沿411或凸起，以与凹槽或孔125卡接。三个凹槽或孔125既可保证固定件120与穿刺针头410之间连接的稳定性，减小连接后穿刺针头410的晃动幅度，也不会额外增加穿刺针头410的直径导致穿刺点直径增加。
同时参见图5及图6，为了将人工腱索100与瓣叶之间的点接触，增大为面接触，从而降低人工腱索100撕裂瓣叶的风险，优选腱索主体110上套设有防滑件130，且防滑件130可以沿腱索主体110的轴向滑动。由于防滑件130预先设置在腱索主体110上，在穿刺针头410穿刺瓣叶并与腱索主体110固定连接后，可将防滑件130带动至穿刺点，并与腱索主体110一起固定在瓣叶上。防滑件130在人工腱索100上的具体设置方式是：防滑件130上设置通孔131，腱索主体110穿过通孔131。通孔131的设置数量与防滑件130的固定方式有关。
一种方式是防滑件130上设置一个通孔131，腱索主体110穿过该通孔131(如图5所示)。
另一种方式是防滑件130上设置至少两个通孔131，一根腱索主体110的第一端和第二端分别穿过不同的通孔131(如图6所示)。为了防止防滑件130从人工腱索100上脱落，通孔131的截面尺寸小于固定件120的截面尺寸。
当腱索主体110的第一端设置固定件120而腱索主体110的第二端没有设置固定件120时，第二端应当通过打结、或者设置球状末端、盘状末端等方式，使得第二端的截面尺寸大于防滑件130上的通孔131的截面尺寸(如图5所示)。
为了将腱索主体110对瓣叶的作用力尽量分散至防滑件130与瓣叶之间的接触面，防滑件130需要与瓣叶尽量贴合，因此防滑件130设有与瓣叶贴合的贴合面132。除了贴合面132外，防滑件130具体结构不作限定，可以有多种结构：例如可以是具有一定面积的片状、盘状或者球状，甚至是不规则形状，优选为片状。防滑件130可以是无孔结构，也可以是网状结构、条栅状结构等。防滑件130应由生物相容性材料制成，可以由弹性材料制成，也可以由非弹性材料制成。具体地，防滑件130选自弹性垫片、心脏补片、毛毡片、网格结构、盘状结构或者双盘状结构中的至少一种。其中具有盘状结构或者双盘状结构的防滑件130的结构类似于现有技术中的封堵器，在此不再赘述。优选地，为了减小器械的整体尺寸，具有盘状结构或者双盘状结构的防滑件130应由形状记忆材料制成。
如图7所示，腱索主体110上也可以不设置防滑件130，只要固定件120与穿刺针头410之间形成固定连接，也可将腱索主体110固定在瓣叶及心室壁或乳突肌之间，替换病变的腱索。
再次参见图3及图4，推送装置200的推送导管210为具有一定轴向长度的管状体或杆状体，其横截面优选为圆形，且圆形的直径范围为10mm至12mm。推送导管210沿轴向设置多个相互分隔的贯通推送导管210的两端的内腔。推送导管210可以采用一体成型的多腔管，也可以将外管和内管套装固定在一起，形成整体结构的推送导管210。推送导管210可以采用生物相容性的高分子材料(例如，聚甲醛POM、聚乙烯PE、尼龙PA、聚氯乙烯PVC、丙烯腈-丁二烯-苯乙烯共聚物ABS、尼龙弹性体Pebax或者聚氨酯PU)、金属材料(例如，不锈钢或者镍钛合金)或者金属-高分子复合材料制成。推送导管210的近端设有第一手柄201，用于操纵推送导管210向远端推送或者向近端回撤。
推送导管210的内腔中活动地穿装穿刺装置400。为了实现二尖瓣的前叶和后叶的双侧人工腱索植入，穿刺装置400包括至少一对穿刺推杆420及分别设于穿刺推杆420远端的穿刺针头410。每根穿刺推杆420均具有一定的轴向长度，且两根穿刺推杆420关于夹持推杆330(即，推送导管210的中心轴)呈对称设置。穿刺针头410在穿刺瓣叶后可与人工腱索100的固定件120连接，以将腱索主体100拉向近端。
穿刺针头410的远端为锥形的直尖端，以利于穿刺瓣叶并减小其在瓣叶上形成的穿刺点直径。现有技术中采用具有钩状头端的针头穿过瓣叶，并勾取作为人工腱索的缝合线，然后后撤针头带动人工腱索穿过瓣叶，再将人工腱索固定在心室壁上，这种具有钩状头端的针头在瓣叶上形成的穿刺点偏大，对瓣叶损伤较大，不仅影响患者术后恢复的过程，还会增加瓣叶被撕裂的风险。而锥形的直尖端在瓣叶上形成的穿刺点小，利于患者的术后愈合。本实施例的双侧人工腱索植入系统在每片瓣叶上形成的单个穿刺点的直径范围为0.3mm至1.5mm，进一步地，通过选择适宜的穿刺针头410的形状及直径，穿刺点的直径可控制为约0.7mm。
穿刺针头410的远端部设有用于与固定件120形成过盈配合或者卡扣连接的至少一个凸齿或至少一圈凸沿411。可以理解的是，在其他实施方式中，穿刺针头410还可以通过螺纹、粘接、摩擦连接等方式与人工腱索100的固定件120之间形成不可拆卸或者可拆卸的连接。穿刺针头410近端连接有穿刺推杆420，穿刺推杆420活动地穿装在推送导管210的内腔中。穿刺推杆420的近端自推送导管210近端穿出并与第三手柄401相连。由此，通过第三手柄401的轴向移动，即可带动穿刺推杆420沿推送导管210的轴向移动，进而驱动穿刺针头410向远端穿刺或者向近端回撤。在瓣叶被夹持装置300夹持后，穿刺针头410可在第三手柄401驱动下，刺穿瓣叶并与人工腱索100的固定件120连接，穿刺针头410与人工腱索100通过固定件120连接成为一个整体。现有技术的具有钩状头端的针头勾取人工腱索的几率比较低，造成手术成功率偏低，延长手术时间；并且在针头勾住人工 腱索后，由于针头与人工腱索之间仅通过微弱的摩擦力连接，在后撤针头的过程中，由于患者血流冲刷或者操作者的动作，均易导致人工腱索从针头上脱落，延长手术时间，甚至造成手术失败。而本实施例的穿刺针头410与人工腱索100的腱索主体110通过固定件120形成稳定可靠的间接连接，使得人工腱索100不易与穿刺针头410脱离，操作者可方便快捷地将人工腱索100与固定件120相连的一端或两端拉至心室壁或乳突肌的预定位置。
夹持装置300可同时夹持二尖瓣的前叶和后叶。夹持装置300的夹持推杆330的近端自推送导管210的近端穿出并设置第二手柄301。由此，向远端推送第二手柄301，带动夹持推杆330向远端移动，使得远端夹头310远离近端夹头320，形成夹持装置300的张开状态，此时在远端夹头310与近端夹头320之间形成空心圆柱状的瓣叶容纳空间，可同时容纳二尖瓣的前叶和后叶。操作者可以调整人工腱索植入系统远端使得二尖瓣的前叶和后叶同时进入到远端夹头310与近端夹头320之间的瓣叶容纳空间，然后向近端回撤第二手柄301，带动夹持推杆330向近端移动，使得远端夹头310向近端夹头320靠近，形成夹持装置300的夹持状态，如图4所示。此时，二尖瓣的前叶和后叶均被夹持装置300夹持并固定。近端夹头320与远端夹头310的形状与推送导管210的形状配合一致，远端夹头310和近端夹头320在闭合后应形成外表光滑的整体，以便于推送并减轻对患者伤口的损伤。可以理解的是，前述的向远端推送第二手柄301使得远端夹头310远离近端夹头320的状态，也可以通过向近端回撤第一手柄201及推送导管210来达到；向近端后撤第二手柄301使得远端夹头310靠近近端夹头320的状态，也可以通过向远端推送第一手柄201及推送导管210来达到。
为了提高夹持的稳定性，近端夹头320的夹持面(即，近端夹头320的远端面)与远端夹头310的夹持面(即，远端夹头310的近端面)应相互贴合，并且分别具有较大的瓣叶接触面积。远端夹头310的近端面作为与瓣叶接触的夹持面，优选设置为由远端向近端凸出的圆锥形表面；而近端夹头320的远端面作为与瓣叶接触的夹持面，优选设置为由远端向近端凹入的圆锥形表面，且其形状与远端夹头310的近端面的圆锥形表面相配合。另外，远端夹头310和/或近端夹头320的夹持面上设有用于增强夹持力的夹持增强件。夹持增强件优选为凸起、凸棱、凹槽或者凹坑中的至少一种，且远端夹头310的近端面(即，夹持面)设置的夹持增强件的形状应当与近端夹头320的远端面(即，夹持面)设置的夹持增强件的形状互相配合，使得闭合后的远端夹头310与近端夹头320之间没有间隙。本实施例中，远端夹头310的夹持面和近端夹头320的夹持面上分别设置多条平行的凸棱作为夹持增强件，当远端夹头310和近端夹头320闭合后，二者之间没有间隙。
如图9所示，夹持推杆330为具有一定轴向长度的管状体或中空杆状体，横截面优选 为椭圆形或者圆形，且夹持推杆330中沿轴向设有人工腱索通道331。如图10至图11所示，远端夹头310中设有两个分别与人工腱索通道331相连通的人工腱索收容腔315和315a，人工腱索收容腔315和315a均贯通至远端夹头310的近端面，且人工腱索收容腔315和315a关于夹持推杆330(即，推送导管210的中心轴)呈对称设置。即，人工腱索通道331的远端分叉为Y型，Y型分叉的两个分支分别作为人工腱索收容腔315和315a。一根人工腱索100的腱索主体110收容于人工腱索通道331及人工腱索收容腔315中，另一根人工腱索100的腱索主体110收容于人工腱索通道331及人工腱索收容腔315a中。
远端夹头310的近端面设有两个分别用于容置两条人工腱索100的固定件120的固定腔313和313a，且固定腔313和313a关于夹持推杆330(即，推送导管210的中心轴)呈对称设置。固定腔313与人工腱索收容腔315之间轴向连通；固定腔313a与人工腱索收容腔315a之间轴向连通。两个固定腔313和313a的位置与两个穿刺针头420的位置分别对应。由此，两根人工腱索100的两个固定件120分别容置在远端夹头310中，且每个固定件120的近端分别对应于一个穿刺针头410。优选地，远端夹头310的近端面为椭圆形，且两个固定腔313及313’均位于椭圆的长轴上，以适应二尖瓣的两片瓣叶闭合时的形状。
可以理解的是，在其他实施例中，固定腔313及313a也可以位于椭圆的其他位置，只要两个固定腔313及313a呈对称设置即可，如图12a至图12c所示。
现有技术将人工腱索暴露在人工腱索植入系统外部，使得人工腱索植入系统外表面不光滑，导致器械进入人体时，对组织造成摩擦损伤，同时出现漏血，增加了患者产生术后并发症的风险。而本实施例的固定腔313可将人工腱索100放置并固定在人工腱索植入系统内部，避免了前述问题。此外，现有技术中，以U型环套结合钩状针头的方式植入的人工腱索会造成瓣叶瓣缘的褶皱，使瓣叶的边缘形成人为缺口，无法形成对合缘，容易造成二尖瓣返流，手术效果不理想。本实施例提供的双侧人工腱索植入系统，固定腔313与夹持推杆330之间的距离即为植入后的人工腱索与瓣叶边缘的间距，可有效避免瓣叶边缘折叠，增强了手术效果。
由于人工腱索100上还设有防滑件130，因此远端夹头310的近端面设有两个分别用于收容两条人工腱索100的防滑件130的收容槽314和314a，且收容槽314和314a关于夹持推杆330(即，推送导管210的中心轴)呈对称设置。收容槽314与人工腱索收容腔315之间径向连通，收容槽314a与人工腱索收容腔315a之间径向连通。收容槽314与固定腔313之间径向连通。收容槽314a与固定腔313a之间径向连通。由此，在两个穿刺针头410分别穿刺二尖瓣的前叶和后叶并分别与一个固定件120连接后，可通过向近端分别后撤一对穿刺推杆420，带动两个穿刺针头410及分别与其相连的固定件120、腱索主体110及防 滑件130依次由远端夹头310的近端面被拉出，直至一侧的穿刺针头410、固定件120及腱索主体110依次穿过二尖瓣的前叶，防滑件130贴合至二尖瓣的前叶的上表面，而另一侧的穿刺针头410、固定件120及腱索主体110依次穿过二尖瓣的后叶，防滑件130贴合至二尖瓣的后叶的上表面，完成二尖瓣的双侧瓣叶的人工腱索植入。
固定腔及收容槽的设置可以实现在不必松开远端夹头310和近端夹头320的前提下将腱索主体110及防滑件130拉至瓣叶，因此在夹持装置300由闭合状态转变至张开状态时，瓣叶自夹持装置300中脱离、恢复搏动的瞬间，腱索主体110不会与瓣叶单独接触，避免腱索主体110的线性切割效应对搏动的瓣叶产生伤害。
以下以位于夹持推杆330一侧的固定腔313、收容槽314及人工腱索收容腔315为例，说明三者的尺寸关系。固定腔313的尺寸应使得人工腱索100的固定件120既可以被固定在固定腔313内，在固定件120受到外力牵拉后又可以从固定腔313内顺利地拉出。因此，固定腔313的形状与固定件120的形状相配合，且固定腔313的内切圆的直径大于人工腱索收容腔315的外接圆的直径。优选地，人工腱索收容腔315的外接圆的直径与固定腔313的内切圆的直径之比为(0.2～0.4)∶1。当固定腔313及人工腱索收容腔315的横截面均为圆形时，固定腔313的内切圆的直径即为固定腔313的圆形横截面的直径，人工腱索收容腔315的外接圆的直径即为人工腱索收容腔315的圆形横截面的直径。本实施例中，固定腔313的横截面为圆形，其直径为D1，人工腱索收容腔315的横截面为圆形，其直径为D2，且D2是D1的30％。如此设置的目的是：若D2过大，穿刺针头410在穿刺推杆420的推动下与人工腱索100的固定件120配合时，由于穿刺推杆420的向远端的推力，固定件120可能从固定腔313内滑脱到人工腱索收容腔315内，导致穿刺针头410与人工腱索100的固定件120之间不能一次性成功连接，延长手术时间；如D2过小，人工腱索100的腱索主体110不能从人工腱索收容腔315中顺利通过，导致穿刺针头410与人工腱索100的固定件120连接后，不能将人工腱索100顺利拉出远端夹头310的夹持面。可以理解的是，在其他实施例中，固定腔313及人工腱索收容腔315的横截面还可以为椭圆形、三角形、四边形、多边形等其他形状，只要固定腔313的形状与固定件120的形状相互配合，且人工腱索收容腔315的形状不影响腱索主体110在其中顺滑通过即可。
为了将腱索主体110及防滑件130均顺利地拉出远端夹头310的夹持面，固定腔313与收容槽314之间径向连通。优选地，固定腔313与收容槽314之间的连通部分的宽度D3是D1的20％-50％，如此设置的目的是：如果D3过大，人工腱索100的固定件120不能牢固地固定在远端夹头310的固定腔313内，容易从固定腔313内滑脱，直接导致人工腱索植入系统失效；如果D3过小，在穿刺针头410与人工腱索100的固定件120连接之后， 不能顺畅地将固定件120从固定腔313内拉出，导致手术失败。
可以理解的是，位于夹持推杆330另一侧的固定腔313a、收容槽314a及人工腱索收容腔315a的尺寸设置与前述的固定腔313、收容槽314及人工腱索收容腔315的尺寸设置完全相同，在此不再赘述。
实施例一提供的双侧人工腱索植入系统与现有技术相比，至少具有以下有益效果：
(1)穿刺针头采用带有直尖端的锥形结构，穿刺针头直径较小，在瓣叶上形成的穿刺点较小，减轻对瓣叶的损伤，加快患者的术后愈合过程；
(2)穿刺针头与人工腱索的固定件通过夹持装置实现定位，可以有效地提高两者的成功连接的概率，从而缩短手术时间；
(3)穿刺针头与人工腱索能形成稳定可靠的间接连接，使得人工腱索不易与穿刺针头脱离，方便快捷地将人工腱索拉至预定位置；
(4)夹持推杆设置在推送导管的大致中心轴处，至少一对穿刺推杆关于夹持推杆呈对称设置，可通过近端夹头与远端夹头之间的相对运动同时夹持二尖瓣的前叶和后叶，进而同时在二尖瓣的前叶和后叶中植入人工腱索，大大缩短手术时间，提高手术效率。
实施例二
实施例二的双侧人工腱索植入系统的结构与实施例一的双侧人工腱索植入系统的结构基本相同，区别之处在于，实施例二的双侧人工腱索植入系统中，穿刺装置包括两对穿刺推杆及分别设于穿刺推杆远端的穿刺针头，且人工腱索的结构与实施例一的人工腱索的结构不同。
具体地，如图13所示，实施例二的双侧人工腱索植入系统中，穿刺装置400包括两对穿刺推杆420及设于每根穿刺推杆420远端的穿刺针头410。两根人工腱索100分别容置在夹持推杆330中，且每根人工腱索100均采用图6的形式，即腱索主体110的两端均设有固定件120。
参见图14，推送导管210中设置四个穿刺推杆通道202，每个穿刺推杆通道202中活动地穿装一根穿刺推杆420。由此，每两根穿刺推杆420为一对，设于推送导管210的一侧(以下称为“第一侧”)，另两根作为另一对，设于推送导管210的与第一侧相对的另一侧(以下称为“第二侧”)，且每对中的两根穿刺推杆420关于推送导管210的中心轴呈对称设置。为了便于操作，每对中的两根穿刺推杆420的近端连接至同一个手柄401。
夹持推杆330活动地穿装在推送导管210的夹持推杆通道203内，并位于大致中心轴处，由此，四根穿刺推杆420关于夹持推杆330呈对称设置。夹持推杆330内沿轴向设置人工腱索通道331。两条人工腱索100均容纳在夹持推杆330的人工腱索通道331中。四 个固定件120均设置在远端夹头310中，并分别对应于四根穿刺推杆420远端的四个穿刺针头410。
如图15至图17所示，远端夹头310中设有四个分别贯通至远端夹头310的夹持面的人工腱索收容腔315，且四个人工腱索收容腔315关于夹持推杆330(即，推送导管210的中心轴)呈对称设置，即，四个人工腱索收容腔315中，每两个为一对，设于远端夹头310的一侧(以下称为“第一侧”)，另两个作为另一对，设于远端夹头310的与第一侧相对的另一侧(以下称为“第二侧”)。每个人工腱索收容腔315的远端与一个固定腔313轴向相连通，每个人工腱索收容腔315的直径D2和与其相连的固定腔313的直径D1之比范围为(0.2～0.4)∶1。
位于第一侧的两个固定腔313之间径向连通，位于第二侧的两个固定腔313之间径向连通。位于第一侧的两个人工腱索收容腔315之间径向连通，位于第二侧的两个人工腱索收容腔315之间径向连通。一根人工腱索100的腱索主体110收容于人工腱索通道331及位于远端夹头310第一侧的两个人工腱索收容腔315中，另一根人工腱索100的腱索主体110收容于人工腱索通道331及位于远端夹头310第二侧的两个人工腱索收容腔315中。即，每条腱索主体110的第一端及第二端经人工腱索通道331穿出后分别经位于远端夹头310同一侧的两个人工腱索收容腔315穿出并分别与一个容置于固定腔313中的固定件120相连。
由此，当操作者向远端分别推送四根穿刺推杆420，位于四根穿刺推杆420远端的四个穿刺针头410分别穿刺二尖瓣的前叶和后叶后，位于第一侧的两个穿刺针头410分别与位于第一侧的两个固定件120相连，位于第二侧的两个穿刺针头410分别与位于第二侧的两个固定件120相连，使得一条腱索主体110及设于该条腱索主体110两端的两个固定件120及两个穿刺针头410形成U形结构，另一条腱索主体110及设于该条腱索主体110两端的两个固定件120及两个穿刺针头410也形成U形结构，之后操作者向近端后撤四根穿刺推杆420，可带动两条腱索主体110分别自远端夹头310的近端面被拉出，两条腱索主体110的一部分分别贴合至二尖瓣的前叶和后叶的上表面，腱索主体110的其余部分则跟随固定件120及穿刺针头410分别穿过前叶和后叶直至到达心室壁或乳突肌的预定位置。故，本实施例的双侧人工腱索植入系统可分别在二尖瓣的前叶和后叶与心室壁或乳突肌之间快速便捷地植入四根人工腱索100，且避免腱索主体110对瓣叶的垂直切割效应导致瓣叶损伤。
本实施例中的人工腱索100上还设有防滑件130。再次参见图6，片状的防滑件130上设置至少两个通孔131，一条人工腱索100的腱索主体110的第一端和第二端分别穿过防滑件130的其中一个通孔131后与一个固定件120相连。由此，在穿刺前，腱索主体110及 防滑件130形成环形的闭合状态。在穿刺后，防滑件130、腱索主体110、两个固定件120及两个穿刺针头410形成开环的U形状态。且腱索主体110压住防滑件130使防滑件130紧贴在瓣叶的上表面，腱索主体110及防滑件130与瓣叶之间的相对位置基本固定，避免植入的腱索主体110导致瓣叶撕裂。
再次参见图15至图17，远端夹头310的近端面还开设有用于收容防滑件130的两个收容槽314，两个收容槽314关于夹持推杆330(即，推送导管210的中心轴)呈对称设置。位于远端夹头310的第一侧的两个固定腔313分别与位于该侧的收容槽314之间径向连通，位于远端夹头310的第二侧的两个固定腔313分别与位于该侧的收容槽314之间径向连通。由此，穿刺后可将位于同一侧的腱索主体110、两个固定件120及防滑件130一并拉出远端夹头310的近端面。优选地，每侧的固定腔313与收容槽314之间的连通部分的宽度D3是固定腔313直径D1的20％-50％。
实施例二的双侧人工腱索植入系统与现有技术相比，至少具有以下有益效果：
(1)可以同时在二尖瓣的前叶和后叶快速植入多根人工腱索，提高手术效率；
(2)不仅可以通过防滑件将人工腱索与瓣叶的点接触增大为面接触，而且可以避免人工腱索的末端从防滑件和瓣叶上脱落，更加有效地维持手术效果；
(3)腱索主体将防滑件紧贴至瓣叶的上表面，腱索主体及防滑件与瓣叶之间的固定方式较为牢固可靠，有效避免瓣叶撕裂或者腱索主体及防滑件自瓣叶表面脱落的风险，手术效果较好。
实施例三
实施例三的双侧人工腱索植入系统的结构与实施例二的双侧人工腱索植入系统的结构基本相同，区别之处在于，实施例三的双侧人工腱索植入系统中还包括夹持辅助装置。
具体地，参见图18，双侧人工腱索植入系统包括夹持装置300、穿刺装置400、推送装置200及夹持辅助装置500。夹持装置300的夹持推杆330位于推送导管210的大致中心轴处。夹持辅助装置500包括至少一对活动地穿装于推送导管210中的夹持辅助臂520及分别设于夹持辅助臂520远端的夹持辅助件510。每对夹持辅助臂520关于夹持推杆330(即，推送导管210的中心轴)呈对称设置。为了方便推送，在夹持辅助臂520近端还可设置第四手柄501。本实施例中，设置一对夹持辅助臂520，两个夹持辅助臂520活动地穿装在推送导管210中且关于夹持推杆330呈对称设置，每个夹持辅助臂520的远端设有夹持辅助件510。
如图19至图21所示，在推送导管210中沿轴向设有辅助臂收容腔250。在穿刺前，夹持辅助件510和夹持辅助臂520都收容在辅助臂收容腔250中。在近端夹头320的远端 面上、推送导管210的侧壁或者近端夹头320的侧壁设置有开口260，开口260与辅助臂收容腔250相贯通。当操作者向远端推送第四手柄501，可驱动夹持辅助臂520推动夹持辅助件510从开口260中穿出，从而支撑在瓣叶的下表面，稳定搏动的瓣叶，减小瓣叶的活动幅度，与夹持装置300配合以夹持并固定瓣叶。
优选地，辅助臂收容腔250远端部的轴向与推送导管210的轴向之间的夹角范围为120-150°。这样设置的原因是，穿刺前，夹持推杆330与瓣叶边缘接触，远端夹头310与近端夹头320仅能夹住部分瓣叶，此时为了尽量让搏动的瓣叶保持稳定便于穿刺，需在每片瓣叶的与边缘相对的另一侧提供支撑力，因此需要使夹持辅助件510与推送导管210之间具有一定夹角，方可支撑在每片瓣叶的与瓣叶边缘相对的另一侧的下表面。
如图22至图23所示，夹持辅助件510支撑在瓣叶下表面并与夹持装置300配合夹持瓣叶。夹持辅助件510由弹性和/或柔性材料制成，以适应瓣叶的解剖结构及瓣叶的活动幅度，并避免损伤瓣叶。弹性材料优选为形状记忆材料。夹持辅助件510可以由金属材料、聚合物材料或者金属-聚合物复合材料制成。本实施例中夹持辅助件510为一根杆状体。杆状体可以为单层或者多层复合结构的实心或空心结构，还可以由单根丝或者多根丝绕制而成。杆状体的截面可以为规则的圆形或者椭圆形、月牙形、半圆形、多边形等形状。夹持辅助件510外形光滑，远端通过激光点焊形成光滑的圆头，没有毛刺、棱边或棱角等缺陷。本实施例中，夹持辅助件510由带有形状记忆功能的弹性镍钛合金制成，横截面为圆形。
夹持辅助臂520为具有一定轴向长度的杆状或管状，且具有一定硬度或刚度以提供支撑性及可推送性。夹持辅助臂520可以由单层或者多层复合结构的空心或实心结构的金属杆或高分子材料杆制成，还可以由单根丝或者多根丝绕制而成。夹持辅助臂520的截面可以为规则的圆形或者椭圆形、月牙形、半圆形、多边形或者环形等形状。夹持辅助臂520可以由金属材料、聚合物材料或者金属-聚合物复合材料制成。本实施例中，夹持辅助臂520由带有记忆功能的弹性材料而成，截面为圆形。
夹持辅助臂520的支撑性及夹持辅助件510的柔软性可以通过使用不同的材料分别制成夹持辅助件510和夹持辅助臂520来达到。即，夹持辅助臂520由硬质材料制成；夹持辅助件510采用弹性和/或柔性材料制成。可以理解的是，也可以先使用相同的材料制作夹持辅助臂520及夹持辅助件510，然后在夹持辅助臂520的外部和/或内部增设硬度较高的材料作为加强管或者加硬衬丝以保证夹持辅助臂520的支撑性。如图23所示，夹持辅助臂520由较柔软的内管521及较硬的外管522组成。
优选地，夹持辅助件510由不透射X射线材料制成。现有技术中，在夹持装置夹持住瓣叶之前，不能通过X射线等操作要求级别较低的方式判断器械与瓣叶之间的相对位置， 必须依赖精准的超声引导才能将夹持装置移动至适宜的位置，并通过超声观察瓣叶的搏动状态，待瓣叶搏动至靠近夹持装置时迅速驱动远端夹头与近端夹头之间的相对运动以夹持瓣叶。超声对医生的操作技术以及心脏超声图像的分析能力有较高的要求，导致手术成本增加，手术难度增大，手术时间增长。由于本实施例的夹持辅助件510由不透射X射线材料制成，在夹持辅助件510与瓣叶接触后，柔性和/或弹性的夹持辅助件510伴随瓣叶的活动幅度产生相应的摆动，因此在夹持装置300夹持住瓣叶之前，操作者可以通过X射线快速准确地判断瓣叶的位置，从而更快速准确地操作夹持装置300以夹持瓣叶，降低手术成本及难度，缩短手术时间，提高手术成功率。
可以理解的是，在其他实施例中，为了增强夹持辅助装置500的强度，夹持辅助件510还可以是由多根杆状体构成的变形结构。变形结构收缩变形后与夹持辅助臂520共同收容于推送导管210中。例如，变形结构为由多根杆状体构成的开放式的分叉结构或者伞状结构。为了便于在推送导管210中被推送，夹持辅助件510具有压缩状态及自然状态时的伸展状态。夹持辅助件510在压缩状态时，可收容在推送导管210的辅助臂收容腔250中并被推送；当夹持辅助件510由设于近端夹头320的夹持面、推送导管210的侧壁或者近端夹头320的侧壁的开口260中伸出后，转变为伸展状态，可支撑在瓣叶的下表面，稳定搏动的瓣叶。这种直径较大的夹持辅助件510与瓣叶的接触面即为夹持辅助件510所在的平面，因此，夹持辅助装置500与瓣叶之间的接触面积更大，可以更好的贴合瓣叶，提高夹持辅助装置500对瓣叶的支撑性。
还可以理解的是，在其他实施例中，分叉结构或者伞状结构的夹持辅助件510的末端可以向夹持辅助臂520近端方向翻卷，多个夹持辅助件510形成一个凹陷区，如图24所示。此时，由于每个夹持辅助件510末端均向内翻卷并指向夹持辅助臂520近端方向，可避免夹持辅助件510的支撑杆末端刺伤瓣叶或者心室壁。
还可以理解的是，在其他实施例中，变形结构还可以是由多根支撑杆构成的闭环结构，闭环结构可以是圆形、菱形、椭圆形、梨形、多边形或者其他不规则但可以形成封闭结构的形状，如图25所示。还可以理解的是，在其他实施例中，闭环结构的支撑杆之间还可以设置至少一根具有柔性和/或弹性的连接杆，以提高闭环结构的自身稳定性，进一步增强夹持辅助件510对瓣叶的支撑力。还可以理解的是，在其他实施例中，当在闭环结构中设置多根支撑杆及连接杆时，闭环结构还可以形成片状结构或网状结构。还可以理解的是，在其他实施例中，还可以对网状结构进行热定型处理，使网状结构形成可拉伸变形的盘状结构(类似于现有技术中的单盘封堵器)，盘状结构可以进一步热定型处理形成柱状、巢状、扁圆状等结构。只要夹持辅助件510由形状记忆材料制成，即可收容在推送导管210的辅 助臂收容腔250中并被输送，再通过开口260伸出，恢复至自然展开状态，与瓣叶下表面接触并对瓣叶提供支撑。
以下以二尖瓣的前叶和后叶同时夹持的双侧人工腱索植入术为例，说明本实施例提供的双侧人工腱索植入系统的实施过程：
第一步，参见图26，将双侧人工腱索植入系统穿过二尖瓣推进至左心室内；
第二步，参见图27，继续推进双侧人工腱索植入系统直至远端夹头310及近端夹头320均位于左心房内，向远端推送第二手柄301，第二手柄301带动夹持推杆330相对于推送导管210向远端移动，位于夹持推杆330远端的远端夹头310与位于推送导管210远端的近端夹头320分离，此时近端夹头320与远端夹头310之间形成中空圆柱形的瓣叶容纳空间；
第三步，参见图28，向远端推动第四手柄501，第四手柄501驱动夹持辅助臂520推送夹持辅助件510从开口260中穿出，此时两个夹持辅助件510分别支撑在二尖瓣的前叶和后叶下表面以协助稳定搏动的瓣叶，保持第一手柄201与第二手柄301之间的相对位置不变，向近端缓慢移动整个人工腱索植入系统，直至二尖瓣的前叶和后叶均进入近端夹头320与远端夹头310之间的瓣叶容纳空间中，此时两个夹持辅助件510可以对二尖瓣的前叶和后叶分别提供一定的支撑力；
第四步，参见图29，微调双侧人工腱索植入系统的远端，直至二尖瓣的前叶和后叶的边缘均与夹持推杆330接触，此时向近端后撤第二手柄301，驱动远端夹头310向近端夹头320移动直至二者闭合，二尖瓣的前叶和后叶均被夹持；
第五步，向远端推送第三手柄401，驱动四个穿刺针头410分别沿推送导管210的轴向向远端夹头310移动，直至四个穿刺针头410分别穿过二尖瓣的前叶和后叶，并分别与设置在远端夹头310中的四个固定件120之间形成固定连接；
第六步，参见图30，后撤第三手柄401，使得穿刺针头410带动固定件120、与固定件120相连的腱索主体110依次穿过瓣叶，防滑件130也自远端夹头310的近端面被拉出，两个防滑件130的贴合面132(即，下表面)分别与二尖瓣的前叶和后叶的上表面接触，同时每条腱索主体110分别压住两个防滑件130的上表面使其分别贴合二尖瓣的前叶和后叶(如图31所示)，此时，人工腱索100与瓣叶之间的点接触被转变为防滑件130与瓣叶之间的面接触，可有效降低瓣叶900撕裂的风险；
第七步，参见图31，继续后撤第三手柄401直至固定件120自推送导管210的近端撤出，后撤第四手柄501，带动夹持辅助件510回撤至辅助臂收容腔250中，撤出整个双侧人工腱索植入系统，并调整留在心脏内的腱索主体110的长度，将腱索主体110的两端分 别固定在心室壁或乳突肌的预定位置，如图32所示，完成二尖瓣的前叶和后叶的双侧人工腱索植入。
在第四步中，如操作者发现瓣叶未被有效夹持，此时可以微调远端夹头310与近端夹头320的相对位置使得二者之间产生一定距离，再调整夹持推杆330与瓣叶之间的相对位置，再次操作夹持装置300以夹持瓣叶，再进行第五步的手术操作。在调整的过程中，由于瓣叶下方的夹持辅助装置500对瓣叶具有一定的支撑作用，可以防止瓣叶从夹持装置300中滑脱。
可以理解的是，在第四步中，当在前叶和后叶分别植入人工腱索后，可以将两组人工腱索固定在一起，从而将前叶和后叶拉向彼此，缩短二者之间的间隙，使二尖瓣形成“双孔化”结构，实现二尖瓣的“缘对缘”修复。
综上，本发明的双侧人工腱索植入系统由于将夹持推杆设置在推送导管的大致中心轴处，且将至少一对穿刺推杆设置在推送导管中并关于夹持推杆对称设置，因此通过近端夹头与远端夹头之间的相对运动可同时夹持二尖瓣的前叶和后叶，进而同时在二尖瓣的前叶和后叶植入人工腱索，大大缩短手术时间，提高手术效率。此外，当在前叶和后叶分别植入人工腱索后，可以将两组人工腱索固定在一起，从而将前叶和后叶拉向彼此，缩短二者之间的间隙，使二尖瓣形成“双孔化”结构，实现二尖瓣的“缘对缘”修复。
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (13)

  1. 一种双侧人工腱索植入系统，包括夹持装置、穿刺装置和推送装置，所述推送装置包括推送导管，所述夹持装置包括夹持推杆及用于配合夹持瓣叶的远端夹头和近端夹头，所述近端夹头设置在所述推送导管的远端，所述远端夹头设置在所述夹持推杆的远端，其特征在于，所述夹持推杆活动地穿装在所述推送导管的大致中心轴处，所述穿刺装置包括至少一对穿刺推杆及分别设于所述穿刺推杆远端的穿刺针头，所述穿刺推杆活动地穿装在所述推送导管中且关于所述夹持推杆呈对称设置。
  2. 根据权利要求1所述的双侧人工腱索植入系统，其特征在于，所述穿刺针头的远端为锥形的直尖端。
  3. 根据权利要求1所述的双侧人工腱索植入系统，其特征在于，所述推送导管的直径范围为10mm至12mm。
  4. 根据权利要求1所述的双侧人工腱索植入系统，其特征在于，所述双侧人工腱索植入系统还包括至少一对人工腱索，每根人工腱索均包括一段具有柔性的腱索主体，所述腱索主体具有相对的第一端和第二端，所述第一端和/或所述第二端连接有固定件，所述固定件用于与所述穿刺针头不可拆卸连接或可拆卸连接。
  5. 根据权利要求4所述的双侧人工腱索植入系统，其特征在于，所述腱索主体容置于所述夹持推杆及所述远端夹头中，所述固定件容置于所述远端夹头中，且每个固定件的近端分别对应一个穿刺针头。
  6. 根据权利要求5所述的双侧人工腱索植入系统，其特征在于，所述夹持推杆中沿轴向设有人工腱索通道，所述远端夹头中设有人工腱索收容腔，所述人工腱索收容腔贯通至所述远端夹头的近端面，所述人工腱索通道与所述人工腱索收容腔相连通，所述腱索主体收容于所述人工腱索通道及所述人工腱索收容腔中。
  7. 根据权利要求6所述的双侧人工腱索植入系统，其特征在于，所述远端夹头的近端面设有用于容置所述固定件的固定腔，所述固定腔与所述人工腱索收容腔之间轴向连通。
  8. 根据权利要求7所述的双侧人工腱索植入系统，其特征在于，所述固定腔的形状与所述固定件的形状相配合，且所述固定腔的内切圆的直径大于所述人工腱索收容腔的外接圆的直径。
  9. 根据权利要求4所述的双侧人工腱索植入系统，其特征在于，所述腱索主体上还套设有防滑件，所述防滑件设有与瓣叶贴合的贴合面，所述防滑件沿所述腱索主体的轴向滑动。
  10. 根据权利要求9所述的双侧人工腱索植入系统，其特征在于，所述远端夹头中设 有人工腱索收容腔，所述远端夹头的夹持面设有用于容置所述固定件的固定腔及用于收容所述防滑件的收容槽，所述收容槽与所述人工腱索收容腔之间径向连通，所述收容槽与所述固定腔之间径向连通。
  11. 根据权利要求1所述的双侧人工腱索植入系统，其特征在于，所述双侧人工腱索植入系统还包括夹持辅助装置；所述夹持辅助装置包括活动地穿装于所述推送导管中的至少两个夹持辅助臂及分别设于所述夹持辅助臂远端的夹持辅助件；所述至少两个夹持辅助臂关于所述夹持推杆呈对称设置；所述夹持辅助件由弹性和/或柔性材料制成；所述夹持辅助臂推动与其相连的所述夹持辅助件从所述推送导管远端或所述夹持装置远端穿出，所述夹持辅助件与所述夹持装置配合夹持瓣叶。
  12. 根据权利要求11所述的双侧人工腱索植入系统，其特征在于，所述推送导管内沿轴向设有辅助臂收容腔，所述辅助臂收容腔的远端部的轴向与所述推送导管的轴向之间的夹角范围为120-150°。
  13. 根据权利要求11所述的双侧人工腱索植入系统，其特征在于，所述夹持辅助件由不透射X射线材料制成。
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT202000006286A1 (it) * 2020-03-25 2021-09-25 Pfm Medical Ag System zur implantation eines medizinischen implantats im menschlichen oder tierischen körper
US11147673B2 (en) 2018-05-22 2021-10-19 Boston Scientific Scimed, Inc. Percutaneous papillary muscle relocation
US11672661B2 (en) 2019-08-22 2023-06-13 Silara Medtech Inc. Annuloplasty systems and methods

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112773472B (zh) * 2019-12-02 2021-11-09 北京领健医疗科技有限公司 穿刺针、耦合器、导引装置及修复器械
WO2021109616A1 (zh) * 2019-12-06 2021-06-10 杭州德晋医疗科技有限公司 瓣膜缝线器及瓣膜修复缝线装置

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080195126A1 (en) * 2007-02-14 2008-08-14 Jan Otto Solem Suture and method for repairing a heart
CN103347464A (zh) * 2010-12-29 2013-10-09 尼奥绰德有限公司 微创修复搏动心脏瓣膜小叶的可替换系统
CN104244841A (zh) * 2012-03-06 2014-12-24 海莱夫简易股份公司 具备环绕功能的医疗导管件
US20160113769A1 (en) * 2010-11-18 2016-04-28 Pavilion Medical Innovations, Llc Tissue restraining devices and methods of use
CN107569301A (zh) * 2017-07-31 2018-01-12 天之纬医疗科技(上海)有限公司 人工腱索及其人工腱索植入系统
CN108186163A (zh) * 2017-11-07 2018-06-22 杭州德晋医疗科技有限公司 带探测装置的人工腱索植入系统

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2876923B1 (fr) * 2004-10-26 2007-03-30 Millipore Corp Aiguille de prelevement double et procede pour sa realisation.
JP5357167B2 (ja) * 2007-10-18 2013-12-04 ネオコード インコーポレイテッド 侵襲性を最小限に抑えた拍動する心臓内の弁尖を修復するための器具
US9414816B2 (en) * 2011-06-23 2016-08-16 Devicor Medical Products, Inc. Introducer for biopsy device
US20160051252A1 (en) * 2014-08-21 2016-02-25 Boston Scientific Scimed, Inc. Anchors and cinching for tissue opposition
CN104436418A (zh) * 2014-12-20 2015-03-25 周化庆 可测颅压的颅内血肿引流管
CN104665888A (zh) * 2015-02-16 2015-06-03 江苏大学 一种微创植入人工腱索的二尖瓣腱索缝纫机及其方法
CN104873307A (zh) * 2015-06-02 2015-09-02 北京迈迪顶峰医疗科技有限公司 瓣膜修复装置
WO2017059426A1 (en) * 2015-10-02 2017-04-06 Harpoon Medical, Inc. Distal anchor apparatus and methods for mitral valve repair
CN106859721B (zh) * 2017-01-12 2019-04-26 上海心瑞医疗科技有限公司 一种隔离装置预装载的介入系统
CN106974721A (zh) * 2017-04-25 2017-07-25 姜树东 可同时双侧注射骨水泥的椎体成形（pvp)操作系统

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080195126A1 (en) * 2007-02-14 2008-08-14 Jan Otto Solem Suture and method for repairing a heart
US20160113769A1 (en) * 2010-11-18 2016-04-28 Pavilion Medical Innovations, Llc Tissue restraining devices and methods of use
CN103347464A (zh) * 2010-12-29 2013-10-09 尼奥绰德有限公司 微创修复搏动心脏瓣膜小叶的可替换系统
CN104244841A (zh) * 2012-03-06 2014-12-24 海莱夫简易股份公司 具备环绕功能的医疗导管件
CN107569301A (zh) * 2017-07-31 2018-01-12 天之纬医疗科技(上海)有限公司 人工腱索及其人工腱索植入系统
CN108186163A (zh) * 2017-11-07 2018-06-22 杭州德晋医疗科技有限公司 带探测装置的人工腱索植入系统

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11147673B2 (en) 2018-05-22 2021-10-19 Boston Scientific Scimed, Inc. Percutaneous papillary muscle relocation
US11678988B2 (en) 2018-05-22 2023-06-20 Boston Scientific Scimed, Inc. Percutaneous papillary muscle relocation
US11672661B2 (en) 2019-08-22 2023-06-13 Silara Medtech Inc. Annuloplasty systems and methods
IT202000006286A1 (it) * 2020-03-25 2021-09-25 Pfm Medical Ag System zur implantation eines medizinischen implantats im menschlichen oder tierischen körper
WO2021191129A1 (de) * 2020-03-25 2021-09-30 Pfm Medical Ag System zur implantation eines medizinischen implantats im menschlichen oder tierischen körper

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