WO2019024725A1 - 人工腱索及人工腱索植入系统 - Google Patents

人工腱索及人工腱索植入系统 Download PDF

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Publication number
WO2019024725A1
WO2019024725A1 PCT/CN2018/096901 CN2018096901W WO2019024725A1 WO 2019024725 A1 WO2019024725 A1 WO 2019024725A1 CN 2018096901 W CN2018096901 W CN 2018096901W WO 2019024725 A1 WO2019024725 A1 WO 2019024725A1
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WO
WIPO (PCT)
Prior art keywords
artificial
chord
puncture
clamping
puncture needle
Prior art date
Application number
PCT/CN2018/096901
Other languages
English (en)
French (fr)
Inventor
张庭超
张伟伟
周春远
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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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
Priority to EP18840531.0A priority Critical patent/EP3662865A4/en
Publication of WO2019024725A1 publication Critical patent/WO2019024725A1/zh
Priority to US16/749,188 priority patent/US11547565B2/en

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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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0406—Pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0472—Multiple-needled, e.g. double-needled, instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0495—Reinforcements for suture lines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06042—Means for attaching suture to needle located close to needle tip
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Definitions

  • the invention relates to the technical field of medical instruments, and relates to a device for repairing a heart valve defect, in particular to an artificial chordae and an 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
  • CT chordae
  • 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
  • chordae rupture As shown in Figure 2, when the left ventricle is in a contracted state, the mitral valve cannot return to a closed state as in the normal state, and the impulse of blood flow will further cause the valve. Leaves detached into the left atrium, causing blood to flow back.
  • chordae lesions are usually used to treat chordae lesions.
  • Invasive thoracotomy is required, and general anesthesia and moderate hypothermic cardiopulmonary bypass are used 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 capture assembly, the needle with the hooked end is passed through the leaflet and hooked Take the suture as the artificial chord, then withdraw the needle to drive the artificial chord through the leaflet, and then fix one end of the artificial chord on the ventricular wall.
  • the device has the following problems: the probability of the needle picking the artificial chord is relatively low, resulting in a low success rate of surgery and prolonging the operation time.
  • the technical problem to be solved by the present invention is to provide a manual chord that can form a stable connection with the puncture needle in view of the above-mentioned drawbacks in the prior art.
  • a further technical problem to be solved by the present invention is to provide an artificial chordae implantation system capable of reliably connecting artificial chordae.
  • An artificial chord comprising a flexible chord body, at least one end of which is connected with a fixing member for connecting with a puncture needle, and the fixing member is provided on a side facing away from the chord body for A puncture connector that is connected to the puncture needle.
  • the fixing member is provided with a receiving cavity for accommodating the puncture needle
  • the puncture connector is a thread, an adhesive layer, a rough surface, or At least one groove or hole that forms an interference fit, a snap connection or a key connection with the puncture needle.
  • chord body is sleeved with a slip preventing member, and the slip preventing member slides along an axial direction of the chord body.
  • a through hole is disposed on the anti-slip member, and the sling body passes through the through hole;
  • two through holes are disposed on the anti-slip member, and two ends of the chord body respectively pass through the through holes; or at least two through holes are disposed on the anti-slip member, and at least two of the chord bodies are respectively Pass through the at least two through holes.
  • the anti-slip member is blocked by the fixing member.
  • the slip preventing member is provided with a fitting surface that is attached to the leaflet.
  • An artificial chordae implantation system includes a clamping device, a puncturing device and a pushing device, the pushing device comprising a pushing catheter, the pushing catheter is provided with a plurality of penetrating lumens in the axial direction, the puncturing device and the device
  • the clamping devices are respectively movably mounted in different lumens in the push catheter;
  • the clamping device includes a clamping pusher and a distal collet and a proximal collet for engaging the leaflets, The proximal collet is disposed at a distal end of the push catheter, and the distal collet is disposed at a distal end of the clamping pusher;
  • the puncture device includes a puncture needle, the distal end of the puncture needle being a tapered straight tip;
  • the artificial chord is housed in the clamping device, and the artificial chord includes a flexible chord body, and at least one end of the chord body is connected with a fixing member for connecting with the puncturing needle.
  • the side of the fixing member facing away from the chord body is provided with a puncture connector, and the puncture needle is further provided with a chord connector connected to the puncture connector.
  • chord connector is at least one convex tooth disposed at a distal end of the puncturing needle and forming an interference fit, a snap connection or a key connection with the puncturing connector Or at least one circle of convex edges;
  • chord connector is a thread, a bonding layer or a rough surface provided on an outer surface of the puncturing needle.
  • the proximal end of the distal collet is provided with a clamping surface
  • the puncturing device comprises a puncture needle and a puncture push rod connected with the puncture needle, the puncture push a rod is inserted into the inner cavity of the pushing duct, and a manual cable passage is arranged in the axial direction of the clamping push rod, and a manual cable receiving cavity is arranged in the distal chuck, and the artificial cable is provided
  • the distal end of the receiving cavity penetrates to the clamping surface, the artificial cable channel communicates with the artificial cable receiving cavity, and the artificial cable is accommodated in the artificial cable channel and the artificial cable In the containment chamber.
  • the chord body is sleeved with a non-slip member sliding along the axial direction of the chord body, and the clamping surface of the distal collet is provided with a non-slip member for accommodating the anti-slip member.
  • the receiving slot has a radial communication between the receiving slot and the artificial cable receiving cavity.
  • the fixing member is received in the distal collet, and the fixing member corresponds to the puncture needle.
  • the clamping surface of the distal collet is provided with a fixing cavity for accommodating the fixing member, and the axial direction between the fixing cavity and the artificial sling receiving cavity In communication, the fixed cavity and the receiving groove are in radial communication.
  • the shape of the fixed cavity corresponds to the shape of the fixing member, and the diameter of the inscribed circle of the fixed cavity is larger than the circumcircle of the artificial chord receiving cavity diameter.
  • the distal end of the proximal collet is provided with a clamping surface, and the clamping surface of the proximal collet and the clamping surface of the distal collet are adhered to each other At least one of the clamping faces is provided with a clamping reinforcement for enhancing the clamping force.
  • the clamping reinforcement is selected from at least one of a protrusion, a rib, a groove or a recess provided on the clamping surface.
  • the proximal end of the distal collet is provided with a clamping surface
  • the puncturing device comprises two puncture needles and two puncture push rods respectively connected to the two puncture needles
  • the puncturing push rod is inserted into the inner cavity of the pusher catheter, and two ends of the chord body of the artificial chord are respectively provided with a fixing member, and two fixing members are accommodated in the distal collet;
  • the puncture needles of one puncture device respectively correspond to two fixing members.
  • the artificial sling channel is axially disposed in the clamping pusher, and the distal collet is provided with two clamping portions respectively penetrating to the distal collet
  • the artificial chord receiving cavity of the surface, the two artificial sling receiving cavities respectively communicate with the artificial chord passage, and the two artificial chord receiving cavities are in radial communication, and the two chord bodies are The end passes through the artificial chord passage and is respectively passed through the two artificial chord receiving chambers and connected to the two fixing members.
  • the clamping surface of the distal collet defines two fixing cavities for accommodating the fixing members, and each of the fixing cavities and the two artificial chord accommodating cavities respectively
  • the axial communication is continuous, and the two fixed cavities are in radial communication.
  • the chord body of the artificial chord is sleeved with a non-slip member, and the anti-slip member is provided with two through holes, and the two ends of the chord body respectively pass through the Said through hole.
  • the clamping surface of the distal collet is provided with two fixing cavities for accommodating the fixing members and a receiving groove for accommodating the anti-slip members, each The fixing cavity is in radial communication with the receiving slot, and the receiving slot is in radial communication with the two artificial cable receiving cavity.
  • the proximal end of the push catheter is provided with a first handle
  • the proximal end of the clamp push rod is provided with a second handle
  • the proximal end of the puncturing device is provided with a third a handle
  • the second handle drives the clamping device to move axially along the pushing catheter
  • the third handle drives the puncture needle to move axially along the pushing catheter.
  • the present invention has at least the following beneficial effects:
  • the chord body is provided with a fixing member connectable to the puncturing needle, whereby although there is no direct contact between the puncturing needle and the artificial chord, the puncturing needle is connected to the fixing member.
  • the artificial chord is connected with the puncture needle to improve the reliability of the connection between the artificial chord and the puncture needle. During the retraction of the puncture needle, the artificial chord can be prevented from falling off the puncture needle.
  • the puncture needle is a conical straight tip, and the puncture needle of the present invention has a smaller diameter and a smaller puncture point formed on the leaflet than the hook needle of the prior art.
  • the diameter of the puncture point can be controlled from 0.3mm to 1.5mm, which can reduce the damage to the leaflets and accelerate the postoperative healing process.
  • the fixing of the puncture needle and the artificial chord is realized by the clamping device, which can effectively improve the probability of successful connection between the puncture needle and the fixing member, thereby shortening the operation time.
  • the puncture needle and the artificial chord can form a stable and reliable indirect connection, so that the artificial chord is not easily detached from the puncture needle, and the artificial chord is conveniently and quickly pulled to a fixed position.
  • 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 first embodiment of the artificial chordae of the present invention.
  • FIG. 4 is a schematic structural view of a second embodiment of the artificial chordae of the present invention.
  • Figure 5 is a schematic structural view of a third embodiment of the artificial chordae of the present invention.
  • FIG. 6 to 9 are schematic structural views of different embodiments of the fixing member of the artificial chordae of the present invention.
  • Figure 10 is a schematic structural view of a fourth embodiment of the artificial chordae of the present invention.
  • Figure 11 is a schematic view showing the structure of a first embodiment of the artificial chordae implantation system of the present invention.
  • Figure 12 is an exploded view of a first embodiment of the artificial chordae implantation system of the present invention.
  • Figure 13 is a schematic view showing the structure of the first embodiment of the artificial chordae implantation system of the present invention.
  • FIG. 14 is a schematic structural view of a first embodiment of a puncture needle of a first embodiment of the artificial chordae implantation system of the present invention.
  • Figure 15 is a schematic view showing the structure of the puncture needle of the artificial chordae implantation system of Figure 14 connected to the fixing member of the corresponding artificial chord;
  • Figure 16 is a schematic view showing the structure of a second embodiment of the puncture needle of the first embodiment of the artificial chordae implantation system of the present invention.
  • Figure 17 is a schematic view showing the structure of the puncture needle of Figure 16 connected to the fixing member of the corresponding artificial chord;
  • Figure 18 is a schematic view showing the structure of a third embodiment of the puncture needle of the first embodiment of the artificial chordae implantation system of the present invention.
  • Figure 19 is a schematic view showing the structure of the puncture needle of Figure 18 connected to the fixing member of the corresponding artificial chord;
  • FIG. 20 is a schematic structural view of a fourth embodiment of a puncture needle of a first embodiment of the artificial chordae implantation system of the present invention.
  • 21 is a schematic structural view showing the connection of the puncture needle of FIG. 20 to the fixing member of the corresponding artificial chord;
  • FIG. 22 is a schematic structural view of a clamping surface of a distal collet of a first embodiment of the artificial chordae implantation system of the present invention
  • Figure 23 is a cross-sectional view taken along line A-A of Figure 22;
  • Figure 24 is an exploded view of a second embodiment of the artificial chordae implantation system of the present invention.
  • FIG. 25 is a schematic structural view of a clamping surface of a distal collet of a second embodiment of the artificial chordae implantation system of the present invention.
  • Figure 26 is a cross-sectional view taken along line B-B of Figure 25;
  • 27 to 32 are schematic views showing the operation of implanting the artificial chordae into the heart in a second embodiment of the artificial chordae implantation system.
  • the orientation near the operator is generally defined as the proximal end, and the orientation away from the operator is defined as the distal end.
  • the artificial chord 100 of the present invention includes a length of chord body 110 having flexibility.
  • the chord body 110 is used to implant into the heart, replacing the lesion chordae within the heart.
  • the chord body 110 has opposite ends (i.e., the first end and the second end).
  • a fixing member 120 is connected to the first end of the chord body 110.
  • a side of the fastener 120 facing away from the chord body 110 is provided with a piercing connector for non-detachable or detachable connection with the lancet.
  • chord body 110 One end of the chord body 110 is fixed on the leaflet, and the other end can be fixed on the ventricular wall or the nipple muscle to replace the diseased chordae, maintaining the tension between the leaflet 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.
  • 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 disposed at one end of the chord body 110.
  • both ends of the chord body 110 may also be provided with a fixing member 120.
  • Various fixing methods such as knotting, winding, welding, bonding, and snapping may be used between the sling body 110 and the fixing member 120, which are not limited in the present invention.
  • one end of the chord body 110 may be knotted out of the fixture 120 to form a larger diameter coil; or the end may be welded to a larger diameter ball; or a positioning rod may be provided at the end.
  • the direction of the axis of the positioning rod in the natural state is different from the direction of the axis of the cable body 110 and the fixing member 120. After the positioning rod and the end of the cable body 110 pass through the fixing member 120, the positioning rod returns to the original state.
  • the back of the fixing member 120 can be locked, thereby fixing one end of the chord body 110 to the fixing member 120.
  • the second end should be knotted, entangled, or
  • the second end is provided with a spherical end, a disc-shaped end or the like such that the cross-sectional dimension of the second end is larger than the cross-sectional dimension of the chord body 110 to block the second end of the chord body 110 against the upper surface of the leaflet.
  • the fixing member 120 forms a detachable connection or a non-detachable connection with the puncture needle, and the shape of the fixing member 120 is matched with different connection manners. Since the distal end of the puncture needle is generally sharply tapered, there should be as large a contact area as possible between the fixture 120 and the outer surface of the puncture needle to form a stable connection. Therefore, the side of the fixing member 120 facing away from the chord body 110 is provided with a accommodating cavity 121 for accommodating the puncture needle.
  • the shape of the accommodating cavity 121 corresponds to the shape of the distal end of the puncturing needle.
  • the shape of the accommodating cavity 121 is generally tapered or cylindrical.
  • the fixing member 120 is generally a cylindrical body, and the cross-sectional shape may be various shapes such as a circle, an ellipse, a polygon, and the like, and a circular shape and an elliptical shape are generally preferable.
  • the fixing member 120 is provided with a receiving cavity 121, and the receiving cavity 121 is provided with a puncture connector 125 connected to the puncture needle.
  • the puncture connector 125 has a plurality of embodiments.
  • the first embodiment is that the puncture connector 125 is an internal thread that is screwed on the side wall of the accommodating cavity 121 and is screwed to the puncture needle. Corresponding external threads are provided on the outer surface of the corresponding puncture needle. That is, the detachable connection is formed between the puncture needle and the fixing member 120 by screwing.
  • the second embodiment is that the puncture connector 125 is an adhesive layer provided on the side wall of the accommodating cavity 121 and adhered to the puncture needle.
  • the biocompatible adhesive is applied to the sidewall of the accommodating cavity 121 of the fixing member 120 to form an adhesive layer, and the outer surface of the corresponding puncture needle is bonded and fixed to the fixing member 120 through the adhesive layer. Together, a non-detachable fixed connection is formed.
  • the third embodiment is that the puncture connector 125 is a rough surface provided on the side wall of the accommodating cavity 121 and frictionally connected with the puncture needle; preferably, the outer surface of the puncture needle is also provided with a rough surface. Cooperating with the rough surface of the side wall of the accommodating cavity 121, a detachable connection is formed by frictional resistance.
  • the rough surface may be a rough surface formed by a plurality of minute protrusions or ridges disposed on the side wall of the accommodating cavity 121 and/or the outer surface of the puncturing needle, or may directly face the side wall of the accommodating cavity 121 and/or
  • the outer surface of the puncture needle is roughened to obtain a rough surface, and the side wall of the accommodating cavity 121 and/or the outer surface of the puncture needle may be directly formed by using a material having a certain coefficient of friction.
  • the fourth embodiment is that the puncture connector 125 is at least one groove or hole formed in the sidewall of the accommodating cavity 121 to form an interference fit, a snap connection or a key connection with the puncture needle.
  • interference fit is that some or all of the wall shape of the groove or hole cooperates with a part or all of the shape of the puncture needle to form an interference fit in the size to form a detachable connection.
  • the snap connection refers to a groove or a hole provided in the side wall of the accommodating cavity 121, and is engaged with a protrusion or a convex edge provided on the puncture needle to form a non-detachable or detachable connection.
  • the structure is adopted.
  • at least one groove 125 is radially disposed on the side wall of the accommodating cavity 121 of the fixing member 120, and a card is inserted between the protruding edge provided on the puncture needle.
  • the hole or the groove may be a blind hole or a through hole as long as the shape thereof substantially matches the protrusion or the convex edge provided on the puncture needle to form a snap connection.
  • three recesses 125 are preferably provided to improve the stability of the connection between the fixing member 120 and the puncture needle, and to reduce the amplitude of the puncture needle can be shaken after the connection.
  • the key connection can select a key connection manner such as a flat key connection, a spline connection, and the like, and form a tight key connection, so that the tensile force can also be transmitted in the axial direction, and the key connection structure is a conventional technique, and details are not described herein again.
  • the risk of tearing the leaflets by the artificial tendon 100 is reduced, preferably
  • the anti-slip member 130 is sleeved on the chord body 110, and the anti-slip member 130 is axially slidable along the chord body 110.
  • the puncture needle punctures the leaflet and fixes the artificial chord 100
  • the anti-slip member 130 is previously disposed on the artificial chord 100, and the anti-slip member 130 can be pushed to the puncture point to fix the anti-slip member 130 together with the artificial sling 100.
  • the leaflets On the leaflets.
  • the specific arrangement of the anti-slip member 130 on the artificial chord 100 is that a through hole 131 is provided in the anti-slip member 130, and the chord body 110 passes through the through hole 131.
  • the second end should be knotted, wound or provided with a spherical end, a disc-shaped end, or the like.
  • the cross-sectional dimension of the second end is made larger than the cross-sectional dimension of the through hole 131 on the anti-skid member 130.
  • a slip preventing member 130 is disposed on each of the chord bodies 110.
  • a through hole 131 is provided in each of the anti-slip members 130 for a sling body 110 to pass through.
  • At least two through holes 131 are provided in the anti-slip member 130, and the first end and the second end of one of the chord bodies 110 respectively pass through the different through holes 131.
  • the anti-slip member 130 is provided with at least two through holes 131, and the chord bodies 110 of the at least two artificial chords 100 respectively pass through different through holes 131, that is, at least two artificial chords 100 share a non-slip. Piece 130.
  • the cross-sectional dimension of the through hole 131 in the slip preventing member 130 is smaller than the sectional size of the fixing member 120.
  • the diameter of the through hole 131 in the anti-slip member 130 is smaller than the diameter of the fixing member 120.
  • the free end of the chord body 110 that is not provided with the fixing member 120 should be knotted, or provided with a spherical end, a disc-shaped end or the like, such that the diameter of the free end is larger than the diameter of the through hole 131 on the anti-skid member 130 (as shown in FIG. 5). Show).
  • 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 In addition to the bonding surface 132, the specific structure of the anti-slip member 130 is not limited, and may have various structures: for example, it may be a sheet having a certain area, a disk shape or a spherical shape, or even an irregular shape, preferably a sheet shape.
  • the structure of the anti-slip member 130 may be a non-porous structure, a mesh structure, a bar-like structure, or the like.
  • the anti-slip member 130 should be made of a biocompatible material, which 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 artificial chord of the present invention has at least the following beneficial effects:
  • At least one end of the chord body is provided with a fixing member for connecting with the puncturing needle, and a puncturing connection member provided on the fixing member forms a detachable connection or a non-detachable fixed connection between the chordae body and the puncturing needle. Therefore, although there is no direct contact between the puncture needle and the artificial chord, the artificial chord, the fixing member and the puncture needle are sequentially connected by the connection of the puncture needle and the fixing member, thereby improving the artificial chord and the puncture needle. The reliability of the connection prevents manual choking from falling off the puncture needle.
  • a first embodiment of the artificial chordae implantation system of the present invention is used to implant an artificial chordae 100 into a patient's heart to replace a lesion chordae.
  • a first embodiment of the artificial chordae implantation system of the present invention includes a manual chord 100, a clamping device 300, a puncturing device 400a, and a pushing device 200.
  • the push device 200 includes a push conduit 210.
  • the push duct 210 is provided with a plurality of through cavities in the axial direction.
  • the lancing device 400a and the clamping device 300 are movably worn in different lumens in the push catheter 210, respectively.
  • the clamping device 300 includes a clamping pusher 330, a distal collet 310 for matingly holding the leaflets, and a proximal collet 320.
  • the proximal collet 320 is disposed at a distal end of the push catheter 210
  • the distal collet 310 is disposed at a distal end of the clamp pusher 330.
  • the puncture device 400a includes a puncture needle 410 and a puncture push rod 420 that is coupled to the proximal end of the puncture needle 410.
  • the distal end of the puncture needle 410 is a tapered straight tip.
  • the artificial chord 100 is housed in the clamping device 300, and the fixture 120 of the artificial chord 100 corresponds to the puncturing needle 410 of the puncturing device 400a.
  • the artificial chord 100 is further provided with a non-slip member 130, and each of the chord bodies 110 is provided with at least one anti-slip member 130.
  • the anti-slip member 130 can smoothly slide on the chord body 110 and does not slip off the chord body 110.
  • the cleat 130 improves the point contact between the artificial chord 100 and the leaflets to face contact, thereby effectively reducing the risk of the artificial chord 100 causing tearing of the leaflets.
  • the push device 200 includes a pusher catheter 210.
  • the pusher catheter 210 is a tubular body having a certain axial length. In the plurality of axial lumens of the push catheter 210, the respective lumens are separated from each other.
  • the pusher catheter 210 can be an integrally formed multi-lumen tube, or a larger sized outer tube and a plurality of smaller sized inner tube sets can be secured together to form the push conduit 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) or a metal material (for example, stainless steel or nickel titanium alloy).
  • 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
  • a metal material for example, stainless steel or nickel titanium alloy
  • the puncture needle 410 functions to puncture the leaflets.
  • the puncture needle 410 is coupled to the fixture 120 of the artificial chord 100 to facilitate pulling the chord body 100 toward the proximal end.
  • the distal end of the puncture needle 410 be a tapered straight tip.
  • the tapered straight-tip puncture needle 410 has a small puncture point formed on the leaflet and is easy to heal after surgery.
  • the diameter of the puncture point formed by the puncture needle 410 on the leaflet generally ranges from 0.3 mm to 1.5 mm. Further, by setting the shape and diameter of the puncture needle 410, the diameter of the puncture point can be controlled to 0.7 mm. about.
  • the puncture needle 410 is also provided with a chord connection member 411 corresponding to the puncture connector 125 of the artificial chord 100.
  • the primary function of the chord connector 411 is to increase the reliability of the connection between the puncture needle 410 and the artificial chord 100.
  • the lanyard connector 411 has the following implementations:
  • the chord connector 411 is at least one convex disposed at the distal end of the puncturing needle 410 and forming an interference fit, a snap connection or a key connection with the fixing member 120. Tooth or at least one turn of the edge.
  • the puncture needle 410 can be inserted into the accommodating cavity 121 to form a tight fit, that is, The connection of the surplus fit.
  • the chord connector 411 is preferably provided with a convex tooth or a convex edge behind the straight end of the puncture needle 410.
  • the outer surface behind the straight end of the puncture needle 410 is provided with at least one convex.
  • the teeth or at least one turn of the ribs are used as the chord connectors 411, and the size of the teeth or ribs is slightly larger than the size of the grooves or holes. At this time, an interference fit can also be formed between the puncture needle 410 and the fixing member 120.
  • a snap connection can also be adopted between the puncture needle 410 and the fixing member 120.
  • a portion or a full turn is removed behind the straight tip of the puncture needle 410 such that the straight tip itself forms a convex or convex edge as the chord connector 411, and the corresponding fixture 120 of the artificial chord 100 is formed.
  • a groove or a hole is formed as the puncture connector 125.
  • the key connection is a structure in which the convex teeth or the convex edges of the chord connection member 411 are keyed, and the puncturing connection member 125 of the artificial chord 100 is formed in a close key connection.
  • the chord connector 411 is provided with an external thread on the outer surface of the puncture needle 410 that is screwed to the fixing member 120; specifically, when the outer surface of the puncture needle 410 is entirely When the external thread is partially disposed, preferably, the puncture needle 410 is provided with an external thread behind the straight end. After the puncture is completed, the puncture needle 410 is screwed to the fixing member 120 of the artificial chord 100 to form a susceptor as shown in FIG. Disassemble the connection.
  • the chord connector 411 is an adhesive layer provided on the outer surface of the puncture needle 410 and bonded to the fixing member 120. Specifically, a biocompatible adhesive is applied to the outer surface of the puncture needle 410 in whole or in part to form an adhesive layer. After the puncture is completed, as shown in FIG. 19, on the fixing member 120 as the puncture connector 125. The bonding layer is bonded and fixed to form a non-detachable connection.
  • the chord connector 411 is a rough surface provided to the outer surface of the puncture needle 410 and frictionally coupled to the fixing member 120.
  • a rough surface is integrally or partially provided on the outer surface of the puncture needle 410.
  • the rough surface has a certain relationship with the rough surface of the fixing member 120 of the artificial chord 100 as the puncture connector 125. Frictional resistance to securely connect the artificial chord 100 and the puncture needle 410.
  • the rough surface may be a rough surface formed by many minute protrusions or ridges provided on the outer surface behind the straight end of the puncture needle 410, or may be roughened directly to the outer surface of the straight end of the puncture needle 410.
  • the side wall of the accommodating cavity 121 or the outer surface behind the straight end of the puncture needle 410 may be directly formed by using a material having a certain coefficient of friction. After the puncture is completed, a detachable connection as shown in Fig. 21 is formed.
  • a puncture push rod 420 is connected to the proximal end of the puncture needle 410, and a third handle 401 is disposed at the proximal end of the puncture push rod 420.
  • the puncture push rod 420 is movably worn in the inner cavity of the push catheter 210.
  • the proximal end of the third handle 401 is passed out from the proximal end of the pusher catheter 210.
  • the puncturing push rod 420 can be moved along the axial direction of the pusher catheter 210, thereby driving the puncture needle.
  • 410 punctures distally or withdraws proximally.
  • the puncture needle 410 is driven by the third handle 401 to pierce the valve leaflets. After being connected to the fixing member 120 of the artificial chordus 100, the puncture needle 410 and the artificial chordae 100 are connected by the fixing member 120. A whole.
  • the proximal end of the clamp pusher 330 is passed out from the proximal end of the pusher catheter 210 and the second handle 301 is disposed. 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 an open state as shown in FIG.
  • Finely adjusting the distal end of the artificial chordae implantation system such that the leaflet enters the space formed between the distal collet 310 and the proximal collet 320, and then withdraws the second handle 301 toward the proximal end to drive the clamping pusher 330 Movement to the proximal end causes the distal collet 310 to approach the proximal collet 320 to form a clamped condition as shown in FIG. At this time, the leaflets are firmly 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 to form a smooth, sleek body that facilitates pushing and reduces damage to the patient's wound. It will be appreciated that pushing the second handle 301 distally such that the distal collet 310 is away from the proximal collet 320 can also be achieved by retracting the first handle 201 and the push catheter 210 proximally.
  • the artificial chord implanted by means of a U-shaped loop sleeve combined with a hook-shaped needle causes wrinkles of the leaflet rim, so that the valvular edge of the leaflet is formed into an artificial gap, and the opposite edge cannot be formed, which is easy to cause two.
  • the cusp regurgitation is not satisfactory.
  • the chordae implantation system of the present invention since the chordae body 110 is received in the clamping pusher 330, the spacing between each artificial chord and the edge of the leaflet is substantially the same, which can effectively avoid wrinkles at the edge of the leaflet and improve the surgical effect.
  • the clamping surface (not labeled) of the distal end of the proximal collet 320 is disposed at the proximal end of the distal collet 310.
  • the clamping faces 311 should conform to each other and have a larger leaflet contact area, respectively.
  • both clamping faces are disposed obliquely, i.e., the clamping faces are at an angle of less than 90° to the axial direction of the pusher conduit 210.
  • at least one of the clamping faces is provided with a clamping reinforcement for enhancing the clamping force.
  • the clamping reinforcement is at least one of a projection, a rib, a groove, and a recess provided on the clamping surface.
  • the clamping surface 311 of the distal collet 310 is provided with a rib as a clamping reinforcement 312, and the ribs are parallel to each other to form a stepped clamping surface 311.
  • a manual cable passage 331 is disposed in the axial direction of the clamp push rod 330, and a manual cable receiving cavity 315 is disposed in the distal clamp 310.
  • the artificial chord receiving cavity 315 is in communication with the artificial chord passage 331.
  • the chord body 110 of the artificial chord 100 is housed in the artificial chord passage 331 and the artificial chord receiving cavity 315.
  • the receiving surface 311 of the distal chuck 310 is provided with a receiving groove 314 for receiving the anti-slip member 130.
  • the receiving groove 314 is in radial communication with the artificial cable receiving cavity 315.
  • the clamping surface 311 of the distal collet 310 is also provided with a fixing cavity 313 for receiving the fixing member 120 of the artificial chord 100.
  • the fixed cavity 313 is in axial communication with the artificial chord receiving cavity 315.
  • the fixed cavity 313 is in radial communication with the receiving groove 314.
  • the fixing member 120 of the artificial chord 100 is housed in the distal collet 310, and the fixing member 120 corresponds to the puncture needle 410.
  • the puncture needle 420 can be pulled back to the proximal end to drive the puncture needle 410, the fixing member 120, the chord body 110 and the anti-slip member 130 simultaneously from the distal collet 310.
  • the face 311 is pulled out until the puncture needle 410, the fixture 120 and the tendon body 110 pass together through the leaflets, and the cleat 130 fits over the upper surface of the leaflets.
  • the fixed cavity 313 is in axial communication with the artificial chord receiving cavity 315.
  • the fixing cavity 313 functions to fix the fixing member 120 of the artificial chord 100 in the fixing cavity 313, and can be smoothly pulled out from the fixing cavity 313 after the fixing member 120 is pulled by the external force. Therefore, the shape of the fixed cavity 313 corresponds to 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 circumscribed circle 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 connected to the fixing member 120 of the artificial chord 100 under the pushing of the puncturing push rod 420, the fixing member 120 may be from the fixed cavity 313 due to the urging force of the puncturing push rod 420.
  • the inner slip is released into the artificial sling receiving cavity 315, so that the puncture needle 410 and the fixing member 120 of the artificial chord 100 can not be successfully connected at one time, and the operation time is prolonged; if the diameter D2 is too small, the chord body of the artificial chord 100 is 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 311 of the clamping pusher 330.
  • 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
  • the purpose of the setting is that if the D3 is too large, the fixing member 120 of the artificial chord 100 will not be firmly Fixed in the fixed cavity 313 of the distal collet 310, which easily slips out of the fixed cavity 313, directly causing the artificial chord implant system to fail; if the D3 is too small, the fixing member 120 of the puncture needle 410 and the artificial chord 100 After the connection, the fixing member 120 cannot be smoothly pulled out from the fixed cavity 313, resulting in a surgical failure.
  • 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 skein body 110 smoothly sliding therethrough.
  • the prior art exposes the artificial chord to the outside of the device, so that the outer surface of the device is not smooth, which causes the frictional damage to the tissue when the device enters the human body, and the problem of blood leakage at the same time increases the risk of postoperative complications.
  • the fixed lumen 313 of the distal collet 310 facilitates placement and fixation of the artificial chordae 100 within the artificial chordae implantation system.
  • the fixed cavity 313 can realize pulling the chord body 110 and the slip preventing member 130 to the leaflets without loosening the distal collet 310 and the proximal collet 320, thus the distal collet 310 and
  • the proximal collet 320 is changed from the closed state to the open state, the leaflets are detached from the clamping device 300, and the moment of the pulsation is resumed. Since the anti-slip member 130 is attached to the upper surface of the leaflet, the pulsating flap can be avoided. The leaves move vigorously relative to the chord body 110, thereby avoiding damage to the leaflets.
  • the puncture needle adopts a tapered structure with a straight tip, and the puncture point formed on the leaflet is small, and the damage to the leaflet is alleviated.
  • the positioning of the puncture needle and the artificial chord is realized by the clamping device, which can effectively improve the probability of successful connection between the two, thereby shortening the operation time.
  • the lancet body of the puncture needle and the artificial chord can form a stable and reliable indirect connection through the fixing member, so that the artificial chord is not easily detached from the puncture needle, and the artificial chord is conveniently and quickly pulled to a fixed position.
  • the second embodiment of the artificial chordae implantation system of the present invention is an improvement based on the first embodiment.
  • the structure of the second embodiment of the artificial chordae implantation system of the present invention is basically the same as that of the first embodiment of the artificial chordae implantation system, and the difference is that the puncturing device 400b is provided with two puncture needles 410 and two respectively The proximal end of the puncture needle 410 is connected to the puncture push rod 420. The proximal end of the two puncture push rods 420 is provided with a third handle 401.
  • the two puncture push rods 420 are worn in the inner cavity of the push catheter 210, and the artificial tendon 100 is
  • the first end and the second end of the chord body 110 are each provided with a fixing member 120, and the two fixing members 120 are respectively received in the distal collet 310.
  • the two puncture needles 410 each correspond to a fixing member 120.
  • a manual chord passage 331 is disposed in the axial direction of the clamp pusher 330.
  • the distal collet 310 is provided with two artificial chord receiving cavities 315 respectively penetrating to the clamping faces 311 of the distal collet 310.
  • Two artificial chord receiving cavities 315 are in communication with the artificial chord passages 331, respectively.
  • the two artificial chord receiving chambers 315 are in radial communication.
  • the clamping surface 311 of the distal collet 310 is provided with two fixing cavities 313 for accommodating the fixing members 120.
  • the two fixed cavities 313 are in radial communication.
  • Each of the fixed cavities 313 is in axial communication with an artificial chord receiving cavity 315, and the ratio of the diameter D2 of the artificial chord receiving cavity 315 to the diameter D1 of the fixed cavity 313 is (0.2 to 0.4):1.
  • the first end and the second end of the chord body 110 are respectively connected to the two fixing members 120 accommodated in the two fixing chambers 313 through the two artificial sling receiving chambers 315 via the artificial chord passages 331 respectively.
  • the two puncture needles 410 are respectively connected to the two fixing members 120, so that the chordae body 110, the two fixing members 120 and the two puncture needles 410 form a U-shaped structure, and the puncture can be retracted by the proximal end.
  • the push rod 420 drives the entire chord body 110 to be pulled out from the clamping surface 311 of the distal collet 310. A part of the chord body 110 is attached to the upper surface of the leaflet, and the rest of the chord body 110 follows the fixing member.
  • the anti-slip member 130 may also be disposed on the chord body 110. Referring to FIG. 10 together, the first end and the second end of the chord body 110 of the artificial chord 100 respectively pass through the two through holes 131 on the same anti-slip member 130. Thus, prior to puncturing, the chord body 110 and the cleat 130 form a closed loop structure. After the puncture, the cleat 130, the chord body 110, the two fixtures 120, and the two puncture needles 410 form a U-shaped structure. And the chord body 110 presses the anti-slip member 130 so that the anti-slip member 130 abuts 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.
  • the clamping surface 311 of the distal collet 310 is further provided with a receiving groove 314 for receiving the anti-slip member 130.
  • the two fixing cavities 313 are respectively in radial communication with the receiving groove 314. Therefore, after the puncture, the chord body 110, the two fixing members 120, and the anti-slip member 130 can be pulled out together from the clamping surface 311 of the distal collet 310.
  • the width D3 of the communicating portion between the fixed cavity 313 and the receiving groove 314 is 20%-50% of the diameter D1 of the fixed cavity 313.
  • the second embodiment of the artificial chordae implantation system of the present invention is implemented as follows:
  • the artificial chordae implantation system is advanced through the mitral valve into the left ventricle; see Figure 28, continuing to advance the artificial chordae implantation system until the distal collet 310 and the proximal collet 320 are located In the left atrium, the second handle 301 is pushed distally, and the second handle 301 drives the clamping push rod 330 to move distally relative to the pushing catheter 210. The distal collet 310 and the proximal collet 320 of the clamping push rod 330 are clamped.
  • the artificial chord implant system is slowly moved proximally until the leaflets enter the leaflet accommodation space formed between the proximal collet 320 and the distal collet 310; see Figure 29, a slight movement of the artificial sling The distal end of the system is inserted until the edge of the leaflet contacts the clamping push rod 330.
  • the second handle 301 is withdrawn proximally, and the distal collet 310 is driven to move toward the proximal collet 320 until the two are closed. Being clamped; pushing the third handle 401 distally to drive the puncture needle 410 along the axis of the push catheter 210 Moving distally, i.e., the puncture needle 410 is moved toward the distal collet 310 until the puncture needle 410 passes through the leaflets and forms a fixed connection with the fixation member 120 of the artificial chord 100; see Figure 30, rear The third handle 401 is removed, so that the puncture needle 410 drives the fixing member 120 of the artificial chord 100, the chord body 110 connected to the fixing member 120 sequentially passes through the leaflets, and the anti-slip member 130 also faces from the clamping surface of the distal collet 310.
  • the abutting surface (ie, the lower surface) of the anti-slip member 130 is in contact with the upper surface of the leaflet 900, and a part of the chord body 110 is pressed against the upper surface of the anti-slip member 130 to fit the leaflet 900 (eg, 31, at this time, the surface contact between the artificial chord 100 and the leaflet 900 can effectively reduce the risk of tearing of the leaflet 900; see FIG.
  • this embodiment has at least the following beneficial effects:
  • chordae body can be implanted at one time to improve the operation efficiency; not only the point contact between the artificial chord and the leaflet can be improved to face contact, but also the artificial chord can be effectively prevented from falling off from the anti-slip member and the leaflet, which can effectively Maintain the effect of surgery.
  • the sling body closely adheres the anti-slip member to the upper surface of the leaflet, and the fixing manner between the chord body and the anti-slip member and the leaflet is relatively firm and reliable, thereby effectively preventing the leaflet from being torn or the chord body and the anti-slip member from the leaflet surface. The risk of shedding is better.

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Abstract

一种人工腱索（100）及人工腱索植入系统，人工腱索（100）包括柔性腱索主体（110），腱索主体（110）的至少一端连接有固定件（120），固定件（120）背向腱索主体（110）的一端设有穿刺连接件（125）。人工腱索植入系统包括夹持装置（300）、穿刺装置（400a）、人工腱索（100）和推送装置（200）。推送装置（200）包括推送导管（210）。穿刺装置（400a）和夹持装置（300）穿装在推送导管（210）中。夹持装置（300）包括夹持推杆（330）、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，远端夹头设置（310）在夹持推杆（330）的远端。穿刺装置（400a）包括穿刺针头（410），穿刺针头（410）的远端为锥形的直尖端。人工腱索（100）容置于夹持装置（300）中。人工腱索（100）的固定件（120）与穿刺针头（410）相对应。人工腱索（100）与穿刺针头（410）形成稳定连接，节省了手术时间。

Description

人工腱索及人工腱索植入系统 技术领域
本发明涉及医疗器械技术领域，涉及一种修复心脏瓣膜缺陷的器械，尤其涉及一种人工腱索及人工腱索植入系统。
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(简称：CT)。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；通过俘获组件将瓣叶俘获后，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，再将人工腱索的一端固定在心室壁上。该器械存在以下问题：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。
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，提供一种能与穿刺针头形成稳定连接的人工腱索。
本发明进一步要解决的技术问题是提供一种能可靠连接人工腱索的人工腱索植入系统。
本发明解决其技术问题所采用的技术方案是：
一种人工腱索，包括一段具有柔性的腱索主体，所述腱索主体的至少一端连接有用于 与穿刺针头相连接的固定件，所述固定件背向腱索主体的一侧设有用于与穿刺针头相连接的穿刺连接件。
所述的人工腱索中，优选所述固定件设有容置穿刺针头的容置腔，所述穿刺连接件为所述容置腔侧壁上设置的螺纹、粘接层、粗糙面、或者至少一个凹槽或孔，所述凹槽或孔与穿刺针头形成过盈配合、卡扣连接或者键连接。
所述的人工腱索中，优选所述腱索主体上套设有防滑件，所述防滑件沿所述腱索主体的轴向滑动。
所述的人工腱索中，优选所述防滑件上设置一个通孔，所述腱索主体穿过所述通孔；
或者所述防滑件上设置两个通孔，所述腱索主体的两端分别穿过所述通孔；或者所述防滑件上设置至少两个通孔，至少两个所述腱索主体各自穿过所述至少两个通孔。
所述的人工腱索中，优选所述防滑件挡止于所述固定件。
所述的人工腱索中，优选所述防滑件设有与瓣叶贴合的贴合面。
一种人工腱索植入系统，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，所述推送导管沿轴向设有多个贯通的内腔，所述穿刺装置和所述夹持装置分别活动地穿装在所述推送导管中的不同内腔中；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；
所述穿刺装置包括穿刺针头，所述穿刺针头的远端为锥形的直尖端；
所述人工腱索容置于所述夹持装置中，所述人工腱索包括一段具有柔性的腱索主体，所述腱索主体的至少一端连接有用于与穿刺针头相连接的固定件。所述人工腱索植入系统中，优选所述固定件背向腱索主体的一侧设有穿刺连接件，所述穿刺针头上还设有与所述穿刺连接件相连接的腱索连接件。
所述人工腱索植入系统中，优选所述腱索连接件为设置在所述穿刺针头的远端且与所述穿刺连接件形成过盈配合、卡扣连接或者键连接的至少一个凸齿或至少一圈凸沿；
或者所述腱索连接件为设置在所述穿刺针头外表面上的螺纹、粘接层或者粗糙面。
所述人工腱索植入系统中，优选所述远端夹头的近端设有一夹持面，所述穿刺装置包括一穿刺针头及与穿刺针头相连接的一穿刺推杆，所述穿刺推杆穿装在所述推送导管的内腔中，所述夹持推杆内沿轴向设有人工腱索通道，所述远端夹头内设有人工腱索收容腔，所述人工腱索收容腔的远端贯通至所述夹持面，所述人工腱索通道与所述人工腱索收容腔相连通，所述人工腱索容置于所述人工腱索通道及所述人工腱索收容腔中。
所述人工腱索植入系统中，优选所述腱索主体上套设有沿腱索主体的轴向滑动的防滑件，所述远端夹头的夹持面开设有用于容置防滑件的收容槽，所述收容槽与所述人工腱索收容腔之间径向连通。
所述人工腱索植入系统中，优选所述固定件容置在所述远端夹头中，且所述固定件与所述穿刺针头相对应。
所述人工腱索植入系统中，优选所述远端夹头的夹持面开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，所述固定腔与所述收容槽之间径向连通。
所述人工腱索植入系统中，优选所述固定腔的形状与所述固定件的形状相对应，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。
所述人工腱索植入系统中，优选所述近端夹头的远端设有一夹持面，所述近端夹头的夹持面与所述远端夹头的夹持面相互贴合，至少一个所述夹持面上设有用于增强夹持力的夹持增强件。
所述人工腱索植入系统中，优选所述夹持增强件选自所述夹持面上设置的凸起、凸棱、凹槽或者凹坑中的至少一种。
所述人工腱索植入系统中，优选所述远端夹头的近端设有一夹持面，所述穿刺装置包括两穿刺针头及与两穿刺针头分别相连接的两穿刺推杆，所述穿刺推杆穿装在所述推送导管的内腔中，所述人工腱索的腱索主体的两端分别设置一固定件，两个固定件均容置于所述远端夹头中；两个穿刺装置的穿刺针头分别对应两个固定件。
所述人工腱索植入系统中，优选所述夹持推杆内沿轴向设置人工腱索通道，所述远端夹头中设有两个分别贯通至所述远端夹头的夹持面的人工腱索收容腔，两个所述人工腱索收容腔分别与所述人工腱索通道相连通，两个所述人工腱索收容腔之间径向连通，所述腱索主体的两端经所述人工腱索通道穿出后分别经两个人工腱索收容腔穿出并与两固定件相连接。
所述人工腱索植入系统中，优选所述远端夹头的夹持面开设两个用于容置所述固定件的固定腔，每个固定腔分别与两个人工腱索收容腔之间轴向连通，两个固定腔之间径向连通。
所述人工腱索植入系统中，优选所述人工腱索的腱索主体上套设有防滑件，所述防滑件上设置两个通孔，所述腱索主体的两端分别穿过所述通孔。
所述人工腱索植入系统中，优选所述远端夹头的夹持面开设有两个用于容置所述固定 件的固定腔及用于收容所述防滑件的收容槽，每个固定腔分别与所述收容槽之间径向连通，所述收容槽与两个人工腱索收容腔之间径向连通。
所述人工腱索植入系统中，优选所述推送导管的近端设有第一手柄，所述夹持推杆的近端设有第二手柄，所述穿刺装置的近端设有第三手柄，所述第二手柄带动所述夹持装置沿所述推送导管轴向移动，所述第三手柄带动所述穿刺针头沿所述推送导管轴向移动。
本发明与现有技术相比，至少具有以下有益效果：
本发明的人工腱索中，在腱索主体的至少一端设有能够与穿刺针头连接的固定件，由此，尽管穿刺针头与人工腱索之间没有直接接触，但通过穿刺针头与固定件连接，将人工腱索与穿刺针头相连接，提高了人工腱索与穿刺针头连接的可靠性，在穿刺针头后撤过程中，可避免人工腱索自穿刺针头上脱落。
本发明的人工腱索植入系统中，穿刺针头为锥形的直尖端，相较现有技术中的钩状针头，本发明的穿刺针头直径较小，在瓣叶上形成的穿刺点较小，穿刺点的直径范围可控制在0.3mm至1.5mm，减轻对瓣叶的损伤，加快患者的术后愈合过程。
穿刺针头与人工腱索的固定件通过夹持装置实现定位，可以有效地提高穿刺针头与固定件成功连接的概率，从而缩短手术时间。另外，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固定位置。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
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是本发明人工腱索的第一种实施方式的结构示意图；
图4是本发明人工腱索的第二种实施方式结构示意图；
图5是本发明人工腱索的第三种实施方式结构示意图；
图6至图9是本发明人工腱索的固定件的不同实施方式结构示意图；
图10是本发明人工腱索的第四种实施方式结构示意图；
图11是本发明人工腱索植入系统的第一实施例的结构示意图；
图12是本发明人工腱索植入系统的第一实施例的爆炸图；
图13是本发明人工腱索植入系统的第一实施例的使用状态的结构示意图；
图14是本发明人工腱索植入系统的第一实施例的穿刺针头的第一种实施方式的结构示意图；
图15是图14的人工腱索植入系统的的穿刺针头与对应的人工腱索的固定件连接的结构示意图；
图16是本发明人工腱索植入系统的第一实施例的穿刺针头的第二种实施方式的结构示意图；
图17是图16的穿刺针头与对应的人工腱索的固定件连接的结构示意图；
图18是本发明人工腱索植入系统的第一实施例的穿刺针头的第三种实施方式的结构示意图；
图19是图18的穿刺针头与对应的人工腱索的固定件连接的结构示意图；
图20是本发明人工腱索植入系统的第一实施例的穿刺针头的第四种实施方式的结构示意图；
图21是图20的穿刺针头与对应的人工腱索的固定件连接的结构示意图；
图22是本发明人工腱索植入系统的第一实施例的远端夹头的夹持面的结构示意图；
图23是图22沿A-A线的剖视图；
图24是本发明人工腱索植入系统的第二实施例的爆炸图；
图25是本发明人工腱索植入系统的第二实施例的远端夹头的夹持面的结构示意图；
图26是图25沿B-B线的剖视图；
图27至图32是人工腱索植入系统的第二实施例将人工腱索植入心脏的工作过程示意图。
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。
在介入医疗器械技术领域，一般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。
如图3所示，本发明人工腱索100，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具有相对的两端(即第一端和第 二端)。腱索主体110的第一端连接有固定件120。固定件120背向腱索主体110的一侧设有用于与穿刺针头不可拆卸连接或可拆卸连接的穿刺连接件。
腱索主体110的一端固定在瓣叶上，另一端可以固定在心室壁上或者乳头肌等部位，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3所示，固定件120可以设置在腱索主体110的一端。
如图4所示，腱索主体110的两端也可以都设置固定件120。
腱索主体110与固定件120之间可以采用打结、缠绕、焊接、粘接、卡接等各种固定方式，本发明不作限定。例如，可以将腱索主体110的一端穿出固定件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；或者在末端设置一个定位杆。定位杆在自然状态下的轴线的方向与腱索主体110及固定件120的轴线的方向不同轴，将定位杆及腱索主体110的一端穿过固定件120后，定位杆恢复原始状态，即可卡挡于固定件120的背面，由此将腱索主体110的一端固定在固定件120上。
如图5所示，当腱索主体110的第一端没有设置固定件120而腱索主体110的第二端没有设置固定件120时，应当通过对第二端进行打结、缠绕、或者在第二端设置球状末端、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的第二端挡止于瓣叶的上表面。
如图6至图9所示，固定件120与穿刺针头形成可拆卸连接或不可拆卸连接，固定件120的形状配合不同的连接方式。由于穿刺针头的远端通常为尖锐的锥形，固定件120与穿刺针头的外表面之间应当具有尽可能大的接触面积，以形成稳定的连接。故，固定件120的背向腱索主体110的一侧设有用于容置穿刺针头的容置腔121。容置腔121的形状与穿刺针头的远端形状相对应。容置腔121的形状通常是锥形或者柱形。固定件120通常为柱形体，横截面形状可以是圆形、椭圆形、多边形等各种形状，一般优选圆形和椭圆形。
固定件120设置有容置腔121，容置腔121设有与穿刺针头连接的穿刺连接件125，穿刺连接件125具有多个实施方式。
如图6所示，第一种实施方式为：穿刺连接件125为容置腔121侧壁上开设的与穿刺针头螺纹连接的内螺纹。对应穿刺针头的外表面设有对应的外螺纹。即，穿刺针头与固定件120之间以螺纹连接的方式形成可拆卸的连接。
如图7所示，第二种实施方式是：穿刺连接件125为容置腔121的侧壁上设置的与穿刺针头粘接的粘接层。具体是指，在固定件120的容置腔121的侧壁涂设生物相容性的粘接剂，形成粘接层，对应的穿刺针头的外表面通过粘接层与固定件120粘接固定在一起，形成不可拆卸的固定连接。
如图8所示，第三种实施方式为：穿刺连接件125为容置腔121的侧壁上设置的与穿刺针头摩擦连接的粗糙面；优选在穿刺针头的外表面也设有粗糙面，与容置腔121侧壁的粗糙面互相配合，通过摩擦阻力形成一种可拆卸的连接。粗糙面可以是设置在容置腔121的侧壁及/或穿刺针头的外表面的很多微小的凸起、凸棱形成的粗糙面，也可以是直接对容置腔121的侧壁及/或穿刺针头的外表面进行粗糙处理得到粗糙面，还可以是直接采用具有一定摩擦系数的材料制成容置腔121的侧壁及/或穿刺针头的外表面。
如图9所示，第四种实施方式为：穿刺连接件125为容置腔121的侧壁开设的与穿刺针头形成过盈配合、卡扣连接或者键连接的至少一个凹槽或孔。
其中过盈配合是凹槽或孔中部分或全部壁面形状与穿刺针头的部分或全部形状配合，在尺寸上形成过盈配合，形成可拆卸连接。
卡扣连接是指以容置腔121侧壁上设置的凹槽或孔，与穿刺针头上设置的凸起或凸沿卡接，形成不可拆卸或可拆卸的连接。本实施例中采用这种结构形式，如图9所示，在固定件120的容置腔121侧壁径向设有至少一个凹槽125，与穿刺针头上设有的凸沿之间配合卡接。可以理解的是，孔或者凹槽可以是盲孔也可以是通孔，只要其形状大致与穿刺针头上设置的凸起或凸沿互相配合，以形成卡扣连接即可。本实施例中，优选设置三个凹槽125，以提高固定件120与穿刺针头之间的连接稳定性，减小连接后穿刺针头可晃动的幅度。
键连接可以选择平键连接、花键连接等键连接方式，并且形成紧键连接，以使得轴向上也能传递拉力，键连接结构为常规技术，在此不再赘述。
如图4、图5及图10所示，为了增加人工腱索100与瓣叶之间的接触面积(将点接触改进为面接触)，以降低人工腱索100撕裂瓣叶的风险，优选腱索主体110上套设有一防滑件130，且防滑件130可以沿腱索主体110轴向滑动。由此，穿刺针头穿刺瓣叶并固定人工腱索100时，防滑件130预先设置在人工腱索100上，可将防滑件130推送至穿刺点，以将防滑件130与人工腱索100一起固定在瓣叶上。防滑件130在人工腱索100上的具体设置方式是：在防滑件130上设置通孔131，腱索主体110穿过通孔131。当腱索主体110的第一端没有设置固定件120而腱索主体110的第二端未设置固定件120时，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，使得该第二端的截面尺寸大于防滑件130 上的通孔131的的截面尺寸。
如图4所示，如每根腱索主体110上均设置一个防滑件130。每一防滑件130上设置一个通孔131供一腱索主体110穿过。
如图10所示，如防滑件130上设置至少两个通孔131，一个腱索主体110的第一端和第二端分别穿过不同的通孔131。
在其他实施方式中，防滑件130上设置至少两个通孔131，至少两个人工腱索100的腱索主体110分别穿过不同的通孔131，即至少两根人工腱索100共用一个防滑件130。
为了防止防滑件130从人工腱索100上脱落，防滑件130上的通孔131的截面尺寸小于固定件120的截面尺寸。例如，当防滑件130上的通孔131为圆孔，固定件120为圆柱时，防滑件130上的通孔131的直径小于固定件120的直径。腱索主体110的没有设置固定件120的自由端应当通过打结、或者设置球状末端、盘状末端等方式，使得该自由端的直径大于防滑件130上的通孔131的直径(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，优选片状。防滑件130的结构可以是无孔结构，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，特性上可以是弹性材料制成，也可以是非弹性材料制成。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。
本发明的人工腱索与现有技术相比，至少具有以下有益效果：
腱索主体的至少一端设有用于与穿刺针头连接的固定件，并通过设置在固定件上的穿刺连接件，使得腱索主体与穿刺针头之间形成可拆卸连接或者不可拆卸的固定连接。由此，尽管穿刺针头与人工腱索之间没有直接接触，但通过穿刺针头与固定件的连接，将人工腱索、固定件及穿刺针头三者依次相连接，提高了人工腱索与穿刺针头连接的可靠性，可避免人工腱索自穿刺针头上脱落。
如图11-图23所示，本发明人工腱索植入系统的第一实施例，用于将人工腱索100植入患者心脏内，替换病变腱索。本发明人工腱索植入系统的第一实施例包括人工腱索100、夹持装置300、穿刺装置400a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。穿刺装置400a和夹持装置300分别活动地穿装在推送导管210中的不同内腔中。夹持装置300包括夹持推杆330、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。穿刺装置400a包括穿刺针头410及与穿刺针头410近端连接的穿刺推杆420。穿刺针头410的远端为锥形的直尖端。人工腱索100容置于夹持装置300中，且人工腱索100的固定件120与穿刺装置400a的穿刺针头410相对应。
为了避免人工腱索100对瓣叶的点接触导致瓣叶损伤，人工腱索100上还设置有防滑件130，每根腱索主体110上均设有至少一个防滑件130。防滑件130可以在腱索主体110上顺畅滑动，且不会从腱索主体110上滑落。防滑件130将人工腱索100与瓣叶的之间的点接触改进为面接触，从而可以有效地降低人工腱索100导致瓣叶撕裂的风险。
如图12所示，推送装置200包括推送导管210。推送导管210为具有一定轴向长度的管状体。在推送导管210的多个轴向内腔中，各个内腔相互分隔。推送导管210可以采用一体成型的多腔管，也可以将较大尺寸的外管和多个较小尺寸的内管套装固定在一起，形成推送导管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)或者金属材料(例如，不锈钢或者镍钛合金)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。
穿刺针头410的作用是用于穿刺瓣叶。穿刺针头410与人工腱索100的固定件120连接，方便将腱索主体100拉向近端。为了便于穿刺并且减小在瓣叶上形成的穿刺点，优选穿刺针头410的远端为锥形的直尖端。相比现有技术中的钩状针头，锥形的直尖端的穿刺针头410在瓣叶上形成的穿刺点小，术后易愈合。本实施例中，穿刺针头410在瓣叶上形成的穿刺点的直径范围通常为0.3mm至1.5mm，进一步地，通过设置穿刺针头410的形状及直径，穿刺点的直径范围可控制在0.7mm左右。
为了使得人工腱索100与穿刺针头410之间形成稳定可靠的连接，穿刺针头410上还对应人工腱索100的穿刺连接件125设有腱索连接件411。腱索连接件411的主要功能是提高穿刺针头410与人工腱索100之间连接的可靠性。腱索连接件411有以下几种实施方式：
如图14-15所示，第一种实施方式中，腱索连接件411为设置在穿刺针头410的远端、且与固定件120形成过盈配合、卡扣连接或者键连接的至少一个凸齿或至少一圈凸沿。
对于过盈配合连接，由于固定件120的背向腱索主体110的一侧设置有容置腔121，在穿刺完成后，可以使穿刺针头410插入容置腔121形成紧配合插接，即过盈配合的连接。 腱索连接件411优选是在穿刺针头410的直尖端后方设有凸齿或凸沿。
可以理解的是，在其他实施例中，当固定件120的容置腔121的侧壁设置至少一个凹槽或孔作为穿刺连接件125时，穿刺针头410直尖端后方的外表面设置至少一个凸齿或者至少一圈凸沿作为腱索连接件411，且凸齿或凸沿的尺寸略大于凹槽或孔的尺寸，此时，穿刺针头410与固定件120之间也可形成过盈配合。
如图15所示，穿刺针头410与固定件120之间还可以采用卡扣连接。如图15所示，在穿刺针头410直尖端后方去除部分或一整圈，使得直尖端本身形成一个作为腱索连接件411的凸齿或凸沿，而对应的人工腱索100的固定件120开有凹槽或孔作为穿刺连接件125，在穿刺完成后，穿刺针头410的凸齿或凸沿卡入固定件120的凹槽或孔中，实现二者之间的可拆卸连接。
键连接是作为腱索连接件411的凸齿或凸沿为键连接的结构，与人工腱索100的穿刺连接件125形成紧键连接。
如图16-17所示，第二种实施方式中，腱索连接件411为设置穿刺针头410外表面上的与固定件120螺接的外螺纹；具体地，当穿刺针头410的外表面整体或部分设置外螺纹时，优选的，穿刺针头410于直尖端后方设有外螺纹，在穿刺完成后，穿刺针头410与人工腱索100的固定件120螺接，形成如图17所示的可拆卸连接。
如图18-19所示，在第三种实施方式中，腱索连接件411为穿刺针头410外表面设置的与固定件120粘接的粘接层。具体地，在穿刺针头410外表面整体或部分施加具有生物相容性的粘胶剂，形成粘接层，在穿刺完成后，如图19所示，与作为穿刺连接件125的固定件120上的粘接层粘接固定，形成不可拆卸的连接。
如图20-21所示，在第四种实施方式中，腱索连接件411为穿刺针头410外表面设置的与固定件120摩擦连接的粗糙面。具体地，在穿刺针头410外表面整体或部分设有粗糙面，在穿刺完成后，该粗糙面与人工腱索100的固定件120中设置的作为穿刺连接件125的粗糙面之间具有一定的摩擦阻力，以固定连接人工腱索100和穿刺针头410。粗糙面可以是设置在穿刺针头410的直尖端后方的外表面的很多微小的凸起、凸棱形成的粗糙面，也可以是直接对穿刺针头410的直尖端后方的外表面进行粗糙处理得到粗糙面，还可以是直接采用具有一定摩擦系数的材料制成容置腔121的侧壁或穿刺针头410的直尖端后方的外表面。穿刺完成后，形成如图21所示的可拆卸连接。
如图12所示，穿刺针头410近端连接有穿刺推杆420，穿刺推杆420近端设有第三手柄401，穿刺推杆420活动地穿装在推送导管210的内腔中。第三手柄401的近端自推送导 管210近端穿出，由此，通过操作第三手柄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。在瓣叶被夹持后，穿刺针头410在第三手柄401驱动下，刺穿瓣叶，与人工腱索100的固定件120连接后，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。
如图11至图13所示，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，形成如图13所示的张开状态，此时可微调人工腱索植入系统的远端，使得瓣叶进入到远端夹头310与近端夹头320之间形成的空间后，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，形成如图11所示的夹持状态。此时，瓣叶被夹持装置300牢固地夹持并固定。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，形成一个外表光滑的整体，便于推送，并减轻对患者伤口的损伤。可以理解的是，向远端推动第二手柄301使得远端夹头310远离近端夹头320，也可以通过向近端回撤第一手柄201及推送导管210来达到。
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，使瓣叶的瓣缘形成人为缺口，无法形成对合缘，容易造成二尖瓣返流，手术效果不理想。本发明人工腱索植入系统，由于腱索主体110收容在夹持推杆330内，使得每根人工腱索与瓣叶边缘的间距基本一致，可有效避免瓣叶边缘褶皱，提高手术效果。
如图11-13、图22-23所示，为了提高夹持的稳定性，近端夹头320的远端设置的夹持面(图未标号)与远端夹头310的近端设置的夹持面311应相互贴合，并且分别具有较大的瓣叶接触面积。优选地，两个夹持面都倾斜设置，即夹持面与推送导管210轴向成小于90°夹角。另外，至少一个夹持面上设有用于增强夹持力的夹持增强件。优选夹持增强件为在夹持面上设置的凸起、凸棱、凹槽、凹坑中的至少一种。本实施例中，远端夹头310的夹持面311上设置凸棱作为夹持增强件312，各个凸棱之间平行，形成台阶状的夹持面311。
如图22-23所示，夹持推杆330内沿轴向设有人工腱索通道331，远端夹头310内设有人工腱索收容腔315。人工腱索收容腔315与人工腱索通道331相连通。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。
远端夹头310的夹持面311开设有用于收容防滑件130的收容槽314。收容槽314与人工腱索收容腔315之间径向连通。
远端夹头310的夹持面311还开设有用于容置人工腱索100的固定件120的固定腔313。 固定腔313与人工腱索收容腔315之间轴向连通。固定腔313与收容槽314之间径向连通。由此，人工腱索100的固定件120容置在远端夹头310中，且固定件120与穿刺针头410相对应。在穿刺针头410与固定件120连接后，可通过向近端后撤穿刺推杆420，带动穿刺针头410、固定件120、腱索主体110及防滑件130同时从远端夹头310的夹持面311被拉出，直至穿刺针头410、固定件120及腱索主体110共同穿过瓣叶，而防滑件130贴合至瓣叶的上表面。
固定腔313与人工腱索收容腔315之间轴向连通。固定腔313的作用是既可将人工腱索100的固定件120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的形状相对应，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连接时，由于穿刺推杆420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；如直径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顺利拉出夹持推杆330的夹持面311。
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311，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将不能牢固地固定在远端夹头310的固定腔313内，很容易从固定腔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，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在其中顺利滑动通过即可。
现有技术将人工腱索暴露在器械外部，使得器械外表面不光滑，导致器械进入人体时，增加了对组织的摩擦损伤，同时出现漏血的问题，增加了患者产生术后并发症的风险。远端夹头310的固定腔313，便于将人工腱索100放置并固定在人工腱索植入系统内部。最重要还在于：固定腔313可以实现在不用松开远端夹头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，因此在远端夹头310和近端夹头320之间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，由于防滑件130贴合于瓣叶的上表面，可避免搏动的瓣叶相对腱索主体110剧烈运动，进而避免对瓣叶造成伤害。
本实施例提供的人工腱索植入系统，与现有技术相比，至少具有以下有益效果：
穿刺针头采用带有直尖端的锥形结构，在瓣叶上形成的穿刺点较小，减轻对瓣叶的损伤。
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。
另外，穿刺针头与人工腱索的腱索主体能通过固定件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固定位置。
如图24所示，本发明人工腱索植入系统的第二实施例是在第一实施例的基础上进行的改进。本发明人工腱索植入系统的第二实施例的结构与人工腱索植入系统的第一实施例的结构基本相同，区别之处在于：穿刺装置400b设有两穿刺针头410及两分别与穿刺针头410的近端连接的穿刺推杆420，两穿刺推杆420的近端设有第三手柄401，两穿刺推杆420穿装在推送导管210的内腔中，且人工腱索100的腱索主体110的第一端和第二端各自设置有固定件120，两个固定件120分别容置于远端夹头310中。两穿刺针头410各自对应一个固定件120。
一并参见图24、图25及图26，夹持推杆330内沿轴向设置人工腱索通道331。远端夹头310中设有两个分别贯通至远端夹头310的夹持面311的人工腱索收容腔315。两个人工腱索收容腔315分别与人工腱索通道331相连通。两个人工腱索收容腔315之间径向连通。远端夹头310的夹持面311开设有两个用于容置固定件120的固定腔313。两个固定腔313之间径向连通。每个固定腔313分别与一个人工腱索收容腔315之间轴向连通，且人工腱索收容腔315的直径D2与固定腔313的直径D1之比为(0.2～0.4)∶1。腱索主体110的第一端及第二端经人工腱索通道331分别穿过两个人工腱索收容腔315与容置于两个固定腔313中的两固定件120分别相连接。
由此，穿刺后，两个穿刺针头410分别与两个固定件120相连，使得腱索主体110、 两个固定件120及两个穿刺针头410形成U形结构，可通过向近端后撤穿刺推杆420，带动整个腱索主体110自远端夹头310的夹持面311被拉出，腱索主体110的一部分贴合至瓣叶的上表面，腱索主体110的其余部分跟随固定件120及穿刺针头410穿过瓣叶直至到达心室壁，可在瓣叶和心室壁之间同时植入两段腱索主体110，防滑件130及腱索主体110的一部分贴合瓣叶的上表面，瓣叶博动时，能减弱瓣叶相对腱索主体110的运动，进而减小对瓣叶的损伤。
在本实施例中，腱索主体110上还可以设置防滑件130。请一并参见图10，人工腱索100的腱索主体110的第一端和第二端分别穿过同一个防滑件130上的两个通孔131。由此，在穿刺前，腱索主体110及防滑件130形成类似环形的闭合结构。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U形结构。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。
再次参见图25及图26，远端夹头310的夹持面311还开设有用于收容防滑件130的收容槽314，两个固定腔313分别与收容槽314之间径向连通。由此，穿刺后可将腱索主体110、两个固定件120及防滑件130一并拉出远端夹头310的夹持面311。优选地，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％。
以二尖瓣后叶夹持的腱索植入术为例，本发明人工腱索植入系统的第二实施例实施过程如下：
请参见图27，将人工腱索植入系统穿过二尖瓣推进至左心室内；请参见图28，继续推进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，夹持推杆330的远端夹头310与近端夹头320分离并相对于近端夹头320向远端移动，此时近端夹头320与远端夹头310之间形成瓣叶容纳空间，保持第一手柄201与第二手柄301之间的相对位置不变，向近端缓慢移动人工腱索植入系统，直至瓣叶进入近端夹头320与远端夹头310之间形成的瓣叶容纳空间中；参见图29，轻微移动人工腱索植入系统的远端，直至瓣叶边缘与夹持推杆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，瓣叶被夹持；向远端推送第三手柄401，驱动穿刺针头410沿推送导管210的轴向向远端移动，即，穿刺针头410向远端夹头310方向移动，直至穿刺针头410穿过瓣叶，并与人工腱索100的固定件120之间形成固定连接；请参见图30，后撤第三手柄401，使得穿刺针头410带动人工腱索100的固定件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的夹持面311拉出，防滑件130的贴合面(即，下表面)与瓣叶900的上表面接触，同时部分的腱索主体110压住防滑件130的上表面使其贴合瓣叶900(如图31所示)，此时，人工腱索100与瓣叶900之间的面接触，可有效降低瓣叶900撕裂的风险；请参见图32，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，撤出人工腱索植入系统，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上。
本实施例与现有技术相比，至少具有以下有益效果：
可以一次植入多根腱索主体，提高手术效率；不仅可以将人工腱索与瓣叶的点接触改进为面接触，而且可以有效地避免人工腱索从防滑件和瓣叶上脱落，可以有效地维持手术效果。
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。
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 (22)

  1. 一种人工腱索，包括一段具有柔性的腱索主体，所述腱索主体的至少一端连接有用于与穿刺针头相连接的固定件，所述固定件背向腱索主体的一侧设有用于与穿刺针头相连接的穿刺连接件。
  2. 根据权利要求1所述的人工腱索，其特征在于，所述固定件设有容置穿刺针头的容置腔，所述穿刺连接件为所述容置腔侧壁上设置的螺纹、粘接层、粗糙面、或者至少一个凹槽或孔，所述凹槽或孔与穿刺针头形成过盈配合、卡扣连接或者键连接。
  3. 根据权利要求1所述的人工腱索，其特征在于，所述腱索主体上套设有防滑件，所述防滑件沿所述腱索主体的轴向滑动。
  4. 根据权利要求3所述的人工腱索，其特征在于，所述防滑件上设置一个通孔，所述腱索主体穿过所述通孔；或者所述防滑件上设置两个通孔，所述腱索主体的两端分别穿过所述两个通孔；或者所述防滑件上设置至少两个通孔，至少两个腱索主体各自穿过所述至少两个通孔。
  5. 根据权利要求4所述的人工腱索，其特征在于，所述防滑件挡止于所述固定件。
  6. 根据权利要求3所述的人工腱索，其特征在于，所述防滑件设有与瓣叶贴合的贴合面。
  7. 一种人工腱索植入系统，包括人工腱索、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，所述推送导管沿轴向设有多个贯通的内腔，所述穿刺装置和所述夹持装置分别活动地穿装在所述推送导管中的不同内腔中；所述夹持装置包括夹持推杆、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；
    所述穿刺装置包括穿刺针头，所述穿刺针头的远端为锥形的直尖端；
    所述人工腱索容置于所述夹持装置中，所述人工腱索包括一段具有柔性的腱索主体，所述腱索主体的至少一端连接有用于与穿刺针头相连接的固定件。
  8. 根据权利要求7所述的人工腱索植入系统，其特征在于，所述固定件背向腱索主体的一侧设有穿刺连接件，所述穿刺针头上还设有与所述穿刺连接件相连接的腱索连接件。
  9. 根据权利要求8所述的人工腱索植入系统，其特征在于，所述腱索连接件为设置在所述穿刺针头的远端且与所述穿刺连接件形成过盈配合、卡扣连接或者键连接的至少一个凸齿或至少一圈凸沿；
    或者所述腱索连接件为设置在所述穿刺针头外表面上的螺纹、粘接层或者粗糙面。
  10. 根据权利要求7所述的人工腱索植入系统，其特征在于，所述远端夹头的近端设有一夹持面，所述穿刺装置包括一穿刺针头及与穿刺针头相连接的一穿刺推杆，所述穿刺推杆穿装在所述推送导管的内腔中，所述夹持推杆内沿轴向设有人工腱索通道，所述远端夹头内设有人工腱索收容腔，所述人工腱索收容腔的远端贯通所述夹持面，所述人工腱索通道与所述人工腱索收容腔相连通，所述人工腱索收容于所述人工腱索通道及所述人工腱索收容腔中。
  11. 根据权利要求10所述的人工腱索植入系统，其特征在于，所述腱索主体上套设有沿腱索主体的轴向滑动的防滑件，所述远端夹头的夹持面开设有用于收容防滑件的收容槽，所述收容槽与所述人工腱索收容腔之间径向连通。
  12. 根据权利要求11所述的人工腱索植入系统，其特征在于，所述固定件容置在所述远端夹头中，且所述固定件与所述穿刺针头相对应。
  13. 根据权利要求12所述的人工腱索植入系统，其特征在于，所述远端夹头的夹持面开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，所述固定腔与所述收容槽之间径向连通。
  14. 根据权利要求13所述的人工腱索植入系统，其特征在于，所述固定腔的形状与所述固定件的形状相对应，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。
  15. 根据权利要求7所述的人工腱索植入系统，其特征在于，所述近端夹头的远端设有一夹持面，所述近端夹头的夹持面与所述远端夹头的夹持面相互贴合，至少一个所述夹持面上设有用于增强夹持力的夹持增强件。
  16. 根据权利要求15所述的人工腱索植入系统，其特征在于，所述夹持增强件选自所述夹持面上设置的凸起、凸棱、凹槽或者凹坑中的至少一种。
  17. 根据权利要求7所述的人工腱索植入系统，其特征在于，所述远端夹头的近端设有一夹持面，所述穿刺装置包括两穿刺针头及与两穿刺针头分别相连接的两穿刺推杆，所述穿刺推杆穿装在所述推送导管的内腔中，所述腱索主体的两端分别设置有一固定件，两个固定件均容置于所述远端夹头中；两个穿刺针头分别对应两个固定件。
  18. 根据权利要求17所述的人工腱索植入系统，其特征在于，所述夹持推杆内沿轴向设置人工腱索通道，所述远端夹头中设有两个分别贯通至所述远端夹头的夹持面的人工腱索收容腔，两个人工腱索收容腔分别与所述人工腱索通道相连通，两个人工腱索收容腔之间径向连通，所述腱索主体的两端经所述人工腱索通道穿出后分别经两个人工腱索收容腔 穿出并分别与两个固定件相连接。
  19. 根据权利要求18所述的人工腱索植入系统，其特征在于，所述远端夹头的夹持面开设两个用于分别容置所述固定件的固定腔，每个固定腔分别与两个人工腱索收容腔之间轴向连通，两个固定腔之间径向连通。
  20. 根据权利要求17所述的人工腱索植入系统，其特征在于，所述人工腱索的腱索主体上套设有防滑件，所述防滑件上设置两个通孔，所述腱索主体的两端分别穿过所述通孔。
  21. 根据权利要求20所述的人工腱索植入系统，其特征在于，所述远端夹头的夹持面开设有两个用于容置所述固定件的固定腔及用于收容防滑件的收容槽，每个固定腔分别与所述收容槽之间径向连通，所述收容槽与两个人工腱索收容腔之间径向连通。
  22. 根据权利要求7所述的人工腱索植入系统，其特征在于，所述推送导管的近端设有第一手柄，所述夹持推杆近端设有第二手柄，所述穿刺装置的近端设有第三手柄，所述第二手柄带动所述夹持装置沿所述推送导管轴向移动，所述第三手柄带动所述穿刺针头沿所述推送导管轴向移动。
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