WO2021036761A1 - 一种用于锁紧缝线的锁钉及介入式远程缝线锁结装置 - Google Patents

一种用于锁紧缝线的锁钉及介入式远程缝线锁结装置 Download PDF

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Publication number
WO2021036761A1
WO2021036761A1 PCT/CN2020/107994 CN2020107994W WO2021036761A1 WO 2021036761 A1 WO2021036761 A1 WO 2021036761A1 CN 2020107994 W CN2020107994 W CN 2020107994W WO 2021036761 A1 WO2021036761 A1 WO 2021036761A1
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WIPO (PCT)
Prior art keywords
locking
lock
suture
lock nail
nail
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PCT/CN2020/107994
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English (en)
French (fr)
Inventor
张庭超
张伟伟
郑贤章
李立光
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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
Priority to EP20858231.2A priority Critical patent/EP4023164A4/en
Publication of WO2021036761A1 publication Critical patent/WO2021036761A1/zh
Priority to US17/572,040 priority patent/US20220125427A1/en

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    • 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
    • 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
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • 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
    • 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
    • A61B2017/0417—T-fasteners
    • 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
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • 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
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A61B2017/0488—Instruments for applying suture clamps, clips or locks
    • 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

Definitions

  • the present invention relates to the technical field of medical devices, in particular to a lock nail for locking sutures and an interventional remote suture locking device using the lock nail.
  • the mitral valve is a one-way valve located between the left atrium (abbreviation: LA) and left ventricle (abbreviation: LV) of the heart.
  • LA left atrium
  • LV left ventricle
  • a normal and healthy mitral valve can control the flow of blood from the left atrium to the left ventricle, while avoiding blood from the left.
  • the ventricle flows to the left atrium.
  • the mitral valve consists of a pair of valve leaflets, called the anterior and posterior leaflets.
  • the anterior and posterior leaflets When the left ventricle is in a diastolic state, the anterior and posterior leaflets are in an open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contracted state, When the edges of the anterior and posterior leaflets coincide, the mitral valve can be completely closed to prevent blood from flowing from the left ventricle to the left atrium.
  • the leaflets of the mitral valve or its related structures undergo qualitative or functional changes, the anterior and posterior leaflets of the mitral valve are not properly aligned. As a result, when the left ventricle of the heart contracts, the mitral valve cannot be completely closed , Causing blood to reflux from the left ventricle to the left atrium, causing a series of pathophysiological changes called "Mitral Regurgitation".
  • one or more sutures can be implanted into the anterior leaflet and/or posterior leaflet of the mitral valve, and the end of the suture can be fixed on the ventricular wall, heart apex or papillary muscle, and the suture can be used as Artificial chordae, to achieve chordal repair, or fix multiple sutures on two leaflets together to achieve "edge-to-edge" repair.
  • sutures are made of polytetrafluoroethylene (abbreviation: PTFE), expanded polytetrafluoroethylene (abbreviation: e-PTFE), polyethylene terephthalate (abbreviation: PET), polyethylene (abbreviation: PE ), polypropylene (abbreviation: PP) and other materials, these sutures are suitable for various types of soft tissue closure and ligation, such as cardiovascular surgery, dentistry, general surgery and dural repair. Since the fixation and knotting of the suture are usually manually tied and fixed by the doctor, the tightness of the suture is not easy to control during the manual knotting process, which affects the effect of the operation.
  • PTFE polytetrafluoroethylene
  • e-PTFE expanded polytetrafluoroethylene
  • PET polyethylene terephthalate
  • PE polyethylene
  • PP polypropylene
  • suture locking device that uses a locking nail to lock the suture.
  • the suture locking device uses a locking nail with a hollow inner cavity, which is deformed by pressing the locking nail to fix the wear The stitches in the lock pegs.
  • the sutures can be fixed to the ventricular wall, papillary muscle or heart apex with lock nails.
  • "Cord tendon repair” can also use lock nails to fix multiple sets of sutures together to achieve "edge-to-edge” repair.
  • the lock nail fixes the suture, since the heart is always performing a strong contraction movement, the suture and the lock nail are also pulled accordingly. If the lock nail and the suture are insufficiently locked or locked Excessive force may cause the sutures to break, loosen or the lock nails to slip off, which not only affects the effect of the operation, but even endangers the life of the patient in severe cases.
  • the technical problem to be solved by the present invention is to provide a lock nail for locking sutures in view of the defects of the prior art.
  • the locking force of the lock nail is suitable.
  • the suture can be locked and the suture can be prevented from being damaged; the present invention also provides an interventional remote suture locking device using the locking nail.
  • the present invention first provides a lock nail for locking sutures, the lock nail includes a locking portion, the lock nail has a threading cavity for threading the suture, and the threading cavity Passing through the locking portion, the threading cavity includes a first inner cavity section located in the locking portion, and the surface roughness of the inner peripheral surface of the first inner cavity section ranges from 0.1 micrometer to 2.5 micrometers.
  • the present invention also provides an interventional remote suture locking device, which includes a lock pin and a chuck assembly, the lock pin includes a locking portion, the lock pin has a threading cavity for threading sutures, and the threading cavity Passing through the locking portion, the threading cavity includes a first inner cavity section located in the locking portion, and the surface roughness of the inner peripheral surface of the first inner cavity section ranges from 0.1 ⁇ m to 2.5 ⁇ m, and the lock nail
  • the chuck assembly presses the lock nail to deform the locking portion to lock the suture inserted in the threading cavity of the lock nail.
  • the locking nail used in the interventional remote suture locking device provided by the present invention includes a locking portion, and the surface roughness of the inner peripheral surface of the first inner cavity section of the threading cavity of the locking nail ranges from 0.1 micrometer to 2.5 micrometers. Therefore, the locking force of the suture locked in the first inner cavity section of the locking nail is suitable, which not only meets the requirement of the locking force, but also prevents the suture from being excessively squeezed and damaged and broken.
  • Fig. 1 is a schematic diagram of a three-dimensional structure of an interventional remote suture locking device provided by one embodiment of the present invention.
  • Fig. 2 is a cross-sectional view taken along line II-II in Fig. 1.
  • Fig. 3 is a schematic diagram of the three-dimensional structure of the locking nail used in the interventional remote suture locking device in Fig. 1.
  • Fig. 4 is a cross-sectional view taken along the line IV-IV in Fig. 3.
  • Fig. 5 is a cross-sectional view taken along the line V-V in Fig. 3.
  • Fig. 6 is an enlarged view of part VI in Fig. 2.
  • Fig. 7 is a schematic structural diagram of the lock nail in Fig. 3 when a suture is inserted.
  • Fig. 8 is a schematic diagram of a state in which the lock nail in Fig. 7 is deformed to lock the suture.
  • Fig. 9 is a cross-sectional view taken along line IX-IX in Fig. 8.
  • Figures 10-12 are schematic diagrams of an interventional remote suture locking device provided by one of the embodiments of the present invention used in the edge-to-edge repair process of a diseased mitral valve.
  • Figures 13-14 are schematic diagrams of the process of the interventional remote suture locking device provided in one of the embodiments of the present invention for fixing the suture in the locking nail.
  • Fig. 15 is an enlarged view of part XV in Fig. 12.
  • 16 is a statistical chart of the results of the lock nail of the present invention and the lock nail of the comparative example through the surface roughness test, the deformation rate test, the locking force test and the fatigue test.
  • proximal end the end close to the operator during the operation
  • distal the end far away from the operator
  • axial direction refers to the center and the proximal end of the distal end of the medical device.
  • the direction of the connection between the terminal and the center; the above definition is only for the convenience of presentation, and cannot be understood as a limitation of this application.
  • an interventional medical device selects an occluder for blocking aortic dissection breaks as an example to illustrate the mechanism and use of the interventional medical device pushing device of the present application.
  • the interventional medical device pushing device of the present application The scope of use is not limited to the occluder.
  • the present invention provides an interventional remote suture locking device 100 for fixing sutures and locking nails 300.
  • the interventional remote suture locking device 100 includes a chuck assembly 20, A drive assembly 40 at the proximal end of the chuck assembly 20 and a push assembly 60 sleeved outside the chuck assembly 20 and the drive assembly 40.
  • the distal end of the chuck assembly 20 is provided with a gap 25 for placing the lock nail 300
  • the lock nail 300 is provided with a threading cavity 301 along the axial direction
  • the interventional remote suture locking device 100 is provided along the axial direction through the chuck assembly 20 and The threading channel 26 of the drive assembly 40.
  • the locking nail 300 includes a locking portion 310 and a retaining portion 330 provided at the distal end of the locking portion 310, and the threading cavity 301 penetrates the locking portion 310 and the retaining portion 330.
  • the locking portion 310 is received in the gap 25 of the chuck assembly 20, and the holding portion 330 is blocked by the distal end surface of the pushing assembly 60.
  • the threading cavity 301 includes a first inner cavity section 302 located at the locking portion 310 and a second inner cavity section 304 located at the holding portion 330.
  • the surface roughness of the inner peripheral surface of the first inner cavity section 302 is greater than or equal to the second inner cavity section The surface roughness of the inner peripheral surface of 304.
  • the suture is threaded through the threading cavity 301 and the threading channel 26 of the lock nail 300, and the driving assembly 40 rotates relative to the pushing assembly 60 and moves in the axial direction to push the chuck assembly 20 to squeeze the lock nail placed in the gap 25 300, deform the lock pin 300 to fix the suture. Since the surface roughness of the inner peripheral surface of the first inner cavity section 302 of the threading cavity 301 of the lock nail 300 is greater than the surface roughness of the inner peripheral surface of the second inner cavity section 304, it can be locked to the first inner cavity section 302 of the lock nail 300.
  • the locking force of the suture in the inner cavity section 302 is relatively high, and the friction between the suture and the inner peripheral surface of the second inner cavity section 304 is not easy to cause the suture to wear, thereby preventing the suture from being damaged.
  • the interventional remote suture locking device 100 further includes a handle 80 connected with the proximal end of the driving assembly 40 and the proximal end of the pushing assembly 60.
  • the handle 80 includes a fixed part 82 at the distal end and a movable part 84 at the proximal end that can move relative to the fixed part 82.
  • the fixed part 82 is fixedly connected to the proximal end of the pushing assembly 60, and the movable part 84 is close to the driving assembly 40.
  • the end connection through the relative movement between the movable part 84 and the fixed part 82, drives the drive assembly 40 to move axially with respect to the push assembly 60.
  • the movable part 84 and the fixed part 82 can rotate relative to each other and move in the axial direction, thereby driving the driving assembly 40 to rotate and move in the axial direction relative to the pushing assembly 60.
  • the driving assembly 40 moves toward the distal end in the axial direction,
  • the chuck assembly 20 can be pressed against the lock pin 300 placed in the gap 25 to complete the fixation of the suture and the lock pin 300.
  • the lock nail 300 is made of biocompatible materials such as stainless steel, pure titanium, nickel-titanium, and cobalt-chromium alloy, and is preferably made of pure titanium or stainless steel.
  • the threading cavity 301 of the lock nail 300 penetrates the opposite ends of the lock nail 300 in the axial direction, and the threading cavity 301 is used for receiving and passing the suture.
  • the locking portion 310 can be crushed when subjected to mechanical external force to fix the suture in the threading cavity 301 of the lock nail 300.
  • the cross section of the threading cavity 301 of the locking part 310 can be in various shapes, for example, cylindrical, prismatic, elliptical, polygonal or irregular shapes, as long as the threading cavity 301 is used for accommodating sutures.
  • the edge of the proximal surface of the locking portion 310 is rounded, and the surface of the rounded corners is smooth, that is, the roughness is small, so as to prevent the proximal surface of the locking portion 310 from damaging the tissue.
  • two opposite positions on the inner peripheral surface of the first inner cavity section 302 are respectively provided with a convex lock platform and a concave lock groove.
  • the first inner cavity section 302 is the main area where the lock nail 300 locks the suture.
  • the inner surface of the first inner cavity section 302 of the lock nail 300 is in direct contact with the suture. Therefore, the inner peripheral surface of the first inner cavity section 302 is The surface roughness directly affects the locking force of the lock nail.
  • Surface roughness refers to the small spacing and small peaks and valleys of the processed surface of the material. The smaller the surface roughness, the smoother the surface of the material.
  • Surface roughness is generally formed by the processing method, surface treatment and other factors used, such as the friction between the tool and the surface of the part during the processing, the plastic deformation of the surface layer metal when the chips are separated, and the high-frequency vibration in the process system Wait.
  • Surface treatment methods include physical polishing, chemical polishing, electroplating, sandblasting, spraying, electrical discharge machining, etc. Due to the difference between the processing method and the surface treatment method, the depth, density, shape and texture of the traces left on the processed surface are different. The influence of the surface roughness of the inner surface of the first inner cavity section 302 on the lock nail 300 is mainly manifested in the following aspects:
  • the surface roughness affects the locking force mainly in affecting the stability of the first inner cavity section 302 of the lock nail 300.
  • the lock nail 300 is threaded and deformed under pressure, there is a clearance fit between the inner cavities of the locking portion 310 of the lock nail 300.
  • the rougher the surface of the inner cavity the easier it is to wear.
  • the continuous movement of the lock pin 300 gradually increases the gap, and the connection strength gradually decreases; the inner peripheral surface of the locking portion 310 of the lock nail 300 and the suture are an interference fit, because the microscopic peaks of the locking portion 310 are squeezed flat , Which reduces the actual effective interference, thereby reducing the connection strength.
  • the fatigue strength of the lock nail 300 is affected.
  • the reason is that the rough surface has large wave troughs and is very sensitive to stress concentration. Therefore, the surface with a larger roughness has a smaller effective contact area between the mating surfaces and a larger pressure. , The friction resistance is larger, the wear is faster, and the abrasion resistance is poor; and the rougher surface is easy for blood to penetrate into the inner layer of the lock nail 300 through the microscopic valleys on the surface, causing surface corrosion.
  • the surface roughness of the inner peripheral surface of the first inner cavity section 302 can be adjusted according to the locking force required by the suture 500.
  • the surface roughness of the inner peripheral surface of the first inner cavity section 302 ranges from 0.1 micrometer to 2.5 micrometers.
  • the chuck assembly 20 squeezes the lock pin 300 to deform the lock pin 300 to fix the suture. Therefore, the deformation rate of the lock nail 300 will affect the locking force and fatigue resistance of the lock nail 300.
  • the deformation rate of the lock pin 300 reflects the degree of deformation of the lock pin 300 after being pressed and gripped.
  • the locking portion 310 is used to fix the cross section of the threading cavity 301 of the suture 500 at the smallest dimension in the direction perpendicular to the axial direction of the threading cavity 301.
  • the thickness of the minor axis is H
  • the one-sided wall thickness of the lock pin 300 in the initial state is T1
  • the deformation rate ⁇ can reflect the size of the internal gap of the threading cavity 301 after the lock pin 300 is crimped and deformed. If the deformation rate of the lock nail 300 is larger, the H value is smaller, indicating that the gap after the lock nail 300 is deformed is smaller and the locking force is higher. However, if the deformation rate is too large, it indicates that the gap after the lock nail 300 is deformed is too small, which may cause the suture 500 to break, or affect the fatigue strength of the lock nail 300.
  • the deformation rate of the locking portion 310 ranges from 50% to 90%, so as to ensure the locking force of the lock nail 300.
  • e-PTFE suture is a commonly used surgical suture. It is chemically synthesized from 100% polytetrafluoroethylene. It is a single-strand non-absorbable surgical suture with high porosity, high smoothness, and low friction coefficient. In the manual knotting process of e-PTFE sutures, it usually takes more than two turns to tighten. When metal lock nails are used to fix the sutures, proper locking force is required to avoid slippage caused by insufficient locking force; but due to e -The PTFE suture is a single-strand thread, and its wear resistance is correspondingly poor.
  • the deformation rate is preferably in the range of 55% to 80%.
  • the deformation rate range is further preferably 60-75%, which is especially suitable for locking 2-6 e-PTFE sutures.
  • the retaining portion 330 is provided at the distal end of the locking portion 310. Specifically, the retaining portion 330 is at least partially radially protruded from the outer wall of the distal end of the locking portion 310, that is, the outer diameter of the retaining portion 330 is larger than the outer diameter of the locking portion 310, and That is, the cross-sectional area of the distal end surface of the holding portion 330 is larger than the radial cross-sectional area of the locking portion 310. Therefore, the retaining portion 330 has a position limiting function to prevent the distal end surface of the lock pin 300 from being pulled or sliding into the gap 25 of the chuck assembly 20 when the distal surface of the lock pin 300 is compressed and deformed.
  • the holding portion 330 is a boss with an annular cross section.
  • the distal end of the lock pin 300 is not provided with a retaining portion 330. When the distal end surface of the lock pin 300 is crushed and deformed, it is easily pulled or slid into the gap 25 of the chuck assembly 20. When the head assembly 20 is opened to return to the initial position, the distal end surface of the lock pin 300 may be caught by the chuck assembly 20, and the lock pin 300 cannot be automatically separated from the distal end of the interventional remote suture locking device 100.
  • the holding portion 330 has a second inner cavity section 304 communicating with the first inner cavity section 302, that is, the second inner cavity section 304 and the first inner cavity section 301 constitute a threading cavity for threading sutures.
  • the surface roughness of the inner circumferential surface of the second inner cavity section 304 is less than or equal to the surface roughness of the inner circumferential surface of the first inner cavity section 302, thereby reducing the friction between the suture and the inner circumferential surface of the second inner cavity section 304 , To avoid long-term friction damage to the suture.
  • the outer peripheral edge of the distal end and the outer peripheral edge of the proximal end of the holding portion 330 are both rounded, and the outer surface of the holding portion 330 is a curved surface to prevent the lock nail 300 from scratching the internal tissue of the patient's body.
  • the holding portion 330 is a boss with an annular cross section, and the outer surface of the boss is an arc surface. The intersection of the distal end surface of the boss and the inner peripheral surface of the second inner cavity section 304 is rounded.
  • a first smooth transition zone 305 is provided at the intersection of the distal end surface of the holding portion 330 and the inner peripheral surface of the first inner cavity section 302, and the suture locked in the threading cavity 301 of the lock nail 300 is inclined to the first
  • the smooth transition area 305 is in contact to avoid cutting the suture at the intersection of the distal end surface of the holding portion 330 and the inner peripheral surface of the first inner cavity section 302, and avoiding friction fatigue or even disconnection of the suture.
  • the first smooth transition zone 305 adopts electrical discharge machining, and its surface roughness ranges from 0.1 ⁇ m to 2.5 ⁇ m to avoid damage to the suture.
  • the first smooth transition zone 305 can also be subjected to a coating process after electrical discharge machining to further reduce the roughness.
  • the surface roughness of the region is in the range of 0.1 ⁇ m to 0.5 ⁇ m.
  • a second smooth transition region 306 is provided between the first smooth transition region 305 and the inner peripheral surface of the first inner cavity section 302, and the surface roughness of the second smooth transition region 306 is less than 2 microns. If the surface roughness of the second smooth transition zone 306 is too large, it will cause friction fatigue to the suture and cause the suture to break. The surface roughness of the second smooth transition zone 306 can be controlled within 2 microns, which can effectively avoid the suture. fracture.
  • electrical discharge machining can be used for the second smooth transition zone 306; in order to further reduce the roughness of the second smooth transition zone 306, a PTFE coating process can be added on the basis of electrical discharge machining .
  • the second smooth transition zone 306 is a tapered surface whose inner diameter gradually decreases from the distal end to the proximal end, and the single-sided slope of the tapered surface is in the range of 0.3°- 0.8 degrees, preferably 0.5 degrees-0.6 degrees.
  • the size of the inner hole D1 of the threading cavity 301 of the lock nail 300 is determined according to the thread diameter and the number of sutures to be locked.
  • the range of the inner hole D1 of the threading cavity 301 is 0.8 micron- 1.2 microns.
  • the currently commonly used e-PTFE sutures have an outer diameter of 0.3 micrometers, and the number to be locked is 2 to 4.
  • the inner hole D1 of the threading cavity 301 ranges from 0.85 micrometers to 1.0 micrometers.
  • the wall thickness T1 of the locking portion 310 of the locking nail 300 ranges from 0.1 micron to 0.2 micron.
  • the wall thickness T1 of the locking portion 310 is less than 0.1 micron, which is not conducive to the fatigue resistance of the locking nail 300.
  • the wall thickness T1 of the locking portion 310 is greater than 0.2 Micrometer is not conducive to the deformation and locking strength of the locking nail 300; preferably, the wall thickness T1 of the locking portion 310 ranges from 0.12 micrometers to 0.18 micrometers.
  • the thickness T2 of the boss of the holding part 330 ranges from 0.3 ⁇ m to 0.6 ⁇ m; preferably, the thickness T2 of the boss of the holding part 330 ranges from 0.4 ⁇ m to 0.5 ⁇ m.
  • the boss outer diameter D2 of the holding part 330 ranges from 1.6 ⁇ m to 2.2 ⁇ m; preferably, the boss outer diameter D2 of the holding part 330 ranges from 1.8 ⁇ m to 2.0 ⁇ m.
  • the overall length L of the lock nail 300 ranges from 4 microns to 6.5 microns; the overall length L of the lock nail 300 is too long not only is not conducive to delivery, but also affects the safety of the lock nail 300 after implantation in the human body.
  • the overall length L of 300 has a length dimension ranging from 4.5 micrometers to 6.0 micrometers.
  • the overall length L of the locking nail 300 minus the thickness T2 of the boss of the holding portion 330 is the length of the first inner cavity section 302.
  • the chuck assembly 20 includes a first chuck 22 and a second chuck 24 that are connected to each other or integrally formed, and the connection between the first chuck 22 and the second chuck 24 and the threading channel 26 is connected.
  • a gap 25 is formed between the distal end of the first chuck 22 and the distal end of the second chuck 24, and the lock pin 300 is placed in the gap 25, that is, the lock pin 300 is inserted into the chuck assembly 20.
  • the first chuck 22 and the second chuck 24 can squeeze Press the lock nail 300 to deform the lock nail 300 to lock the suture in the threading cavity 301 of the lock nail 300.
  • the proximal end of the first chuck 22 and the proximal end of the second chuck 24 are rotatably connected by a rotating shaft 27, and the rotating shaft 27 defines a through hole 271 communicating with the threading channel 26.
  • An inclined sliding guide surface 226 is provided on the side of the first chuck 22 facing away from the second chuck 24.
  • the sliding guide surface 226 is located at the distal end of the first chuck 22 and extends obliquely toward the side away from the threading channel 26.
  • the side surface of the first chuck 22 facing the second chuck 24 is provided with a first clamping tooth 227 adjacent to the distal end.
  • the first clamping tooth 227 includes a plurality of tooth grooves, and each tooth groove extends in an axial direction substantially parallel to the shaft hole 224 .
  • the second chuck 24 faces the side of the first chuck 22 and is provided with a second clamping tooth 243 adjacent to the distal end.
  • the second clamping tooth 243 includes a plurality of tooth grooves. The extending direction of each tooth groove of the second clamping tooth 243 is the same as the The extending directions of the tooth grooves of a clamping tooth 227 are the same.
  • the chuck assembly 20 further includes an elastic member 28.
  • the elastic member 28 is used for the rotation and resetting of the first chuck 22 and/or the second chuck 24, so that the lock nail 300 can be inserted between the first chuck 22 and the second chuck 24.
  • the first chuck 22 is reset so that the lock nail 300 can be released smoothly.
  • the driving member 44 includes a screw 442 and a rotating mandrel 445 axially connected to the screw 442. Specifically, the distal end of the rotating mandrel 445 is fixedly connected to the screw 442, and the proximal end of the rotating mandrel 445 is fixedly connected to the movable part 84. The rotation of the portion 84 can drive the rotating mandrel 445 and the screw 442 to rotate together.
  • the ejector member 42 includes an ejector rod 421 for slidingly abutting against the sliding surface 226 of the first chuck 22 in the axial direction, and a connecting block 423 provided at the proximal end of the ejector rod 421, and the ejector rod 421 is located at One side of the connecting block 423 in the radial direction.
  • the connecting block 423 defines a through hole along the axial direction, the through hole penetrates through the distal end surface and the proximal end surface of the connecting block 423, and the connecting rod pin 45 is rotatably inserted into the through hole.
  • the pushing assembly 60 includes a thrust tube 62 rotatably sleeved on the screw 442, a front end outer tube 64 connected to the distal end of the thrust tube 62, a pushing shaft 66 connected to the distal end of the thrust tube 62, and covering the distal end of the front outer tube 64 The end cap 67.
  • the thrust tube 62 is provided with an internal thread corresponding to the screw 442, and the rotation of the rotating mandrel 445 drives the screw 442 to rotate relative to the thrust tube 62 and move in the axial direction; preferably, the inner wall of the thrust tube 62 is provided with an internal thread 622 corresponding to the screw 442 to push
  • the distal end of the shaft 66 is fixedly connected to the proximal end of the thrust tube 62, and the proximal end of the pushing shaft 66 is fixedly connected to the fixing portion 82.
  • the first step as shown in Figure 10, firstly puncture the patient’s femoral vein and after transatrial septum puncture, implant multiple sutures with elastic pads 501 into the anterior leaflet 401 and posterior leaflet 403 of the mitral valve. 500, the point contact between the suture 500 and the valve leaflet is converted to the surface contact between the elastic gasket 501 and the valve leaflet, which can effectively reduce the risk of leaflet tearing;
  • Step 2 As shown in Figure 11 and Figure 13, the multiple sutures 500 on both valve leaflets are inserted into the threading cavity 301 of the lock nail 300 outside the patient's body, and the proximal ends of the sutures 500 are successively passed through the intervention
  • the lead hole of the pin 45 and the hollow inner hole of the rotating shaft 445 pass through the proximal end of the movable part 84;
  • Step 3 Push the distal end of the interventional remote suture locking device 100 into the heart through the femoral vein and atrial septum with the help of a bending sheath (not shown), move closer to the leaflets of the mitral valve, and pull the suture at the same time Thread 500 until the distal end of the interventional remote suture locking device 100 reaches the predetermined position;
  • Step 4 Adjust the tightness of the sutures 500 on the anterior leaflet 401 and the posterior leaf 403, and determine the lightest state of mitral regurgitation through ultrasound. When this state is reached, stop the adjustment and maintain the two sets of sutures.
  • the tightness of 500 that is, maintaining the relative distance between the anterior leaflet 401 and the posterior leaflet 403 of the mitral valve;
  • Step 5 As shown in Figures 11 and 14, keep the fixed part 82 of the handle 80 still, and drive the movable part 84 to rotate to the distal end. At this time, the rotating mandrel 445 drives the screw 442 farther away from the pushing shaft 66 The screw 442 drives the ejector member 42 to move distally, and the distal end of the ejector rod 421 of the ejector member 42 continues to press the first chuck 22, so that the first chuck 22 moves closer to the second chuck 24 and presses Hold the lock pin 300 located between the first chuck 22 and the second chuck 24, the elastic member 28 is squeezed and elastically deformed until the lock pin 300 is deformed, and the lock pin 300 is connected to the thread of the lock pin 300.
  • the sutures 500 in the cavity 301 are fixed together, and the holding portion 330 is stopped outside the end cap 67; then the movable portion 84 is driven to move proximally, and the top rod 421 releases the squeezing of the first chuck 22, and the first chuck
  • the head 22 expands and returns to the initial position under the action of the elastic reset of the elastic member 28, and the deformed lock nail 300 is released from the gap between the first chuck 22 and the second chuck 24; at this time, the suture 500 is locked in the first inner cavity section 302 of the deformed locking portion 310, so that the locking force of the suture 500 is relatively high; in addition, the first smooth transition area 305 and the second smooth transition area of the suture 500 and the lock nail 300
  • the transition zone 306 is in contact. Since the surface roughness of the first smooth transition zone 305 and the second smooth transition zone 306 are both small, damage to the suture 500 can be avoided.
  • Step 6 As shown in Figure 12 and Figure 15, the distal end of the interventional remote suture locking device 100 is withdrawn from the patient's body, the locking nail 300 is left in the patient's body, and the suture 500 at the end of the locking nail 300 is cut At this time, the locking nail 300 fixes the two sets of sutures 500 that respectively pass through the anterior leaflet 401 and the posterior leaflet 403 together.
  • the anterior leaflet 401 and the posterior leaflet 403 of the mitral valve form a double hole structure to complete the edge-to-edge repair.
  • interventional remote suture locking device to perform an interventional mitral valve repair process through the femoral vein-atrial septum-left atrium-mitral valve path as an example to illustrate the present invention
  • interventional remote suture locking device of the present invention can also be used to lock and fix sutures in other surgical procedures.
  • the interventional remote suture locking device 100 of the present invention is particularly suitable for the following scenarios, such as:
  • Interventional mitral valve repair surgery is performed through the path of jugular vein-atrial septum-left atrium-mitral valve.
  • Interventional tricuspid valve repair surgery via the femoral vein-right atrium-tricuspid valve path Interventional tricuspid valve repair surgery via the jugular vein-right atrium-tricuspid valve path
  • Interventional tricuspid valve repair surgery via the jugular vein-right atrium-tricuspid valve path Flap repair surgery.
  • the interventional remote suture locking device 100 is operated remotely outside the patient's body to fix the suture 500 implanted on the valve leaflet with the locking nail 300.
  • the lock nails in other embodiments are similar in structure to the lock nail 300 in Embodiment 1, except that: after the lock nail is made, the inner peripheral surface of the first inner cavity section of the lock nail is subjected to mirror discharge treatment or wire cutting Processing, so that the surface roughness of the inner peripheral surface of the first inner cavity section is different from the surface roughness of the inner peripheral surface of the first inner cavity section 302 in Example 1, and the lock nails of Examples 2-9 are obtained respectively, such as Shown in Figure 16.
  • Test principle of stylus method When the stylus gently slides along the surface to be tested, the stylus will move up and down along the peaks and valleys due to the tiny peaks and valleys on the surface. The movement of the stylus reflects the surface profile.
  • Test instrument Dektak 6M probe type surface profiler from Bruker of the United States.
  • Test parameters probe pressure: 10mg; sliding distance: 800 microns; sliding time: 8 seconds, sliding speed 100 microns/sec.
  • Test method Cut the lock nails 300 of Examples 1 to 9 and Comparative Examples 1 to 16 in half along the axis, and divide them into two symmetrical parts. Take 3 to 10 in the first cavity section 302 of each part. At each sampling point, test the changes in the surface profile of the probe with a pressure of 10 mg at a speed of 100 ⁇ m/sec while sliding 800 ⁇ m at a speed of 100 ⁇ m/sec. The test results of all sampling points of the two parts are averaged. That is, the surface roughness of the inner peripheral surface of the lock nail 300.
  • Test method first measure the outer diameter of the lock nail 300 with a micrometer, measure the inner diameter of the lock nail 300 with a needle gauge, and then subtract the inner diameter from the outer diameter to obtain the bilateral wall thickness, respectively, to obtain the locks of Examples 1-9 and Comparative Examples 1-16
  • the bilateral wall thickness of the nail 300 in the initial state is 2T1; then the interventional suture locking device 100 is used, and the locking nails 300 of Examples 1-9 and Comparative Examples 1-16 are respectively used for two U-shaped folds.
  • the e-PTFE suture 500 is locked; afterwards, the locking part 310 of the locked nail 300 is measured by the VMS322 optical image measuring instrument produced by Shenzhen Zhitai Precision Instrument Co., Ltd.
  • Test method In the deformation rate test, the locking nail 300 and the suture 500 after being locked are tested for the locking force.
  • the testing equipment is the HY-0580 electronic universal tensile testing machine produced by Shanghai Hengyi Precision Instrument Co., Ltd.
  • the test procedure is as follows: the locked sample has two closed coils, one coil is fixed on the hook of the fixed end of the tensile testing machine as a fixed end, and the other coil penetrates into the hook of the mobile end of the tensile testing machine, and the moving speed of the moving end of the tensile testing machine Set to 100 microns/min.
  • the maximum value of the suture being pulled or broken by the tensile testing machine is recorded as the locking force of the lock nail. According to related literature, when the locking force is 3N, it can meet the clinical requirements for suture tension.
  • the purpose of the fatigue test is to verify whether the locking nail 300 can be used as a medical device implant for 10 years after the suture 500 is locked. Before the test, lock the two e-PTFE sutures 500 folded in half with the lock nail 300, and then place the lock nail 300 and the suture 500 in a fatigue testing machine that simulates the beating of the left heart system of the human heart. Destructive fatigue testing.
  • the fatigue test equipment is the AWT-1000 artificial heart valve fatigue performance tester manufactured by Shanghai Heart Valve Testing Equipment Co., Ltd.
  • the locking force value is too large, and the suture 500 is frayed, causing the fatigue test to fail and failing to meet the fatigue performance requirements.
  • the lock nail 300 When the deformation rate of the lock nail 300 is greater than 0.90, the lock nail 300 is likely to squeeze the suture 500, and the locking force value of the lock nail 300 tends to decrease, and the fatigue performance requirement cannot be met.
  • Embodiments 1 to 9 in FIG. 16 meet the requirements of better locking ability and fatigue resistance at the same time.
  • the inner peripheral surface of the first inner cavity section 302 of the lock nail 300 of the present invention The surface roughness of the lock nail 300 ranges from 0.1 micron to 0.25 micron; the deformation rate of the locking portion 310 of the lock nail 300 ranges from 50% to 90%.
  • the locking portion 310 is deformed and folded in half to the two
  • the e-PTFE suture 500 worn in the lock nail 300 has a suitable locking force and fatigue resistance.
  • the lock nails in Comparative Example 1 to Comparative Example 16 in FIG. 16 do not meet the requirements of fatigue performance.

Abstract

一种用于锁紧缝线（500）的锁钉（300），锁钉（300）包括锁定部（310），锁钉（300）具有用于穿装缝线（500）的穿线腔（301），穿线腔（301）穿通锁定部（310），穿线腔（301）包括位于锁定部（310）的第一内腔段（302），第一内腔段（302）的内周面的表面粗糙度范围为0.1微米-2.5微米。通过控制锁定部（310）的内周面的表面粗糙度，能使锁紧于锁钉（300）的第一内腔段（302）内的缝线（500）的锁紧力适宜，不仅满足锁紧力需求也能避免缝线（500）被过度挤压导致受损断裂；且缝线（500）与第二内腔段（304）的内周面的摩擦不易使缝线（500）磨损，从而能防止缝线（500）受损。还提供使用锁钉（300）的一种介入式远程缝线锁结装置（100）。

Description

一种用于锁紧缝线的锁钉及介入式远程缝线锁结装置 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种用于锁紧缝线的锁钉及采用所述锁钉的介入式远程缝线锁结装置。
背景技术
二尖瓣是位于心脏左心房(简称：LA)与左心室(简称：LV)之间的单向阀门，正常健康的二尖瓣可以控制血液从左心房流到左心室，同时避免血液从左心室流到左心房。二尖瓣包括一对瓣叶，称为前叶及后叶，当左心室处于舒张状态时，前叶和后叶处于张开状态，血液从左心房流向左心室；左心室处于收缩状态时，前叶和后叶的边缘对合时，二尖瓣可完全闭合，避免血液从左心室流到左心房。当二尖瓣的瓣叶或其相关结构发生质性改变或功能性改变时，二尖瓣的前叶和后叶对合不良，由此，当心脏左心室收缩时，二尖瓣不能完全关闭，导致血液从左心室返流至左心房，从而引起一系列的病理生理改变，称为“二尖瓣返流”。
现有技术中可以通过向二尖瓣的前叶和/或后叶分别植入一根或者多根缝线，并将缝线的末端固定在心室壁、心尖或乳头肌上，以缝线作为人工腱索，实现腱索修复，或者将两片瓣叶上的多根缝线固定在一起实现“缘对缘”修复。常用的缝线由聚四氟乙烯(简称：PTFE)、膨体聚四氟乙烯(简称：e-PTFE)、聚对苯二甲酸乙二醇酯(简称：PET)、聚乙烯(简称：PE)、聚丙烯(简称：PP)等材料制成，这些缝线适用于各种类型的软组织闭合和与结扎，例如心血管外科手术、牙科、普通外科和硬脑脊膜修补等。由于缝线的固定及打结通常由医生手动打结并固定，在手动打结过程中，缝线的松紧度不易控制，从而影响手术效果。
目前，也出现采用锁钉对缝线进行锁固的缝线锁结装置，所述缝线锁结装置使用一具有中空内腔的锁钉，通过压握锁钉使其变形，从而固定穿装在锁钉中的缝线。在二尖瓣的瓣膜修复术中，操作者在二尖瓣的前叶和/或后叶分别植入缝线后，可以通过锁钉将缝线固定在心室壁、乳头肌或心尖等部位实现“腱索修复”，也可以通过锁钉将多组缝线固定在一起实现“缘对缘”修复。然而，在锁钉将缝线固定后，由于心脏始终在进行强力的收缩运动，因此，缝线及锁钉也相应地受到牵拉，若锁钉与缝线之间锁紧力不足或锁紧力过大，可能导致缝线断裂、松脱或者锁钉滑落，不仅影响手术效果，严重时甚至会危害患者生命。
申请内容
本发明要解决的技术问题在于，针对现有技术的缺陷，提供一种用于锁紧缝线的锁钉，通过控制锁钉内腔的表面粗糙度，使锁钉的锁紧力适宜，既能锁紧缝线，也可防止缝线受损；本发明还提供一种使用所述锁钉的介入式远程缝线锁结装置。
为了解决上述技术问题，本发明首先提供了一种用于锁紧缝线的锁钉，所述锁钉包括锁定部，所述锁钉具有用于穿装缝线的穿线腔，所述穿线腔穿通所述锁定部，所述穿线腔包括位于所述锁定部的第一内腔段，所述第一内腔段的内周面的表面粗糙度范围为0.1微米-2.5微米。
本发明还提供一种介入式远程缝线锁结装置，包括锁钉及夹头组件，所述锁钉包括锁定部，所述锁钉具有用于穿装缝线的穿线腔，所述穿线腔穿通所述锁定部，所述穿线腔包括位于所述锁定部的第一内腔段，所述第一内腔段的内周面的表面粗糙度范围为0.1微米-2.5微米，所述锁钉穿装在所述夹头组件中，所述夹头组件压握所述锁钉使所述锁定部变形，以锁定穿装于所述锁钉的所述穿线腔内的缝线。
本发明提供的介入式远程缝线锁结装置采用的锁钉包括锁定部，所述锁钉的穿线腔的第一内腔段的内周面的表面粗糙度范围为0.1微米-2.5微米。因此，能使锁紧于锁钉的第一内腔段内的缝线的锁紧力适宜，不仅满足锁紧力需求也能避免缝线被过度挤压导致受损断裂。
附图说明
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领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明显变形方式。
图1是本发明其中一实施例提供的介入式远程缝线锁结装置的立体结构示意图。
图2是图1中沿II-II线的剖视图。
图3是图1中介入式远程缝线锁结装置采用的锁钉的立体结构示意图。
图4是图3中沿IV-IV线的剖视图。
图5是图3中沿V-V线的剖视图。
图6是图2中VI部分的放大图。
图7是图3中的锁钉穿装有缝线时的结构示意图。
图8是图7中的锁钉变形锁定缝线的状态示意图。
图9是图8中沿IX-IX线的剖视图。
图10-图12是本发明其中一实施例提供的介入式远程缝线锁结装置用于病变二尖瓣的缘对缘修复过程的示意图。
图13-图14是本发明其中一实施例提供的介入式远程缝线锁结装置用于固定缝线在锁钉中的过程示意图。
图15是图12中XV部分的放大图。
图16是本发明锁钉及对比例的锁钉经表面粗糙度测试、变形率测试、锁紧力测试及疲劳测试的结果统计图表。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
此外，以下各实施例的说明是参考附加的图示，用以例示本申请可用以实施的特定实施例。本申请中所提到的方向用语，例如，“上”、“下”、“前”、“后”、“左”、“右”、“内”、“外”、“侧面”等，仅是参考附加图式的方向，因此，使用的方向用语是为了更好、更清楚地说明及理解本申请，而不是指示或暗指所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制，另外，“轴向”是指推送件的轴心线的方向或者推送管的轴心线的方向。
方位定义：为了描述清晰，以下将手术过程中，靠近操作者的一端称为“近端”，将远离操作者的一端称为“远端”；轴向指平行于医疗器械远端中心和近端中心连线的方向；上述定义只是为了表述方便，并不能理解为对本申请的限制。
本实施例以介入医疗器械选用封堵主动脉夹层破口的封堵器为例对本申请的介入医疗器械推送装置的机构及其使用做出具体的说明公开，但本申请的介入医疗器械推送装置的使用范围不限于该封堵器。
请参阅图1至图6，本发明提供一种介入式远程缝线锁结装置100，用于缝线与锁钉300的固定，介入式远程缝线锁结装置100包括夹头组件20、设置于夹头组件20近端的驱动组件40，以及套设于夹头组件20及驱动组件40外的推送组件60。夹头组件20的远端设置用于放置锁钉300的空隙25，锁钉300沿轴向设有穿线腔301，介入式远程缝线锁结装置100沿轴向开设穿过夹头组件20及驱动组件40的穿线通道26。锁钉300包括锁定部310及设置于锁定部310远端的保持部330，穿线腔301穿通锁定部310及保持部330。锁定部310收纳于夹头组件20的空隙25内，保持部330挡止于推送组件60的远端面。穿线腔301包括位于锁定部310的第一内腔段302及位于保持部330的第二内腔段304，第一内腔段302的内周面的表面粗糙度大于或等于第二内腔段304的内周面的表面粗糙度。缝线穿设于锁钉300的穿线腔301及穿线通道26，驱动组件40相对于推送组件60转动并沿轴向移动而抵推夹头组件20，以挤压放置于空隙25内的锁钉300，使锁钉300变形以固定缝线。由于锁钉300的穿线腔301的第一内腔段302的内周面的表面粗糙度大于第二内腔段304的内周面的表面粗糙度，能使锁紧于锁钉300的第一内腔段302内的缝线的锁紧力较高，且缝线与第二内腔段304的内周面的摩擦不易使缝线磨损，从而能防止缝线受损。
介入式远程缝线锁结装置100还包括与驱动组件40的近端及推送组件60的近端相连接的手柄80。手柄80包括位于远端的固定部82及位于近端、且能相对于固定部82运动的活动部84，固定部82与推送组件60的近端固定连接，活动部84与驱动组件40的近端连接，通过活动部84与固定部82之间的相对运动，带动驱动组件40相对于推送组件60之间的轴向移动。具体地，活动部84与固定部82之间可相对旋转和沿轴向移动，从而带动驱动组件40相对于推送组件60旋转和沿轴向移动，当驱动组件40沿轴向朝远端移动而抵推夹头组件20，可挤压放置于空隙25内的锁钉300，以完成缝线与锁钉300的固定。
锁钉300由不锈钢、纯钛、镍钛、钴铬合金等生物相容性材料制成，优选由纯钛或不锈钢制成。
请参阅图3至图5，锁钉300的穿线腔301沿轴向穿通锁钉300相对的两端，穿线腔301用于容纳并通过缝线。锁定部310受到机械外力作用时可被压瘪，以将缝线固定在锁钉300的穿线腔301中。锁定部310的穿线腔301的截面可以是多种形状，例如，圆柱形、棱柱形、椭圆形、多边形或不规则形状，只要具有穿线腔301用于容纳缝线即可。锁定部310的近端面边缘设置圆角，且圆角的表面光滑，即粗糙度较小，以避免锁定部310的近端面损伤组织。
在其他实施例中，第一内腔段302的内周面相对的两个位置分别设置凸起的锁台和凹入的锁槽，当锁钉300受到外部的压握力作用，锁定部310变形，使得所述锁台被压入对应的所述锁槽内。当锁钉300继续变形，所述锁台和所述锁槽同时变形直至无法分离，此时，缝线500被牢固地固定在锁钉300的穿线腔301中。
第一内腔段302为锁钉300锁紧缝线的主要区域，锁钉300的第一内腔段302的内表面与缝线直接接触，因此，第一内腔段302的内周面的表面粗糙度直接影响锁钉的锁紧力。表面粗糙度是指材料的加工表面具有的较小间距和微小峰谷的不平度。表面粗糙度越小，说明材料的表面越光滑。表面粗糙度一般是由所采用的加工方法、表面处理和其他因素所形成的，例如加工过程中刀具与零件表面间的摩擦、切屑分离时表面层金属的塑性变形以及工艺系统中的高频振动等。表面处理的方法包含物理抛光、化学抛光、电镀、喷砂、喷涂、放电加工等。由于加工方法和表面处理方法的不同，被加工表面留下痕迹的深浅、疏密、形状和纹理都有差别。第一内腔段302的内表面的表面粗糙度对锁钉300的影响主要表现在以下几个方面：
第一，影响锁钉300的锁紧力，具体的，表面粗糙度对锁紧力的影响主要表现在影响 锁钉300的第一内腔段302配合的稳定性。在锁钉300穿设缝线并受压变形后，锁钉300的锁定部310的内腔之间为间隙配合，内腔表面越粗糙，就越易磨损，锁紧缝线后随着人体组织的不停运动，间隙逐渐增大，连接强度逐渐降低；锁钉300的锁定部310的内周面与缝线之间为过盈配合，由于压握时将锁定部310的微观凸峰挤平，减小了实际有效过盈，从而降低连接强度。
第二，影响锁钉300的疲劳强度，原因是粗糙的表面存在较大的波谷，对应力集中很敏感，故，粗糙度较大的表面，配合表面间的有效接触面积较小，压强较大，摩擦阻力较大，磨损较快，耐磨性较差；而较粗糙的表面易使血液通过表面的微观凹谷渗入到锁钉300内层，造成表面腐蚀。
由此，第一内腔段302的内周面的表面粗糙度可以根据缝线500所需的锁紧力来进行调整。为了保证锁紧力与疲劳强度之间相互平衡，保证锁钉300的安全性和有效性，第一内腔段302的内周面的表面粗糙度范围为0.1微米-2.5微米。
请一并参阅图7至图9，缝线500穿插于锁钉300的穿线腔301后，夹头组件20挤压锁钉300，使锁钉300变形以固定缝线。因此，锁钉300的变形率会影响锁钉300的锁紧力和抗疲劳能力。锁钉300的变形率反映了锁钉300被压握后的变形程度。本发明中，以锁钉300的锁定部310被压握后，锁定部310用于固定缝线500的穿线腔301在垂直于穿线腔301轴向的方向上的最小尺寸处所在的横截面的短轴的厚度为H，锁钉300初始状态时的单边壁厚为T1，则锁钉300的变形率ε＝2W/H×100％。变形率ε可以反映出锁钉300被压握变形后，穿线腔301的内部间隙的大小。若锁钉300变形率较大，则H值较小，说明锁钉300变形后的间隙较小，锁紧力较高。但变形率过大，说明锁钉300变形后的间隙过小，有可能导致缝线500断裂，或者影响锁钉300的抗疲劳强度。本发明中，锁定部310的变形率的范围为50％～90％，从而保证锁钉300的锁紧力。
e-PTFE缝线是常用的手术缝线，由100％聚四氟乙烯化学合成，是单股的不可吸收手术缝合线，具有高度孔洞性，平滑度高，摩擦系数低等特点。在e-PTFE缝线的手动打结过程中，通常需要超过两圈以上才可以打紧，当采用金属锁钉固定缝线时，要求锁紧力适宜，避免锁紧力不足导致滑脱；但由于e-PTFE缝线是单股线，其耐磨性相应较差，因此同时需要避免过大的锁紧力导致缝线断裂，并保证锁钉与e-PTFE缝线结合后，在心脏持续跳动状态下，缝线和锁钉反复受到牵拉时，锁钉的抗疲劳能力。本实施例中，变形率范围优选为55％～80％，通过将锁定部310的内周面的表面粗糙度与锁定部310的变形率相匹配，使得锁紧力和抗疲劳强度之间达到平衡，尤其适用于e-PTFE缝线等单股缝线的锁紧固定。在其他实施例中，变形率范围进一步优选为60～75％，尤其适用于锁定2～6根e-PTFE缝线。
保持部330设置于锁定部310的远端，具体地，保持部330至少部分自锁定部310的远端外壁径向凸设，即，保持部330的外径大于锁定部310的外径，也即，保持部330的远端面的横截面积大于锁定部310的径向横截面积。由此，保持部330具有限位的作用，以防止锁钉300远端面被压瘪产生变形时被拉入或滑动至夹头组件20的空隙25内。本实施例中，保持部330为横截面是环形的凸台。现有技术中，锁钉300的远端没有设置保持部330，当锁钉300的远端面被压瘪产生变形后容易被拉入或滑入夹头组件20的空隙25内，则在夹头组件20张开恢复到初始位置时，锁钉300的远端面可能会被夹头组件20挂住，无法使锁钉300从介入式远程缝线锁结装置100的远端自动分离。
保持部330具有与第一内腔段302相连通的第二内腔段304，即，第二内腔段304与第一内腔段301构成用于穿装缝线的穿线腔。第二内腔段304的内周面的表面粗糙度小于或等于第一内腔段302的内周面的表面粗糙度，从而降低缝线与第二内腔段304的内周面的摩擦力，避免缝线长期摩擦受损。
保持部330的远端外周边缘及近端外周边缘均设置圆角，保持部330的外表面为弧面，以防止锁钉300划伤患者身体内部组织。本实施例中，保持部330为横截面为环形的凸台，且凸台的外表面为弧面。凸台的远端面与第二内腔段304的内周面的相交处设置圆角。
保持部330的远端面与第一内腔段302的内周面的相交处设置第一圆滑过渡区305，锁固于锁钉300的穿线腔301内的缝线以一定倾斜角度与第一圆滑过渡区305接触，以避免保持部330的远端面与第一内腔段302的内周面的相交处切割缝线，避免缝线摩擦疲劳甚至断线。本实施例中，第一圆滑过渡区305采用放电加工，其表面粗糙度范围为0.1微米-2.5微米，以避免损坏缝线。在其他实施例中，第一圆滑过渡区305也可以经放电加工后再进行镀膜工艺以进一步减少粗糙度，通过镀PTFE膜，其表面粗糙度范围为0.1微米-0.5微米。
如图4所示，第一圆滑过渡区305与第一内腔段302的内周面之间设置第二圆滑过渡区306，第二圆滑过渡区306的表面粗糙度小于2微米。如果第二圆滑过渡区306的表面粗糙度过大，会对缝线产生摩擦疲劳并导致缝线断线，将第二圆滑过渡区306的表面粗糙度控制在2微米以内，能有效避免缝线断裂。
为了减小第二圆滑过渡区306粗糙度，可以对第二圆滑过渡区306采用放电加工；为了进一步减小第二圆滑过渡区306的粗糙度，可以在放电加工的基础上增加镀PTFE膜工艺。
为了进一步减小第二圆滑过渡区306的粗糙度或断差，第二圆滑过渡区306是自远端至近端内径逐渐减小的锥面，锥面的单边斜度范围为0.3度-0.8度，优选为0.5度-0.6度。
请一并参阅图4及图5，锁钉300的穿线腔301的内孔D1大小根据需要锁紧的缝线的线径和数量来决定，穿线腔301的内孔D1的范围为0.8微米-1.2微米。目前常用的e-PTFE缝线的外径为0.3微米，需要锁紧的数量为2根至4根，优选的，穿线腔301的内孔D1范围为0.85微米-1.0微米。锁钉300的锁定部310的壁厚T1的范围为0.1微米-0.2微米，锁定部310的壁厚T1低于0.1微米不利于锁钉300的抗疲劳能力，锁定部310的壁厚T1大于0.2微米不利于锁钉300的变形及锁紧力度；优选的，锁定部310的壁厚T1的范围为0.12微米-0.18微米。
保持部330的凸台厚度T2范围为0.3微米-0.6微米；优选的，保持部330的凸台厚度T2范围为0.4微米-0.5微米。保持部330的凸台外径D2的范围为1.6微米-2.2微米；优选的，保持部330的凸台外径D2的范围为1.8微米-2.0微米。锁钉300的整体长度L的尺寸范围为4微米-6.5微米；锁钉300的整体长度L过长不仅不利于输送，也会影响锁钉300植入人体后的安全性，优选的，锁钉300的整体长度L的长度尺寸范围为4.5微米-6.0微米。锁钉300的整体长度L减去保持部330的凸台厚度T2即为第一内腔段302的长度。
请一并参阅图2及图6，夹头组件20包括相互连接或一体成型的第一夹头22及第二夹头24，第一夹头22及第二夹头24的连接处与穿线通道26相连通。空隙25形成于第一夹头22的远端与第二夹头24的远端之间，锁钉300放置于空隙25处，即，锁钉300穿装在夹头组件20中。当驱动组件40相对于推送组件60转动并沿轴向移动而抵推夹头组件20的第一夹头22与第二夹头24相向转动，第一夹头22与第二夹头24能挤压锁钉300，使锁钉300变形，以锁定穿装于锁钉300的穿线腔301内缝线。
本实施例中，第一夹头22的近端与第二夹头24的近端通过转轴27转动连接，转轴27开设连通穿线通道26的通孔271。第一夹头22背离第二夹头24的一侧设置倾斜的导滑面226，导滑面226位于第一夹头22的远端并朝远离穿线通道26的一侧倾斜延伸。第一夹头22面朝第二夹头24的侧面邻近远端处设置第一夹齿227，第一夹齿227包括若干齿槽，每一齿槽沿大致平行于轴孔224的轴向延伸。第二夹头24面朝第一夹头22的侧面 邻近远端处设置第二夹齿243，第二夹齿243包括若干齿槽，第二夹齿243的每一齿槽的延伸方向与第一夹齿227的齿槽的延伸方向相同。当第一夹头22与第二夹头24通过转轴27转动连接后，第一夹头22的第一夹齿227与第二夹头24的第二夹齿243错位并能相互啮合，因此，第一夹头22朝第二夹头24转动，第一夹齿227及第二夹齿243将放置于空隙25内的锁钉300挤压成具有曲率的形状。夹头组件20还包括弹性件28，弹性件28用于第一夹头22和/或第二夹头24的转动复位，以便于锁钉300插入第一夹头22与第二夹头24之间的空隙25内，及在第一夹头22与第二夹头24挤压锁钉300后，第一夹头22复位以便于锁钉300顺利解脱。
驱动件44包括螺杆442及轴向连接于螺杆442的旋转芯轴445，具体的，旋转芯轴445的远端固定连接于螺杆442，旋转芯轴445的近端固定连接于活动部84，活动部84的转动能带动旋转芯轴445及螺杆442一并转动。
顶杆件42包括用于沿轴向滑动地抵接于第一夹头22的导滑面226的顶杆421，以及设置于所述顶杆421的近端的连接块423，顶杆421位于连接块423径向的一侧。连接块423沿轴向开设通孔，通孔穿通连接块423的远端面及近端面，连杆销钉45可转动地插接于通孔内。推送组件60包括转动地套接于螺杆442的推力管62、连接于推力管62远端的前端外管64、连接于推力管62远端的推送轴66，以及覆盖于前端外管64远端的端盖67。推力管62设置对应螺杆442的内螺纹，旋转芯轴445的转动带动螺杆442相对于推力管62转动并沿轴向移动；优选的，推力管62的内壁设置对应螺杆442的内螺纹622，推送轴66的远端固定连接于推力管62的近端，推送轴66的近端固定连接于固定部82。
请参阅图10至图15，以下以心脏二尖瓣的瓣膜修复术为例，说明本发明提供的介入式远程缝线锁结装置100及锁钉300在二尖瓣膜的缘对缘修复术中的使用。
第一步：如图10所示，首先在患者的股静脉穿刺，经房间隔穿刺后，向二尖瓣的前叶401和后叶403分别植入多根带有弹性垫片501的缝线500，缝线500与瓣叶之间的点接触被转变为弹性垫片501与瓣叶之间的面接触，可有效降低瓣叶撕裂的风险；
第二步：如图11及图13所示，在患者体外把两侧瓣叶上的多根缝线500均穿入锁钉300的穿线腔301中，并将缝线500近端依次经过介入式远程缝线锁结装置100的锁钉300的穿线腔301、第一夹头22与第二夹头24之间的空隙、转轴27的通孔271、前端外管64的通孔、连杆销钉45的引线孔及旋转轴445的中空内孔，从活动部84的近端穿出；
第三步：借助调弯鞘管(图未示出)将介入式远程缝线锁结装置100远端经股静脉和房间隔推入心脏，向二尖瓣的瓣叶移动靠近，同时拉动缝线500，直至介入式远程缝线锁结装置100远端到达预定位置；
第四步：分别调节前叶401和后叶403上的缝线500的松紧度，同时通过超声确定二尖瓣反流最轻的状态，当到达该状态时，停止调节，保持两组缝线500的松紧状态，即，保持二尖瓣的前叶401和后叶403之间的相对距离；
第五步：如图11及图14所示，保持手柄80的固定部82不动，驱动活动部84向远端旋转运动，此时，旋转芯轴445带动螺杆442相对于推送轴66向远端移动，螺杆442驱动顶杆件42向远端移动，顶杆件42的顶杆421的远端持续挤压第一夹头22，使得第一夹头22向第二夹头24靠拢，压握位于第一夹头22及第二夹头24之间的锁钉300，弹性件28被挤压而发生弹性变形，直至锁钉300变形，将锁钉300与穿装在锁钉300的穿线腔301中的缝线500固定在一起，保持部330被止挡于端盖67外；然后驱动活动部84向近端运动，顶杆421解除对第一夹头22的挤压，第一夹头22在弹性件28的弹性复位的作用下张开并恢复到初始位置，变形后的锁钉300自第一夹头22与第二夹头24之间的空隙处解脱；此时，缝线500被锁紧于变形的锁定部310的第一内腔段302内，使得缝线500的锁紧力较高；另外，缝线500与锁钉300的第一圆滑过渡区305及第二圆滑过渡区306 接触，由于第一圆滑过渡区305及第二圆滑过渡区306的表面粗糙度均较小，因此，能避免缝线500的损坏。
第六步：如图12及图15所示，将介入式远程缝线锁结装置100的远端撤出患者体外，锁钉300留在患者体内，将锁钉300末部的缝线500裁剪掉，此时，锁钉300将分别穿过前叶401和后叶403的两组缝线500固定在一起，二尖瓣的前叶401和后叶403形成双孔化结构，完成缘对缘修复。
可以理解的是，上述仅以介入式远程缝线锁结装置用于经股静脉-房间隔-左心房-二尖瓣的路径进行介入式的二尖瓣修复过程为例，说明了本发明的使用过程，本发明的介入式远程缝线锁结装置也可用于其他手术过程中的缝线的锁紧及固定。
本发明的介入式远程缝线锁结装置100尤其适用于以下场景，如：
经股静脉-房间隔-左心房-二尖瓣的路径进行介入式二尖瓣修复手术；
经股动脉-主动脉弓-主动脉瓣-左心室-二尖瓣的路径进行介入式二尖瓣修复手术；
经颈静脉-房间隔-左心房-二尖瓣的路径进行介入式二尖瓣修复手术。
也适用于如下场景：(1)经股静脉-右心房-三尖瓣的路径进行介入式三尖瓣修复手术；(2)经颈静脉-右心房-三尖瓣的路径进行介入式三尖瓣修复手术。通过微创介入的方式，在患者体外远程操作介入式远程缝线锁结装置100将植入在瓣叶上的缝线500通过锁钉300固定。
其他实施例中的锁钉与实施例1中的锁钉300结构相似，不同之处在于：在制作锁钉后，将锁钉的第一内腔段的内周面经过镜面放电处理或者线切割处理，使得第一内腔段的内周面的表面粗糙度与实施例1中的第一内腔段302的内周面的表面粗糙度不同，分别得到实施例2～9的锁钉，如图16所示。
采用相同的工艺制备与实施例1的锁钉300的尺寸、结构均相同的锁钉，再通过镜面放电处理或者线切割处理将锁钉的内周面的表面粗糙度调整至不同范围，作为对比例1～16的锁钉，如图16所示。
对实施例1～9，及对比例1～16中的锁钉，分别进行表面粗糙度测试、变形率测试、锁紧力测试及疲劳测试，结果如图16所示。
表面粗糙度测试
触针法测试原理：当触针沿被测表面轻轻滑过时，由于表面有微小的峰谷使触针在滑行时，还沿峰谷上下运动，触针的运动情况反映表面轮廓的情况。
测试标准：GB/T1031，GB/T10610。
测试仪器：美国Bruker公司的Dektak 6M型探针式表面轮廓仪。
测试参数：探针压力：10mg；滑行距离：800微米；滑行时间：8秒，滑行速度100微米/秒。
测试方法：将实施例1至9，及对比例1至16的锁钉300沿轴线对半切开，分为对称的两部分，在每部分的第一内腔段302分别取3至10个点，在每个取样点分别测试压力为10mg的探针以100微米/秒的速度滑行800微米的过程中，表面轮廓的变化情况，并对两部分的所有取样点的测试结果取平均值，即为锁钉300的内周面的表面粗糙度。
变形率测试
测试方法：先通过千分尺测量锁钉300外径，用针规测量锁钉300内径，再通过外径减去内径得到双边壁厚，分别得到实施例1～9，及对比例1～16的锁钉300在初始状态时的双边壁厚2T1；然后采用介入式缝线锁结装置100，分别将实施例1～9，及对比例1～16的锁钉300分别用于两根呈U形对折的e-PTFE缝线500的锁固；之后通过深圳智泰精密仪器有限公司生产的VMS322型光学影像测量仪测量锁固后的锁钉300的锁定部310在垂直于第一内腔段302轴向的方向上的最小尺寸处所在截面的短轴的厚度H，然后根据 ε＝2W/H×100％计算锁钉的变形率，结果如图16所示。
锁紧力测试
测试方法：对变形率测试中，锁固后的锁钉300及缝线500进行锁紧力测试。测试设备为上海衡翼精密仪器有限公司生产的HY-0580型电子式万能拉力试验机。测试步骤如下：锁固后的样品具有两个闭合的线圈，一个线圈作为固定端固定在拉力试验机固定端的拉钩上，另一个线圈穿入拉力试验机移动端的拉钩，拉力试验机移动端的移动速度设置为100微米/min。以拉力试验机所采集到缝线被拉脱或拉断的最大值记录为锁钉的锁紧力。根据相关文献，当锁紧力为3N时，可以满足临床上关于缝线的拉力要求。
疲劳测试
疲劳测试的目的是验证锁钉300锁紧缝线500后是否能够满足作为医疗器械植入件植入10年载荷使用。测试前，先用锁钉300锁紧两根呈U形对折的e-PTFE缝线500，然后把锁钉300及缝线500放置在模拟人体心脏左心系统跳动的疲劳测试机里，进行非破坏性疲劳测试。疲劳测试设备为上海心瓣测试设备有限公司的AWT-1000型人工心脏瓣膜耐疲劳性能测试机。按照ISO 5840及GB 12279—2008《心血管植入物人工心脏瓣膜》中关于“疲劳试验”的方法进行测试，周期：≥4亿次，记录疲劳测试周期内因负荷产生的锁钉300滑动及锁钉300对缝线500损伤情况，验证是否满足ISO 5840及GB 12279—2008《心血管植入物人工心脏瓣膜》的相关要求。
从图16所示的测试结果可知：
当锁钉300的第一内腔段302的表面粗糙度相同时，锁钉300的变形率增大，则锁紧力随之增大；当锁钉300的变形率相同时，第一内腔段302的表面粗糙度增大，则锁紧力随之增大。
当锁钉300的第一内腔段302的粗糙度小于0.10微米时，锁紧力值偏小，缝线500滑脱导致疲劳测试失效，不能满足疲劳性能要求。
当锁钉300的第一内腔段302的粗糙度大于2.5微米时，锁紧力值过大，缝线500被磨断导致疲劳测试失效，不能满足疲劳性能要求。
当锁钉300的变形率小于0.50时，说明锁钉300变形后的间隙较大，锁紧力偏小，不能有效锁紧缝线500，且不能满足疲劳性能要求。
当锁钉300的变形率大于0.90时，锁钉300容易挤伤缝线500，锁钉300的锁紧力值呈下降趋势，且不能满足疲劳性能要求。
由此可知，图16中的实施例1至实施例9同时满足较好的锁紧能力及抗疲劳能力的要求，具体的，本发明的锁钉300的第一内腔段302的内周面的表面粗糙度的范围为0.1微米-0.25微米；锁钉300的锁定部310的变形率的范围为50％-90％，当两者匹配时，锁定部310变形后对两根呈U形对折穿装在锁钉300中的e-PTFE缝线500具有合适的锁紧力及抗疲劳能力。图16中的对比例1-对比例16中的锁钉不满足疲劳性能的要求。
以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。

Claims (15)

  1. 一种用于锁紧缝线的锁钉，所述锁钉包括锁定部，所述锁钉具有用于穿装缝线的穿线腔，所述穿线腔穿通所述锁定部，其特征在于，所述穿线腔包括位于所述锁定部的第一内腔段，所述第一内腔段的内周面的表面粗糙度范围为0.1微米-2.5微米。
  2. 根据权利要求1所述的锁钉，其特征在于，所述锁定部的变形率的范围为50％～90％。
  3. 根据权利要求1所述的锁钉，其特征在于，所述锁定部的变形率的范围为60％～75％。
  4. 根据权利要求1所述的锁钉，其特征在于，所述穿线腔的内径范围为0.8微米-1.2微米，所述锁定部的壁厚范围为0.1微米-0.2微米。
  5. 根据权利要求1所述的锁钉，其特征在于，所述第一内腔段的内周面相对的两侧分别设置凸起的锁台和凹入的锁槽，当锁钉受到外部的压力作用，所述锁定部变形，使所述锁台被压入所述锁槽内。
  6. 根据权利要求1至5任意一项所述的锁钉，其特征在于，所述锁钉还包括设置于所述锁定部远端的保持部，所述穿线腔还包括穿通所述保持部的第二内腔段，所述第二内腔段与所述第一内腔段相连通，且所述第二内腔段的内周面的表面粗糙度小于或等于所述第一内腔段的内周面的表面粗糙度。
  7. 根据权利要求6所述的锁钉，其特征在于，所述保持部至少部分自所述锁定部的远端外壁径向凸设。
  8. 根据权利要求6所述的锁钉，其特征在于，所述保持部的远端外周边缘及近端外周边缘均设置圆角，所述保持部的外表面为弧面。
  9. 根据权利要求6所述的锁钉，其特征在于，所述保持部的远端面与所述第一内腔段的内周面的相交处设置第一圆滑过渡区。
  10. 根据权利要求9所述的锁钉，其特征在于，所述第一圆滑过渡区的表面粗糙度范围为0.1微米-2.5微米。
  11. 根据权利要求9所述的锁钉，其特征在于，所述第一圆滑过渡区与所述第一内腔段的内周面之间设置第二圆滑过渡区，所述第二圆滑过渡区的表面粗糙度小于2微米。
  12. 根据权利要求11所述的锁钉，其特征在于，所述第二圆滑过渡区为自远端至近端内径逐渐减小的锥面，所述锥面的单边斜度范围为0.3度-0.8度。
  13. 根据权利要求6所述的锁钉，其特征在于，所述保持部的外径范围为1.6微米-2.2微米，所述保持部的壁厚范围为0.3微米-0.6微米。
  14. 一种介入式远程缝线锁结装置，其特征在于，包括如权利要求1至13任意一项所述的锁钉，还包括夹头组件，所述锁钉穿装在所述夹头组件中，所述夹头组件压握所述锁钉使所述锁定部变形，以锁定穿装于所述锁钉的所述穿线腔内的缝线。
  15. 根据权利要求14所述的介入式远程缝线锁结装置，其特征在于，所述介入式远程缝线锁结装置还包括设置于所述夹头组件近端的驱动组件及推送组件，所述推送组件用于推送所述夹头组件及所述驱动组件，所述驱动组件用于驱动所述夹头组件压握所述锁钉。
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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113317910A (zh) * 2021-05-17 2021-08-31 上海汇禾医疗科技有限公司 二尖瓣瓣环成形系统及其操作方法
CN114073554B (zh) * 2022-01-19 2022-04-15 江苏泰科博曼医疗器械有限公司 微创手术缝合线端部锁结装置、方法及操作枪体

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5766183A (en) * 1996-10-21 1998-06-16 Lasersurge, Inc. Vascular hole closure
US20040220591A1 (en) * 2003-04-30 2004-11-04 Bonutti Peter M. Tissue fastener and methods for using same
CN101674777A (zh) * 2007-04-06 2010-03-17 介入治疗公司 缝合、卷曲和切割装置
US20110301619A1 (en) * 2010-06-08 2011-12-08 Walters Greg A Deployment instrument for closure device for percutaneously sealing punctures
US20140276979A1 (en) * 2013-03-15 2014-09-18 Lsi Solutions, Inc. Method and devices for securing bidirectional suture loops using coaxial mechanical fasteners
US20160345989A1 (en) * 2015-06-01 2016-12-01 Cook Medical Technologies Llc Snare auto micro-lock
WO2017161232A1 (en) * 2016-03-17 2017-09-21 Children's Medical Center Corporation Knotting tube
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
CN109199468A (zh) * 2018-06-08 2019-01-15 杭州德晋医疗科技有限公司 可调节的心脏瓣膜修复系统
CN209186798U (zh) * 2018-06-08 2019-08-02 杭州德晋医疗科技有限公司 可调节的缝合线锁结装置

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4328690B4 (de) * 1993-08-26 2006-08-17 SDGI Holdings, Inc., Wilmington Zwischenwirbelimplantat zur Wirbelkörperverblockung und Implantationsinstrument zum Positionieren des Zwischenwirbelimplantats
US5391173A (en) * 1994-02-10 1995-02-21 Wilk; Peter J. Laparoscopic suturing technique and associated device
US7381210B2 (en) * 2003-03-14 2008-06-03 Edwards Lifesciences Corporation Mitral valve repair system and method for use
US20070270907A1 (en) * 2006-05-19 2007-11-22 Stokes Michael J Suture locking device
US8758406B2 (en) * 2007-03-05 2014-06-24 Tomier, Inc. Tack anchor systems, bone anchor systems, and methods of use
CN102262015B (zh) * 2010-05-27 2013-07-31 北京服装学院 一种弹力织物疲劳测试方法
US9078645B2 (en) * 2011-12-19 2015-07-14 Edwards Lifesciences Corporation Knotless suture anchoring devices and tools for implants
US9078652B2 (en) * 2011-12-19 2015-07-14 Edwards Lifesciences Corporation Side-entry knotless suture anchoring clamps and deployment tools
US8961594B2 (en) * 2012-05-31 2015-02-24 4Tech Inc. Heart valve repair system
CN117481866A (zh) * 2017-12-27 2024-02-02 苏州优迈医疗器械有限公司 一种手术网调节并固定张力的装置及其手术应用
CN208799272U (zh) * 2018-03-28 2019-04-30 杭州德晋医疗科技有限公司 缝合线锁扣及缝合线锁结系统
CN209153791U (zh) * 2018-03-28 2019-07-26 杭州德晋医疗科技有限公司 心脏瓣膜修复系统

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5766183A (en) * 1996-10-21 1998-06-16 Lasersurge, Inc. Vascular hole closure
US20040220591A1 (en) * 2003-04-30 2004-11-04 Bonutti Peter M. Tissue fastener and methods for using same
CN101674777A (zh) * 2007-04-06 2010-03-17 介入治疗公司 缝合、卷曲和切割装置
US20110301619A1 (en) * 2010-06-08 2011-12-08 Walters Greg A Deployment instrument for closure device for percutaneously sealing punctures
US20140276979A1 (en) * 2013-03-15 2014-09-18 Lsi Solutions, Inc. Method and devices for securing bidirectional suture loops using coaxial mechanical fasteners
US20160345989A1 (en) * 2015-06-01 2016-12-01 Cook Medical Technologies Llc Snare auto micro-lock
WO2017161232A1 (en) * 2016-03-17 2017-09-21 Children's Medical Center Corporation Knotting tube
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
CN109199468A (zh) * 2018-06-08 2019-01-15 杭州德晋医疗科技有限公司 可调节的心脏瓣膜修复系统
CN209186798U (zh) * 2018-06-08 2019-08-02 杭州德晋医疗科技有限公司 可调节的缝合线锁结装置

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4023164A4 *

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