WO2021098371A1 - 可独立控制的瓣膜夹合系统 - Google Patents

可独立控制的瓣膜夹合系统 Download PDF

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Publication number
WO2021098371A1
WO2021098371A1 PCT/CN2020/117249 CN2020117249W WO2021098371A1 WO 2021098371 A1 WO2021098371 A1 WO 2021098371A1 CN 2020117249 W CN2020117249 W CN 2020117249W WO 2021098371 A1 WO2021098371 A1 WO 2021098371A1
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WO
WIPO (PCT)
Prior art keywords
valve
proximal
clip
control
pair
Prior art date
Application number
PCT/CN2020/117249
Other languages
English (en)
French (fr)
Inventor
张庭超
王泽涛
张伟伟
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201911138749.1A external-priority patent/CN111789699A/zh
Priority claimed from CN201922008013.4U external-priority patent/CN211934427U/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Priority to EP20890245.2A priority Critical patent/EP4062873A4/en
Publication of WO2021098371A1 publication Critical patent/WO2021098371A1/zh
Priority to US17/583,839 priority patent/US20220142781A1/en

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Classifications

    • 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
    • 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
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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

  • This application relates to the field of medical devices, and in particular to an independently controllable valve clamping system.
  • Mitral valve 1 is a one-way valve located between the left atrium 2 and left ventricle 3 of the heart.
  • a normal and healthy mitral valve 1 can control the flow of blood from the left atrium 2 to the left ventricle 3, while preventing blood from flowing from The left ventricle 3 flows to the left atrium 2.
  • the mitral valve 1 includes a pair of leaflets, called the anterior leaflet 1a and the posterior leaflet 1b.
  • the anterior lobe 1a and the posterior lobe 1b are fixed to the papillary muscle of the left ventricle 3 through the chordae 4.
  • valve clamp is delivered to the mitral valve through an interventional catheter, and then the anterior leaflet and the mitral valve are clamped by the relative opening of the clamp.
  • the posterior leaflets thereby drawing the leaflets closer to each other, alleviating "Mitral Regurgitation".
  • Mitral Regurgitation In the process of clamping the valve leaflets, since the two leaflets of the mitral valve are always in a state of large and powerful opening and closing activities, it is difficult to clamp, and it is usually desired to control the clamping action of each leaflet separately.
  • an existing valve clamp 100' includes two sets of proximal clips 20' and distal clips 30' respectively located on opposite sides of the axis of the delivery sheath 210'.
  • the end clips 20' are controlled to move through the control wire 230', and the two proximal clips 20' can be released separately and expand relative to the fixing seat 10' to the corresponding distal clips under the action of their own elasticity.
  • 30' close together to clamp the two leaflets of the mitral valve respectively.
  • the incoming and outgoing wires of the control wire 230' that control each proximal clip 20' are all passing through the same one side of the axis of the delivery sheath 210'.
  • the cavity 211' is implemented.
  • the unilateral proximal clip 20' In the process of repeated surgical operations, when the unilateral proximal clip 20' is tightened by the control wire 230' and is retracted relative to the fixing seat 10', it acts on the proximal clip 20
  • the pulling force F'on the delivery sheath 210' is located on the axis line side of the delivery sheath 210'.
  • the pulling force F' will generate a certain torque on the valve clamp 100', which will cause the valve clamp 100' to move toward the side where the pulling force F'is located. Swing, and further cause the delivery sheath 210' to bend, so that the operator needs to adjust the position of the valve clamp 100' several times to accurately release the proximal clip 20' to re-clamp the leaflets of the mitral valve.
  • the operation time is relatively long.
  • the swing of the valve clamp 100' may also pull the valve leaflets or entangle the chordae, thereby tearing the valve leaflets or hanging the chordae, which will not only cause failure of
  • the present application provides an independently controllable valve clamping system, which can not only clamp one side of the valve leaflet separately, but also avoid the bending of the delivery sheath and the swing of the valve clamp, which is beneficial to reduce the operation time , Improve the efficiency of the operation and avoid harm to the patient.
  • the present application provides an independently controllable valve clamping system, including a valve clamping device and a conveying device for conveying the valve clamping device.
  • the valve clamping device includes a fixing seat and a valve Relative to the proximal clip that is collapsed or unfolded from the fixing seat
  • the delivery device includes a delivery sheath and a control member, and each of the control members is correspondingly connected to a proximal clip to control the proximal clip Folded or unfolded relative to the fixed seat; wherein the delivery sheath is provided with at least one pair of first cavities extending in the axial direction, and at least one pair of the first cavities is relative to the axis of the delivery sheath Symmetrically, each of the control members movably penetrates through at least a pair of the first cavities.
  • the control member is inserted in at least a pair of first cavities opened symmetrically about the axis of the delivery sheath, and when the corresponding proximal clip is controlled to be opposed by the control member
  • the fixing seat is closed, the resultant force of the pulling force of the control member acting on the corresponding proximal clip is located on the axis of the delivery sheath, thereby avoiding bending of the delivery sheath and swinging of the valve clamp, which is beneficial to reduce the operation time, Improve the efficiency of surgery and avoid harm to the patient.
  • Figure 1 is a schematic diagram of the mitral valve in a normal state.
  • Figure 2 is a schematic diagram of mitral valve disease.
  • Fig. 3 is a schematic diagram of the three-dimensional structure of a valve clamp and a delivery sheath in the prior art.
  • Fig. 4 is a schematic diagram of the proximal clip on one side of the valve clamp in Fig. 3 when it is tightened.
  • Fig. 5 is a schematic diagram of the three-dimensional structure of the valve clamping system provided by the first embodiment of the present application.
  • Fig. 6 is a schematic diagram of the proximal clip of one side of the valve clamp in Fig. 5 being tightened.
  • Fig. 7 is a three-dimensional schematic diagram of a partial structure of the valve clamping system in Fig. 5.
  • FIG. 8 is a schematic diagram of the three-dimensional structure of the fixing seat in FIG. 7.
  • FIG. 9 is a schematic diagram of the three-dimensional structure of the proximal clip in FIG. 7.
  • Fig. 10 is a schematic diagram of the state of use of the valve clamp in Fig. 5.
  • Fig. 11 is a schematic diagram of the mitral valve when the heart is contracted after the valve leaflet is clamped by the valve clamp in Fig. 10.
  • Fig. 12 is a schematic diagram of the mitral valve during diastole after the valve leaflet is clamped by the valve clamp in Fig. 10.
  • Fig. 13 is a schematic view of the distal end of the delivery sheath in Fig. 5.
  • 14 and 15 are schematic diagrams of the distal end surface of the delivery sheath in other embodiments.
  • Fig. 16 is a partial three-dimensional structure diagram of the conveying device in Fig. 5.
  • Fig. 17 is a cross-sectional view of the conveying device in Fig. 16.
  • FIGs 18-21 are schematic diagrams of the use process of the valve clamping system in Figure 5.
  • Fig. 22 is a three-dimensional schematic diagram of a partial structure of the valve clamping system provided by the second embodiment of the present application.
  • FIG. 23 is a three-dimensional structure diagram of a partial structure of the valve clamping system provided by the third embodiment of the present application.
  • FIG. 24 is a schematic structural diagram of the valve clamping system provided by the fourth embodiment of the present application.
  • the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator;
  • the axial direction refers to the end parallel to the natural The direction of the connection between the distal center and the proximal center of the medical device in the state.
  • the first embodiment of the present application provides an independently controllable valve clamping system, including a valve clamping device 100 and a delivery device 200 for delivering the valve clamping device 100.
  • the valve clamp 100 includes a fixing base 10 and a proximal clip 20 that can be folded or unfolded relative to the fixing base 10.
  • the delivery device 200 includes a delivery sheath 210 and a control member 230. Each control member 230 is correspondingly connected to a proximal clip 20 to control the proximal clip 20 to be folded or unfolded relative to the fixing seat 10.
  • the delivery sheath 210 defines at least one pair of first cavities 211 extending in the axial direction and symmetrical about the axis of the delivery sheath 210, and each control member 230 movably penetrates through at least one pair of first cavities In 211, therefore, when the control member 230 is tightened toward the proximal end to control the corresponding proximal clip 20 to be folded relative to the fixing base 10, the resultant force of the pulling force of each control member 230 acting on the corresponding proximal clip 20 F is located on the axis of the delivery sheath 210, so as to avoid bending of the delivery sheath 210 and swing of the valve clamp 100.
  • the valve clamp 100 further includes a distal clip 30 rotatably connected to the fixing base 10 and a drive assembly for driving the distal clip 30 to open and close relative to the fixing base 10.
  • the drive assembly includes an axially slidable arrangement.
  • the push rod 40 in the fixing base 10 and the connecting rod 50 connecting the distal end clip 30 and the push rod 40.
  • the control of the proximal clip 20 by the control member 230 is released, the proximal clip 20 is released and expands relative to the fixing seat 10, and the proximal clip 20 is moved closer to the distal clip 30 to clamp the clip between the two valve.
  • the operator can control the corresponding proximal clip 20 to close relative to the holder 10 by tightening the control member 230, so that the proximal clip 20 can be released again to re-clamp the valve. .
  • the control member 230 penetrates through at least one pair of first cavities 211 that are symmetrically opened about the axis of the delivery sheath 210.
  • the control member 230 controls the corresponding proximal clip 20 relative to the fixing seat 10
  • the resultant force F of the pulling force exerted by the control member 230 on the corresponding proximal clip 20 is located on the axis of the delivery sheath 210, so that the resultant force F exerts zero torque on the valve clamp 100, thereby avoiding
  • the operator does not need to adjust the position of the valve clamp 100 many times to quickly and accurately release the proximal clamp 20 to clamp the valve, which is beneficial to reduce the operation time , Improve the efficiency of the operation, and can avoid the damage to the patient caused by the swing of the valve clamp 100.
  • the number of the proximal clip 20 and the distal clip 30 are both two, and the two proximal clips 20 and the two distal clips 30 correspond one-to-one to form two clamps, and two The two clamps are arranged symmetrically about the axis of the fixing base 10.
  • the valve clamper 100 is delivered to the mitral valve of the patient through the delivery device 200.
  • the two clamps can respectively clamp the anterior and posterior leaflets of the mitral valve to reduce the leaflet gap and remain as an implant.
  • the patient's body to reduce or treat the patient's "Mitral Regurgitation".
  • the holder 10, the proximal clip 20 and the distal clip 30 are respectively made of biocompatible metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy
  • the push rod 40 and the connecting rod 50 are respectively made of polyester, silicone resin, stainless steel, cobalt alloy, cobalt chromium alloy or titanium alloy and other biocompatible polymer materials or metal materials.
  • the fixing base 10, the distal clip 30, the push rod 40, and the connecting rod 50 are all made of stainless steel or cobalt-chromium alloy with higher hardness, and the proximal clip 20 It is made of a material with a shape memory function, preferably a super-elastic nickel-titanium alloy.
  • the fixing base 10 includes a first base 11 at the proximal end, a second base 12 at the distal end, and a transitional connection between the first base 11 and the second base.
  • the third seat body 13 of the seat body 12 may be an integral structure or a non-integral structure. In this embodiment, the three are an integral structure.
  • the first seat body 11 is axially provided with a lumen penetrating both ends, and the proximal end of the first seat body 11 is provided with two rectangular clamping holes 111 communicating with the lumen and symmetrical about the axis of the first seat body 11. It is used to connect with the connecting rod 250 of the conveying device 200.
  • the second seat body 12 is provided with accommodating cavities 14 passing through opposite sides of the second seat body 12 along a direction perpendicular to the axial direction.
  • the second seat body 12 is axially opened with an inner wall of the distal end of the accommodating cavity 14 to pass through
  • the axis of the through hole is collinear with the axis of the lumen of the first seat 11.
  • a rectangular block 121 protrudes from the other two opposite sides of the second base 12 respectively.
  • Two opposite planes of the third base 13 are respectively provided with a connecting block 131, and the connecting block 131 is provided with a pin hole for installing a rotating pin or a bolt.
  • the third seat body 13 is provided with a through hole (not shown in the figure) along the axial direction, the lumen of the first seat body 11, the through hole of the third seat body 13, and the accommodating cavity 14 of the second seat body 12. And the through hole located on the inner wall of the distal end of the accommodating cavity 14 is coaxially communicated to form a through channel 15.
  • the driving assembly includes a push rod 40, and the push rod 40 is slidably inserted in the through channel of the fixing base 10 along the axial direction.
  • the proximal end of the push rod 40 is connected with the mandrel (not shown in the figure) of the delivery device 200.
  • a connecting seat 45 is provided at the distal end of the push rod 40, and two penetrating pin holes are opened at the opposite ends of the connecting seat 45.
  • the shape of the connecting seat 45 is any structure such as a hemisphere, a spherical crown, or a bullet shape, so that the valve clamp 100 can be transported more easily in the body.
  • the accommodating cavity of the fixed seat 10 is provided with a locking member, and two opposite sides of the fixed seat 10 are respectively provided with adjusting members.
  • the push rod can be realized by the cooperation of the locking member and the adjusting member. 40 is fixed or unlocked relative to the fixed seat 10.
  • the locking member may be a combination of a deformed elastic sheet and a steel sheet in the prior art
  • the adjusting member may be a metal wire made of nickel-titanium alloy, etc. Improvement has nothing to do with creation, so I won’t go into details here.
  • the driving assembly further includes two connecting rods 50 arranged oppositely, and each connecting rod 50 is used to connect the distal end clip 30 on the corresponding side to the pusher.
  • the connecting seat 45 at the distal end of the rod 40 can be opened and closed relative to the fixed seat 10 by pulling the distal clip 30 through the connecting rod 50 when the push rod 40 slides in the axial direction in the fixed seat 10.
  • each distal clip 30 includes a connecting section 31 located at the distal end and a clamping section 32 connected to the proximal end of the connecting section 31.
  • the end of the connecting section 31 away from the corresponding clamping section 32 is rotatably connected to the fixing base 10.
  • the connecting block 131 of the third seat 13 of the third seat body, the end of the connecting section 31 close to the clamping section 32 is rotatably connected to the proximal end of the connecting rod 50 on the corresponding side, and the distal end of the connecting rod 50 is rotatably connected to the connecting rod 50 by a rotating pin or bolt
  • the pin hole of the connecting seat 45 The pin hole of the connecting seat 45.
  • the push rod 40 is unlocked with respect to the fixed seat 10 through the cooperation of the locking member and the adjusting member provided on the fixed seat 10, and the push rod 40 can slide toward the distal end in the axial direction to move relative to the fixed seat 10.
  • the connecting seat 45 at the distal end of the push rod 40 moves relative to the fixing seat 10, and the connecting seat 45 drives the connecting rod 50 to move.
  • the distal clip 30 can surround the pin hole on the connecting block 131 The center rotates and expands relative to the fixed seat 10.
  • a leaflet containing space is formed between the proximal clip 20 and the distal clip 30, and the proximal clip 20 faces the corresponding far
  • the end clip 30 closes to clamp the valve between the two; after the proximal clip 20 and the distal clip 30 clamp the valve, the push rod 40 is driven to slide toward the proximal end in the axial direction, and the connecting rod 50 then drives The distal clip 30 is closed relative to the fixing base 10 until the distal clip 30 is completely closed relative to the fixing base 10.
  • valve clip 100 is in the retracted state, and again through the cooperation of the locking member and the adjusting member, The push rod 40 is fixed relative to the fixing base 10 to prevent the distal clip 30 from opening relative to the fixing base 10, and the valve clamp 100 in the collapsed state falls under the valve.
  • the distal clip 30 When the connecting rod 50 drives the distal clip 30 to open and close relative to the fixing base 10, the distal clip 30 can be opened and closed relative to the fixing base 10 in a larger range.
  • the included angle can reach a maximum of 300 degrees, that is, after the distal end clip 30 is opened relative to the fixing base 10, it can be turned downward to a certain extent, which is beneficial to clamping the valve that is constantly in motion and improving the success rate of clamping.
  • the angle between the two distal clips 30 is preferably 0-240 degrees, more preferably 120-180 degrees.
  • the first surface of the distal clip 30 facing the proximal clip 20 may be provided with a clamping anti-skid structure (not shown in the figure) to enhance the frictional force when the distal clip 30 contacts the valve, thereby providing stability
  • the clamping force is high, and it can prevent the distal end clip 30 from causing damage to the valve.
  • the clamping anti-skid structure may be a protrusion, a groove provided on the first surface, or a pad made of a biocompatible material with a relatively high friction coefficient and attached to the first surface.
  • the first surface may be a flat surface or a curved surface.
  • the first surface is set to a curved surface to increase the contact area and clamping area between the distal clip 30 and the valve, so as to provide a stable clamping force; furthermore, the curved first surface forms a receiving groove near the When the end clip 20 is close to the distal clip 30, the proximal clip 20 is at least partially received in the receiving groove to compress the valve between the two, and can minimize the volume of the valve clip 100 when it is folded. Conducive to delivery in the body.
  • active drugs may be applied to the first surface of the distal clip 30, or at least one opening may be opened to promote the crawling and growth of endothelial cells of the valve tissue on the inner surface of the distal clip 30; and In addition, opening the opening can also reduce the overall weight of the valve clamp 100, thereby preventing the overweight valve clamp 100 from falling under the leaflets for a long time to cause slippage or damage the leaflets.
  • Each proximal clip 20 includes a connecting end 21 and a free end 22 disposed oppositely, and the connecting end 21 is fixed relative to the fixing base 10.
  • the two proximal clips 20 are connected as a whole through a connecting frame 23.
  • the connecting frame 23 is provided with a through hole 24 for the push rod 40 to pass through.
  • the two opposite sides of the connecting frame 23 are also provided for second A rectangular hole 25 through which the rectangular block 121 on the seat body 12 passes.
  • the connecting frame 23 is sleeved on the outside of the second seat body 12 and the third seat body 13 to oppose the connecting ends 21 of the two proximal clips 20. Fixed to the fixed seat 10.
  • the connecting end 21 of the proximal clip 20 may be directly fixed to the fixing base 10 by welding, crimping or other connection methods.
  • Each proximal clip 20 is at least partially made of a material with a shape memory function. After the heat-setting process, in a natural state, the proximal clip 20 extends radially outward with respect to the fixing base 10, and preferably extends toward the proximal end so as to cooperate with the distal clip 30 to clamp the valve leaflet.
  • the proximal clip 20 is cut from a nickel-titanium alloy and placed in a shaping mold, and then the shaping mold is heat-treated at 300-650°C, taken out and quickly cooled, and the shaping mold is removed to obtain a shaped proximal end Clip 20.
  • the entire proximal clip 20 is made of super-elastic Nitinol
  • the connecting frame 23 is also made of Nitinol and is integrally formed with the proximal clip 20 to reduce the difficulty of the production process. Simplify the process and reduce production costs.
  • the connecting frame 23 can also be made of stainless steel, and then welded to the proximal clip 20 to improve the strength of the connection between the connecting frame 23 and the second base body 12.
  • Each proximal clip 20 is provided with at least one connecting structure 26 for connecting with the control member 230.
  • each proximal clip 20 is provided with a connecting hole, and the connecting hole is the connecting structure 26, and the control member 230 penetrates the connection of the corresponding proximal clip 20.
  • the operator controls the corresponding proximal clip 20 to be folded or unfolded relative to the fixing seat 10 through the control member 230 of the external part.
  • the connecting structure 26 is provided at the end of the proximal clip 20 far away from the fixing base 10 after being unfolded relative to the fixing base 10, that is, the free end 22, which is beneficial for the operator to use a smaller pulling force to control
  • the proximal clip 20 is folded relative to the fixing base 10.
  • the connecting structure 26 may be two or more connecting holes opened on the proximal clip 20, and the control member 230 sequentially passes through the multiple connecting holes to control the proximal clip 20.
  • the connecting structure 26 may be at least one connecting ring protrudingly provided on the surface of the proximal clip 20 facing the fixing seat 10, and the control member 230 penetrates through the connecting ring to control the proximal clip 20.
  • the connecting ring and the proximal clip 20 may be an integral structure or a non-integral structure.
  • the connecting ring is integrally formed with the proximal clip 20 by machining or stamping processing; in other embodiments, the connecting ring may be a part with a connecting hole and is connected to the proximal end.
  • the clips 20 are combined together by crimping, bonding or welding.
  • each proximal clip 20 is provided with at least two connection structures 26, preferably, the central line of the at least two connection structures 26 is located at or close to the axial center line of the proximal clip 20 (ie, near The end clip 20 is along the center line of the direction from the connecting end 21 to the free end 22) to avoid the tension of the control member 230 acting on the corresponding proximal clip 20 to cause the proximal clip 20 to be twisted and deformed around its axial centerline. .
  • a clamping reinforcement member is provided on the second surface of each proximal clip 20 facing the distal clip 30 to increase the friction between the proximal clip 20 and the valve and improve the pairing of the valve clip 100
  • the clamping force of the valve is two rows of barbs 27 arranged at intervals on opposite sides of the second surface.
  • the barbs 27 can be formed on the proximal clip 20 by an integral molding method, or the barbs 27 can be formed of the same or different material as the proximal clip 20 and then connected to the second surface of the proximal clip 20 .
  • the angle between the extending direction of the barb 27 and the second surface is less than or equal to 90 degrees, preferably 30-60 degrees, so as to enhance the clamping force of the valve clamp 100 on the valve.
  • the clamping reinforcement may be a ridge, boss, or other irregularly distributed protrusions protruding on the second surface, and may also be a rough surface or more than a few that cover the second surface at least partially. Combination of these forms to improve the holding force of the valve.
  • each proximal clip 20 can also be applied with active drugs or at least one opening 28 can be opened.
  • the included angle between the two proximal clips 20 in the natural unfolded state should be slightly larger than the included angle between the two distal clips 30 to provide a more stable clamping force, that is, the proximal clip
  • the angle between the piece 20 and the fixing base 10 is greater than or equal to the angle between the distal clip 30 and the fixing base 10 when the distal end clip 30 corresponding to the side is fully opened relative to the fixing base 10, so as to ensure close proximity There is a certain clamping force between the end clip 20 and the distal clip 30 to clamp the valve leaflet located between the two.
  • the angle between the length direction of the proximal clip 20 and the axial direction of the fixing seat 10 ranges from 0 to 150 degrees, that is, in the natural state, the angle between the two proximal clips 20
  • the included angle can be up to 300 degrees, and the opening angle range between the two proximal clips 20 is preferably 0-240 degrees, more preferably 160-200 degrees.
  • valve clamp 100 provided in this embodiment can be used to reduce or treat "mitral valve regurgitation." Specifically, please refer to FIGS. 10 to 12 together, and place the valve clamp 100 at the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot align normally, so that the corresponding set of proximal clips 20 And the distal clip 30 clamps the edge of the anterior leaflet 1a of the mitral valve, and another set of corresponding proximal clip 20 and the distal clip 30 clamp the edge of the posterior leaflet 1b of the mitral valve to The positions where the anterior leaf 1a and the posterior leaf 1b cannot be normally aligned are clamped together.
  • the arrow direction shown in Fig. 11 and Fig. 12 is the blood flow direction.
  • the anterior leaflets 1a and the posterior leaflets 1b are closed, the area A of the mitral valve opening becomes smaller or the mitral valve can be completely closed, thereby reducing or treating "mitral valve regurgitation".
  • the anterior leaflets 1a and the posterior leaflets 1b are only aligned at the position B sandwiched by the valve clamp 100, and the other positions of the anterior leaflets 1a and the posterior leaflets 1b are still in normal diastole, so that Blood can enter the left ventricle from the left atrium to ensure the normal circulation of blood.
  • the two leaflets of the mitral valve are always open and close, it is difficult to clamp, and often only one leaflet is successfully clamped, and the other leaflet may only be partially clamped. This may As a result, the clamping position of the two leaflets of the mitral valve is not ideal or the partially clamped leaflets eventually slip from the valve clamp 100. At this time, the surgical operation can only be repeated, that is, the proximal end is tightened.
  • the control member 230 controls the proximal clip 20, which is pressed on the only partially clamped leaflet, to be folded relative to the fixing seat 10, and adjusts the position of the valve clamp 100 so that the distal clip 30 is located in the proper position of the leaflet.
  • the control member 230 penetrates
  • the delivery sheath 210 extends into at least a pair of first cavities 211 symmetrically opened with respect to its axis to extend outside the patient's body.
  • each The resultant force F of the pulling force exerted by the control member 230 on the corresponding proximal clip 20 is located on the axis of the delivery sheath 210, so that the resultant force F exerts zero torque on the valve clamp 100, thereby avoiding the delivery sheath
  • the tube 210 is bent and the valve clamp 100 swings.
  • the operator does not need to adjust the position of the valve clamp 100 multiple times to quickly and accurately release the proximal clip 20 to re-clamp the valve, which is beneficial to reduce the operation time and improve The operation is efficient, and it can avoid the damage to the patient caused by the valve clamp 100 swinging and hurting the chordae or tissue.
  • the delivery sheath 210 is provided with two pairs of first cavities 211, and each pair of first cavities 211 is provided with a control member 230 for controlling a corresponding proximal clip.
  • Piece 20 the two control members 230 respectively used to control the two proximal clips 20 penetrate through two different pairs of first cavities 211.
  • Each control member 230 is a single control wire. After the control wire passes through the corresponding proximal clip 20, the two ends of the control wire are respectively passed through a pair of first cavities 211 and extend outside the patient's body. Specifically, the inlet channel of the control wire is one of the first cavity 211 of the pair of first cavities 211, and the outlet channel is the other first cavity 211 of the pair of first cavities 211, namely , The inlet channel and outlet channel of the control line are symmetrical with respect to the axis of the delivery sheath 210. As shown in FIG.
  • the control wire reaches the corresponding proximal clip 20 along the inlet channel, passes through the connecting structure 26 on the proximal clip 20, and then is reversely bent and then extends through the outlet channel to The patient is outside the body.
  • FIG. 6 when the operator pulls one of the control wires toward the proximal end to control the corresponding proximal clip 20 to be folded relative to the fixing base 10, the control wires bent into two parts act on the corresponding The pulling forces on the proximal clip 20 are F1 and F2, respectively.
  • the pulling force F1 and the pulling force F2 are symmetrical about the axis of the delivery sheath 210, and the resultant force F is located on the axis of the delivery sheath 210, so that the resultant force F acts on the valve clamp
  • the torque generated by the combiner 100 is zero, which can prevent the delivery sheath 210 from bending and the valve holder 100 from swinging.
  • the operator can quickly adjust the position of the valve holder 100 and accurately release the proximal clip 20 for re-clamping.
  • the valve is beneficial to reduce the operation time, improve the operation efficiency, and can avoid the damage to the patient caused by the swing of the valve clamp 100.
  • control wire is a single wire or a plurality of wound wires, and the wire is selected from nickel-titanium wire, stainless steel wire or high-strength polymer wire.
  • control wire adopts a single nickel-titanium wire, that is, the control member 230 is a single nickel-titanium wire.
  • the shape of the first cavity 211 may be a circle, a square, a polygon, or other special shapes. In this embodiment, the first cavity 211 is a circular cavity.
  • each first cavity 211 is connected to the other pair of first cavities.
  • the distance between the two first cavities 211 of 211 is equal, that is, the two pairs of first cavities 211 are distributed in a square shape.
  • the distance between each first cavity 211 and the two first cavities 211 of another pair of first cavities 211 may not be equal, that is, the two pairs of first cavities 211 are distributed in a rectangular shape. , As shown in Figure 14.
  • the distance between the axis of the two pairs of first cavities 211 and the axis of the delivery sheath 210 may not be equal, that is, the two pairs of first cavities 211 are distributed in a parallelogram, as shown in FIG. 15 Show.
  • the delivery sheath 210 may only have a pair of first cavities 211, and the two control wires respectively used to control the two proximal clips 20 pass through the pair of first cavities 211.
  • the inlet channels of the two control wires are the same first cavity 211 in the pair of first cavities 211, and the outlet channels of the two control wires are the pair of first cavities 211. In the other first cavity 211.
  • the valve clamping system further includes a pressure sensor (not shown in the figure), and the delivery sheath 210 is provided with a second cavity 212 extending in the axial direction.
  • the pressure sensor is movably penetrated in the second cavity 212 and can extend from the distal end of the second cavity 212.
  • the pressure sensor can be removed from the distal end of the second cavity 212 Extend into the left atrium of the heart to feed back the pressure value in the heart in real time to confirm the reduction of the patient’s "mitral regurgitation", thereby determining whether it is necessary to adjust the position of the valve clamp 100 and re-clamp the mitral valve
  • the valve leaflets to optimize the treatment effect.
  • the pressure sensor can be assembled in the second cavity 212 of the delivery sheath 210 at the factory, or other compatible commercial pressure sensors can be used, which are assembled in the delivery sheath 210 by the operator before the operation. In the second cavity 212.
  • the valve clamping system provided in this embodiment includes a valve clamping device 100 and a delivery device 200.
  • the valve clamping device 100 is delivered to the mitral through the delivery device 200 And adjust the valve clamp 100 to the appropriate position of the mitral valve.
  • the delivery device 200 includes an operating handle and a delivery component, the proximal end of the delivery component is connected with the operating handle, and the distal end of the delivery component is detachably connected with the valve clamp 100.
  • the delivery assembly includes the aforementioned delivery sheath 210 and a control member 230 penetrating through the first cavity 211 of the delivery sheath 210. Further, the delivery assembly also includes a connector 250 that is inserted into the distal end of the delivery sheath 210, The liner 270 is movably coaxially sleeved in the lumen of the connector 250 and the mandrel 290 is movably coaxially sleeved in the liner 270. The operator can tighten the control member 230 through an operating handle placed outside the patient's body, and respectively drive the liner 270 and the mandrel 290 to move or rotate relative to each other.
  • the delivery sheath 210 defines a third cavity 213 along the axial direction.
  • the connecting member 250 is inserted into the distal end of the third cavity 213.
  • the liner 270 and the mandrel 290 pass through the third cavity 213 and extend outside the patient's body.
  • the distal end of the delivery sheath 210 is provided with a fixing member 214, and the connecting member 250, the liner 270 and the mandrel 290 coaxially fitted together are inserted into the delivery sheath 210 through the fixing member 214.
  • the fixing member 214 is provided with a plurality of through holes respectively communicating with the first cavity 211, the second cavity 212 and the third cavity 213.
  • the delivery sheath 210 can be a multi-lumen tube made of biocompatible metal material or polymer material through integral molding, or it can be several single tubes made of biocompatible metal material or polymer material.
  • the body is a multi-lumen tube formed by crimping, welding or bonding.
  • the metal material is selected from stainless steel, aluminum alloy or cobalt-chromium alloy;
  • the polymer material is selected from polycarbonate, polyethylene or polyamide.
  • the pushing catheter 210 is an integrally formed multi-lumen tube, which is provided with a number of cavities extending along the axial direction of the pushing catheter 210.
  • the plurality of cavities form the aforementioned at least one pair of first cavities 211, A second cavity 212 and a third cavity 213.
  • the connecting member 250 is substantially tubular, and two connecting rods 253 are arranged axisymmetrically at the distal end of the connecting member 250, and the distal end of each connecting rod 253 is provided with a buckle 255 for detachably connecting with the fixing base 10.
  • the inner surfaces of the two axisymmetrically arranged connecting rods 253 facing each other are arc surfaces that are smoothly transitioned to the cylindrical surface of the lumen of the connecting member 250, and the arc surface of each connecting rod 253 is aligned with the axis of the connecting member 250.
  • each connecting rod 253 is inclined toward the axis of the connecting member 250, and the two connecting rods 253 gradually converge and approach from the proximal end to the distal end.
  • the connecting rod 253 is made of an elastic material. When the connecting rod 253 is pushed outward in the radial direction of the connecting member 250, the distal end of the connecting rod 253 expands outward.
  • the liner 270 of the delivery device 200 is movably inserted into the lumen of the connecting member 250, and the liner 270 is driven to move toward the distal end.
  • the liner 270 pushes the connecting rod 253 outward in the radial direction, and the buckle 255 of the connecting rod 253 Expand outwards and snap into the hole 111 of the fixing base 10, so that the delivery device 200 is connected to the fixing base 10 through the connecting member 250; it is understandable that the liner 270 is retracted toward the proximal end, and the connecting rod 253 returns due to its own elasticity. Then, the distal end of the connecting rod 253 is retracted toward the axis of the connecting member 250, the buckle 255 exits the corresponding hole 111, and the connection state between the conveying device 200 and the fixing base 10 is released.
  • the mandrel 290 is detachably connected with the push rod 40 to drive the push rod 40 to slide along the axial direction of the fixing base 10 so as to drive the distal end clip 30 to open and close relative to the fixing base 10.
  • the mandrel 290 is a round rod body with an internal threaded hole (not shown in the figure) at the distal end, and the internal threaded hole is used for threaded connection with the external thread of the proximal end of the push rod 40.
  • the delivery assembly may not include the liner 270, and the overall diameter of the mandrel 290 or the diameter of the distal end of the mandrel 290 is larger, so that the distal end of the mandrel 290 can directly push the distal end of the connector 250
  • the buckle 255 expands outward, that is, the mandrel 290 can be used to push the buckle 255 at the distal end of the connector 250 to expand outward, or it can be used to drive the push rod 40 along the axial direction of the fixing seat 10. slide.
  • the delivery assembly and the valve clamp 100 can be delivered into the patient's body by using an existing adjustable curved sheath.
  • the following takes the mitral valve repair process as an example to illustrate the operation method of the valve clamping system of the present application, which mainly includes the following steps:
  • the first step the delivery component is detachably connected to the valve clamp 100. Specifically, the buckle 255 at the distal end of the connecting member 250 is pushed outward by the liner 270, so that the buckle 255 is locked into the fixing seat 10
  • the fixing base 10 and the connecting member 250 are in a connected state in the clamping hole 111; the mandrel 290 is rotated to make the mandrel 290 and the push rod 40 screwed and fixed. Pull the control member 230 toward the proximal end to control the proximal clip 20 to be folded relative to the fixing base 10 so that the free end 22 of the proximal clip 20 fits on the surface of the fixing base 10.
  • the second step using the transatrial septum path, the delivery assembly and the valve clamp 100 are advanced from the left atrium through the adjustable curved sheath, through the mitral valve to the left ventricle, as shown in FIG. 18.
  • the third step adjust the relative position of the valve clamp 100 and the mitral valve, so that the valve clamp 100 is close to the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve.
  • Step 4 Move the mandrel 290 toward the proximal end by operating the handle, thereby driving the push rod 40 to slide toward the proximal end to drive the distal clip 30 to open relative to the holder 10, and adjust the direction of the valve clip 100 to make the distal
  • the end clip 30 is perpendicular to the occlusal line of the mitral valve.
  • Step 5 Withdraw the entire valve clamp 100 toward the proximal end, so that the distal clamp 30 supports the valve leaflets on the left ventricle side, as shown in FIG. 19.
  • Step 6 Release the control of each control member 230 on the corresponding proximal clip 20, and release the proximal clips 20 on both sides in turn.
  • the proximal clips 20 on each side press the valve leaflets on the atrial side and engage with that side.
  • the distal end clip 30 cooperates to clamp the leaflets.
  • the operator simultaneously pulls the wire inlet and outlet ends of the control member 230 corresponding to the proximal clip 20 that needs to be tightened outside the body to act on the magnitude of the pulling force of the wire inlet and outlet Equivalently, since the inlet channel and the outlet channel are in the two first cavities 211 that are symmetrical to the axis of the delivery sheath 210, the resultant force of the pulling force exerted by the control member 230 on the corresponding proximal clip 20 is located in the delivery sheath.
  • the anterior leaflet 1a and the posterior leaflet of the mitral valve 1b is respectively clamped between the corresponding proximal clip 20 and the distal clip 30 to achieve complete clamping of the valve leaflets, as shown in FIG. 20.
  • Step 7 Extend the pressure sensor from the distal end of the second cavity 212 of the delivery sheath 210 into the left atrium, and detect the pressure value in the heart to confirm the reduction of the patient’s "mitral regurgitation". Therefore, it is determined whether it is necessary to adjust the position of the valve clamp 100 and re-clamp the valve leaflets to optimize the treatment effect.
  • the control member 230 is tightened toward the proximal end to control the proximal clamp piece 20 pressed on the valve leaflet whose clamping position is not ideal to be folded relative to the holder 10, and the valve clamper is adjusted 100 position, the distal clip 30 is located in the proper position of the valve leaflet, and then the control member 230 is released from the control of the proximal clip 20, so that the proximal clip 20 is expanded relative to the fixing seat 10 to move closer to the distal clip 30 To re-clamp the valve leaflets until the mitral valve leaflets are completely clamped.
  • Step 8 Move the mandrel 290 toward the distal end again, and the mandrel 290 drives the push rod 40 to axially slide toward the distal end, thereby driving the distal clip 30 to close relative to the fixing seat 10 until the valve clamp 100 is completely retracted. As shown in Figure 21.
  • Step 9 Control the rotation of the mandrel 290 by operating the handle to unlock the threaded connection between the mandrel 290 and the push rod 40, and then withdraw the liner 270 and the mandrel 290 toward the proximal end until the distal end of the connector 250 is locked.
  • the buckle 255 is unlocked and separated from the hole 111 of the fixing seat 10, and the valve clamp 100 is completely separated from the delivery assembly.
  • the delivery assembly is withdrawn from the patient's body.
  • the valve clamp 100 pulls the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve toward each other to obtain a bi-foramen mitral valve and complete the edge alignment of the mitral valve.
  • the valve clamp 100 is left in the patient's body, as shown in FIG. 10.
  • valve clamping system of the present application can also use a path such as transapex to deliver the valve clamp to the mitral valve.
  • each control element 230b includes at least two control wires, that is, each proximal clip 20 is controlled by at least two control wires to realize folding or unfolding relative to the fixing base 10.
  • each control member 230b includes two control wires, the two control wires pass through the same pair of first cavities 211 of the delivery sheath 210, and the wire inlet channels of the two control wires are selected.
  • One of the first cavities 211 of the pair of first cavities 211, the outlet channel of the two control lines is the other first cavity 211 of the pair of first cavities 211, and each control line
  • the inlet channel and the outlet channel are still symmetrical about the axis of the delivery sheath 210, so as to prevent the valve clamp 100 from swinging.
  • each control member 230b includes at least two control wires, which can improve the control force of each control member 230b on the corresponding proximal clip 20, that is, at least two control wires can provide greater pulling force.
  • the proximal clip 20 is made to be as close to the fixing seat 10 as possible, and the proximal clip 20 is prevented from being released in advance due to insufficient tension.
  • each control element The 230c includes at least one pair of control wires, that is, each proximal clip 20 is controlled by at least one pair of control wires to realize folding or unfolding relative to the fixing base 10. After at least a pair of control wires are respectively threaded through the corresponding proximal clips 20, each pair of control wires is passed through a pair of first cavities 211 of the delivery sheath 210 and extends outside the patient's body.
  • each control member 230c includes a pair of control wires, and the pair of control wires pass through a pair of first cavities 211 of the delivery sheath 210.
  • the inlet channel and the outlet channel of one of the control wires are the same as one of the first holes in the pair of first cavities 211 Cavity 211
  • the inlet channel and outlet channel of the other control line are the other first cavity 211 in the pair of first cavities 211, that is, used to control one of the proximal clips 20
  • the control line is symmetrically arranged with respect to the axis of the delivery sheath 210, so as to prevent the valve clamp 100 from swinging.
  • each control member 230c may include at least two pairs of control wires, each pair of control wires passing through a pair of first cavities 211 of the delivery sheath 210 and extending outside the patient's body.
  • the two different pairs of control wires can pass through the same pair of first cavities 211 out of the patient's body, or they can pass through a pair of first cavities 211 respectively.
  • a cavity 211 penetrates out of the patient's body.
  • each control member 230c includes at least one pair of control wires, which can improve the control force of each control member 230c on the corresponding proximal clip 20, that is, at least one pair of control wires can provide greater pulling force.
  • the proximal clip 20 is made to be as close to the fixing seat 10 as possible, and the proximal clip 20 is prevented from being released in advance due to insufficient tension.
  • the structure of the valve clamping system provided by the fourth embodiment of the present application is similar to that of the valve clamping system in the first embodiment, except that: in the fourth embodiment, the connecting member 250 or The fixing seat 10 is provided with at least one winding post 235, and the wire-in end and/or the wire-out end of the control wire (ie, the control member 230) bypasses the at least one winding post 235 and extends to the outside of the patient.
  • the outer wall of the connecting piece 250 is protrudingly provided with two winding posts 235, the two winding posts 235 are symmetrical with respect to the axis of the connecting piece 250, and the inlet end of the control wire is connected to the corresponding After the proximal clip 20, its outlet end bypasses a bobbin 235 and then extends upward into the outlet channel of the delivery sheath 210 until it extends outside the patient's body.
  • the two control wires used to control the two proximal clips 20 respectively bypass different winding posts 235.
  • each control wire can bypass the bobbin 235 and then pass through the corresponding proximal clip 20, and the outlet end directly extends upward into the outlet channel of the delivery sheath 210 until Extend to the patient's body.
  • each control wire can bypass the winding post 235 and extend to the outside of the patient through the wire inlet channel and the wire outlet channel of the delivery sheath 210, respectively.
  • only one bobbin 235 may be provided to control the incoming and/or outgoing ends of the two control wires of different proximal clips 20 to bypass the same bobbin 235.
  • At least one winding groove may be provided on the winding post 235, and the control wire is partially wound in the at least one winding groove.
  • the winding post 235 Open multiple winding slots at intervals to avoid mutual influence of control lines.
  • the incoming and/or outgoing ends of the control wire are wound on the winding post 235, and the control wire is tightened toward the proximal end to control the corresponding proximal clip 20 relative to the fixing base 10 when the The wire inlet end and/or the wire outlet slides around the bobbin 235, the bobbin 235 acts as a fixed pulley, which is beneficial for the operator to use a small pulling force to tighten the proximal clip 20 and avoid the proximal clip 20 released early.
  • valve clamps to reduce or treat "Mitral Regurgitation” as an example. It is understandable that in other embodiments, the valve clamp can also be used to reduce or treat "tricuspid regurgitation", and its principle and structure are the same as those used in the embodiments of this application to solve “mitral regurgitation”.
  • the principle and structure of the valve clamp is roughly the same. It only needs to use multiple sets of proximal and distal clips to form multiple clamps, and each clamp can clamp a leaflet separately, which will not be repeated here. .
  • valve clamp provided by the present application can also be applied to other minimally invasive surgical operations that require three or more sheet-shaped valves to be clamped together.

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Abstract

一种可独立控制的瓣膜夹合系统，包括瓣膜夹合器（100）及用于输送瓣膜夹合器（100）的输送装置（200）。瓣膜夹合器（100）包括固定座（10）及可相对于固定座（10）收拢或展开的近端夹片（20）。输送装置（200）包括输送鞘管（210）及控制件（230，230b，230c），输送鞘管（210）开设至少一对沿轴向延伸且关于其轴心线对称的第一孔腔（211），每一控制件（230，230b，230c）活动地穿设于至少一对第一孔腔（211）中，每一控制件（230，230b，230c）对应连接一近端夹片（20）以控制近端夹片（20）相对于固定座（10）收拢或展开。朝近端拉紧控制件（230，230b，230c）以控制对应的近端夹片（20）相对于固定座（10）收拢时，每一控制件（230，230b，230c）作用于对应的近端夹片（20）上的拉力的合力位于输送鞘管（210）的轴心线上，从而避免输送鞘管（210）弯曲及瓣膜夹合器（100）发生摆动，有利于减少手术时间、提高手术效率，并避免对患者产生伤害。

Description

可独立控制的瓣膜夹合系统 技术领域
本申请涉及医疗器械领域，尤其涉及一种可独立控制的瓣膜夹合系统。
背景技术
请参阅图1，二尖瓣1是位于心脏左心房2与左心室3之间的单向阀，正常健康的二尖瓣1可以控制血液从左心房2流到左心室3，同时避免血液从左心室3流到左心房2。二尖瓣1包括一对瓣叶，称为前叶1a及后叶1b。前叶1a及后叶1b通过腱索4固定于左心室3的乳头肌上。正常情况下，心脏左心室3收缩时，前叶1a和后叶1b的边缘完全对合，避免血液从左心室3流到左心房2。请参阅图2，当二尖瓣1的瓣叶或其相关结构发生器质性改变或功能性改变时，如腱索4部分断裂，二尖瓣1的前叶1a和后叶1b对合不良，由此，当心脏左心室3收缩时，二尖瓣1不能完全关闭，导致血液从左心室3反流至左心房2，从而引起一系列的病理生理改变，称为“二尖瓣反流”。
现有一种微创治疗手术，其基于瓣膜的缘对缘手术原理，将瓣膜夹钳通过介入导管输送至二尖瓣处，再通过夹钳的相对开合同时夹持二尖瓣的前叶和后叶，从而将瓣叶拉近彼此，减轻“二尖瓣反流”。在夹持瓣叶过程中，由于二尖瓣的两个瓣叶始终处于大幅度、大力度的开合活动状态，夹持难度较大，通常希望能单独控制每侧瓣叶的夹持动作。
请参阅图3，现有一种瓣膜夹钳100'，包括分别位于输送鞘管210'的轴心线相对的两侧的两组近端夹片20'和远端夹片30'，每一近端夹片20'均通过对穿的控制线230'来控制运动，两个近端夹片20'可单独释放并在自身弹性作用下相对于固定座10'展开而向对应的远端夹片30'靠拢以分别夹持二尖瓣的两个瓣叶。然而，如图4所示，在现有技术中，控制每一近端夹片20'的控制线230'的进线与出线都是通过输送鞘管210'的轴心线一侧的同一个孔腔211'来实现，在重复手术操作的过程中，当单侧的近端夹片20'被控制线230'拉紧而相对于固定座10'收拢时，作用于该近端夹片20'上的拉力F'位于输送鞘管210'的轴心线一侧，拉力F'会对瓣膜夹钳100'产生一定的力矩，进而导致瓣膜夹钳100'朝拉力F'所在的一侧发生摆动，并进一步导致输送鞘管210'发生弯曲，使得操作者需要多次调整瓣膜夹钳100'的位置才能准确释放近端夹片20'以重新夹持二尖瓣的瓣叶，手术时间较长、效率较低；再者，瓣膜夹钳100'发生摆动还可能会牵拉瓣叶或缠挂腱索，进而撕裂瓣叶或挂断腱索，不仅会造成手术失败，甚至会对患者造成严重伤害。
发明内容
有鉴于此，本申请提供一种可独立控制的瓣膜夹合系统，不仅能够单独夹持一侧的瓣叶，并能够避免输送鞘管的弯曲及瓣膜夹合器发生摆动，有利于减少手术时间、提高手术效率，并避免对患者产生伤害。
为解决上述技术问题，本申请提供一种可独立控制的瓣膜夹合系统，包括瓣膜夹合器及用于输送所述瓣膜夹合器的输送装置，所述瓣膜夹合器包括固定座及可相对于所述固定座收拢或展开的近端夹片，所述输送装置包括输送鞘管及控制件，每一所述控制件对应连接一所述近端夹片以控制所述近端夹片相对于所述固定座收拢或展开；其中，所述输送鞘管开设至少一对沿轴向延伸的第一孔腔，至少一对所述第一孔腔关于所述输送鞘管的轴心线对称，每一所述控制件活动地穿设于至少一对所述第一孔腔中。
本申请提供的可独立控制的瓣膜夹合系统，控制件穿设于输送鞘管关于其轴心线对称开设的至少一对第一孔腔中，当通过控制件控制对应的近端夹片相对于固定座收拢时，控制件作用于对应的近端夹片上的拉力的合力位于输送鞘管的轴心线上，从而避免输送鞘管弯曲及瓣膜夹合器发生摆动，有利于减少手术时间、提高手术效率，并避免对患者产生伤害。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施方式中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请一些实施方式，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是二尖瓣正常状态时的示意图。
图2是二尖瓣出现病变时的示意图。
图3是现有技术中的瓣膜夹合器和输送鞘管的立体结构示意图。
图4是图3中的瓣膜夹合器单侧的近端夹片被拉紧时的示意图。
图5是本申请第一实施例提供的瓣膜夹合系统的立体结构示意图。
图6是图5中的瓣膜夹合器单侧的近端夹片被拉紧时的示意图。
图7是图5中的瓣膜夹合系统的部分结构的立体结构示意图。
图8是图7中的固定座的立体结构示意图。
图9是图7中的近端夹片的立体结构示意图。
图10是图5中的瓣膜夹合器的使用状态示意图。
图11是图10中的瓣膜夹合器夹持瓣叶后，心脏收缩时二尖瓣示意图。
图12是图10中的瓣膜夹合器夹持瓣叶后，心脏舒张时二尖瓣示意图。
图13图5中的输送鞘管的远端面示意图。
图14和图15是其他实施方式中的输送鞘管的远端面示意图。
图16是图5中的输送装置的部分立体结构示意图。
图17是图16中的输送装置的剖视图。
图18至图21是图5中的瓣膜夹合系统的使用过程示意图。
图22是本申请第二实施例提供的瓣膜夹合系统的部分结构的立体结构示意图。
图23是本申请第三实施例提供的瓣膜夹合系统的部分结构的立体结构示意图。
图24是本申请第四实施例提供的瓣膜夹合系统的结构示意图。
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。
在本申请的描述中，需要说明的是，术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示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。此外，术语“第一”、“第二”、“第三”等仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本申请的描述中，需要说明的是，在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；轴向是指平行于自然状态下的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。
请一并参阅图5和图6，本申请的第一实施例提供一种可独立控制的瓣膜夹合系统，包括瓣膜夹合器100及用于输送瓣膜夹合器100的输送装置200。瓣膜夹合器100包括固定座10及可相对于固定座10收拢或展开的近端夹片20。输送装置200包括输送鞘管210及控制件230，每一控制件230对应连接一近端夹片20以控制近端夹片20相对于固定座10收拢或展开。具体的，输送鞘管210开设至少一对沿轴向延伸且关于输送鞘管210的轴心线对称的第一孔腔211，每一控制件230活动地穿设于至少一对第一孔腔211中，由此，当朝近端拉紧控制件230以控制对应的近端夹片20相对于固定座10收拢，每一控制件230作用于对应的近端夹片20上的拉力的合力F位于输送鞘管210的轴心线上，从而避免输送鞘管210弯曲及瓣膜夹合器100摆动。
其中，瓣膜夹合器100还包括转动连接于固定座10的远端夹片30及用于驱动远端夹片30相对于固定座10开合的驱动组件，驱动组件包括沿轴向滑动地设置于固定座10内的 推杆40及连接远端夹片30与推杆40的连杆50。当推杆40相对于固定座10沿轴向滑动时，在连杆50的拉动下，远端夹片30相对于固定座10张开，将远端夹片30置于瓣膜下方的适当位置后，解除控制件230对近端夹片20的控制，近端夹片20被释放而相对于固定座10展开，近端夹片20向远端夹片30靠拢以夹持位于二者之间的瓣膜。当出现瓣膜夹持不牢靠的问题时，操作者可通过拉紧控制件230控制对应的近端夹片20相对于固定座10收拢，以便于能再次释放近端夹片20以重新夹持瓣膜。
本申请中，控制件230穿设于输送鞘管210关于其轴心线对称开设的至少一对第一孔腔211中，当通过控制件230控制对应的近端夹片20相对于固定座10收拢时，控制件230作用于对应的近端夹片20上的拉力的合力F位于输送鞘管210的轴心线上，使得该合力F对瓣膜夹合器100产生的力矩为零，从而避免输送鞘管210的弯曲及瓣膜夹合器100发生摆动，操作者不需要多次调整瓣膜夹合器100的位置即可快速准确地释放近端夹片20以夹持瓣膜，有利于减少手术时间、提高手术效率，并且能够避免瓣膜夹合器100摆动对患者产生的伤害。
本实施例中，近端夹片20与远端夹片30的数量均为两个，两个近端夹片20与两个远端夹片30一一对应以构成两个夹钳，且两个夹钳关于固定座10轴对称设置。通过输送装置200将瓣膜夹合器100输送至患者的二尖瓣处，两个夹钳可分别夹持二尖瓣的前叶和后叶以减小瓣叶间隙，并作为植入物留在患者的体内，以减轻或治疗患者的“二尖瓣反流”。
为保证植入后的安全性，固定座10、近端夹片20及远端夹片30分别由不锈钢、钴合金、钴铬合金、钛合金或镍钛合金等生物相容性金属材料制成；推杆40及连杆50分别由聚酯、硅树脂、不锈钢、钴合金、钴铬合金或钛合金等生物相容性高分子材料或金属材料制成。优选的，为了提高夹持力，本实施例中，固定座10、远端夹片30、推杆40及连杆50均由硬度较高的不锈钢或钴铬合金制成，近端夹片20由具有形状记忆功能的材料制成，优选超弹性的镍钛合金。
具体的，请一并参阅图7和图8，固定座10包括位于近端的第一座体11、位于远端的第二座体12，以及用于过渡连接第一座体11与第二座体12的第三座体13，三者可以是一体结构或非一体结构。本实施例中，三者为一体结构。
第一座体11沿轴向开设有贯通两端面的管腔，第一座体11的近端设置有连通管腔且关于第一座体11的轴心线对称的两个矩形卡孔111，用于与输送装置200的连接杆250连接。
第二座体12沿垂直于轴向的方向开设有贯通第二座体12相对的两侧面的容置腔14，第二座体12于容置腔14的远端内壁沿轴向开设有通孔，该通孔的轴心线与第一座体11的管腔的轴心线共线。第二座体12相对的另外两侧面分别凸设有一矩形块121。
第三座体13相对的两个平面分别凸设有一连接块131，连接块131开设有销钉孔，以用于安装转动销钉或螺栓。
进一步的，第三座体13沿轴向开设有贯通孔(图中未示)，第一座体11的管腔、第三座体13的贯通孔、第二座体12的容置腔14以及位于容置腔14的远端内壁的通孔同轴连通而构成一穿设通道15。
请一并参阅图5和图6，驱动组件包括推杆40，推杆40沿轴向滑动地穿设于固定座10的穿设通道内。推杆40的近端与输送装置200的芯轴(图中未示)连接。推杆40的远端设置连接座45，连接座45相对的两端开设有贯通的两个销钉孔。连接座45的形状为半球体、球冠或弹头形等任一结构，以使瓣膜夹合器100更容易在体内进行输送。
需要说明的是，固定座10的容置腔内设置有锁紧件，固定座10相对的两侧面还分别设置有调节件，通过所述锁紧件与所述调节件的配合可以实现推杆40相对于固定座10固定或解锁，具体的，锁紧件可以是现有技术中的变形弹片及钢片的组合，调节件可以是镍钛合金等制成的金属丝，因与本申请的改进与创造无关，此处不做赘述。
进一步的，如图5和图6所示，本实施例中，驱动组件还包括相对设置的两个连杆50，每一连杆50用于将对应一侧的远端夹片30连接于推杆40远端的连接座45，当推杆40在固定座10内沿轴向滑动时，可以通过连杆50拉动远端夹片30相对于固定座10开合。
具体的，每一远端夹片30包括位于远端的连接段31以及连接于连接段31近端的夹持 段32，连接段31远离对应的夹持段32的一端转动连接于固定座10的第三座体13的连接块131，连接段31靠近夹持段32的一端转动连接于相应一侧的连杆50的近端，该连杆50的远端通过转动销钉或螺栓转动连接于连接座45的销钉孔处。
本申请中，通过设置于固定座10的锁紧件及调节件的配合，使推杆40相对于固定座10解锁，推杆40可沿轴向朝远端滑动而相对于固定座10运动，由此，推杆40远端的连接座45相对于固定座10运动，连接座45带动连杆50运动，在连杆50的拉动下，远端夹片30可围绕连接块131上的销钉孔的中心转动而相对于固定座10张开，当近端夹片20被释放后，近端夹片20与远端夹片30之间形成瓣叶容纳空间，近端夹片20向对应的远端夹片30靠拢以夹持位于二者之间的瓣膜；在近端夹片20与远端夹片30夹紧瓣膜后，驱动推杆40沿轴向朝近端滑动，连杆50进而带动远端夹片30相对于固定座10闭合，直至远端夹片30相对于固定座10完全闭合，此时，瓣膜夹合器100处于收拢状态，再次通过锁紧件及调节件的配合，使推杆40相对于固定座10固定，以避免远端夹片30相对于固定座10张开，收拢状态的瓣膜夹合器100坠于瓣膜的下方。
其中，连杆50带动远端夹片30相对于固定座10开合时，可以实现远端夹片30相对于固定座10在较大范围内开合，两个远端夹片30之间的夹角最大可达到300度，即，远端夹片30相对于固定座10打开后，可以实现一定程度的向下翻转，从而有利于夹持不断处于运动中的瓣膜，提高夹持成功率。本实施例中，两个远端夹片30之间的夹角范围优选为0-240度，更优为120-180度。
优选的，远端夹片30朝向近端夹片20的第一表面上可以设置夹持防滑结构(图中未示)，以增强远端夹片30与瓣膜接触时的摩擦力，从而提供稳定的夹持力，并能够避免远端夹片30对瓣膜造成损伤。夹持防滑结构可以是设置于第一表面的凸起、凹槽或贴设于第一表面的由摩擦系数较高的生物相容性材料制成的垫片。
其中，第一表面可以是平面，也可以是曲面。优选的，第一表面设置为曲面，以增加远端夹片30与瓣膜的接触面积及夹持面积，从而可以提供稳定的夹持力；再者，曲面的第一表面形成一收容槽，近端夹片20向远端夹片30靠拢时，近端夹片20至少部分收容于收容槽内，以压紧二者之间的瓣膜，并且能够尽量缩小瓣膜夹合器100收拢时的体积，利于在体内进行输送。
进一步优选的，远端夹片30的第一表面上还可以施加活性药物，或开设至少一个开孔，以促进瓣膜组织在远端夹片30的内表面上的内皮细胞爬覆及生长；再者，开设开孔还可以减轻瓣膜夹合器100的整体重量，从而避免过重的瓣膜夹合器100长期坠在瓣叶下方产生滑脱或损伤瓣叶。
请一并参阅图5、图7和图9，每一近端夹片20包括相对设置的连接端21及自由端22，连接端21相对于固定座10固定。本实施例中，两个近端夹片20通过连接框23连接为一体，连接框23开设有供推杆40穿过的一通孔24，连接框23相对的两侧还分别开设有供第二座体12上的矩形块121穿过的一矩形孔25，连接框23套接于第二座体12及第三座体13的外侧，以将两个近端夹片20的连接端21相对固定于固定座10。在其他实施例中，近端夹片20的连接端21可以直接通过焊接、压接等连接方式固定于固定座10。
每一近端夹片20至少部分由具有形状记忆功能的材料制成。经过热定型处理后，在自然状态下，近端夹片20相对于固定座10向外辐射延伸，且优选朝近端延伸以便于和远端夹片30配合以夹持瓣叶。本实施例中，近端夹片20由镍钛合金切割后放置到定型模具中，再将定型模具于300-650℃条件下进行热处理，取出并迅速冷却，拆除定型模具得到定型好的近端夹片20。具体的，本实施例中，近端夹片20整体由超弹性的镍钛合金制成，连接框23也采用镍钛合金制成并与近端夹片20一体成型，以降低生产工艺难度，简化工艺流程，降低生产成本。在其他实施例中，连接框23也可以采用不锈钢制成，再与近端夹片20焊接，以提高连接框23与第二座体12的连接强度。
每一近端夹片20设置至少一连接结构26，以用于与控制件230连接。具体的，如图7所示，本实施例中，每一近端夹片20开设有一连接孔，该连接孔即为连接结构26，控制件230穿接于对应的近端夹片20的连接孔处并通过输送鞘管210延伸至患者体外，操作者通过体外部分的控制件230控制对应的近端夹片20相对于固定座10收拢或展开。优选的， 本实施例中，连接结构26设置于近端夹片20相对于固定座10展开后远离固定座10的一端，即，自由端22，有利于操作者使用较小的拉力即可控制近端夹片20相对于固定座10收拢。
在其他实施例中，连接结构26可以是开设于近端夹片20上的两个或两个以上的连接孔，控制件230依次穿过多个连接孔以控制近端夹片20。
在其他实施例中，连接结构26可以是凸设于近端夹片20朝向固定座10的表面上的至少一连接环，控制件230穿接于连接环上以控制近端夹片20。连接环与近端夹片20可以是一体结构或非一体结构。具体的，在一些实施例中，连接环通过机加工或冲压加工等加工方式与近端夹片20一体成型；在另一些实施例中，连接环可以是带有连接孔的零件并与近端夹片20通过压接、粘结或焊接等连接方式组合在一起。
其中，当每一近端夹片20设置有至少两个连接结构26时，优选的，至少两个连接结构26的中心连线位于或靠近于近端夹片20的轴向中心线(即近端夹片20沿连接端21至自由端22方向的中心线)，以避免控制件230作用于对应的近端夹片20上的拉力使近端夹片20绕其轴向中心线发生扭曲变形。
进一步的，每一近端夹片20朝向远端夹片30的第二表面上设置有夹持增强件，以增加近端夹片20与瓣膜之间的摩擦力，提高瓣膜夹合器100对瓣膜的夹持力。具体的，本实施例中，夹持增强件为设置于第二表面相对的两侧的两列间隔设置的倒刺27。倒刺27可以采用一体成型方式在近端夹片20上形成，也可以采用与近端夹片20相同或不同的材料形成倒刺27再将其连接于近端夹片20的第二表面上。倒刺27的延伸方向与第二表面之间的夹角小于或等于90度，优选为30-60度，以增强瓣膜夹合器100对瓣膜的夹持力。
在其他实施例中，夹持增强件可以是凸设于第二表面的凸棱、凸台或其它不规则分布的凸起等结构，还可以是至少部分覆盖第二表面的粗糙表面或以上几种形式的组合，以提高对瓣膜的夹持力。
优选的，每一近端夹片20上还可以施加活性药物或开设至少一个开孔28。
需要说明的是，朝近端拉紧控制件230可以控制近端夹片20的自由端22相对于固定座10收拢，使得近端夹片20的自由端22贴合于固定座10的表面上以便于输送，而在解除控制件230对自由端22的控制后，近端夹片20的自由端22被释放，近端夹片20由于自身弹性记忆性能回弹并恢复自然状态，近端夹片20的自由端22相对于固定座10展开，以将瓣叶压向远端夹片30。优选的，自然展开状态下的两个近端夹片20之间的夹角应略大于两个远端夹片30之间的夹角，以提供更稳定的夹持力，即，近端夹片20与固定座10之间的夹角大于或等于与该侧对应的远端夹片30相对于固定座10完全张开时的远端夹片30与固定座10之间的夹角，从而保证近端夹片20与远端夹片30之间具有一定的夹紧力，以夹紧位于二者之间的瓣叶。本实施例中，近端夹片20的长度方向与固定座10的轴向之间的夹角的角度范围为0-150度，即，自然状态下，两个近端夹片20之间的夹角最大可达300度，两个近端夹片20之间的打开角度范围优选为0-240度，更优为160-200度。
如前所述，本实施例提供的瓣膜夹合器100能够用于减轻或治疗“二尖瓣反流”。具体的，请一并参阅图10至图12，将瓣膜夹合器100置于二尖瓣的前叶1a及后叶1b的不能正常对合的位置，使得对应的一组近端夹片20及远端夹片30夹持二尖瓣的前叶1a边缘，另一组对应的近端夹片20及远端夹片30夹持二尖瓣的后叶1b边缘，以将二尖瓣的前叶1a及后叶1b不能正常对合的位置夹持在一起，图11和图12中所示箭头方向为血流方向。如图11所示，当心脏收缩时，前叶1a与后叶1b收拢，二尖瓣开口的面积A变小或二尖瓣能完全闭合，从而可减轻或治疗“二尖瓣反流”。如图12所示，当心脏舒张时，前叶1a及后叶1b仅在瓣膜夹合器100夹合的位置B对合在一起，前叶1a及后叶1b其它的位置仍然正常舒张，使得血液能够从左心房进入左心室，从而保证血液的正常流通。
可以理解的是，由于二尖瓣的两个瓣叶始终处于开合活动状态，夹持难度较大，往往只有一个瓣叶夹持成功，另外一个瓣叶则可能只被部分夹持，这可能导致二尖瓣的两个瓣叶夹合位置不理想或被部分夹持的瓣叶最终从瓣膜夹合器100中滑移，此时，只能重复进行手术操作，即，朝近端拉紧控制件230以控制压覆于只被部分夹持的瓣叶上的近端夹片20相对于固定座10收拢，调整瓣膜夹合器100的位置，使远端夹片30位于瓣叶的适当位 置，然后解除控制件230对近端夹片20的控制，使近端夹片20相对于固定座10展开而靠拢远端夹片30以重新夹持瓣叶，直至二尖瓣的瓣叶被牢固夹持，反流消失或者达到最轻微状态。
请参阅图5和图6，为了避免控制件230作用于对应的近端夹片20上的拉力导致输送鞘管210弯曲及瓣膜夹合器100发生摆动，本申请中，控制件230穿设于输送鞘管210关于其轴心线对称开设的至少一对第一孔腔211中而延伸至患者体外，当通过控制件230控制对应的近端夹片20相对于固定座10收拢时，每一控制件230作用于对应的近端夹片20上的拉力的合力F位于输送鞘管210的轴心线上，以使该合力F对瓣膜夹合器100产生的力矩为零，从而避免输送鞘管210弯曲及瓣膜夹合器100发生摆动，操作者不需要多次调整瓣膜夹合器100的位置即可快速准确地释放近端夹片20以重新夹持瓣膜，有利于减少手术时间、提高手术效率，并且能够避免瓣膜夹合器100摆动挂伤腱索或者组织对患者产生的伤害。
如图5所示，本实施例中，输送鞘管210开设有两对第一孔腔211，每一对第一孔腔211中穿设有一控制件230以用于控制对应的一近端夹片20。也即是说，本实施例中，分别用于控制两个近端夹片20的两个控制件230穿设于不同的两对第一孔腔211中。
每一控制件230为单根控制线，所述控制线穿接于对应的近端夹片20后控制线的两末端分别穿设于一对第一孔腔211中并延伸至患者体外。具体的，控制线的进线通道为一对第一孔腔211中的其中一个第一孔腔211，出线通道为所述一对第一孔腔211中的另一个第一孔腔211，即，控制线的进线通道与出线通道关于输送鞘管210的轴心线对称。如图5所示，本实施例中，控制线沿进线通道到达对应的近端夹片20后穿过近端夹片20上的连接结构26，然后反向弯折再通过出线通道延伸至患者体外。如图6所示，操作者朝近端拉紧其中一根控制线以控制对应的一近端夹片20相对于固定座10收拢时，弯折成两部分的所述控制线作用于对应的近端夹片20上的拉力分别为F1和F2，拉力F1和拉力F2关于输送鞘管210的轴心线对称，其合力F位于输送鞘管210的轴心线上，使得合力F对瓣膜夹合器100产生的力矩为零，从而可以避免输送鞘管210弯曲及瓣膜夹合器100发生摆动，操作者可以快速调整瓣膜夹合器100的位置并准确释放近端夹片20以重新夹持瓣膜，有利于减少手术时间、提高手术效率，并且能够避免瓣膜夹合器100摆动对患者产生的伤害。
其中，控制线为单根丝线或者缠绕的多根丝线，所述丝线选自镍钛丝、不锈钢丝或高强度的高分子线。本实施例中，控制线采用单根镍钛丝，即，控制件230为单根镍钛丝。
其中，第一孔腔211的形状可以是圆形、方形、多边形或其他异形形状。本实施例中，第一孔腔211为圆形孔腔。
请参阅图13，本实施例中，两对第一孔腔211的轴心线至输送鞘管210的轴心线的距离相等，且每一第一孔腔211与另一对第一孔腔211的两个第一孔腔211的距离相等，即，两对第一孔腔211呈正方形分布。显然，在其他实施例中，每一第一孔腔211与另一对第一孔腔211的两个第一孔腔211的距离可以不相等，即，两对第一孔腔211呈长方形分布，如图14所示。
在其他实施例中，两对第一孔腔211的轴心线至输送鞘管210的轴心线的距离可以不相等，即，两对第一孔腔211呈平行四边形分布，如图15所示。
在其他实施例中，输送鞘管210可以只开设一对第一孔腔211，分别用于控制两个近端夹片20的两根控制线均穿设于所述一对第一孔腔211中，具体的，两个控制线的进线通道为所述一对第一孔腔211中的同一个第一孔腔211，两根控制线的出线通道为所述一对第一孔腔211中的另一个第一孔腔211。
进一步的，如图5和图13所示，本实施例中，瓣膜夹合系统还包括压力传感器(图中未示)，输送鞘管210开设有沿轴向延伸的一第二孔腔212，压力传感器活动地穿设于第二孔腔212中，且可自第二孔腔212的远端伸出。当输送装置200将瓣膜夹合器100输送至心脏左心室并利用瓣膜夹合器100将二尖瓣的两个瓣叶夹合在一起后，可将压力传感器自第二孔腔212的远端伸入心脏的左心房，从而实时反馈心脏内的压力值，以确认患者的“二尖瓣反流”的减少情况，从而确定是否需要调整瓣膜夹合器100的位置并重新夹持二尖瓣的瓣叶以优化治疗效果。
可以理解的是，压力传感器可以是在出厂时组装在输送鞘管210的第二孔腔212中，也可以采用其他兼容的商用压力传感器，由手术操作者在手术前组装在输送鞘管210的第二孔腔212中。
请一并参阅图5、图7、图16及图17，本实施例提供的瓣膜夹合系统包括瓣膜夹合器100及输送装置200，通过输送装置200将瓣膜夹合器100输送至二尖瓣处，并调整瓣膜夹合器100于二尖瓣的适宜位置。输送装置200包括操作手柄及输送组件，输送组件的近端与操作手柄连接，输送组件的远端与瓣膜夹合器100可拆卸连接。
输送组件包括前述的输送鞘管210及穿设于输送鞘管210的第一孔腔211中的控制件230，进一步的，输送组件还包括插接于输送鞘管210远端的连接件250、活动地同轴套装于连接件250的管腔内的衬管270，以及活动地同轴套装于衬管270内的芯轴290。操作者通过置于患者体外的操作手柄能够拉紧控制件230，以及分别驱动衬管270、芯轴290进行相对移动或旋转。
输送鞘管210沿轴向开设有一第三孔腔213，连接件250插接于第三孔腔213的远端，衬管270、芯轴290穿过第三孔腔213而延伸至患者体外。优选的，本实施例中，输送鞘管210的远端设置有一固定件214，同轴套装在一起的连接件250、衬管270及芯轴290通过固定件214插接于输送鞘管210的第三孔腔213内，以提高连接强度。可以理解的是，固定件214开设有若干分别连通第一孔腔211、第二孔腔212及第三孔腔213的通孔。
其中，输送鞘管210可以是生物相容性的金属材料或高分子材料通过一体成型制成的多腔管，也可以是生物相容性的金属材料或高分子材料制成的若干单根管体通过压接、熔接或粘结形成的多腔管。所述金属材料选自不锈钢、铝合金或钴铬合金；所述高分子材料选自聚碳酸酯、聚乙烯或聚酰胺。本实施例中，推送导管210为一体成型制成的多腔管，开设沿推送导管210的轴向延伸的若干孔腔，所述若干孔腔即形成前述的至少一对第一孔腔211、一第二孔腔212及一第三孔腔213。
连接件250大致呈管状，连接件250的远端轴对称设置两个连接杆253，每一连接杆253的远端设置用于与固定座10可拆卸连接的卡扣255。轴对称设置的两个连接杆253彼此相对的内表面为与连接件250的管腔内圆柱面光滑过渡连接的弧面，且每一连接杆253的弧面至连接件250的轴心线的距离自近端向远端逐渐减小，即，每一连接杆253的远端朝连接件250的轴心线方向倾斜，两个连接杆253自近端向远端逐渐收拢靠近。
连接杆253由弹性材料制成，当连接杆253受到沿连接件250的径向向外的推力时，连接杆253的远端向外扩张。输送装置200的衬管270活动地穿设于连接件250的管腔内，驱动衬管270朝远端移动，衬管270沿径向向外抵推连接杆253，连接杆253的卡扣255向外扩张而卡入固定座10的卡孔111内，使得输送装置200通过连接件250与固定座10处于连接状态；可以理解，向近端回撤衬管270，连接杆253由于自身弹性回弹，连接杆253的远端朝连接件250的轴心线方向收拢，卡扣255退出对应的卡孔111，输送装置200与固定座10的连接状态即被解除。
芯轴290与推杆40可拆卸连接，以用于驱动推杆40沿固定座10的轴向滑动，从而带动远端夹片30相对于固定座10开合。本实施例中，芯轴290为远端开设有内螺纹孔(图中未标示)的圆杆体，内螺纹孔用于与推杆40近端的外螺纹进行螺纹连接。
在其他实施例中，输送组件可以不包括衬管270，芯轴290的整体直径或芯轴290的远端部分直径较大，使得芯轴290的远端部分能直接抵推连接件250远端的卡扣255向外扩张，也即是说，芯轴290既可以用于抵推连接件250远端的卡扣255向外扩张，也可以用于驱动推杆40沿固定座10的轴向滑动。
需要说明的是，输送组件及瓣膜夹合器100可以采用现有的可调弯鞘管输送至患者体内。
以下以二尖瓣的瓣膜修复过程为例，说明本申请的瓣膜夹合系统的操作方法，主要包括以下步骤：
第一步：将输送组件可拆卸连接于瓣膜夹合器100，具体的，利用衬管270将连接件250远端的卡扣255向外抵推，以使得卡扣255卡入到固定座10的卡孔111内，使固定座10与连接件250处于连接状态；旋转芯轴290，使芯轴290与推杆40螺接固定。朝近端拉 紧控制件230以控制近端夹片20相对于固定座10收拢，使近端夹片20的自由端22贴合在固定座10的表面上。然后通过操作手柄朝远端移动芯轴290而带动推杆40沿轴向朝远端滑动，驱动远端夹片30相对于固定座10闭合，以使瓣膜夹合器100处于完全收拢状态，近端夹片20及远端夹片30均贴近于固定座10的表面，保持收拢状态不变。
第二步：采用经房间隔的路径，通过可调弯鞘管将输送组件以及瓣膜夹合器100从左心房推进，经过二尖瓣到达左心室，如图18所示。
第三步：调整瓣膜夹合器100与二尖瓣的相对位置，使得瓣膜夹合器100接近二尖瓣的前叶1a和后叶1b。
第四步：通过操作手柄朝近端移动芯轴290，从而带动推杆40朝近端滑动以驱动远端夹片30相对于固定座10张开，调整瓣膜夹合器100的方向，使得远端夹片30垂直于二尖瓣的对合线。
第五步：朝近端回撤整个瓣膜夹合器100，使远端夹片30在左心室一侧托住瓣叶，如图19所示。
第六步：解除每一控制件230对相应近端夹片20的控制，依次释放两侧的近端夹片20，每侧的近端夹片20在心房侧压住瓣叶并与该侧的远端夹片30配合以夹持瓣叶。在释放单侧近端夹片20的过程中，操作者在体外同时拉动需要收紧的近端夹片20对应的控制件230的进线端与出线端，作用于进线与出线的拉力大小相当，由于进线通道与出线通道处于输送鞘管210轴心线对称的两个第一孔腔211中，使得控制件230作用于对应的近端夹片20上的拉力的合力位于输送鞘管210的轴心线上，以避免输送鞘管210弯曲及瓣膜夹合器100摆动，从而实现独立控制每一近端夹片20相对于固定座10展开，二尖瓣的前叶1a和后叶1b分别被夹持在对应的近端夹片20及远端夹片30之间，实现瓣叶的完整夹持，如图20所示。
第七步：将压力传感器自输送鞘管210的第二孔腔212的远端伸出进入到左心房，检测心脏内的压力值，以确认患者的“二尖瓣反流”的减少情况，从而确定是否需要调整瓣膜夹合器100的位置并重新夹持瓣叶以优化治疗效果。对于需要重新夹持瓣叶的情况，朝近端拉紧控制件230以控制压覆于夹持位置不理想的瓣叶上的近端夹片20相对于固定座10收拢，调整瓣膜夹合器100的位置，使远端夹片30位于瓣叶的适当位置，然后解除控制件230对近端夹片20的控制，使近端夹片20相对于固定座10展开而靠拢远端夹片30以重新夹持瓣叶，直至二尖瓣的瓣叶被完全夹持。
第八步：再次朝远端移动芯轴290，芯轴290带动推杆40朝远端轴向滑动，从而驱动远端夹片30相对于固定座10闭合，直至瓣膜夹合器100完全收拢，如图21所示。
第九步：通过操作手柄控制芯轴290旋转，使芯轴290与推杆40之间的螺纹连接解锁，再朝近端回撤衬管270和芯轴290，直至连接件250远端的卡扣255与固定座10的卡孔111解锁分离，瓣膜夹合器100与输送组件完全分离。最后，将输送组件撤出患者体外，此时，瓣膜夹合器100将二尖瓣的前叶1a和后叶1b拉向彼此，得到双孔化的二尖瓣，完成二尖瓣的缘对缘修复，瓣膜夹合器100留置于患者体内，如图10所示。
可以理解的是，本申请的瓣膜夹合系统也可采用经心尖等路径输送瓣膜夹合器至二尖瓣处。
请参阅图22，本申请第二实施例提供的瓣膜夹合系统的结构与第一实施例中的瓣膜夹合系统的结构相似，不同之处在于：在第二实施例中，每一控制件230b包括至少两根控制线，也即是说，每一近端夹片20通过至少两根控制线进行控制以实现相对于固定座10的收拢或展开。具体的，本实施例中，每一控制件230b包括两根控制线，两根控制线穿设于输送鞘管210的同一对第一孔腔211中，两根控制线的进线通道为所述一对第一孔腔211中的其中一个第一孔腔211，两根控制线的出线通道为所述一对第一孔腔211中的另一个第一孔腔211，每一根控制线的进线通道与出线通道仍关于输送鞘管210的轴心线对称，从而避免瓣膜夹合器100发生摆动。
可以理解的是，每一控制件230b包括至少两根控制线，能够提高每一控制件230b对相应的近端夹片20的控制力，即，至少两根控制线可以提供更大的拉力，使近端夹片20尽量紧贴固定座10，并防止近端夹片20因拉力不足而提前释放。
请参阅图23，本申请第三实施例提供的瓣膜夹合系统的结构与第一实施例中的瓣膜夹合系统的结构相似，不同之处在于：在第三实施例中，每一控制件230c包括至少一对控制线，也即是说，每一近端夹片20通过至少一对控制线进行控制以实现相对于固定座10的收拢或展开。至少一对控制线分别穿接于对应的近端夹片20后，每一对控制线穿设于输送鞘管210的一对第一孔腔211中并延伸至患者体外。
本实施例中，每一控制件230c包括一对控制线，一对控制线穿设于输送鞘管210的一对第一孔腔211中。具体的，用于控制每一近端夹片20的一对控制线中，其中一根控制线的进线通道与出线通道同为所述一对第一孔腔211中的其中一第一孔腔211，另一根控制线的进线通道与出线通道同为所述一对第一孔腔211中的另一第一孔腔211，即，用于控制每一近端夹片20的一对控制线关于输送鞘管210的轴心线对称设置，从而避免瓣膜夹合器100发生摆动。
在其他实施例中，每一控制件230c可以包括至少两对控制线，每一对控制线穿设于输送鞘管210的一对第一孔腔211中并延伸至患者体外。其中，用于控制每一近端夹片20的至少两对控制线中，不同的两对控制线可以通过相同的一对第一孔腔211穿出至患者体外，也可以分别通过一对第一孔腔211穿出至患者体外。
可以理解的是，每一控制件230c包括至少一对控制线，能够提高每一控制件230c对相应的近端夹片20的控制力，即，至少一对控制线可以提供更大的拉力，使近端夹片20尽量紧贴固定座10，并防止近端夹片20因拉力不足而提前释放。
请参阅图24，本申请第四实施例提供的瓣膜夹合系统的结构与第一实施例中的瓣膜夹合系统的结构相似，不同之处在于：在第四实施例中，连接件250或固定座10上设置有至少一绕线柱235，控制线(即控制件230)的进线端和/或出线端绕过至少一绕线柱235而延伸至患者体外。具体的，本实施例中，连接件250的外壁凸设有两个绕线柱235，两个绕线柱235关于连接件250的轴心线对称，控制线的进线端穿接于对应的近端夹片20后，其出线端绕过一绕线柱235而后向上延伸进入输送鞘管210的出线通道，直至延伸至患者体外。本实施例中，用于控制两个近端夹片20的两根控制线分别绕过不同的绕线柱235。
在其他实施例中，每一控制线的进线端可以绕过绕线柱235后再穿接于对应的近端夹片20，其出线端直接向上延伸进入输送鞘管210的出线通道，直至延伸至患者体外。
在其他实施例中，每一控制线的进线端和出线端都可以绕过绕线柱235而分别通过输送鞘管210的进线通道和出线通道延伸至患者体外。
在其他实施例中，绕线柱235可以只设置有一个，用于控制不同的近端夹片20的两根控制线的进线端和/或出线端绕过同一个绕线柱235。
优选的，绕线柱235上可以开设至少一绕线槽，控制线部分绕设于至少一绕线槽内。当控制线的进线端和出线端或者用于控制不同的近端夹片20的两根控制线的进线端和/或出线端同时绕设于绕线柱235上时，绕线柱235开设间隔的多个绕线槽，以避免控制线相互影响。
可以理解的是，控制线的进线端和/或出线端绕设于绕线柱235上，朝近端拉紧控制线以控制对应的近端夹片20相对于固定座10收拢时，控制线进线端和/或出线围绕绕线柱235滑动，绕线柱235起到定滑轮的作用，有利于操作者使用较小的拉力即可拉紧近端夹片20，避免近端夹片20提前释放。
需要说明的是，以上内容均是以瓣膜夹合器用于减轻或治疗“二尖瓣反流”为例进行描述的。可以理解的是，在其他实施例中，瓣膜夹合器也可以用于减轻或治疗“三尖瓣反流”，其原理及结构与本申请实施例中用于解决“二尖瓣反流”的瓣膜夹合器的原理及结构大致相同，只需通过多组近端夹片和远端夹片构成多个夹钳，每个夹钳分别夹合一片瓣叶即可，此处不做赘述。
显然，在其他实施例中，本申请提供的瓣膜夹合器还可以应用于需要将三个以上片状的瓣膜夹合在一起的其他微创外科手术中。
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 (16)

  1. 一种可独立控制的瓣膜夹合系统，其特征在于，包括：
    瓣膜夹合器，所述瓣膜夹合器包括固定座及可相对于所述固定座收拢或展开的近端夹片；
    用于输送所述瓣膜夹合器的输送装置，所述输送装置包括输送鞘管及控制件，每一所述控制件对应连接一所述近端夹片以控制所述近端夹片相对于所述固定座收拢或展开；
    其中，所述输送鞘管开设至少一对沿轴向延伸的第一孔腔，至少一对所述第一孔腔关于所述输送鞘管的轴心线对称，每一所述控制件活动地穿设于至少一对所述第一孔腔中。
  2. 如权利要求1所述的瓣膜夹合系统，其特征在于，每一所述控制件包括至少一根控制线，至少一根所述控制线穿接于对应的近端夹片后，每一根所述控制线的两末端分别经由一对所述第一孔腔延伸至患者体外。
  3. 如权利要求2所述的瓣膜夹合系统，其特征在于，每一根所述控制线的进线通道为一对第一孔腔中的其中一第一孔腔，出线通道为所述一对第一孔腔中的另一第一孔腔。
  4. 如权利要求1所述的瓣膜夹合系统，其特征在于，每一所述控制件包括至少一对控制线，至少一对所述控制线分别穿接于对应的近端夹片后，一对所述控制线分别穿设于一对所述第一孔腔中并延伸至患者体外。
  5. 如权利要求4所述的瓣膜夹合系统，其特征在于，在至少一对所述控制线中，其中一控制线的进线通道与出线通道同为一对第一孔腔中的其中一第一孔腔，另一控制线的进线通道与出线通道同为所述一对第一孔腔中的另一第一孔腔。
  6. 如权利要求2或4所述的瓣膜夹合系统，其特征在于，所述输送装置的远端设置连接件，所述输送装置通过所述连接件与所述固定座可拆卸连接，所述连接件或所述固定座上设置至少一绕线柱，所述控制线的进线端和/或出线端绕过至少一所述绕线柱而延伸至患者体外。
  7. 如权利要求6所述的瓣膜夹合系统，其特征在于，每一控制线为单根丝线或者缠绕的多根丝线，所述丝线选自镍钛丝、不锈钢丝或高强度的高分子线。
  8. 如权利要求1所述的瓣膜夹合系统，其特征在于，所述输送鞘管开设有两对所述第一孔腔，两对所述第一孔腔的轴心线至所述输送鞘管的轴心线的距离相等或者不相等，每一对所述第一孔腔穿设有一所述控制件。
  9. 如权利要求1所述的瓣膜夹合系统，其特征在于，每一所述近端夹片设置至少一连接结构，至少一所述连接结构用于连接所述控制件。
  10. 如权利要求9所述的瓣膜夹合系统，其特征在于，所述连接结构设置于所述近端夹片相对于所述固定座展开后远离所述固定座的一端。
  11. 如权利要求9所述的瓣膜夹合系统，其特征在于，每一所述近端夹片设置至少两个连接结构，至少两个所述连接结构的中心连线位于或靠近于所述近端夹片的轴向中心线。
  12. 如权利要求9至11任一项所述的瓣膜夹合系统，其特征在于，所述连接结构为开设于所述近端夹片上的连接孔，或者为凸设于所述近端夹片上的连接环。
  13. 如权利要求1所述的瓣膜夹合系统，其特征在于，所述输送鞘管为生物相容性的金属材料或高分子材料通过一体成型制成的多腔管；或者为生物相容性的金属材料或高分子材料制成的若干单根管体通过压接、熔接或粘结形成的多腔管。
  14. 如权利要求1所述的瓣膜夹合系统，其特征在于，所述瓣膜夹合器还包括可相对于所述固定座收拢或展开的远端夹片，所述远端夹片与所述近端夹片之间形成瓣叶容纳空间。
  15. 如权利要求14所述的瓣膜夹合系统，其特征在于，所述近端夹片至少部分由具有形状记忆功能的材料制成，所述远端夹片的硬度大于所述近端夹片的硬度。
  16. 如权利要求1所述的瓣膜夹合系统，其特征在于，所述瓣膜夹合系统还包括压力传感器，所述输送鞘管设置沿轴向延伸的第二孔腔，所述压力传感器穿设于所述第二孔腔中，且可自所述第二孔腔的远端伸出推送装置。
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