WO2018018873A1 - 一种瓣膜夹合器 - Google Patents

一种瓣膜夹合器 Download PDF

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Publication number
WO2018018873A1
WO2018018873A1 PCT/CN2017/073563 CN2017073563W WO2018018873A1 WO 2018018873 A1 WO2018018873 A1 WO 2018018873A1 CN 2017073563 W CN2017073563 W CN 2017073563W WO 2018018873 A1 WO2018018873 A1 WO 2018018873A1
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WO
WIPO (PCT)
Prior art keywords
clamping
valve
ring
clip
conveying
Prior art date
Application number
PCT/CN2017/073563
Other languages
English (en)
French (fr)
Inventor
潘文志
周达新
葛均波
程蕾蕾
Original Assignee
复旦大学附属中山医院
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
Application filed by 复旦大学附属中山医院 filed Critical 复旦大学附属中山医院
Priority to JP2018503495A priority Critical patent/JP6629956B2/ja
Priority to US15/736,298 priority patent/US10603168B2/en
Priority to PCT/CN2017/073563 priority patent/WO2018018873A1/zh
Priority to EP17828830.4A priority patent/EP3323353B1/en
Priority to ES17828830T priority patent/ES2890849T3/es
Publication of WO2018018873A1 publication Critical patent/WO2018018873A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—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
    • 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
    • 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
    • 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
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

Definitions

  • the present invention relates to a valve clip, and more particularly to a valve clip for treating heart valve regurgitation.
  • the mitral valve is a valve attached to the periphery of the left atrioventricular mouth (as shown in Figure 1). It is connected to the papillary muscle by the chordae, which prevents the left ventricle from flowing back to the left atrium.
  • Mitral regurgitation is caused by qualitative or functional changes in the mitral valve leaf and its related structural generators, resulting in poor anterior and posterior mitral anastomosis, blood flow from the left ventricle to the left atrium, causing a series of pathology Physiological changes. Severe MR can cause left ventricular enlargement, which eventually leads to left ventricular systolic dysfunction and heart failure, while left atrial pressure also increases due to reflux, which easily leads to left atrial enlargement, atrial fibrillation and pulmonary hypertension.
  • the prognosis of MR is poor, the annual mortality rate of patients with symptoms and without surgery is about 5%, and the 5-year mortality rate of patients with severe heart failure is 60%.
  • MR is also one of the most common heart diseases. According to statistics, the incidence rates of people over 65 and 75 years old are 6.4% and 9.3%, respectively. With the development of economy and society and the aging of the population, the incidence of mitral regurgitation has increased significantly.
  • FIG. 2a when the mitral regurgitation, the two lobes of the systole can not close and close the gap, resulting in the left ventricular blood flow returning from the space to the left atrium; Surgical edge-to-edge suture sutures the midpoint of the two leaflets of the mitral valve, causing the interlobular space to change from one large hole to two small holes during systole, thereby reducing mitral regurgitation (Fig. 2a).
  • the left ventricular blood flow was not affected by diastolic mitral valve opening (Fig. 2b).
  • the only international minimally invasive interventional device for the treatment of MR is Evalve's MitraClip, a valve clamp device.
  • the device needs to pass through the vein, the right atrium, the interatrial septum, and the left atrium to reach the left ventricle during the operation.
  • the way of the road is long and curved.
  • the operation is very complicated.
  • the doctor needs to fine-tune the curvature, direction, horizontal position and vertical depth of the delivery system. After reaching the ideal position, the valve can be clamped. Therefore, doctors often take a long time to complete a surgery. Deep Suffering from rickets.
  • the Chinese Patent Publication No. CN102860846A discloses a rim-to-edge clamp device, but the device is used for tricuspid regurgitation and cannot be used for the treatment of mitral regurgitation.
  • the valve leaflets are not further clamped and gathered toward the center, resulting in a gap between the valve leaves, and the blood flow can still pass through the gap, and the surgical effect is greatly reduced.
  • the technical problem to be solved by the present invention is how to treat MR safely and effectively using a minimally invasive interventional method.
  • the present invention provides a valve clamp for treating MR.
  • the clip is effective in treating MR after implantation through a minimally invasive surgical approach.
  • the valve clipper includes a first clamping member, a second clamping member, and a connecting member;
  • the first clamping member includes at least two first clamping arms
  • the second clamping member includes the first a second clamping arm corresponding to a clamping arm, each of the first clamping arms and the corresponding second clamping arm thereof can be combined into a set of clamps, and the two are mutually close together and squeezed to produce mutual mutual a force to clamp an object therein;
  • the connecting member is for connecting the first clamping member and the second clamping member.
  • first clamping arm is inclined toward the front of the clamp
  • second clamping arm is also inclined toward the front of the clamp, but the inclination angle thereof is larger than that of the first clamping arm
  • the inclination angle wherein the first clamping arm has an inclination angle of 20-30 degrees
  • the second clamping arm has an inclination angle of 25-35 degrees.
  • the number of the first clamping arms is two or three, and correspondingly, the number of the second clamping arms is two or three, that is, the number of sets of the clamp is two or three.
  • other numbers of clamping arms can be designed according to the actual situation.
  • the lengths of the first clamping arm and the second clamping arm are respectively 4.0-8.0 mm, and most preferably 6.0 mm.
  • the valve clip has a pair of first clamping arms and a pair of corresponding second clamping arms and is symmetrical to each other.
  • the pair of first clamping arms have a forward V-shape with an angle between 120-140 degrees, preferably 130 degrees; the pair of second clamping arms are also forward
  • the V-shape has an angle slightly smaller than the angle between the pair of first clamping arms, which is 110-130 degrees, and most preferably 120 degrees.
  • the opposite faces of the first clamping arm and the second clamping arm each have a plurality of protrusions, so that the friction between the clamping arm and the valve tissue can be enhanced, and the sandwiched valve tissue can be prevented from slipping out.
  • the protrusions are serrated or wavy, and the ridges or wavy lines between the opposing faces of the clamping arms coincide.
  • the projections are small thorns that can penetrate the valve tissue and also serve to enhance the ability of the clamping arms to sandwich the valve.
  • the connecting member includes a locking lever and a locking ring that cooperate with each other; the first clamping member and the second clamping member are separately disposed on the locking bar or the locking ring, that is, the first a clamping member and the second clamping member are respectively connected to the lock bar or the lock ring, and the lock bar realizes the first clamping member and the inside by inserting into a ring hole of the lock ring A second clamping member is coupled, and a locking member is further disposed between the locking bar and the locking ring. In addition to locking the connection of the lock bar and the lock ring, the locking member can lock the sandwiching state between the first clamping arm and the second clamping arm.
  • the locking member has operational reversibility, and the locking bar and the locking ring can be separated when the clamping effect is unsatisfactory, thereby facilitating recovery of the valve clip.
  • the first clamping member is disposed on the lock bar, and the second clamping member is disposed on the lock ring; in another implementation of the present invention In one aspect, the first clamping member is disposed on the lock ring, and the second clamping member is disposed on the lock bar.
  • the lock bar has an axial length of 5.0-8.0 mm; the lock ring has an outer diameter of 4.0-6.0 mm, and the lock ring has an axial length of 3.0-5.0 mm.
  • the first clamping member is composed of the lock bar and a plurality of the first clamping arms, and the plurality of first clamping arms are The center extends outwardly
  • the second clamping member is composed of the lock ring and a plurality of the second clamping arms, and the plurality of second clamping arms extend outwardly around the locking ring.
  • the locking member is disposed on the lock bar, which may be an elastic tab or a spring knob, or may be an elastic high-streak material that is fixed around the outer periphery of the lock bar.
  • the locking member is composed of a spring knob provided on the lock lever and a recess provided on the lock ring.
  • the locking member has operational reversibility; when the elastic insert is used, the locking ring can pass over the elastic insert on the locking rod, and the insert can obliquely support the locking ring to prevent it from being retracted, thereby The locking ring is fixed; however, after the retracting force is increased, the locking ring can still reversely pass over the elastic insert, so that the locking ring is separated from the locking rod, so that the first clamping of the combination can be disassembled when the clamping effect is not satisfactory.
  • the component and the second clamping component retract the valve clamp.
  • the lock bar is disposed in a square column shape, and the ring hole of the lock ring is disposed as a corresponding square column hole; the square column shape
  • the length of the side of the section is preferably from 1.5 to 2.5 mm.
  • connection port for connecting the conveying device; preferably, the connection port is connected with the conveying device in a threaded manner, that is, the connecting port is provided with an internal thread, and An external thread is provided on the conveying rod for conveying.
  • first clamping arm and the second clamping arm each have a first form of complete radial contraction, a second form of complete radial expansion, and a third form of semi-contracted semi-expansion (in the sandwiched state) Form, the first form
  • the second aspect is a form in which the clipper is released from the transport device
  • the third aspect is that the clipper clamps the valve The working form after the organization.
  • the valve clip is made of a material having a high supporting strength, in particular, an elastic alloy material having a strong restoring force, such as a nickel titanium alloy.
  • the clipper further includes a closed loop, the closed loop is sleeved on an outer circumference of the first clamping part and the second clamping part, the first clamping arm and the second The clamping arms can be folded as needed to make the clamping closer.
  • the closed loop has an axial length of 5.0 to 9.0 mm, an inner diameter of 4.0 to 6.0 mm, and an outer diameter of 4.5 to 7.0 mm.
  • the inner surface of the closed ring is provided with an internal thread
  • the outer surface of the lock ring is provided with an external thread, which are matched, so that the closed ring can be more tightly combined with the lock ring, and the closed ring can be freely adjusted Relative position to the lock ring.
  • the present invention also provides a delivery device for the valve clipper, the delivery device comprising a delivery rod, a delivery tube and a delivery sheath; the delivery rod being connectable to the lock rod for transporting the lock a first or second clamping member on the rod; the delivery tube being connectable to the lock ring for conveying a second or first clamping member disposed on the locking ring;
  • the valve clamp is wrapped to provide a transport track.
  • the delivery rod is located at the innermost layer, the delivery tube is located at the intermediate layer, and the delivery sheath is located at the outermost layer.
  • the conveying rod has a diameter of 1.2-2.0 mm; the conveying tube has an inner diameter of 4.0-6.0 mm, an outer diameter of 4.5-7.0 mm; the conveying sheath has an inner diameter of 4.5-7.0 mm, and the outer diameter is 5.0-7.5mm.
  • the front end of the delivery rod is provided with an external thread for connection with the internal thread of the lock rod, thereby realizing the delivery of the first or second clamping member provided on the lock rod.
  • the front end of the conveying pipe is provided with a closing ring connecting member, so that the closing ring can be detachably connected to the conveying pipe, and the closing ring can be screwed with the locking ring, thereby realizing the setting on the lock Delivery of a second or first clamping member on the ring;
  • the closed loop connecting member can be a thread, a snap, a card slot, a stitch, or the like.
  • the rear end ring wall of the closed ring is provided with 3-4 axial small holes
  • the front end of the conveying pipe is provided with 3-4 edges.
  • a suture can be designed between the two, and the suture is extended to the outside of the body, and the suture is cut in vitro when the clamping is in a satisfactory working state. Line, you can separate the two.
  • front end refers to the end of the valve clip that is transported into the body and away from the operator.
  • back end refers to the end of the valve clip that is placed into the body and is near the operator; and “front” or “front” as used herein refers to being remote from the operator along the delivery axis.
  • the direction, “back”, “rear” refers to the direction of the operator along the conveying axis.
  • the surgical implantation method of the valve clamp of the present invention can be performed by puncture the apex and feeding into the delivery sheath to reach the vicinity of the mitral valve.
  • the design of the delivery sheath is linear.
  • Another solution is to puncture the femoral artery, the delivery sheath is retrograde from the femoral artery to the ascending aorta, and across the aortic valve to the vicinity of the mitral valve.
  • the delivery sheath at this time is designed to have a "J" shape with a curved front end.
  • the present invention can also be used to treat tricuspid regurgitation, as well as other minimally invasive surgery (including extracardiac surgery) where several sheets of tissue need to be clamped.
  • valve clamp of the invention does not need to open the chest when implanting, and is inserted through the apex or peripheral artery, the wound is small, no cardiac arrest is required, and no extracorporeal circulation is needed, which is a minimally invasive surgery and can be used for traditional surgery. High-risk or contraindicated patients.
  • the preparation is simple and mature: the clamp of the invention is simple in design, and the preparation method is similar to the commonly used vascular stent and delivery system, so the preparation is relatively simple and mature.
  • the operation difficulty is low: one embodiment of the present invention is completed through the apical approach, from the anterior region to the left ventricle directly to the valve, the surgical entrance is very close to the valve, the sheath inflow path is straight and short, and the delivery system does not need Turning the curve, it is easy to adjust and control, and the operation is easier.
  • the effect is certain: the therapeutic effect of surgical marginal suture technique on mitral regurgitation has been clearly confirmed.
  • the valve clamp of the present invention is designed according to the principle of the surgical edge-to-edge suture technique, and the two cusps of the mitral valve are finally clamped after the clamp is implanted, which has the same effect as the suture operation of the surgical margin. .
  • Figure 1 is a schematic view of the anatomy of the heart; H1 is the superior vena cava, H2 is the inferior vena cava, H3 is the right atrium, H4 is the tricuspid valve, H5 is the right ventricle, H6 is the pulmonary valve, H7 is the pulmonary artery, and H8 is the pulmonary vein. H9 is the left atrium, H10 is the mitral valve, H11 is the left ventricle, H12 is the aortic valve, H13 is the main artery, H14 is the descending aorta, H15 is the oxygenated blood flow direction, and H16 is the hypoxic blood flow direction;
  • Figure 2a and Figure 2b are schematic diagrams of the surgical mitral valve edge-to-edge suture technique, wherein Figure 2a is when the mitral valve is closed and Figure 2b is when the mitral valve is open;
  • FIG. 3 is a schematic view showing the combination of a first clamping member and a second clamping member in a preferred embodiment of the present invention
  • FIG. 4 is a schematic structural view of a first clamping member according to a preferred embodiment of the present invention.
  • Figure 5 is a schematic view showing the structure of a second clamping member according to a preferred embodiment of the present invention.
  • FIG. 6a and 6b are schematic perspective structural views of a first clamping member according to a preferred embodiment of the present invention.
  • FIG. 7a and 7b are schematic perspective structural views of a second clamping member according to a preferred embodiment of the present invention.
  • Figure 8 is a perspective view showing the structure of a closed loop of a preferred embodiment of the present invention.
  • Figure 9 is a schematic view of the three-layer structure of the conveying device.
  • the valve clipper includes a first clamping member 1 and a second clamping member 2, and the first clamping member includes a first clamping member.
  • the second clamping member includes a pair of V-shaped second clamping arms 21 and connecting the same
  • the locking ring 22 of the pair of second clamping arms 21, the locking bar 12 and the locking ring 22 can be coupled to each other, wherein the angle between the arms of the first clamping arm 11 is slightly larger than the arms of the second clamping arm 21
  • the angle between the first clamping arm 11 is slightly smaller than the inclination angle ⁇ of the second clamping arm 21, and the inclination angle ⁇ of the first clamping arm 11 means the first clamping arm 11 and
  • the angle perpendicular to the axial direction of the lock lever 12, the inclination angle ⁇ of the second clamp arm 21 refers to the angle between the second clamp arm 21 and the
  • the lock lever 12 and the lock ring 22 are used as connecting members. Since the connecting member is directly connected to the first clamping arm 11 and the second clamping arm 21 in this embodiment, the present embodiment is convenient for description.
  • the lock bar 12 and the lock ring 22 are respectively defined as the components of the first clamping component 1 and the second clamping component 2.
  • the locking bar and the locking ring can also pass other structures and A clamping component and a second clamping component are associated.
  • the lower surface of the first clamping arm 11 has a serrated protrusion 111
  • the upper surface of the second clamping arm 21 also has a corresponding serrated protrusion 211, which can enhance the clamping arm. Friction between the valve tissue and the valve tissue prevents the pinched valve tissue from slipping out.
  • the protrusions may also be wavy or thorn shaped or the like.
  • the lock bar 12 is in the shape of a square cylinder.
  • the lock ring 22 is provided with a square-shaped ring hole 221, which is just matched with the shape of the lock bar 12.
  • the lock bar 12 is further provided with an elastic insert 13 , the opening direction of the elastic insert is directed toward the first clamping arm 11 , and the distance from the fixed position of the first clamping arm 11 on the lock bar 12 is less than or equal to the lock.
  • the axial length of the ring 22 When assembling, the lock bar 12 only needs to be inserted into the ring hole 221 of the lock ring 22 from the rear end, and when it passes through the elastic insert 13, it will gather.
  • the elastic insert 13 After the elastic insert 13 is passed, the two pieces automatically pop up and lock the lock.
  • the ring 22 locks its relative position with the lock lever 12, which also determines the clamped state of the first clamp arm 11 and the second clamp arm 21.
  • the elastic insert 13 may be made of an elastic polymer material or an elastic metal material as the locking member. In other embodiments of the invention, the locking member may also be a spring knob or other form of a latching member.
  • connection port 14 for connecting and conveying The device may be connected in a threaded manner.
  • the valve clip of this embodiment further includes a closed loop 3 (shown in Figure 8) having an internal thread 31 and three small holes 32, while the outer surface of the lock ring 22 in this embodiment has an external thread 222 (e.g. 7a and 7b), the lock ring 22 can be screwed or screwed into the closed ring 3 as needed, and the two second clamping arms 21 are placed in the lock for better screwing in and out.
  • the front end plane of the ring 22 is close to the outer edge; when the lock ring 22 is completely screwed in, the closed ring 3 can function to close and close the first and second clamping arms toward the center line, and the clamping arm can be further enlarged.
  • the ability to grip the valve tissue and to clamp the sandwiched valve tissue toward the center can be adjusted by adjusting the relative position of the closure ring 3 and the lock ring 22.
  • the three small holes 32 at the rear end of the closed loop 3 are used to insert the nails on the delivery tube to flexibly connect the delivery tubes.
  • Figure 9 is a schematic view showing the structure of the conveying device of the present embodiment, the conveying device comprising a conveying rod 4, a conveying pipe 5 and a conveying sheath 6, the rear ends of which can be pushed, pulled, rotated, etc.
  • the conveying rod 4 is used for
  • the lock bar 12 of the first clamping part 1 is connected, and the front end thereof can be provided with an external thread for cooperating with the connecting port 14;
  • the front end of the conveying pipe 5 is provided with three nails 51, and three small holes at the rear end of the closing ring 3 32, the nail 51 can be inserted into the small hole 32 to integrate the closed ring 3 with the conveying pipe 4, and when the conveying pipe 4 is pushed forward or rotated, the closing ring 3 will also advance or rotate together, and when the conveying pipe 4 When retreating, the closed loop 3 and the delivery tube 4 can be separated.
  • a suture can be designed between the two, and the suture can be extended to the outside of the body.
  • the suture is cut in vitro to separate the two; the conveying sheath 6 provides a track for transporting, and by pushing the conveying rod 4 and the conveying tube 5, the clamping arm travels in the conveying sheath, In vitro into the heart, the delivery sheath is still Protection of human tissue is not damaged by clamping arm.
  • the valve clip has three forms, a first form of full radial contraction, a second form of complete radial expansion, and a third form of semi-contracted semi-expansion (in a sandwiched state);
  • the first form is The form when the clamp is conveyed through the catheter, that is, the first clamping arm 11 and the second clamping arm 21 are both received into the conveying sheath 6;
  • the second form is that the clamp is transported from the sheath After the sheath 6 is released, the first clamping arm 11 and the second clamping arm 21 are completely extended outward, and the two can be respectively positioned on both sides of the valve for the next clamping.
  • the third embodiment is an operation form after the clipper clamps the valve tissue, that is, a shape when the lock ring 22 is screwed into the closed loop 3 and the positions of the lock ring 22 are fixed.
  • valve clip The preferred use path of the valve clip is apical puncture, from the anterior region to the left ventricle directly to the valve, the surgical entrance is close to the valve, the sheath is straight and short, and the delivery system does not need to be turned, so it is easy Adjustment, control, and surgery are easier.
  • the valve clip of this embodiment uses a laser cutting and engraving technique.
  • the preparation method is not unique, and in other preferred embodiments, it can also be produced by an integrally formed 3D printing technique.
  • the basic material of this embodiment is a commonly used nickel-titanium alloy, and the conveying pipe, the conveying sheath and the closed ring are commonly used materials such as polyethylene, and the conveying rod is stainless steel.
  • the first clamping part of the clamp is passed through the inside of the second clamping part, and is connected with the conveying rod, the conveying rod is located in the conveying pipe;
  • the second clamping part is connected with the conveying pipe, and the conveying pipe is Located in the delivery sheath, eventually Having both the first clamping member and the second clamping member are located within the delivery sheath;

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Abstract

一种治疗心脏瓣膜反流的瓣膜夹合器，该瓣膜夹合器包括第一夹合部件（1）、第二夹合部件（2）以及连接部件；其中第一夹合部件（1）具有第一夹合臂（11），第二夹合部件（2）具有对应数量的第二夹合臂（21），所述第一夹合臂（11）与所述第二夹合臂（21）可通过相互靠拢并挤压产生的相互作用力来夹住其中的物体；此外，该瓣膜夹合器还可包括闭合环（3），其套在第一夹合部件（1）与第二夹合部件（2）的外周，使夹合臂（11,21）可根据需要收拢，从而使夹合更紧密。该瓣膜夹合器具有微创植入、制作简单、操作难度低、效果良好等优点，可用于治疗二尖瓣反流、三尖瓣反流，也可以用于需要夹合几个片状组织时的其它微创外科手术。

Description

一种瓣膜夹合器 技术领域
本发明涉及一种瓣膜夹合器，尤其涉及一种用于治疗心脏瓣膜反流的瓣膜夹合器。
背景技术
二尖瓣是附于左房室口周缘的两片瓣膜(如图1所示)，借腱索连于乳头肌，有阻止左心室的血液流回左心房的作用。
二尖瓣反流(MR)是由于二尖瓣叶及其相关结构发生器质性或功能性改变导致二尖瓣前后叶吻合不良，血流从左心室倒流至左心房，引起一系列的病理生理改变。严重MR会引起左室扩大，最终导致左心收缩功能衰竭障碍及心衰，同时左心房压力也因为反流而增大，容易导致左心房扩大、房颤和肺动脉高压。MR预后较差，有症状而未行手术者年死亡率在5％左右，而出现严重心衰者5年死亡率达60％。同时，MR也是最常见的心脏病之一。据统计，超过65和75岁的人群的发病率分别为6.4％和9.3％。随着经济社会的发展和人口的老龄化，二尖瓣反流的发病率呈明显上升的态势。
临床试验显示药物治疗只能改善患者症状，而不能延长患者生存或手术时机。外科手术瓣膜修复或置换术被认为是该疾病的标准治疗方法，已被证实能缓解患者的症状及延长其寿命。然而，外科手术具有创伤大、术后疼痛明显、恢复慢、风险高等缺点，此外，一些高龄、有开胸病史、心功能差且合并多脏器功能不全的患者常由于外科手术风险大而被拒绝外科手术。因此，研发微创的、低风险的、治疗MR的介入治疗器械具有巨大社会效益和市场需求。近年来，随着瓣膜介入治疗技术获得突破性的发展，MR的介入器械目前已成为国内外心血管器械研发的重点方向之一。
其中，依据外科手术瓣膜缘对缘缝合技术原理而研发的瓣膜钳夹器械因为安全性高、技术原理简单、可行性大目前最受肯定。外科瓣膜缘对缘缝合技术原理如图2a和2b所示：二尖瓣反流时，心脏收缩期两个瓣叶边缘无法对合关闭出现空隙，导致左心室的血流从空隙返回左心房；外科缘对缘缝合将二尖瓣两个瓣叶边缘中间点缝合，使得心脏收缩期时瓣叶间空隙由一个大孔变成两个小孔，从而减少二尖瓣反流(图2a)，而心脏舒张期二尖瓣开放时流入左心室血流又不受影响(图2b)。国际上唯一获批上市治疗MR的微创介入器械为Evalve公司的MitraClip就是一种瓣膜钳夹装置。但是其含有复杂的操控系统，制作和生产的成本也很高；该器械在手术时需经静脉、右心房、房间隔、左心房最后到达左心室，路入途径又长又多处弯曲，故手术操作非常复杂，医师需要反复的细调输送系统弯度、方向、水平位置、垂直深度，到达理想位置后才能夹住瓣膜，因此医生经常需要花费很长时间，才能完成一台手术，这一缺点深 受诟病。
目前我国尚未有上市的或者进入临床试验的MR器械，研发MR的介入器械具有更重要的意义。中国公开号为CN102860846A的专利虽然也公开了一种缘对缘钳夹装置，但是该装置是用于三尖瓣反流的，并不能用于二尖瓣反流的治疗。另外，该装置夹住瓣膜瓣叶后，并没有把瓣叶进一步夹合、向中心收拢，导致瓣叶之间还有间隙，血流仍能从间隙通过，手术效果会大打折扣。
因此本领域技术人员致力于开发一种成本低、操作简单、效果理想的MR介入器械。
发明内容
鉴于目前外科技术的上述缺陷，本发明所要解决的技术问题是如何采用微创的介入方法，安全有效地治疗MR。
为实现上述目的，本发明提供了一种治疗MR的瓣膜夹合器。该夹合器经微创的手术途径植入后，可有效治疗MR。
该瓣膜夹合器包括第一夹合部件、第二夹合部件以及连接部件；所述第一夹合部件包括至少两个第一夹合臂，所述第二夹合部件包括与所述第一夹合臂对应的第二夹合臂，每个所述第一夹合臂与其所对应的所述第二夹合臂可组合成为一组夹具，两者通过相互靠拢并挤压产生的相互作用力来夹住其中的物体；所述连接部件用于连接所述第一夹合部件与所述第二夹合部件。
进一步，所述第一夹合臂向所述夹合器的前方倾斜，所述第二夹合臂也向所述夹合器的前方倾斜，但其倾斜角大于所述第一夹合臂的倾斜角；其中所述第一夹合臂的倾斜角为20-30度，所述第二夹合臂的倾斜角为25-35度。该夹合器在使用时所述第一夹合臂与所述第二夹合臂分别从瓣膜的两侧相互靠拢，从而起到夹住瓣膜的作用。
优选地，所述第一夹合臂的数量为两个或三个，对应地，所述第二夹合臂的数量为两个或三个，即所述夹具的组数为两组或三组，其中两组夹具的实施方案对应于二尖瓣，三组夹具的实施方案对应于三尖瓣。此外根据实际情况还可设计其它数量的夹合臂。
优选地，所述第一夹合臂及第二夹合臂的长度分别为4.0-8.0mm，最优为6.0mm。
在本发明的一种优选实施方式中，所述瓣膜夹合器具有一对第一夹合臂和一对对应的第二夹合臂，且相互对称。进一步，所述一对第一夹合臂呈向前的V字形，两者之间的夹角为120-140度，最优为130度；所述一对第二夹合臂也呈向前的V字形，两者之间的夹角比所述一对第一夹合臂之间的夹角略小，为110-130度，最优为120度。
优选地，所述第一夹合臂与所述第二夹合臂的相对面均具有若干凸起，从而可以增强夹合臂与瓣膜组织之间的摩擦力，防止夹住的瓣膜组织滑脱出来。在本发明的一 种优选实施方式中，所述凸起为锯齿状或波浪状，且夹合臂相对面之间的齿纹或波浪纹相吻合。在本发明的另一种优选实施方式中，所述凸起为小刺，这些小刺可以刺入瓣膜组织，同样起到加强夹合臂之间夹住瓣膜能力的作用。
进一步，所述连接部件包括相互配合的锁杆和锁环；所述第一夹合部件与所述第二夹合部件被分开设置在所述锁杆或所述锁环上，即所述第一夹合部件和所述第二夹合部件分别与所述锁杆或所述锁环连接，所述锁杆通过插入所述锁环的环孔内实现所述第一夹合部件与所述第二夹合部件的连接，且所述锁杆和所述锁环之间还设置有锁定部件。所述锁定部件除了可以锁定所述锁杆和所述锁环的连接以外，还可以锁定所述第一夹合臂与所述第二夹合臂之间的夹合状态。
进一步，所述锁定部件具有操作可逆性，当夹合效果不满意时可将所述锁杆和所述锁环分开，便于回收所述瓣膜夹合器。
在本发明的一种实施方式中，所述第一夹合部件被设置在所述锁杆上，所述第二夹合部件被设置在所述锁环上；在本发明的另一种实施方式中，所述第一夹合部件被设置在所述锁环上，所述第二夹合部件被设置在所述锁杆上。
优选地，所述锁杆的轴向长度为5.0-8.0mm；所述锁环的外径为4.0-6.0mm，所述锁环的轴向长度为3.0-5.0mm。
在本发明的一种优选实施方式中，所述第一夹合部件由所述锁杆和多个所述第一夹合臂组成，所述多个第一夹合臂以所述锁杆为中心向外延伸，所述第二夹合部件由所述锁环和多个所述第二夹合臂组成，所述多个第二夹合臂以所述锁环为中心向外延伸。
在本发明的一种实施方式中，所述锁定部件被设置在所述锁杆上，其可为弹性插片或弹簧凸钮，也可为包围固定在锁杆外周的弹性高分材料。在本发明的另一种实施方式中，所述锁定部件由设置在所述锁杆上的弹簧凸钮和设置在所述锁环上的凹槽组成。
优选地，所述锁定部件具有操作可逆性；如采用弹性插片时，所述锁环能够越过锁杆上的弹性插片，该插片可倾斜支撑所述锁环，防止其回撤，从而固定锁环；但加大回撤力后，所述锁环依然能反向越过弹性插片，使锁环与锁杆分离，这样可以在夹合效果不满意时，拆开结合的第一夹合部件与第二夹合部件，并收回该瓣膜夹合器。
进一步，为了避免锁杆与锁环之间的旋转位移，所述锁杆被设置为方柱形，而所述锁环的环孔被设置为对应的方柱形孔；所述方柱形的截面边长优选为1.5-2.5mm。
进一步，所述锁杆的后端设置有连接口，用于连接输送装置；优选地，所述连接口与所述输送装置的连接方式是螺纹连接，即所述连接口内设置有内螺纹，而用于输送的输送杆上设置有外螺纹。
进一步，所述第一夹合臂与所述第二夹合臂均具有完全径向收缩的第一形态、完全径向扩张的第二形态以及半收缩半扩张(夹合状态下)的第三形态，所述第一形态 为所述夹合器被经导管输送时的形态，所述第二形态为所述夹合器被从输送装置内释放出来后的形态，所述第三形态为所述夹合器夹住瓣膜组织之后的工作形态。
优选地，所述瓣膜夹合器由具有高支撑强度的材料制成，特别是由具有强回复力的弹性合金材料制成，如镍钛合金。
优选地，所述夹合器还包括闭合环，所述闭合环套在所述第一夹合部件与所述第二夹合部件的外周，使所述第一夹合臂与所述第二夹合臂可根据需要收拢，从而使夹合更紧密。
优选地，所述闭合环的轴向长度为5.0-9.0mm，内径为4.0-6.0mm，外径为4.5-7.0mm。
进一步，所述闭合环的内表面设置有内螺纹，所述锁环外表面设置有外螺纹，两者相匹配，可使闭合环与所述锁环更紧密地结合，并可自由调节闭合环与锁环的相对位置。当锁环完全旋入闭合环后，该闭合环可起到将第一及第二夹合臂向中线收拢、闭合的作用，可进一步加大夹合臂夹住瓣膜组织的能力，并把所夹住的瓣膜组织向中间夹合靠拢。
本发明还提供了所述瓣膜夹合器的输送装置，所述输送装置包括输送杆、输送管和输送鞘；所述输送杆可与所述锁杆相连接，用于输送设置在所述锁杆上的第一或第二夹合部件；所述输送管可与所述锁环相连接，用于输送设置在所述锁环上的第二或第一夹合部件；所述输送鞘用于包裹所述瓣膜夹合器，同时提供输送轨道。所述输送杆位于最内层，所述输送管位于中间层，所述输送鞘位于最外层。
优选地，所述输送杆的直径为1.2-2.0mm；所述输送管的内径为4.0-6.0mm，外径为4.5-7.0mm；所述输送鞘的内径为4.5-7.0mm，外径为5.0-7.5mm。
优选地，所述输送杆的前端设置有外螺纹用于与所述锁杆的内螺纹相连接，从而实现设置有所述锁杆上的第一或第二夹合部件的输送。
优选地，所述输送管的前端设置有闭合环连接部件，使闭合环能可拆卸地与输送管连接，而所述闭合环又可与所述锁环螺纹连接，从而实现设置于所述锁环上的第二或第一夹合部件的输送；所述闭合环连接部件可以是螺纹、卡扣、卡槽、缝线等。
在本发明的一种优选实施方式中，所述闭合环的后端环壁上设置有3-4个沿轴向的小孔，所述输送管的前端管壁上设置有3-4个沿轴向的钉子，所述钉子可插入所述小孔内使所述闭合环与所述输送管结合成为一体，当推动所述输送管前进或旋转时，所述闭合环也会一起前进或旋转，而当所述输送管后退时，所述闭合环与所述输送管即可分离。
进一步，为了巩固所述闭合环与所述输送管之间的结合，还可以在两者之间设计缝合线，并将缝合线延长至体外，当夹合达到满意工作状态时候，在体外剪断缝合线，即可使两者分离。
本文中所述的“前端”是指所述瓣膜夹合器被输送入人体中后远离操作者的一端， 本文中所述的“后端”是指所述瓣膜夹合器被输送入人体中后靠近操作者的一端；且本文中所述“前”、“前方”是指沿着输送轴远离操作者的方向，“后”、“后方”是指沿着输送轴指向操作者的方向。
本发明所述瓣膜夹合器的手术植入方式可通过穿刺心尖，送入输送鞘，直达二尖瓣附近，此时输送鞘的设计为直线形。另外一种方案是通过穿刺股动脉，输送鞘从股动脉逆行到升主动脉，跨过主动脉瓣到达二尖瓣附近，此时的输送鞘的设计为前端可调弯的“J”形。
本发明除了用于治疗二尖瓣反流，还可以用于治疗三尖瓣反流，也可以用于需要夹合几个片状组织时的其它微创外科手术(包括心脏以外手术)。
本发明具有以下有益技术效果：
①微创植入：本发明的瓣膜夹合器植入时候无需开胸，经心尖或者外周动脉植入，伤口小，无需心脏停搏，无需体外循环，属于微创手术，可用于传统外科手术高危或禁忌的患者。
②制作简单、成熟：本发明的夹合器设计简单，其制作方法与目前常用血管支架和输送系统类似，故制备相对简单、成熟。
③手术操作难度低：本发明的一种实施方式是经心尖途径完成，从心前区进入左心室直达瓣膜处，手术入口距离瓣膜很近，鞘管路入途径又直又短，输送系统无需调弯，故易于调整、控制，手术操作较容易。
④效果肯定：外科缘对缘缝合技术对二尖瓣反流的治疗作用已被明确的证实。本发明的瓣膜夹合器根据目前外科手术缘对缘缝合技术原理而设计的，夹合器植入后最终夹合二尖瓣两个瓣尖，起到与外科缘对缘缝合手术同样的效果。
以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明，以充分地了解本发明的目的、特征和效果。
附图说明
图1是心脏解剖结构示意图；图中H1为上腔静脉，H2为下腔静脉，H3为右心房，H4为三尖瓣，H5为右心室，H6为肺动脉瓣，H7为肺动脉，H8为肺静脉，H9为左心房，H10为二尖瓣，H11为左心室，H12为主动脉瓣，H13为主动脉，H14为降主动脉，H15为含氧血流向，H16为缺氧血流向；
图2a和图2b是外科二尖瓣缘对缘缝合技术原理图，其中图2a是二尖瓣关闭时，图2b是二尖瓣开放时；
图3是本发明优选实施例第一夹合部件与第二夹合部件的结合示意图；
图4是本发明优选实施例第一夹合部件的结构示意图；
图5是本发明优选实施例第二夹合部件的结构示意图；
图6a和图6b是本发明优选实施例第一夹合部件的立体结构示意图；
图7a和图7b是本发明优选实施例第二夹合部件的立体结构示意图；
图8是本发明优选实施例闭合环的立体结构示意图；
图9是输送装置的三层结构示意图。
具体实施方式
如图3-5所示为本发明一种二尖瓣瓣膜夹合器的结构示意图，该瓣膜夹合器包括第一夹合部件1和第二夹合部件2，第一夹合部件包括一对呈V字形的第一夹合臂11和连接所述一对第一夹合臂11的锁杆12，第二夹合部件包括一对呈V字形的第二夹合臂21和连接所述一对第二夹合臂21的锁环22，锁杆12和锁环22可相互配合连接，其中第一夹合臂11两臂之间的夹角略大于第二夹合臂21两臂之间的夹角，或者说，第一夹合臂11的倾斜角α略小于第二夹合臂21的倾斜角β，第一夹合臂11的倾斜角α是指第一夹合臂11与垂直于锁杆12的轴线方向的夹角，第二夹合臂21的倾斜角β是指第二夹合臂21与垂直于锁环22的轴线方向的夹角，α优选为25度，β优选为30度，所述一对第一夹合臂11与所述一对第二夹合臂21一一对应，当它们靠拢后可产生相互挤压的力，从而组成两组夹具用于夹持二尖瓣瓣膜。在本发明的其它实施例中，所述第一夹合臂可以设置在锁环上，所述第二夹合臂可以设置在锁杆上，只要能满足本发明的夹合原理即可。
本实施例中，锁杆12和锁环22作为连接部件，由于在本实施例中该连接部件分别与第一夹合臂11和第二夹合臂21直接相连，因此为了方便描述，本实施例分别将锁杆12和锁环22定义为第一夹合部件1和第二夹合部件2的组成部分，在本发明的其它实施例中，锁杆和锁环也可通过其它结构与第一夹合部件及第二夹合部件相关联。
从图6a-图7b中分别可知第一夹合臂11的下表面具有锯齿状凸起111，第二夹合臂21的上表面也具有对应的锯齿状凸起211，这样可以增强夹合臂与瓣膜组织之间的摩擦力，防止夹住的瓣膜组织滑脱出来。在本发明的其它实施例中，所述凸起还可以是波浪形或刺形等。
所述锁杆12为方柱形，所述锁环22内设置有方柱形环孔221，正好与锁杆12的外形匹配，锁杆12插入锁环22后不会发现旋转位移或倾斜。所述锁杆12上还设置有弹性插片13，该弹性插片的开口方向向着第一夹合臂11，且离开第一夹合臂11在锁杆12上的固定位置的距离小于等于锁环22的轴向长度。装配时，只需将锁杆12从后端开始插入锁环22的环孔221内，经过弹性插片13时，其会收拢，越过弹性插片13后，两片插片自动弹出卡住锁环22，从而锁定其与锁杆12的相对位置，该锁定位置也决定了第一夹合臂11与第二夹合臂21的夹紧状态。弹性插片13作为锁定部件可采用弹性高分子材料或弹性金属材料制成，在本发明的其它实施例中所述锁定部件还可以是弹簧凸钮，或其它形式的卡位部件。
进一步，所述锁杆12的后端(图中为下端)还设置有连接口14，用于连接输送 装置，其连接的方式可以是螺纹连接。
本实施例的瓣膜夹合器还包括闭合环3(如图8所示)，具有内螺纹31和三个小孔32，而本实施例中的锁环22的外表面具有外螺纹222(如图7a和7b所示)，锁环22可按需要旋入或旋出于闭合环3内，为了更好地旋入和旋出，所述两个第二夹合臂21设置在所述锁环22的前端平面靠近外缘处；当锁环22完全旋入后，该闭合环3可起到将第一、第二夹合臂向中线收拢、闭合的作用，可进一步加大夹合臂夹住瓣膜组织的能力，并把所夹住的瓣膜组织向中间夹合靠拢，靠拢的程度可通过调节闭合环3与锁环22的相对位置来调节。闭合环3后端的三个小孔32用于插入输送管上的钉子，从而灵活地连接输送管。
图9所示为本实施例的输送装置结构示意图，该输送装置包括输送杆4、输送管5和输送鞘6，它们的后端可由手术操作人员进行推拉、旋转等操作；输送杆4用于连接第一夹合部件1的锁杆12，其前端可设置外螺纹，用于与连接口14相配合；输送管5的前端设置有3个钉子51，与闭合环3后端的三个小孔32相配合，钉子51可插入小孔32内使所述闭合环3与输送管4结合成为一体，当推动输送管4前进或旋转时，闭合环3也会一起前进或旋转，而当输送管4后退时，闭合环3与输送管4即可分离，为了巩固闭合环3与输送管4之间的结合，还可以在两者之间设计缝合线，并将缝合线延长至体外，当夹合达到满意工作状态时候，在体外剪断缝合线，即可使两者分离；输送鞘6为输送提供了轨道，通过推动输送杆4及输送管5，使得夹合臂在输送鞘内走行，由体外进入心脏内，输送鞘还可保护人体组织不被夹合臂所损伤。
该瓣膜夹合器具有三种形态，分别为完全径向收缩的第一形态、完全径向扩张的第二形态以及半收缩半扩张(夹合状态下)的第三形态；所述第一形态为所述夹合器被经导管输送时的形态，即第一夹合臂11与第二夹合臂21均收入输送鞘6内的形态；所述第二形态为所述夹合器被从输送鞘6内释放出来后的形态，此时第一夹合臂11与第二夹合臂21均完全向外伸展，并可将两者分别定位于瓣膜的两侧，为下一步的夹合做准备；所述第三形态为所述夹合器夹住瓣膜组织之后的工作形态，也即锁环22旋入闭合环3后两者位置固定时的形态。
该瓣膜夹合器的较佳使用路径为心尖穿刺，从心前区进入左心室直达瓣膜处，手术入口距离瓣膜很近，鞘管路入途径又直又短，输送系统无需调弯，故易于调整、控制，手术操作较容易。
本实施例的瓣膜夹合器使用激光切割、雕刻技术。但该制备方法不唯一，在其它的优选实施方式中也可以采用一体成型的3D打印技术制作。本实施例的基本材料为常用的镍钛合金，输送管、输送鞘及闭合环为聚乙烯等常用材料，输送杆为不锈钢。
本实施例的瓣膜夹合器在实际植入时可采用以下步骤：
1)在体外，将夹合器第一夹合部件从第二夹合部件内部穿过，并与输送杆连接，输送杆位于输送管内；将第二夹合部件与输送管连接，输送管又位于输送鞘内，最终 使得第一夹合部件及第二夹合部件均位于输送鞘内；
2)将输送鞘送入左心室管后跨过二尖瓣瓣口到达左心房，回撤输送鞘，使得第一夹合部件离开输送鞘并打开于左心房内；
3)继续回撤输送鞘至左心室，使得第二夹合部件离开输送鞘并打开于左心室内；
4)上推第二夹合部件，将二尖瓣瓣尖推向左心房并使之减少活动，下拉第一夹合部件，使得插片通过锁环的环孔后，两组夹合臂就牢牢合在一起形成夹具，两组夹具将夹住两个二尖瓣瓣尖；
5)上推输送鞘将两组夹具部分地收进输送鞘，通过旋转输送管而旋转闭合环，将两组夹具收进闭合环内，使得它们向中线靠拢、闭合；
6)回撤输送鞘，旋出输送杆，解离闭合环和输送管，最终释放夹合器，完成手术，夹合器留在体内，夹合二尖瓣瓣尖。
以上详细描述了本发明的较佳具体实施例。应当理解，本领域的普通技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。因此，凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案，皆应在由权利要求书所确定的保护范围内。

Claims (13)

  1. 一种瓣膜夹合器，其特征在于，包括第一夹合部件、第二夹合部件以及连接部件；所述第一夹合部件包括至少两个第一夹合臂，所述第二夹合部件包括与所述第一夹合臂对应的第二夹合臂，每个所述第一夹合臂与其所对应的所述第二夹合臂组合成为一组夹具，两者通过相互靠拢并挤压产生的相互作用力来夹住其中的物体；所述连接部件用于连接所述第一夹合部件与所述第二夹合部件。
  2. 如权利要求1所述的瓣膜夹合器，其特征在于，所述第一夹合臂向所述夹合器的前方倾斜，所述第二夹合臂也向所述夹合器的前方倾斜，但其倾斜角大于所述第一夹合臂的倾斜角。
  3. 如权利要求1所述的瓣膜夹合器，其特征在于，所述第一夹合臂的倾斜角为20-30度，所述第二夹合臂的倾斜角为25-35度。
  4. 如权利要求1所述的瓣膜夹合器，其特征在于，所述第一夹合臂与所述第二夹合臂的相对面均具有若干凸起。
  5. 如权利要求1所述的瓣膜夹合器，其特征在于，所述第一夹合臂的数量为两个或三个。
  6. 如权利要求1至4任一项所述的瓣膜夹合器，其特征在于，所述连接部件包括相互配合的锁杆和锁环；所述第一夹合部件和所述第二夹合部件分别与所述锁杆或所述锁环连接，所述锁杆通过插入所述锁环的环孔内实现所述第一夹合部件与所述第二夹合部件的连接，且所述锁杆和所述锁环之间还设置有锁定部件。
  7. 如权利6所述的瓣膜夹合器，其特征在于，所述锁杆为方柱形，所述锁环的环孔为对应的方柱形孔。
  8. 如权利6所述的瓣膜夹合器，其特征在于，所述锁定部件设置在所述锁杆上，为弹性插片。
  9. 如权利要求6所述的瓣膜夹合器，其特征在于，还包括闭合环，所述闭合环套在所述第一夹合部件与所述第二夹合部件的外周，使所述第一夹合臂与所述第二夹合臂可根据需要收拢，从而使夹合更紧密。
  10. 如权利要求9所述的瓣膜夹合器，其特征在于，所述闭合环的内表面设置有内螺纹，所述锁环外表面设置有外螺纹，两者相匹配。
  11. 一种用于输送如权利要求6所述的瓣膜夹合器的输送装置，其特征在于，包括输送杆、输送管和输送鞘；所述输送杆与所述锁杆相连接，用于输送与所述锁杆连接的第一夹合部件或第二夹合部件；所述输送管与所述锁环相连接，用于输送与所述锁环连接的第二夹合部件或第一夹合部件；所述输送鞘用于包裹所述瓣膜夹合器，同时提供输送轨道。
  12. 一种用于输送如权利要求9所述的瓣膜夹合器的输送装置，其特征在于，包括输 送杆、输送管和输送鞘；所述输送杆与所述锁杆相连接，用于输送与所述锁杆连接的第一夹合部件或第二夹合部件；所述输送管与所述锁环相连接，用于输送与所述锁环连接的第二夹合部件或第一夹合部件，所述输送管的前端设置有闭合环连接部件，使闭合环能可拆卸地与输送管连接；所述输送鞘用于包裹所述瓣膜夹合器，同时提供输送轨道。
  13. 一种瓣膜夹合器系统，其特征在于，包括瓣膜夹合器及输送装置；所述瓣膜夹合器包括第一夹合部件、第二夹合部件以及连接部件；所述第一夹合部件包括至少两个第一夹合臂，所述第二夹合部件包括与所述第一夹合臂对应的第二夹合臂，每个所述第一夹合臂与其所对应的所述第二夹合臂组合成为一组夹具，两者通过相互靠拢并挤压产生的相互作用力来夹住其中的物体；所述连接部件用于连接所述第一夹合部件与所述第二夹合部件；所述连接部件包括相互配合的锁杆和锁环；所述第一夹合部件和所述第二夹合部件分别与所述锁杆或所述锁环连接，所述锁杆通过插入所述锁环的环孔内实现所述第一夹合部件与所述第二夹合部件的连接，且所述锁杆和所述锁环之间还设置有锁定部件；所述输送装置包括输送杆、输送管和输送鞘；所述输送杆与所述锁杆相连接，用于输送与所述锁杆连接的第一夹合部件或第二夹合部件；所述输送管与所述锁环相连接，用于输送与所述锁环连接的第二夹合部件或第一夹合部件；所述输送鞘用于包裹所述瓣膜夹合器，同时提供输送轨道。
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