WO2021008461A1 - Easily operable valve clamping device and valve clamping system - Google Patents

Easily operable valve clamping device and valve clamping system Download PDF

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Publication number
WO2021008461A1
WO2021008461A1 PCT/CN2020/101374 CN2020101374W WO2021008461A1 WO 2021008461 A1 WO2021008461 A1 WO 2021008461A1 CN 2020101374 W CN2020101374 W CN 2020101374W WO 2021008461 A1 WO2021008461 A1 WO 2021008461A1
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WO
WIPO (PCT)
Prior art keywords
clamp
arm
valve
push rod
clamping
Prior art date
Application number
PCT/CN2020/101374
Other languages
French (fr)
Chinese (zh)
Inventor
张庭超
张伟伟
郑贤章
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 CN201910632959.XA external-priority patent/CN112206017A/en
Priority claimed from CN201921097737.4U external-priority patent/CN211834508U/en
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2021008461A1 publication Critical patent/WO2021008461A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • the present application relates to the field of medical equipment, and in particular to an easy-to-clamp valve clamp and valve clamp 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 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 inner wall of the left ventricle 3 by the chordae 4.
  • valve leaflet clamps are delivered to the mitral valve through a delivery device, and then the anterior and posterior leaflets of the mitral valve are clamped by the relative opening of the clamps, so that the anterior and posterior leaflets of the mitral valve
  • the leaves are fixed with the posterior leaves to reduce mitral valve regurgitation.
  • the two leaflets of the mitral valve are always in a state of large and powerful opening and closing activities, it is more difficult for the clamp to quickly and successfully capture the movable leaflet tissue, and the operation time is longer.
  • the purpose of the present application is to provide an easy-to-clamp valve clamp and valve clamping system in view of the above-mentioned defects in the prior art, which can easily and quickly capture movable leaflets Organization, thereby reducing the difficulty of surgery and improving the efficiency of surgery.
  • the easy-to-clamp valve clamp includes a push rod, at least two clamp arms, and at least one extension arm.
  • the clamp arm includes a fixed end and a free end, the fixed end is connected to the push rod, and the push rod moves axially to drive the clamp arm to open and close with respect to the push rod with the fixed end as the center of rotation
  • the extension arm extends or retracts along the axial direction of the pliers arm, when the extension arm extends along the fixed end of the pliers arm toward the free end, the end of the extension arm extends beyond the pliers arm Free end.
  • the valve clamping system includes a pushing device and the above-mentioned easy-to-clamp valve clamping device.
  • the pushing device includes an operating handle and a pushing shaft with a certain axial length, and the proximal end of the pushing shaft is connected with the operating handle, The distal end of the pushing shaft and the valve clamp are detachably connected.
  • the easy-to-hold valve clamp and valve clamping system provided in this application are provided with an extension arm that can be extended or retracted along the axial direction of the clamp arm, so that when the clamp arm is opened relative to the push rod, the end of the extension arm exceeds
  • the free end of the forceps arm is equivalent to increasing the length of the forceps arm when capturing the valve leaflets.
  • the longer forceps arm can have a better supporting effect on the valve leaflets when capturing the valve leaflets and avoid the leaflets from the surface of the forceps arm. Slippage, so as to quickly capture the active valve leaflet tissue, reduce the difficulty of the operation and improve the efficiency of the operation.
  • 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 structure of the easy-to-hold valve clamp of an embodiment of the present application when folded;
  • Fig. 4 is a schematic structural view of the valve clamp shown in Fig. 3 from a perspective when the forceps arms are opened;
  • Fig. 5 is a schematic structural diagram of the valve clamp shown in Fig. 3 from another perspective when the forceps arms are opened;
  • Fig. 6 is a schematic diagram of the position of the valve clamp of the present application at the mitral valve
  • Figure 7a is a schematic diagram of the mitral valve when the heart is contracted after the valve leaflets are clamped by the valve clamp of the present application;
  • Fig. 7b is a schematic diagram of the mitral valve during diastole after the valve leaflet is clamped by the valve clamp of the present application;
  • Fig. 8 is a schematic structural diagram of the push rod of the valve clamp shown in Fig. 3;
  • Fig. 9 is a schematic structural view of the fixed base of the valve clamp shown in Fig. 3;
  • Fig. 10 is a schematic structural view of the base connecting pipe of the valve clamp shown in Fig. 3;
  • Fig. 11 is a schematic structural view of the forceps arm of the valve clamp shown in Fig. 3;
  • Fig. 12a is a schematic structural diagram of the valve clamp shown in Fig. 3 when the clamping arm is folded;
  • Fig. 12b is a schematic structural diagram of the valve clamp shown in Fig. 3 when the clamping arm is opened;
  • Figure 13 is a schematic structural view of the extension arm of the valve clamp shown in Figure 3;
  • Fig. 15 is a schematic structural view of the valve clamp of the embodiment shown in Fig. 14c;
  • Fig. 16 is a schematic structural diagram of a valve clamp according to another embodiment of the present application.
  • FIG. 17 is a schematic diagram of the structure of the clamp arm of the valve clamp of the embodiment shown in FIG. 16;
  • 18 is a schematic diagram of the structure of the forceps arm of the valve clamp of another embodiment of the present application.
  • 19 is a schematic structural diagram of the valve clamp when the valve clamp is connected to the push shaft when the clamp arm of the valve clamp of an embodiment of the present application is in an open state;
  • Figure 20 is a schematic cross-sectional view of the valve clamp shown in Figure 19 when connected to the push shaft;
  • Figure 21 is a schematic structural diagram of the valve clamp when the valve clamp is connected to the push shaft when the clamp arm of the valve clamp is in the folded state according to an embodiment of the present application;
  • Fig. 22 is a schematic cross-sectional view of the valve clamp shown in Fig. 21 when connected to the push shaft.
  • the present application provides a valve clamp 100 that is easy to clamp.
  • the valve clamp 100 includes a push rod 40, two clamp arms 11, and at least one extension arm 20.
  • the number of pliers arms 11 is two, and the two pliers arms 11 are arranged symmetrically about the push rod 40 and can be opened and closed relative to the push rod 40.
  • the valve clamp 100 of the present application can be used for the edge-to-edge repair of mitral valve regurgitation.
  • the valve clamp 100 is placed on the anterior and posterior leaflets of the mitral valve.
  • FIG. 7a shows a schematic diagram of the state of the mitral valve during systole, where the arrow direction is the blood flow direction.
  • FIG. 7b shows a schematic diagram of the state of the mitral valve during diastole, where the arrow direction is the blood flow direction.
  • the anterior leaflet 1a and posterior leaflet 1b are only fixed together at the position where the valve clamp 100 is clamped, and other positions of the anterior leaflet 1a and posterior leaflet 1b are still in normal diastole, so that a large amount of blood can enter the left from the left atrium.
  • the ventricle thus ensuring the normal flow of blood.
  • valve clamp 100 of other embodiments of the present application can also be used to reduce or treat "tricuspid regurgitation", that is, the valve clamp 100 has three clamp arms 11, and the three clamp arms 11 separate the three The leaflets are fixed together to reduce or avoid "tricuspid regurgitation.”
  • the principle and structure are the same as the principle and structure of the valve clamp 100 for solving mitral regurgitation in the embodiment of the present application, and will not be repeated here. It is understandable that the valve clamp 100 of other embodiments of the present application can also be applied to other minimally invasive surgical operations that require several pieces of tissue to be clamped together, and the number of clamp arms 11 is based on actual conditions. Use requirements to change.
  • the push rod 40 is a rod-shaped structure.
  • the push rod 40 moves in the axial direction to push the pliers arm 11 to open and close relative to the push rod 40, and to drive the extension arm 20 to move to realize the extension arm.
  • the distal end of 20 extends or retracts the clamp arm 11.
  • FIG. 8 shows the structure of the push rod 40 according to an embodiment of the application.
  • the push rod 40 includes a round rod section 41 and a square rod section 42 connected to the distal end of the round rod section 41.
  • the cross section at any position in the axial direction of the round rod section 41 is circular
  • the cross section at any position in the axial direction of the square rod section 42 is square.
  • a rack 421 is provided on two opposite surfaces of the square rod section 42 of the push rod 40.
  • the rack 421 refers to the concave-convex tooth structure formed on the surface of the square rod section 42.
  • the proximal ring of the push rod 40 is provided with a slot 411.
  • the proximal end ring of the round rod section 41 is provided with a ring groove 411, and the proximal end surface of the round rod section 41 is provided with a threaded hole 412 toward the inner direction of the push rod 40.
  • the push rod 40 may also be a round rod or a square rod, that is, the cross section at any position in the axial direction of the push rod 40 is circular or square.
  • a base 43 is provided on the distal end of the push rod 40.
  • the base 43 includes two opposite first surfaces 431 and a second surface 432 connecting the two first surfaces 431.
  • the distal end of the push rod 40 is fixed on the second surface 432, and a notch 433 is provided on the two first surfaces 431.
  • Pin holes 434 are provided on the inner walls on opposite sides of the notch 433.
  • the outer surface of the base 43 is smooth, which facilitates the smooth advancement of the base 43 in the valve clamp 100 and prevents the base 43 from damaging human tissues or hooking tendons.
  • the base 43 may be a structure of any shape, such as a rectangular parallelepiped, a hemisphere, a spherical cap, a bullet-shaped structure, and the like.
  • the base 43 has a rectangular parallelepiped shape.
  • the cross-sectional size of the base 43 in the direction parallel to the second plane 412 gradually decreases from the proximal end to the distal end, so that the valve clamp 100 is easier to advance in the body.
  • the push rod 40 and the base 43 are made of biocompatible materials.
  • the biocompatible material is selected from stainless steel, cobalt alloy or titanium alloy, preferably titanium alloy.
  • the valve clamp 100 further includes a fixing base 50.
  • FIG. 9 is a schematic structural diagram of a fixed base 50 according to an embodiment of the application.
  • the fixed base 50 includes two opposite clamping plates 51, and the two clamping plates 51 are connected by two connecting rods 52 arranged at intervals.
  • the two connecting rods 52 and the two splints 51 enclose a through channel 53.
  • the push rod 40 is inserted into the through channel 53 and can move axially in the through channel 53.
  • the valve clamp 100 further includes a base connecting tube 60 that is sleeved on the outside of the push rod 40 and fixed to the fixed base 50.
  • the base connecting pipe 60 is provided with an opening 61, and an elastic piece 62 is provided in the opening 61.
  • the elastic piece 62 includes a connecting end and a free end opposite to the connecting end, and the connecting end is connected to the edge of the opening 61. In a natural state, the free end is inclined toward the inside of the base connecting pipe 60 relative to the connecting section.
  • the proximal end of the base connecting tube 60 is provided with a connecting portion 63 for connecting with a pushing device that pushes the valve clamp 100 to the heart valve.
  • the connecting portion 63 is a T-shaped groove, and the T-shaped groove includes a first groove section 631 and a second groove section 632 crossing the first groove section 631.
  • the extending direction of the first groove section 631 is the same as the axial direction of the base connecting tube 60, and is formed from the end surface of the proximal end of the base connecting tube 60 to the distal direction of the proximal end of the base connecting tube 60.
  • FIG. 11 is a schematic diagram of the structure of the clamp arm 11 in some embodiments of the application.
  • Each pliers arm 11 includes a fixed end 11a at the distal end and a free end 11b at the proximal end.
  • the pliers arm 11 opens and closes relative to the push rod 40 with the fixed end 11a as the center of rotation.
  • the fixed end 11 a of the clamp arm 11 has a gear 111, and the gear 111 meshes with the rack 421 on the push rod 40.
  • the fixed end 11 a of the clamp arm 11 is located between the two clamping plates 51 of the fixed base 50, and the gear 111 is axially connected to the two clamping plates 51.
  • the gear 111 is provided with a through pin hole 114 along the axial direction, and the two clamping plates 51 are correspondingly provided with a fixing hole 54.
  • the pin 122 passes through the pin hole 114 and both ends of the pin 122 are respectively fixed in the fixing holes 54 of the clamping plate 51. Due to the meshing between the gear 111 and the rack 421, when the push rod 40 moves in the axial direction, the gear 111 rotates with the pin 122 as an axis, so that the pliers arm 11 rotates to open and close the push rod 40 with the gear 111 as the rotation center.
  • the rack 421 drives the gear 111 to rotate, so that the clamp arm 11 is retracted relative to the push rod 40; when the push rod 40 axially moves toward the proximal end, the rack 421 drives the gear 111 to rotate, so that the clamp arm 11 is opened relative to the push rod 40.
  • the angle between the two clamp arms 11 ranges from 0° to 200°, that is, the two clamp arms in the initial state (closed) are parallel, and the angle is 0°.
  • the meshing of the rack 421 of the rod 40 with the gear 111 of the pliers arm 11 can achieve a wide range of angle opening between the two pliers arms 11, and the maximum angle between the two pliers arms 11 can be To reach 200°, by setting the specific specifications of the meshing of the gear 111 and the rack 421, it is preferable that the maximum included angle between the two opened jaw arms 11 is 150°.
  • the size of the jaw opening can reach 20-36mm, which is good for clamping the valve leaflets.
  • the opening and closing of the two forceps arms 11 are performed at a uniform speed, which facilitates the operator to adjust the position of the forceps arms 11 in real time according to the relative position between the valve clamp 100 and the leaflets during the clamping process, and avoid clamping Too fast or too slow causes the valve leaflets to slip and cause clamping failure.
  • the size of the included angle between the two clamp arms 11 corresponding thereto can be known, which is beneficial to the operator's clamping judgment.
  • the fixed ends 11a of the two pliers arms 11 can also be rotatably connected to the push rod 40 by means of pins or bolts, so that the two pliers arms 11 can perform relative to the push rod 40. Rotate opening and closing.
  • the pliers arm 11 is provided with a plurality of through holes arranged at intervals. By providing the through hole on the forceps arm 11, the weight of the forceps arm 11 can be reduced, and it can facilitate the climbing and growth of endothelial cells.
  • the pliers arm 11 includes a first surface 112 a facing the push rod 40.
  • the first surface 112a is provided with a clamping reinforcement 113, so that when the clamp arm 11 and the push rod 40 cooperate to clamp the valve leaflet, the friction between the clamp arm 11 and the valve leaflet is enhanced, thereby providing a stable Holding force.
  • the clamping reinforcement 113 may be a protrusion or groove provided on the first surface 112a or a gasket made of a biocompatible material with a relatively high friction coefficient and attached to the first surface 112a.
  • the forceps arm 11 has certain size regulations. Specifically, when the forceps arm 11 is too long, the forceps arm 11 tends to clamp the excessive anterior leaflets 1a and posterior leaflets 1b together, and the two leaflets are forced to each other and fixed together, which not only easily leads to the mitral valve The function is abnormal, and when the heart beats and the valve leaflets move, too many valve leaflets may be restricted from moving, which may also cause serious consequences such as valve leaflet tear; when the clamp arm 11 is too short, only a small part of the The valve leaflet makes the valve leaflet easy to slide out, and the clamping and fixing effect is poor.
  • the forceps arm 11 since the valve leaflets are relatively soft, during the clamping process, the forceps arm 11 cannot easily support the valve leaflets or cooperate with the clamping arm 12 to clamp the valve leaflets, which prolongs the operation time.
  • the axial length of the forceps arm 11 (that is, the distance from the fixed end 11a to the free end 11b) should be greater than or equal to 4 mm, preferably 6-10 mm.
  • the width of the forceps arm 11 is also limited to a certain extent, so as to avoid that the width of the forceps arm 11 is too narrow to cause damage to the valve leaflets, and at the same time to avoid the effect of the forceps arm 11 on the movement of the valve leaflets when the width of the forceps arm 11 is too wide.
  • the width of the clamp arm 11 (that is, the length of the direction perpendicular to the axial direction of the clamp arm 11) should be greater than or equal to 2 mm, preferably 4-6 mm.
  • the forceps arm 11 should be made of biocompatible materials, and have a certain degree of flexibility and rigidity, so as to prevent the forceps arm 11 from damaging the valve leaflets, and at the same time, it can clamp the fixed valve. leaf.
  • the biocompatible material is selected from stainless steel, cobalt alloy or titanium alloy.
  • active drugs can be applied to the first surface 112a of the forceps arm 11, or multiple openings can be provided to promote the crawling and growth of endothelial cells of the valve tissue on the inner surface of the forceps arm 11.
  • the first surface 112a may also be configured as a concave-convex surface with a concave-convex structure, thereby increasing the friction between the forceps arm 11 and the valve leaflets, and improving the ability of the valve clamp 100 to fix the valve leaflets.
  • the valve clamp 100 includes a clamping member having elasticity, and the clamping member includes two clamping arms 12.
  • the two clamping arms 12 of the clamping piece correspond to the two clamping arms 11, and each clamping arm 12 is located between the corresponding clamping arm 11 and the push rod 40, and each clamping arm 11 and A clamping arm 12 mates to clamp the leaflets.
  • Figure 12a shows a schematic diagram of the structure of some embodiments of the application in a tightened (conveying) state
  • Figure 12b shows a diagram of some embodiments of the application
  • the structure diagram of the clamp in the natural (released) state The clamping piece is cut from nickel-titanium alloy or cobalt-chromium alloy sheet metal and other materials, and then placed in a shaping mold, and the shape shown in FIG. 12b is obtained through heat-setting treatment. Due to the elasticity of the clamping member, it can be transported in the catheter through the state shown in FIG. 12a, and restored to the state shown in FIG.
  • Each clamping arm 12 of the clamping member includes a free end 12a and a fixed end 12b that are oppositely arranged.
  • the fixed end 12b is fixed on the fixed base 50.
  • the fixed end 12 b is fixed between the fixed base 50 and the base connecting pipe 60.
  • the fixed ends 12b of the two clamping arms 12 are connected into an integral structure (that is, the clamping member is U-shaped) through a connecting piece 12c, and the connecting piece 12c and the fixed base 50 are detachable or non-detachable.
  • the two clamping arms 12 are fixedly connected to the fixed end 12b of the fixed base 50 to be fixed.
  • the clamping arm 12 is at least partially made of an elastic material such as Nitinol.
  • the fixed end 12b of the clamping arm 12 is made of elastic material.
  • the free end 12a of the clamping arm 12 may be made of non-elastic materials such as aluminum alloy, as long as it is ensured that the clamping arm 12 has a natural state and a tightened state after heat setting. In a natural state, the clamping arm 12 and the push rod 40 are arranged at an angle. The angle between the two clamping arms 12 ranges from 0° to 160°.
  • the included angle between the two clamping arms 12 should be slightly larger than the included angle between the two clamp arms 11 to provide a more stable clamping force, that is, each clamping arm 12 and the push rod
  • the included angle between 40 is greater than or equal to the included angle between the clamp arm 11 and the push rod 40 when the clamp arm 11 corresponding to the clamp arm 12 is opened to the maximum state, so as to ensure that the clamp arm 11 and the clamp arm 12 There is a certain clamping force between them to clamp the leaflets between the clamp arm 11 and the clamping arm 12.
  • the angle between the clamp arm 12 and the push rod 40 may also be smaller than the angle between the clamp arm 11 and the push rod 40 when the clamp arm 11 is expanded to the maximum state.
  • the free end 12a of the clamping arm 12 is connected with the control member 13 in the pushing device, and the free end 12a of the clamping arm 12 is controlled by the control member 13 to adjust the angle between the clamping arm 12 and the push rod 40 and the clamping The opening and closing between the arm 12 and the clamp arm 11.
  • the control member 13 is an adjustment wire made of a polymer material such as metal or PTFE.
  • the adjustment wire passes through the free end 12a of the clamping arm 12, and binds the clamping arm 12 to the surface of the push rod 40 so that the two
  • the clamping arm 12 is in a tightened state, which facilitates delivery through the curved blood vessel through the catheter; when the position of the clamp arm 11 and the valve leaflets are adjusted, release the adjustment wire to control the free end 12a of the clamping arm 12, and clamp
  • the free end 12a of the holding arm 12 rebounds to both sides and away from the push rod 40 due to its own elastic memory performance.
  • the holding arm 12 is in a natural state, and the holding arm 12 and the clamp arm 11 are clamped at The leaflets between the two.
  • the clamping arm 12 includes a third surface 12d opposite to the clamp arm 11.
  • the third surface 12d is provided with a clamping reinforcement 121 to increase the friction between the clamping arm 12 and the leaflets clamped between the clamping arm 11 and the clamping arm 12, and to improve the clamping arm 11 and the clamping arm.
  • the clamping force of 12 pairs of valve leaflets may be a rib, barb, boss or other irregularly distributed protrusions protruding on the third surface 12d, or may be a rough surface at least partially covering the third surface 12d to improve The clamping force of the valve clamp 100 on the valve leaflets.
  • the outer surface of the push rod 40 is covered with a gasket made of a biocompatible material with a higher friction coefficient to increase the surface roughness coefficient of the third surface 12d, thereby improving the clamping force of the valve clamp 100 on the valve leaflets .
  • the clamping reinforcement 121 can also be a magnetic body arranged on the clamping arm 12. At this time, a corresponding magnetic body is also arranged on the clamping arm 11, through the mutual magnetic attraction between the clamping arm 11 and the clamping arm 12, To achieve the purpose of enhancing the clamping force.
  • the clamping reinforcement 121 is two rows of convex teeth arranged at intervals. Two rows of protruding teeth are arranged opposite to the two sides of the clamping arm 12.
  • the included angle between the axial direction of each protruding tooth and the third surface 12d is less than or equal to 90° to further enhance the clamping force.
  • the end of the convex teeth away from the third surface 12d is a smooth arc surface, thereby avoiding damage to the valve leaflets.
  • the clamping arm 12 is provided with convex teeth, in order to avoid the influence of the convex teeth on the coupling of the clamping arm 11 and the clamping arm 12, the width of the clamping arm 11 is smaller than the width of the clamping arm 12, so that When the clamp arm 11 is aligned with the clamp arm 12, the protruding teeth on the clamp arm 12 are located on both sides of the clamp arm 11.
  • the first surface 112a of the clamp arm 11 is in contact with the third surface 12d of the clamp arm 12, so that The clamp arm 11 and the clamping arm 12 can more stably clamp the valve leaflets located between the clamp arm 11 and the clamping arm 12.
  • the clamping arm 12 is provided with a through hole 122 to reduce the weight of the clamping arm 12, enhance the elasticity of the clamping arm 12, and facilitate the crawling and growth of endothelial cells.
  • the extension arm 20 is at least one.
  • the extension arm 20 is provided on the surface or inside of the clamp arm 11.
  • there are two extension arms 20 which are respectively provided on the surfaces of the two clamp arms 11.
  • the extension arm 20 may be provided on the first surface 112a of the forceps arm 11 (ie, the inner surface of the forceps arm 11) or on a second surface opposite to the first surface 112a (that is, the outer surface of the forceps arm 11).
  • the extension arm 20 is provided inside the clamp arm 11.
  • the pliers arm 11 is provided with a through hole extending from the fixed end 11 a to the free end 11 b, and the extension arm 20 penetrates through the through hole, so that the extension arm 20 is disposed inside the pliers arm 11.
  • the extension arm 20 is provided on the second surface of the clamp arm 11.
  • a limiting member 14 is provided on the second surface of the clamp arm 11, and the limiting member 14 is used to limit the extension arm 20 in the direction from the fixed end 11a to the free end 11b of the clamp arm 11 to limit the extension arm 20.
  • the limiting member 14 may be various limiting structures such as a limiting ring, a limiting groove, or a limiting tube.
  • the limiting member 14 is a limiting ring or a limiting tube.
  • the limiting member 14 can also fix the extension arm 20 to the second surface of the clamp arm 11 to prevent the extension arm 20 from being on the second surface during movement. Break away.
  • the limiting member 14 is a tubular member with a certain length, and the extension arm 20 can movably pass through the tubular member.
  • the extension arm 20 includes a fixed end 20 a and a free end 20 b opposite to each other.
  • the fixed end 20 a is rotatably fixed to the distal end of the push rod 40.
  • the fixed end 20 a is rotatably fixed on the base 43 at the distal end of the push rod 40.
  • the fixed end 20 a of the extension arm 20 is located in the notch 411 on the base 43.
  • the fixed end 20 a has a pin hole 114, the pin passes through the pin hole 114 and the two ends of the pin are fixed to the inner wall of the notch 411, so that the fixed end 20 a and the base 43 are fixed in rotation.
  • the push rod 40 drives the end of the extension arm 20 to exceed the free end 11 a of the clamp arm 11.
  • the end of the extension arm 20 can be driven to retract along the axial direction of the clamp arm 11; when the push rod 40 axially moves toward the proximal end, the extension arm can be driven
  • the end of 20 extends along the axial direction of the clamp arm 11.
  • since the axial movement of the push rod 40 can drive the clamp arm 11 to open and close relative to the push rod 40 it is possible to move the push rod 40 axially while controlling the clamp arm 11 relative to the push rod 40.
  • the opening and closing and extension arm 20 extends and retracts along the axial direction of the forceps arm 11, so as to achieve the opening and closing control of the forceps arm 11 relative to the push rod 40 and the relative extension of the extension arm 20 without adding additional surgical steps.
  • the axial extension and contraction of the clamp arm 11 are controlled to reduce the difficulty of the operation. It can be understood that in other embodiments of the present application, the extension or retraction of the extension arm 20 and the opening or closing of the clamp arm 11 relative to the push rod 40 may also be asynchronous.
  • the pliers arm 11 and the extension arm 20 are connected to different driving structures, so that the pliers arm 11 can move separately from the extension arm 20, so that the extension arm 20 is extended or retracted and the pliers arm 11 is relative to the push rod 40.
  • the opening or closing of the can be asynchronous.
  • the gear 111 of the pliers arm 11 can be meshed with the rack 421 of the push rod 40, so that the opening and closing of the pliers arm 11 relative to the push rod 40 is realized by the axial movement of the push rod 40.
  • another push rod is provided, and the extension arm 20 is connected with another push rod, so that the extension arm 20 is driven to extend or retract through the other push rod, that is, the clamp arm 11 and the extension arm 20 pass through independent
  • the push rod is controlled so that the extension or retraction of the extension arm 20 is not synchronized with the opening or closing of the clamp arm 11 relative to the push rod 40.
  • the valve clamp 100 further includes an extension arm steel sleeve 21, and the fixed end 20a of the extension arm 20 is fixed to the extension arm steel sleeve 21 by welding or crimping.
  • the end of the extension arm steel sleeve 21 away from the extension arm 20 is located in the notch 433 on the base 43.
  • the extension arm steel sleeve 21 has a pin hole on one end away from the extension arm 20, and the two opposite side walls of the notch 433 have fixing holes 434.
  • the pins pass through the pin holes and both ends of the pins are fixed in the fixing holes 434. In this way, the extension arm steel sleeve 21 and the base 43 are rotationally fixed, and the fixed end 20a of the extension arm 20 and the base 43 are rotationally fixed.
  • the extension arm 20 extending out of the clamp arm 11 means that the end of the extension arm 20 extends out of the free end 11b of the clamp arm 11, that is, the end of the extension arm 20 is located at the free end 11b of the clamp arm 11 away from the fixed end 11a.
  • Side; the end of the extension arm 20 into the clamp arm 11 means that the end of the extension arm 20 is retracted to between the free end 11b and the fixed end 11a of the clamp arm 11.
  • the extension arm 20 When the extension arm 20 extends out of the forceps arm 11, the extension arm 20 is equivalent to extending the length of the forceps arm 11.
  • the extended forceps arm 11 can increase the supporting capacity
  • the length of the valve leaflet makes it difficult for the valve leaflet to slip off the forceps arm 11, thereby making it easier for the valve clamp 100 to capture the valve leaflet and facilitate clamping.
  • the length of the valve leaflet clamped by the valve clamp 100 does not actually change, which avoids possible problems caused by the valve clamp 100 being too long.
  • at least one extension arm 20 is provided on the inner surface and/or outer surface of each clamp arm 11.
  • each forceps arm 11 can be lengthened, so that each forceps arm 11 can easily capture the valve leaflets.
  • the extension arm 20 is smooth as a whole, and the end of the extension arm 11 is laser spot welded to form a smooth round head, without defects such as burrs, edges, corners, etc., to avoid damage to the valve leaflets.
  • the extension arm 20 includes an extension arm body.
  • the extension arm body includes one or more supporting rods arranged side by side to directly support the valve leaflets through the supporting rods.
  • the support rod can be a solid or hollow structure, or a single-layer or multi-layer composite structure.
  • the support rod may be a solid or hollow rod formed of one material, or may be a hollow tube with different inner diameters formed by multiple different materials.
  • the support rod can also be wound by a single wire or multiple wires.
  • the cross section of the support rod can be a regular circle or an ellipse, crescent, semicircle, polygon, etc., preferably a circle, which is easy to process and can avoid damage to the valve leaflets by the support rod.
  • the support rod is made of a flexible and/or elastic biocompatible material to adapt to the anatomical structure of the valve leaflet and the range of movement of the valve leaflet, and to avoid damage to the valve leaflet.
  • it can be made of metal material, polymer material or metal-polymer composite material.
  • the support rod is made of a metal-polymer composite material.
  • Nitinol and PTFE are used.
  • the extension arm 20 includes an extension arm body made of a flexible material, and also includes a support body, which is made of a rigid material, such as stainless steel or titanium alloy.
  • the support body is arranged inside and/or outside the extension arm body to enhance the strength of the extension arm 20, so that the extension arm 20 has a certain flexibility to adapt to the anatomical structure of the valve leaflet and the range of movement of the valve leaflet, while having a certain rigidity to match
  • the valve leaflets provide effective support.
  • the extension arm body is a flexible tube made of a softer material
  • the support body is a rigid rod made of a material with higher hardness
  • the flexible tube is sleeved outside the rigid rod to form the extension arm 20.
  • the support body is arranged outside the extension arm body.
  • the extension arm body is a flexible rod
  • the support body is a rigid tube made of a material with higher hardness
  • the rigid tube is sleeved outside the flexible rod to form the extension arm 20.
  • the support body Set inside the main body of the extension arm.
  • a heat-shrinkable tube is used as a support body to wrap the outer surface of the softer extension arm body, and then heated to shrink the heat-shrinkable tube and wrap it on the outer surface of the extension arm body to improve support, that is,
  • the main body of the extension arm is a flexible rod
  • the rigid support is a heat-shrinkable tube.
  • the heat-shrinkable tube is sheathed outside the flexible rod and heated and contracted to be fixed with the flexible rod.
  • the extension arm body is made by winding at least one flexible wire (for example, stainless steel wire), and then a thermoplastic elastomer (for example, Pebax) is wrapped around the extension arm body, and then heated to Pebax melts and covers the outside of the extension arm body. At the same time, part of the Pebax will penetrate into the extension arm body through the gap between the flexible wires. Therefore, the support body at this time is provided inside and outside the extension arm body.
  • a thermoplastic elastomer for example, Pebax
  • the extension arm 20 is at least partially made of an X-ray non-transmissive material.
  • the extension arm body and/or the support body are made of radiopaque material, so that after the extension arm 20 extends from the valve clamp 100 and contacts the valve leaflet, the extension arm 20 can be generated with the movement range of the valve leaflet. With corresponding swing, the operator can quickly and accurately determine the position of the valve leaflet through X-rays. If the position is reasonable, the operator can drive the valve clamp 100 to clamp the valve leaflet, thereby shortening the operation time and improving the success rate of the operation.
  • the radiopaque material is selected from stainless steel or Nitinol.
  • FIGS. 14a to 14e are schematic diagrams of the extension arms of other embodiments of the present application.
  • the free end 20b of the extension arm 20 is further provided with a bearing portion 22.
  • the width of the bearing portion 22 is greater than the diameter of the extension arm 20, so that the bearing portion 22 has a larger bearing area and better supports the valve leaflets.
  • the width direction of the supporting portion 22 is the same as the width direction of the clamp arm 11.
  • the supporting portion 22 may be a plate-shaped structure or an elastic member. As shown in FIG. 14a, the carrying portion 22 has a plate-shaped structure, specifically a plate-shaped structure.
  • the carrying portion 22 is an elastic member.
  • the elastic member is compressed and in a compressed state when the extension arm 20 is received in the clamp arm 11, and when the elastic member extends out of the clamp arm 11 with the extension arm 20, it extends When the end of the arm 20 exceeds the free end of the clamp arm 11, the elastic member is no longer compressed by the outside and is stretched and in a stretched state.
  • the area of the elastic member in the stretched state is greater than the area of the elastic member in the compressed state, so that the elastic member and There is a larger contact area between the leaflets to better fit the leaflets and improve the support of the extension arm 20 to the leaflets.
  • the surface on which the elastic member is stretched is parallel to the first surface 112a of the forceps arm 11, so that there is a larger contact area between the elastic member and the leaflets after the elastic member is stretched, so as to achieve alignment of the leaflets.
  • the first flat surface 112a and the surface on which the elastic member is stretched may both be flat or curved.
  • the elastic member is a deformable net cage.
  • the elastic member is a cage structure formed by weaving silk threads with certain elasticity and tension.
  • the net cage is squeezed and deformed to be in a compressed state, and can be received in the clamp arm 11.
  • the net cage extends out of the clamp arm 11, the net cage stretches and is in a stretched state.
  • the volume of the net cage after expansion is larger than the volume of the net cage when squeezed, thereby providing more space for the valve leaflets supported on the extension arm 20. Stable support.
  • the wire forming the net cage may be a metal wire with good biocompatibility or a wire made of a polymer material with a certain elasticity.
  • Nitinol wire is used.
  • the elastic member of this embodiment has a three-dimensional structure, can have a more three-dimensional visualization effect, and can be a petal supported on the extension arm 20 The leaves provide more stable support (as shown in Figure 16).
  • the net cage includes a woven net 221, a head 222 and a fixing tube 223 respectively fixed to both ends of the woven net 221.
  • the nickel-titanium wire forms a cylindrical woven mesh 221, and one end of the woven mesh 221 is fixed in the head 222. That is, the head 222 gathers and fixes an open end of the woven net 221. The other end of the woven mesh 221 is gathered and fixed in the fixing tube 223.
  • the end of the fixing tube 223 facing away from the woven mesh 221 is connected to the extension arm 20.
  • Both the head 222 and the fixing tube 223 can be made of metal material or polymer plastic material. In this embodiment, the head 222 is made of stainless steel.
  • the mesh cage has a cylindrical shape in the middle, a cone at both ends, and the cone angles of the cones at both ends are the same.
  • the net cage can also have any other shape.
  • the net cage may be a spindle-shaped structure with the same taper angle at both ends as shown in FIG. 14d, or a structure with different taper angles at both ends as shown in FIG. 14e.
  • FIG. 16 shows a valve clamp 100 according to another embodiment of the present application
  • FIG. 17 is a structural diagram of the forceps arm 12 of the embodiment shown in FIG. 16.
  • the width of the clamp arm 11 is greater than the width of the clamping arm 12.
  • the pliers arm 11 is provided with a receiving groove 15.
  • the width of the clamp arm 11 is greater than the width of the clamp arm 12, so that the clamping area of the clamp arm 11 and the clamping arm 12 to clamp the leaflets is increased, and the clamping force is more dispersed.
  • the strain on the valve is reduced; and the first surface 112a of the clamp arm 11 can be attached to the third surface 12d of the clamping arm 12, so that when the clamp arm 11 is attached to the push rod 40,
  • the outer diameter of the valve clamp 100 is smaller, which facilitates the delivery process of the valve clamp 100.
  • the width of the clamp arm 11 is increased to 6 mm.
  • the forceps arm 11 is provided with a through hole 115, and the through hole 115 is provided in the receiving groove 15, and the through hole 115 is provided to facilitate the crawling of endothelial cells. It can be understood that, as shown in FIG. 18, in some embodiments, the pliers arm 11 may not have a through hole 115.
  • the present application also provides a valve clamping system.
  • the valve clamping system includes a pushing device and the aforementioned valve clamping device 100.
  • the valve clamping device 100 can be delivered to the mitral valve through the pushing device. And adjust the valve clamp 100 to the appropriate position of the mitral valve.
  • the pushing device includes an operating handle for the operator to hold and a pushing shaft connected to the distal end of the operating handle and having a certain axial length. The proximal end of the pushing shaft is connected to the operating handle, and the distal end of the pushing shaft is connected to the valve clamp 100 Removable connection between.
  • the pushing shaft includes a mandrel 210, a liner 220 sleeved outside the mandrel 210, and an outer tube 230 sleeved outside the liner 220.
  • the operating handle can respectively drive the mandrel 210, the liner 220, and the outer tube 230 for relative movement.
  • the distal end of the mandrel 210 has an external thread 211 corresponding to the internal thread in the threaded hole 412 at the proximal end of the push rod 40.
  • a T-shaped elastic piece 231 is provided on the distal end of the outer tube 230 for mating with the T-shaped groove 63 on the base connecting tube 60 to realize the connection and unlocking of the outer tube 230 and the base connecting tube 60.
  • one end of the T-shaped elastic piece is connected to the distal end of the outer tube 230, and the other end is inclined at the position of the axis of the outer tube 230.
  • the mandrel 210 is threadedly connected with the push rod 40, and the operating handle drives the liner 220 to move, so that when the liner 220 extends into the base connecting tube 60, the liner 220
  • the T-shaped elastic piece 231 of the outer tube 230 is pushed up so that the T-shaped elastic piece 231 is inserted into the T-shaped groove 63 of the base connecting tube 60.
  • the base connecting tube 60 and the outer tube 230 are in a connected state;
  • the handle causes the liner 220 to leave the base connecting tube 60, and the T-shaped elastic piece 231 of the outer tube 230 is in a natural state, that is, deforms inwardly and detaches from the T-shaped groove 63, so that the base connecting tube 60 and the outer tube 230 are unlocked .
  • 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 connect the push shaft with the valve clamp 100.
  • the mandrel 210 of the push shaft is rotated to make the mandrel 210 and the push rod 40 fixed.
  • the free end of the elastic piece 62 on the base connecting tube 60 is located in the ring groove 411 of the push rod 40, so that the clamp arm 11 and the clamping arm 12 are both gathered on the surface of the push rod 40.
  • the connection state of the push shaft and the valve clamp 100 is shown in FIGS. 21 and 22.
  • Step 2 Push the valve clamp 100 connected to it from the left atrium through the push shaft, and pass through the mitral valve to the left ventricle.
  • the third step move the liner 220 axially to the distal end, so that the liner 220 pushes up the free end of the elastic piece 62 on the base connecting pipe 60 so that the free end of the elastic piece 62 escapes from the ring groove 411.
  • the push rod 40 can move axially within the base connecting pipe 60 to push the jaw arm 11 to open and close relative to the push rod 40 and drive the extension and contraction of the extension arm 20.
  • Step 4 Move the mandrel 210 to the proximal end by operating the handle, thereby driving the push rod 40 connected with the mandrel 210 to move in the proximal direction to drive the pliers arm 11 to open relative to the push rod 40, and at the same time make the extension arm 20 self The clamp arm 11 extends.
  • Step 5 Adjust the direction of the valve clamp 100, and observe the relative position of each forceps arm 11 to the anterior leaflet 1a and posterior leaflet 1b through X-rays and other equipment, so that the forceps arm 11 is perpendicular to the aligning line of the mitral valve .
  • Step 6 Withdraw the entire adjustment valve clamp 100 proximally, so that the forceps arm 11 and the extension arm 20 support the valve leaflets on the side of the ventricle.
  • Step 7 Release the clamping arm 12 so that the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are respectively clamped between a pair of clamp arms 11 and clamping arms 12, thereby grasping the leaflets.
  • Step 8 Move the mandrel 210 to the distal end, and the mandrel 210 drives the push rod 40 to move distally, thereby driving the pliers arm 11 to close, and the extension arm 20 is received into the stopper 14, that is, the end of the extension arm 20 Retract
  • Step 9 The outer tube 230 is fixed and the liner 220 is retracted to the proximal end for a certain distance. At this time, the free end of the elastic piece 62 of the base connecting tube 60 is locked into the ring groove 411 of the push rod 40 to ensure The clamp arm 11 is always closed.
  • the mandrel 210 is controlled to rotate through the operating handle, so that the thread between the mandrel 210 and the push rod 40 is unlocked.
  • the liner 220 and the mandrel 210 are retracted to the proximal end until the T-shaped elastic piece 231 of the outer tube 230 is unlocked and separated from the T-shaped slot 63 of the base connecting tube 60.
  • the valve clamp 100 is completely separated from the pushing shaft.
  • the push shaft is withdrawn from the patient's body, and the valve clamp 100 is left in the patient's body to complete the edge-to-edge repair of the mitral valve leaflet.
  • valve clamping system of the present application can be operated outside the body to clamp the valve leaflet with the valve clamp, thereby reducing or avoiding the problem of "mitral valve regurgitation".
  • the valve clamp can easily capture the valve leaflets, the difficulty of performing "Mitral Regurgitation" surgery through the valve clamp system is greatly reduced, and the operation time is reduced.

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Abstract

An easily operable valve clamping device (100) and a valve clamping system. The valve clamping system comprises the valve clamping device (100) and a push device. The valve clamping device (100) comprises a push rod (40), at least two clamp arms (11) and at least one extension arm (20). The push rod (40) moves axially so as to drive the clamp arms (11) to open and close relative to the push rod (40), and drive the extension arm (20) to extend or retract along the axial direction of a clamp arm (11). In the system, the telescopic extension arm (20) is arranged on the surface of a clamp arm (11) in the valve clamping device (100), and the extension arm (20) extends out of the clamp arm (11) at the time as the clamp arm (11) opens relative to the push rod (40) of the valve clamping device (100), which is equivalent to increasing the length of the clamp arm (11). The longer clamp arm (11) can have better bearing effect on valve leaflets when the valve leaflets are captured, thereby preventing the valve leaflets from slipping off the surface of the clamp arm (11), enabling quick capture of moving valve leaflets, reducing surgery difficulty and improving surgery efficiency.

Description

易夹持的瓣膜夹合器及瓣膜夹合系统Easily clamped valve clamp and valve clamp system
本申请要求于2019年7月12日提交中国专利局,申请号为201910632959.X、申请名称为“易夹持的瓣膜夹合器及瓣膜夹合系统”的中国专利申请以及申请号为201921097737.4、申请名称为“易夹持的瓣膜夹合器及瓣膜夹合系统”的中国专利申请的优先权,其全部内容通过引用结合在本申请中。This application is required to be submitted to the Chinese Patent Office on July 12, 2019. The application number is 201910632959.X, the application name is "Easy-clamping valve clamp and valve clamping system" Chinese patent application and the application number is 201921097737.4, The priority of the Chinese patent application titled "Easy-clamping valve clamp and valve clamping system", the entire content of which is incorporated into this application by reference.
技术领域Technical field
本申请涉及医疗器械领域,尤其涉及一种易夹持的瓣膜夹合器及瓣膜夹合系统。The present application relates to the field of medical equipment, and in particular to an easy-to-clamp valve clamp and valve clamp system.
背景技术Background technique
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的内壁上。正常情况下,心脏左心室收缩时,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,当二尖瓣的瓣叶或其相关结构发生器质性改变或功能性改变(如腱索4)部分断裂时,二尖瓣的前叶1a和后叶1b对合不良,当心脏左心室收缩时,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”。Please refer to Figure 1. 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 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 inner wall of the left ventricle 3 by the chordae 4. Under normal circumstances, when the left ventricle of the heart contracts, the edges of the anterior lobe 1a and the posterior lobe 1b are completely aligned to prevent blood from flowing from the left ventricle 3 to the left atrium 2. Please refer to Figure 2. When the qualitative or functional changes of the mitral valve leaflets or related structures (such as chordae 4) are partially ruptured, the anterior leaflet 1a and posterior leaflet 1b of the mitral valve are not properly aligned. When the left ventricle of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, causing a series of pathophysiological changes called "Mitral Regurgitation".
现有一种微创治疗手术,将瓣叶夹钳通过输送装置输送至二尖瓣处,再通过夹钳的相对开合同时夹住二尖瓣的前叶和后叶,使得二尖瓣的前叶与后叶固定从而达到减少二尖瓣反流的目的。但是,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,夹钳快速、成功地捕获活动的瓣叶组织的难度较大,手术时间较长。There is a minimally invasive surgery in which the valve leaflet clamps are delivered to the mitral valve through a delivery device, and then the anterior and posterior leaflets of the mitral valve are clamped by the relative opening of the clamps, so that the anterior and posterior leaflets of the mitral valve The leaves are fixed with the posterior leaves to reduce mitral valve regurgitation. However, because the two leaflets of the mitral valve are always in a state of large and powerful opening and closing activities, it is more difficult for the clamp to quickly and successfully capture the movable leaflet tissue, and the operation time is longer.
发明内容Summary of the invention
本申请的目的在于,针对上述现有技术的缺陷,提供一种易夹持的瓣膜夹合器及瓣膜夹合系统,所述易夹持的瓣膜夹合器能够容易快速地捕获活动的瓣叶组织,从而降低手术难度、提高手术效率。The purpose of the present application is to provide an easy-to-clamp valve clamp and valve clamping system in view of the above-mentioned defects in the prior art, which can easily and quickly capture movable leaflets Organization, thereby reducing the difficulty of surgery and improving the efficiency of surgery.
所述易夹持的瓣膜夹合器,包括推杆、至少两个钳臂、至少一根延伸臂。所述钳臂包括固定端及自由端,所述固定端与所述推杆连接,所述推杆轴向移动以带动所述钳臂以所述固定端为旋转中心相对所述推杆开合;所述延伸臂沿所述钳臂的轴向伸长或缩回,当所述延伸臂沿钳臂的固定端向自由端方向伸长时,所述延伸臂的末端超出所述钳臂的自由端。The easy-to-clamp valve clamp includes a push rod, at least two clamp arms, and at least one extension arm. The clamp arm includes a fixed end and a free end, the fixed end is connected to the push rod, and the push rod moves axially to drive the clamp arm to open and close with respect to the push rod with the fixed end as the center of rotation The extension arm extends or retracts along the axial direction of the pliers arm, when the extension arm extends along the fixed end of the pliers arm toward the free end, the end of the extension arm extends beyond the pliers arm Free end.
所述瓣膜夹合系统包括推送装置及上述易夹持的瓣膜夹合器,所述推送装置包括操作手柄及具有一定轴向长度的推送轴,所述推送轴近端与所述操作手柄连接,所述推送轴的远端与所述瓣膜夹合器之间可拆卸连接。The valve clamping system includes a pushing device and the above-mentioned easy-to-clamp valve clamping device. The pushing device includes an operating handle and a pushing shaft with a certain axial length, and the proximal end of the pushing shaft is connected with the operating handle, The distal end of the pushing shaft and the valve clamp are detachably connected.
本申请提供的易夹持的瓣膜夹合器及瓣膜夹合系统,通过设置可以沿钳臂的轴向伸长或缩回的延伸臂,使得钳臂相对推杆打开时,延伸臂的末端超出钳臂的自由端,相当于增加了钳臂在捕捉瓣叶时的长度,较长的钳臂能够在捕捉瓣叶时对瓣叶起到较好的承托效果,避免瓣叶从钳臂表面滑脱,从而快速地捕获活动的瓣叶组织,降低手术难度、提高手术效率。The easy-to-hold valve clamp and valve clamping system provided in this application are provided with an extension arm that can be extended or retracted along the axial direction of the clamp arm, so that when the clamp arm is opened relative to the push rod, the end of the extension arm exceeds The free end of the forceps arm is equivalent to increasing the length of the forceps arm when capturing the valve leaflets. The longer forceps arm can have a better supporting effect on the valve leaflets when capturing the valve leaflets and avoid the leaflets from the surface of the forceps arm. Slippage, so as to quickly capture the active valve leaflet tissue, reduce the difficulty of the operation and improve the efficiency of the operation.
附图说明Description of the drawings
为更清楚地阐述本申请的构造特征和功效,下面结合附图与具体实施例来对其进行详细说明。In order to more clearly illustrate the structural features and effects of the present application, the following will describe it in detail with reference to the drawings and specific embodiments.
图1是二尖瓣正常状态时的示意图;Figure 1 is a schematic diagram of the mitral valve in a normal state;
图2是二尖瓣出现病变时的示意图;Figure 2 is a schematic diagram of mitral valve disease;
图3是本申请一实施例的易夹持的瓣膜夹合器收拢时的结构示意图;Fig. 3 is a schematic diagram of the structure of the easy-to-hold valve clamp of an embodiment of the present application when folded;
图4是图3所示的瓣膜夹合器的钳臂张开时的一个视角下的结构示意图;Fig. 4 is a schematic structural view of the valve clamp shown in Fig. 3 from a perspective when the forceps arms are opened;
图5是图3所示的瓣膜夹合器的钳臂张开时的另一个视角下的结构示意图;Fig. 5 is a schematic structural diagram of the valve clamp shown in Fig. 3 from another perspective when the forceps arms are opened;
图6是本申请所述瓣膜夹合器在二尖瓣处的位置示意图;Fig. 6 is a schematic diagram of the position of the valve clamp of the present application at the mitral valve;
图7a是本申请所述瓣膜夹合器夹持瓣叶后,心脏收缩时二尖瓣示意图;Figure 7a is a schematic diagram of the mitral valve when the heart is contracted after the valve leaflets are clamped by the valve clamp of the present application;
图7b是本申请所述瓣膜夹合器夹持瓣叶后,心脏舒张时二尖瓣示意图;Fig. 7b is a schematic diagram of the mitral valve during diastole after the valve leaflet is clamped by the valve clamp of the present application;
图8是图3所示的瓣膜夹合器的推杆的结构示意图;Fig. 8 is a schematic structural diagram of the push rod of the valve clamp shown in Fig. 3;
图9是图3所示的瓣膜夹合器的固定基座的结构示意图;Fig. 9 is a schematic structural view of the fixed base of the valve clamp shown in Fig. 3;
图10是图3所示的瓣膜夹合器的基座连接管的结构示意图;Fig. 10 is a schematic structural view of the base connecting pipe of the valve clamp shown in Fig. 3;
图11是图3所示的瓣膜夹合器的钳臂的结构示意图;Fig. 11 is a schematic structural view of the forceps arm of the valve clamp shown in Fig. 3;
图12a是图3所示的瓣膜夹合器的夹持臂收拢时的结构示意图;Fig. 12a is a schematic structural diagram of the valve clamp shown in Fig. 3 when the clamping arm is folded;
图12b是图3所示的瓣膜夹合器的夹持臂张开时的结构示意图;Fig. 12b is a schematic structural diagram of the valve clamp shown in Fig. 3 when the clamping arm is opened;
图13是图3所示的瓣膜夹合器的延伸臂的结构示意图;Figure 13 is a schematic structural view of the extension arm of the valve clamp shown in Figure 3;
图14a至图14e是本申请不同实施例的瓣膜夹合器的延伸臂的承载部的结构示意图;14a to 14e are schematic diagrams of the structure of the bearing part of the extension arm of the valve clamp of different embodiments of the present application;
图15是图14c所示实施例的瓣膜夹合器的结构示意图;Fig. 15 is a schematic structural view of the valve clamp of the embodiment shown in Fig. 14c;
图16是本申请另一实施例的瓣膜夹合器的结构示意图;Fig. 16 is a schematic structural diagram of a valve clamp according to another embodiment of the present application;
图17是图16所示实施例的瓣膜夹合器的钳臂的结构示意图;FIG. 17 is a schematic diagram of the structure of the clamp arm of the valve clamp of the embodiment shown in FIG. 16;
图18是本申请另一实施例的瓣膜夹合器的钳臂的结构示意图;18 is a schematic diagram of the structure of the forceps arm of the valve clamp of another embodiment of the present application;
图19是本申请一实施例的瓣膜夹合器的钳臂处于张开状态时,所述瓣膜夹合器与所述推送轴连接时的结构示意图;19 is a schematic structural diagram of the valve clamp when the valve clamp is connected to the push shaft when the clamp arm of the valve clamp of an embodiment of the present application is in an open state;
图20是图19所示的所述瓣膜夹合器与所述推送轴连接时的截面示意图;Figure 20 is a schematic cross-sectional view of the valve clamp shown in Figure 19 when connected to the push shaft;
图21是本申请一实施例的瓣膜夹合器的钳臂处于收拢状态时,所述瓣膜夹合器与所述推送轴连接时的结构示意图;Figure 21 is a schematic structural diagram of the valve clamp when the valve clamp is connected to the push shaft when the clamp arm of the valve clamp is in the folded state according to an embodiment of the present application;
图22是图21所示的所述瓣膜夹合器与所述推送轴连接时的截面示意图。Fig. 22 is a schematic cross-sectional view of the valve clamp shown in Fig. 21 when connected to the push shaft.
具体实施方式Detailed ways
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。其中,附图仅用于示例性说明,表示的仅是示意图,不能理解为对本专利的限制。需要强调的是,本申请中所说的“近端”是指靠近操作者的方向;“远端”是指远离操作者的方向。The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Among them, the drawings are only used for exemplary description, and they are only schematic diagrams and cannot be understood as a limitation of the patent. It should be emphasized that the "proximal end" in this application refers to the direction close to the operator; the "distal end" refers to the direction away from the operator.
请参阅图3至图5,本申请提供一种易夹持的瓣膜夹合器100。瓣膜夹合器100包括推杆40、两个钳臂11,至少一个延伸臂20。本实施例中,钳臂11的数量为两个,两个钳臂11以推杆40为轴对称设置并能够相对推杆40开合。本申请的瓣膜夹合器100可用于二尖瓣反流的缘对缘修复,具体的,请参阅图6,将瓣膜夹合器100置于二尖瓣的前叶及后叶的不能正常对合的位置,使得一个钳臂11承托二尖瓣的前叶1a边缘,另一个钳臂11承托二尖瓣的后 叶1b边缘,通过两个钳臂11将二尖瓣的前叶1a及后叶1b的不能正常对合的位置固定在一起。图7a所示为心脏收缩时二尖瓣的状态示意图,其中,箭头方向为血流方向。当心脏收缩时,前叶1a与后叶1b靠拢,且前叶1a边缘与后叶1b边缘通过瓣膜夹合器100夹合,使得二尖瓣能够完全关闭或者开口的面积变小,从而减轻或治疗“二尖瓣反流”。请参阅图7b,图7b所示为心脏舒张时二尖瓣的状态示意图,其中,箭头方向为血流方向。当心脏舒张时,前叶1a及后叶1b仅在瓣膜夹合器100夹合的位置固定在一起,前叶1a及后叶1b其它的位置仍然正常舒张,使得大量血液能够从左心房进入左心室,从而保证血液的正常流动。本申请的其它实施例的瓣膜夹合器100也能够用于减轻或者治疗“三尖瓣反流”,即瓣膜夹合器100的钳臂11为三个,通过三个钳臂11将三个瓣叶固定在一起,从而减轻或者避免“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100的原理及结构相同,在此不进行赘述。可以理解的是,本申请的其它实施例的瓣膜夹合器100还可以应用于其它需要将几个片状的组织夹合在一起的其它微创外科手术中,且钳臂11的数量根据实际使用需求进行变化。Please refer to FIGS. 3 to 5. The present application provides a valve clamp 100 that is easy to clamp. The valve clamp 100 includes a push rod 40, two clamp arms 11, and at least one extension arm 20. In this embodiment, the number of pliers arms 11 is two, and the two pliers arms 11 are arranged symmetrically about the push rod 40 and can be opened and closed relative to the push rod 40. The valve clamp 100 of the present application can be used for the edge-to-edge repair of mitral valve regurgitation. For details, please refer to FIG. 6, the valve clamp 100 is placed on the anterior and posterior leaflets of the mitral valve. The closed position makes one clamp arm 11 support the edge of the anterior leaflet 1a of the mitral valve, and the other clamp arm 11 supports the edge of the posterior leaflet 1b of the mitral valve. The two forceps arms 11 hold the anterior leaflet 1a of the mitral valve. And the positions of the posterior lobe 1b that cannot be normally aligned are fixed together. Figure 7a shows a schematic diagram of the state of the mitral valve during systole, where the arrow direction is the blood flow direction. When the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b close together, and the edge of the anterior leaflet 1a and the edge of the posterior leaflet 1b are clamped by the valve clamp 100, so that the mitral valve can be completely closed or the opening area is reduced, thereby reducing or Treatment of "Mitral Regurgitation". Please refer to Figure 7b. Figure 7b shows a schematic diagram of the state of the mitral valve during diastole, where the arrow direction is the blood flow direction. When the heart is in diastole, the anterior leaflet 1a and posterior leaflet 1b are only fixed together at the position where the valve clamp 100 is clamped, and other positions of the anterior leaflet 1a and posterior leaflet 1b are still in normal diastole, so that a large amount of blood can enter the left from the left atrium. The ventricle, thus ensuring the normal flow of blood. The valve clamp 100 of other embodiments of the present application can also be used to reduce or treat "tricuspid regurgitation", that is, the valve clamp 100 has three clamp arms 11, and the three clamp arms 11 separate the three The leaflets are fixed together to reduce or avoid "tricuspid regurgitation." The principle and structure are the same as the principle and structure of the valve clamp 100 for solving mitral regurgitation in the embodiment of the present application, and will not be repeated here. It is understandable that the valve clamp 100 of other embodiments of the present application can also be applied to other minimally invasive surgical operations that require several pieces of tissue to be clamped together, and the number of clamp arms 11 is based on actual conditions. Use requirements to change.
请一并参阅图3及图8,推杆40为杆状结构,通过推杆40沿轴向移动以推动钳臂11相对推杆40进行开合,以及带动延伸臂20运动,以实现延伸臂20的远端伸出或者缩回钳臂11。图8所示为本申请一实施例的推杆40的结构。推杆40包括圆杆段41以及连接于圆杆段41远端的方杆段42。其中,圆杆段41的轴向方向上的任意位置的截面为圆形,方杆段42轴向方向上的任意位置的截面为方形。推杆40的方杆段42的相对的两个表面上设有齿条421。其中,齿条421即是指方杆段42的表面上形成的凹凸的齿状结构。推杆40的近端环设有卡槽411。圆杆段41的近端环设有环槽411,且圆杆段41的近端的端面上向推杆40的内部方向设有螺纹孔412。可以理解的是,一些实施例中,所述推杆40也可以为圆杆或者方杆,即推杆40的轴向方向上的任意位置的截面均为圆形或者方形。Please refer to FIGS. 3 and 8 together. The push rod 40 is a rod-shaped structure. The push rod 40 moves in the axial direction to push the pliers arm 11 to open and close relative to the push rod 40, and to drive the extension arm 20 to move to realize the extension arm. The distal end of 20 extends or retracts the clamp arm 11. FIG. 8 shows the structure of the push rod 40 according to an embodiment of the application. The push rod 40 includes a round rod section 41 and a square rod section 42 connected to the distal end of the round rod section 41. Wherein, the cross section at any position in the axial direction of the round rod section 41 is circular, and the cross section at any position in the axial direction of the square rod section 42 is square. A rack 421 is provided on two opposite surfaces of the square rod section 42 of the push rod 40. Among them, the rack 421 refers to the concave-convex tooth structure formed on the surface of the square rod section 42. The proximal ring of the push rod 40 is provided with a slot 411. The proximal end ring of the round rod section 41 is provided with a ring groove 411, and the proximal end surface of the round rod section 41 is provided with a threaded hole 412 toward the inner direction of the push rod 40. It can be understood that, in some embodiments, the push rod 40 may also be a round rod or a square rod, that is, the cross section at any position in the axial direction of the push rod 40 is circular or square.
本申请的一些实施例中,所述推杆40的远端上设有基座43。其中,基座43包括相对的两个第一表面431及连接两个第一表面431的第二表面432。所述推杆40的远端固定于所述第二表面432上,两个第一表面上431上均设有一个缺口433。缺口433相对的两侧内壁上设有销钉孔434。In some embodiments of the present application, a base 43 is provided on the distal end of the push rod 40. The base 43 includes two opposite first surfaces 431 and a second surface 432 connecting the two first surfaces 431. The distal end of the push rod 40 is fixed on the second surface 432, and a notch 433 is provided on the two first surfaces 431. Pin holes 434 are provided on the inner walls on opposite sides of the notch 433.
基座43外表面光滑,从而便于基座43在瓣膜夹合器100能够顺利的推进,并避免基座43损伤人体组织或钩挂腱索。基座43可以为任意形状的结构,例如长方体、半球体、球冠、弹头形等结构。本实施例中,基座43为长方体形状。优选地,基座43的平行于第二平面412方向的截面尺寸由近端至远端逐渐减小,使得瓣膜夹合器100更容易在体内进行推进。The outer surface of the base 43 is smooth, which facilitates the smooth advancement of the base 43 in the valve clamp 100 and prevents the base 43 from damaging human tissues or hooking tendons. The base 43 may be a structure of any shape, such as a rectangular parallelepiped, a hemisphere, a spherical cap, a bullet-shaped structure, and the like. In this embodiment, the base 43 has a rectangular parallelepiped shape. Preferably, the cross-sectional size of the base 43 in the direction parallel to the second plane 412 gradually decreases from the proximal end to the distal end, so that the valve clamp 100 is easier to advance in the body.
推杆40及基座43由生物相容性材料制成。生物相容性材料选自不锈钢、钴合金或钛合金,优选为钛合金。The push rod 40 and the base 43 are made of biocompatible materials. The biocompatible material is selected from stainless steel, cobalt alloy or titanium alloy, preferably titanium alloy.
请参阅图3及图9,本申请的一些实施例中,瓣膜夹合器100还包括固定基座50。图9所示为本申请一实施例的固定基座50的结构示意图。固定基座50包括两块相对的夹板51,两块夹板51通过两根间隔设置的连接杆52连接。两根连接杆52与两块夹板51围成穿设通道53,推杆40插入穿设通道53中,并能够在穿设通道53内进行轴向移动。Referring to FIGS. 3 and 9, in some embodiments of the present application, the valve clamp 100 further includes a fixing base 50. FIG. 9 is a schematic structural diagram of a fixed base 50 according to an embodiment of the application. The fixed base 50 includes two opposite clamping plates 51, and the two clamping plates 51 are connected by two connecting rods 52 arranged at intervals. The two connecting rods 52 and the two splints 51 enclose a through channel 53. The push rod 40 is inserted into the through channel 53 and can move axially in the through channel 53.
请参阅图3及图10,本申请一些实施例中,瓣膜夹合器100还包括基座连接管60,基座连接管60套设于推杆40的外部并与固定基座50固定。基座连接管60上设有一开孔61,开孔61内设有一弹片62。弹片62包括连接端以及与连接端相对的自由端,连接端连接于开孔61边缘。自然状态下,自由端相对连接段朝向基座连接管60的内部倾斜。钳臂11收拢于推 杆40上时,弹片62的自由端卡入于推杆40的近端的卡槽411内,阻止推杆40沿轴向的移动,以避免钳臂11相对推杆40打开。Please refer to FIGS. 3 and 10. In some embodiments of the present application, the valve clamp 100 further includes a base connecting tube 60 that is sleeved on the outside of the push rod 40 and fixed to the fixed base 50. The base connecting pipe 60 is provided with an opening 61, and an elastic piece 62 is provided in the opening 61. The elastic piece 62 includes a connecting end and a free end opposite to the connecting end, and the connecting end is connected to the edge of the opening 61. In a natural state, the free end is inclined toward the inside of the base connecting pipe 60 relative to the connecting section. When the pliers arm 11 is folded on the push rod 40, the free end of the elastic piece 62 is locked into the groove 411 at the proximal end of the push rod 40 to prevent the push rod 40 from moving in the axial direction to prevent the pliers arm 11 from moving relative to the push rod 40. turn on.
进一步的,基座连接管60的近端设有连接部63,用于与推动瓣膜夹合器100至心脏瓣膜处的推送装置进行连接。本申请一些实施例中,连接部63为T型槽,T型槽包括第一槽段631以及与第一槽段631交叉的第二槽段632。其中,第一槽段631的延伸方向与基座连接管60的轴向相同,并从基座连接管60的近端的端面上向基座连接管60的近端的远端方向延伸形成。Further, the proximal end of the base connecting tube 60 is provided with a connecting portion 63 for connecting with a pushing device that pushes the valve clamp 100 to the heart valve. In some embodiments of the present application, the connecting portion 63 is a T-shaped groove, and the T-shaped groove includes a first groove section 631 and a second groove section 632 crossing the first groove section 631. Wherein, the extending direction of the first groove section 631 is the same as the axial direction of the base connecting tube 60, and is formed from the end surface of the proximal end of the base connecting tube 60 to the distal direction of the proximal end of the base connecting tube 60.
请重新参阅图3至图5,钳臂11用于与夹持臂12或推杆40相对开合以夹紧或松开瓣叶。请一并参阅图8及图11,图11所示为本申请一些实施例中的钳臂11的结构示意图。每个钳臂11均包括位于远端的固定端11a及位于近端的自由端11b,钳臂11以固定端11a为旋转中心相对推杆40进行开合。具体的,钳臂11的固定端11a具有齿轮111,齿轮111与推杆40上的齿条421啮合。钳臂11的固定端11a位于固定基座50的两块夹板51之间,且齿轮111轴向旋转连接于两块夹板51上。具体的,齿轮111沿轴向设有贯通的销钉孔114,两块夹板51上对应设有固定孔54。销钉122穿过销钉孔114且销钉122的两端分别固定于夹板51的固定孔54内。由于齿轮111与齿条421的啮合,推杆40沿轴向进行移动时,齿轮111以销钉122为轴进行旋转,使得钳臂11以齿轮111为旋转中心相对推杆40进行旋转开合。具体的,当推杆40向远端进行轴向移动时,齿条421带动齿轮111转动,以使得钳臂11相对推杆40收拢;当推杆40向近端进行轴向移动时,齿条421带动齿轮111转动,以使得钳臂11相对推杆40打开。Please refer to FIGS. 3 to 5 again. The clamp arm 11 is used for opening and closing relative to the clamping arm 12 or the push rod 40 to clamp or loosen the valve leaflets. Please refer to FIGS. 8 and 11 together. FIG. 11 is a schematic diagram of the structure of the clamp arm 11 in some embodiments of the application. Each pliers arm 11 includes a fixed end 11a at the distal end and a free end 11b at the proximal end. The pliers arm 11 opens and closes relative to the push rod 40 with the fixed end 11a as the center of rotation. Specifically, the fixed end 11 a of the clamp arm 11 has a gear 111, and the gear 111 meshes with the rack 421 on the push rod 40. The fixed end 11 a of the clamp arm 11 is located between the two clamping plates 51 of the fixed base 50, and the gear 111 is axially connected to the two clamping plates 51. Specifically, the gear 111 is provided with a through pin hole 114 along the axial direction, and the two clamping plates 51 are correspondingly provided with a fixing hole 54. The pin 122 passes through the pin hole 114 and both ends of the pin 122 are respectively fixed in the fixing holes 54 of the clamping plate 51. Due to the meshing between the gear 111 and the rack 421, when the push rod 40 moves in the axial direction, the gear 111 rotates with the pin 122 as an axis, so that the pliers arm 11 rotates to open and close the push rod 40 with the gear 111 as the rotation center. Specifically, when the push rod 40 axially moves to the distal end, the rack 421 drives the gear 111 to rotate, so that the clamp arm 11 is retracted relative to the push rod 40; when the push rod 40 axially moves toward the proximal end, the rack 421 drives the gear 111 to rotate, so that the clamp arm 11 is opened relative to the push rod 40.
本申请一些实施例中,两个钳臂11之间的夹角范围为0°至200°,即,初始状态(闭合)的两个钳臂之间平行,夹角为0°,而通过推杆40的齿条421与钳臂11的齿轮111的啮合,能够实现两个钳臂11之间较大范围的夹角张开幅度,张开的两个钳臂11之间的夹角最大可达到200°,通过设置齿轮111和齿条421的啮合的具体规格,优选两个张开的钳臂11之间的最大夹角为150°。钳口开口尺寸范围可达20-36mm,有利于夹持瓣叶。并且,两个钳臂11的张开及收拢均是匀速进行,利于操作者在夹持过程中根据瓣膜夹合器100与瓣叶之间的相对位置实时调整钳臂11的位置,避免夹持过快或者过慢导致瓣叶滑脱造成夹持失败。并且,通过推杆40的进给行程,能够得知与之对应的两个钳臂11之间夹角的大小,有利操作者的夹持判断。In some embodiments of the present application, the angle between the two clamp arms 11 ranges from 0° to 200°, that is, the two clamp arms in the initial state (closed) are parallel, and the angle is 0°. The meshing of the rack 421 of the rod 40 with the gear 111 of the pliers arm 11 can achieve a wide range of angle opening between the two pliers arms 11, and the maximum angle between the two pliers arms 11 can be To reach 200°, by setting the specific specifications of the meshing of the gear 111 and the rack 421, it is preferable that the maximum included angle between the two opened jaw arms 11 is 150°. The size of the jaw opening can reach 20-36mm, which is good for clamping the valve leaflets. In addition, the opening and closing of the two forceps arms 11 are performed at a uniform speed, which facilitates the operator to adjust the position of the forceps arms 11 in real time according to the relative position between the valve clamp 100 and the leaflets during the clamping process, and avoid clamping Too fast or too slow causes the valve leaflets to slip and cause clamping failure. In addition, through the feed stroke of the push rod 40, the size of the included angle between the two clamp arms 11 corresponding thereto can be known, which is beneficial to the operator's clamping judgment.
可以理解的是,本申请的其他实施例中,两个钳臂11的固定端11a也可以通过销钉或螺栓等方式旋转连接于推杆40上,使得两个钳臂11能够相对推杆40进行旋转开合。It can be understood that, in other embodiments of the present application, the fixed ends 11a of the two pliers arms 11 can also be rotatably connected to the push rod 40 by means of pins or bolts, so that the two pliers arms 11 can perform relative to the push rod 40. Rotate opening and closing.
一些实施例中,钳臂11上设有多个间隔设置的通孔。通过在钳臂11上设置所述通孔,能够减轻所述钳臂11的重量,并且能够有利于内皮细胞的爬覆及生长。In some embodiments, the pliers arm 11 is provided with a plurality of through holes arranged at intervals. By providing the through hole on the forceps arm 11, the weight of the forceps arm 11 can be reduced, and it can facilitate the climbing and growth of endothelial cells.
钳臂11包括朝向推杆40的第一表面112a。一些实施例中,第一表面112a上设有夹持增强件113,使得钳臂11与推杆40配合夹紧瓣叶时,增强钳臂11与瓣叶之间的摩擦力,从而提供稳定的夹持力。其中,夹持增强件113可以为设于第一表面112a的凸起、凹槽或者贴合于第一表面112a的由摩擦系数较高的生物相容性材料制成的垫片。The pliers arm 11 includes a first surface 112 a facing the push rod 40. In some embodiments, the first surface 112a is provided with a clamping reinforcement 113, so that when the clamp arm 11 and the push rod 40 cooperate to clamp the valve leaflet, the friction between the clamp arm 11 and the valve leaflet is enhanced, thereby providing a stable Holding force. Wherein, the clamping reinforcement 113 may be a protrusion or groove provided on the first surface 112a or a gasket made of a biocompatible material with a relatively high friction coefficient and attached to the first surface 112a.
为了保证稳定的夹持力并适应瓣叶的大小,钳臂11具有一定的尺寸规定。具体的,当钳臂11过长时,钳臂11易将过多的前叶1a和后叶1b夹在一起,两个瓣叶被强行拉向彼此并固定在一起,不仅容易导致二尖瓣功能异常,并且在心脏跳动和瓣叶运动的时候,由于过多的瓣叶被限制运动,还可能导致瓣叶撕裂等严重后果;当钳臂11过短时,只能夹住小部分的 瓣叶,使得瓣叶容易滑出,夹合固定效果较差。并且,由于瓣叶较为柔软,在夹持过程中,钳臂11不易承托瓣叶或与夹持臂12配合夹持瓣叶,延长手术时间。本申请一些实施例中,钳臂11的轴向长度(即固定端11a至自由端11b的距离)应大于或等于4mm,优选为6-10mm。并且,钳臂11的宽度也有一定的限制,以避免钳臂11的宽度过窄而对瓣叶产生伤害,同时也避免钳臂11的宽度过宽时对瓣叶运动的影响。钳臂11的宽度(即与钳臂11的轴向方向垂直的方向的长度)应大于或等于2mm,优选为4-6mm。并且,为了保证植入后的安全性,钳臂11应由生物相容性材料制成,并具有一定的柔性及刚性,从而避免钳臂11对瓣叶造成伤害,同时又能够夹紧固定瓣叶。具体地,生物相容性材料选自不锈钢、钴合金或钛合金。In order to ensure a stable clamping force and adapt to the size of the valve leaflets, the forceps arm 11 has certain size regulations. Specifically, when the forceps arm 11 is too long, the forceps arm 11 tends to clamp the excessive anterior leaflets 1a and posterior leaflets 1b together, and the two leaflets are forced to each other and fixed together, which not only easily leads to the mitral valve The function is abnormal, and when the heart beats and the valve leaflets move, too many valve leaflets may be restricted from moving, which may also cause serious consequences such as valve leaflet tear; when the clamp arm 11 is too short, only a small part of the The valve leaflet makes the valve leaflet easy to slide out, and the clamping and fixing effect is poor. In addition, since the valve leaflets are relatively soft, during the clamping process, the forceps arm 11 cannot easily support the valve leaflets or cooperate with the clamping arm 12 to clamp the valve leaflets, which prolongs the operation time. In some embodiments of the present application, the axial length of the forceps arm 11 (that is, the distance from the fixed end 11a to the free end 11b) should be greater than or equal to 4 mm, preferably 6-10 mm. In addition, the width of the forceps arm 11 is also limited to a certain extent, so as to avoid that the width of the forceps arm 11 is too narrow to cause damage to the valve leaflets, and at the same time to avoid the effect of the forceps arm 11 on the movement of the valve leaflets when the width of the forceps arm 11 is too wide. The width of the clamp arm 11 (that is, the length of the direction perpendicular to the axial direction of the clamp arm 11) should be greater than or equal to 2 mm, preferably 4-6 mm. In addition, in order to ensure the safety after implantation, the forceps arm 11 should be made of biocompatible materials, and have a certain degree of flexibility and rigidity, so as to prevent the forceps arm 11 from damaging the valve leaflets, and at the same time, it can clamp the fixed valve. leaf. Specifically, the biocompatible material is selected from stainless steel, cobalt alloy or titanium alloy.
进一步的,钳臂11的第一表面112a上还可以施加活性药物,或者设置多个开口,以促进瓣膜组织在钳臂11的内表面上的内皮细胞爬覆及生长。进一步的,第一表面112a也可以设置为具有凹凸结构的凹凸表面,从而增加钳臂11与瓣叶之间的摩擦力,提高瓣膜夹合器100对瓣叶的固定能力。Further, active drugs can be applied to the first surface 112a of the forceps arm 11, or multiple openings can be provided to promote the crawling and growth of endothelial cells of the valve tissue on the inner surface of the forceps arm 11. Further, the first surface 112a may also be configured as a concave-convex surface with a concave-convex structure, thereby increasing the friction between the forceps arm 11 and the valve leaflets, and improving the ability of the valve clamp 100 to fix the valve leaflets.
请重新参阅图3至图5,本申请一实施例中,瓣膜夹合器100包括具有弹性的夹持件,夹持件包括两个夹持臂12。夹持件的两个夹持臂12与两个钳臂11分别对应,且每个夹持臂12分别位于同其对应的一个钳臂11与推杆40之间,通过每个钳臂11与一个夹持臂12对合从而夹紧瓣叶。Please refer to FIGS. 3 to 5 again. In an embodiment of the present application, the valve clamp 100 includes a clamping member having elasticity, and the clamping member includes two clamping arms 12. The two clamping arms 12 of the clamping piece correspond to the two clamping arms 11, and each clamping arm 12 is located between the corresponding clamping arm 11 and the push rod 40, and each clamping arm 11 and A clamping arm 12 mates to clamp the leaflets.
请一并参阅图3、图12a及图12b,图12a所示为本申请一些实施例的夹持件处于收紧(输送)状态下的结构示意图;图12b所示为本申请一些实施例的夹持件处于自然(释放)状态下的结构示意图。夹持件由镍钛合金或者钴铬合金的钣金等材料切割,然后放入到定型模具中,通过热定型处理得到图12b所示的形状。由于夹持件具有弹性,可通过图12a所示的状态在导管中输送,并在解除束缚后恢复至图12b所示的状态,从而与钳臂11配合夹紧瓣叶。夹持件的每个夹持臂12均包括相对设置的自由端12a及固定端12b。固定端12b固定于固定基座50上。一些实施例中,固定端12b固定于固定基座50与基座连接管60之间。一些实施例中,两个夹持臂12的固定端12b通过连接片12c连接为一体结构(即,夹持件呈U形),并将连接片12c与固定基座50进行可拆卸或者不可拆卸固定连接,以实现两个夹持臂12的固定端12b与固定基座50的固定。本申请一些实施例中,夹持臂12至少部分由镍钛合金等弹性材料制成。本申请一实施例中,夹持臂12的固定端12b由弹性材料制成。夹持臂12的自由端12a可以由铝合金等非弹性材料制成,只要保证夹持臂12通过热定型,具有自然状态及收紧状态即可。自然状态下,夹持臂12与推杆40之间呈角度设置。两个夹持臂12之间的夹角范围为0°-160°。一些实施例中,两个夹持臂12之间的夹角应略大于两个钳臂11之间的夹角,以提供更稳定的夹持力,即,每个夹持臂12与推杆40之间的夹角大于或等于与该夹持臂12对应的钳臂11张开至最大状态时的钳臂11与推杆40之间的夹角,从而保证钳臂11与夹持臂12之间具有一定的夹紧力,以夹紧位于钳臂11与夹持臂12之间的瓣叶。可以理解的是,一些实施例中,夹持臂12与推杆40之间的夹角也可以小于钳臂11张开至最大状态时的钳臂11与推杆40之间的夹角。Please refer to Figure 3, Figure 12a and Figure 12b together. Figure 12a shows a schematic diagram of the structure of some embodiments of the application in a tightened (conveying) state; Figure 12b shows a diagram of some embodiments of the application The structure diagram of the clamp in the natural (released) state. The clamping piece is cut from nickel-titanium alloy or cobalt-chromium alloy sheet metal and other materials, and then placed in a shaping mold, and the shape shown in FIG. 12b is obtained through heat-setting treatment. Due to the elasticity of the clamping member, it can be transported in the catheter through the state shown in FIG. 12a, and restored to the state shown in FIG. Each clamping arm 12 of the clamping member includes a free end 12a and a fixed end 12b that are oppositely arranged. The fixed end 12b is fixed on the fixed base 50. In some embodiments, the fixed end 12 b is fixed between the fixed base 50 and the base connecting pipe 60. In some embodiments, the fixed ends 12b of the two clamping arms 12 are connected into an integral structure (that is, the clamping member is U-shaped) through a connecting piece 12c, and the connecting piece 12c and the fixed base 50 are detachable or non-detachable. The two clamping arms 12 are fixedly connected to the fixed end 12b of the fixed base 50 to be fixed. In some embodiments of the present application, the clamping arm 12 is at least partially made of an elastic material such as Nitinol. In an embodiment of the present application, the fixed end 12b of the clamping arm 12 is made of elastic material. The free end 12a of the clamping arm 12 may be made of non-elastic materials such as aluminum alloy, as long as it is ensured that the clamping arm 12 has a natural state and a tightened state after heat setting. In a natural state, the clamping arm 12 and the push rod 40 are arranged at an angle. The angle between the two clamping arms 12 ranges from 0° to 160°. In some embodiments, the included angle between the two clamping arms 12 should be slightly larger than the included angle between the two clamp arms 11 to provide a more stable clamping force, that is, each clamping arm 12 and the push rod The included angle between 40 is greater than or equal to the included angle between the clamp arm 11 and the push rod 40 when the clamp arm 11 corresponding to the clamp arm 12 is opened to the maximum state, so as to ensure that the clamp arm 11 and the clamp arm 12 There is a certain clamping force between them to clamp the leaflets between the clamp arm 11 and the clamping arm 12. It is understandable that, in some embodiments, the angle between the clamp arm 12 and the push rod 40 may also be smaller than the angle between the clamp arm 11 and the push rod 40 when the clamp arm 11 is expanded to the maximum state.
夹持臂12的自由端12a与推送装置中的控制件13进行连接,通过控制件13控制夹持臂12的自由端12a,以调整夹持臂12与推杆40之间的角度以及夹持臂12与钳臂11之间的开合。本实施例中,控制件13为金属或者PTFE等高分子材料制成的调节线,调节线穿过夹持臂12的自由端12a,将夹持臂12束缚于推杆40的表面,使得两个夹持臂12处于收紧状态,利于通过导管经由弯曲的血管进行输送;当钳臂11与瓣叶的位置调整好后,放开调节线对夹 持臂12的自由端12a的控制,夹持臂12的自由端12a由于自身的弹性记忆性能,向两侧回弹并远离推杆40,此时所述夹持臂12处于自然状态,并使得夹持臂12与钳臂11夹紧位于二者之间的瓣叶。The free end 12a of the clamping arm 12 is connected with the control member 13 in the pushing device, and the free end 12a of the clamping arm 12 is controlled by the control member 13 to adjust the angle between the clamping arm 12 and the push rod 40 and the clamping The opening and closing between the arm 12 and the clamp arm 11. In this embodiment, the control member 13 is an adjustment wire made of a polymer material such as metal or PTFE. The adjustment wire passes through the free end 12a of the clamping arm 12, and binds the clamping arm 12 to the surface of the push rod 40 so that the two The clamping arm 12 is in a tightened state, which facilitates delivery through the curved blood vessel through the catheter; when the position of the clamp arm 11 and the valve leaflets are adjusted, release the adjustment wire to control the free end 12a of the clamping arm 12, and clamp The free end 12a of the holding arm 12 rebounds to both sides and away from the push rod 40 due to its own elastic memory performance. At this time, the holding arm 12 is in a natural state, and the holding arm 12 and the clamp arm 11 are clamped at The leaflets between the two.
进一步的,夹持臂12包括与钳臂11相对的第三表面12d。第三表面12d上设有夹持增强件121,以增加夹持臂12与夹持于钳臂11与夹持臂12之间的瓣叶之间的摩擦力,提高钳臂11与夹持臂12对瓣叶的夹持力。夹持增强件121可以是凸设于第三表面12d的凸棱、倒钩、凸台或者其它不规则分布的凸起等结构,还可以是至少部分覆盖第三表面12d的粗糙表面,以提高瓣膜夹合器100对瓣叶的夹持力。例如,在推杆40外表面覆盖由摩擦系数较高的生物相容性材料制成的垫片,增加第三表面12d的表面粗糙系数,从而提高瓣膜夹合器100对瓣叶的夹持力。夹持增强件121还可以是设置在夹持臂12上的磁性体,此时,在钳臂11上也设置对应的磁性体,通过钳臂11与夹持臂12之间的相互磁性吸力,达到增强夹持力的目的。Further, the clamping arm 12 includes a third surface 12d opposite to the clamp arm 11. The third surface 12d is provided with a clamping reinforcement 121 to increase the friction between the clamping arm 12 and the leaflets clamped between the clamping arm 11 and the clamping arm 12, and to improve the clamping arm 11 and the clamping arm. The clamping force of 12 pairs of valve leaflets. The clamping reinforcement 121 may be a rib, barb, boss or other irregularly distributed protrusions protruding on the third surface 12d, or may be a rough surface at least partially covering the third surface 12d to improve The clamping force of the valve clamp 100 on the valve leaflets. For example, the outer surface of the push rod 40 is covered with a gasket made of a biocompatible material with a higher friction coefficient to increase the surface roughness coefficient of the third surface 12d, thereby improving the clamping force of the valve clamp 100 on the valve leaflets . The clamping reinforcement 121 can also be a magnetic body arranged on the clamping arm 12. At this time, a corresponding magnetic body is also arranged on the clamping arm 11, through the mutual magnetic attraction between the clamping arm 11 and the clamping arm 12, To achieve the purpose of enhancing the clamping force.
本申请一实施例中,夹持增强件121为两列间隔设置的凸齿。两列凸齿相对设置于夹持臂12的两侧边缘。并且,每个凸齿的轴向与第三表面12d之间的夹角小于或等于90°,以进一步增强夹持力。进一步的,凸齿远离第三表面12d的一端为光滑的弧形面,从而避免损伤瓣叶。本实施例中,由于夹持臂12上设有凸齿,因此,为了避免凸齿对钳臂11与夹持臂12对合的影响,钳臂11的宽度小于夹持臂12的宽度,使得钳臂11与夹持臂12对合时,夹持臂12上的凸齿均位于钳臂11的两侧,钳臂11的第一表面112a与夹持臂12的第三表面12d接触,使得钳臂11与夹持臂12能够更加稳定的夹紧位于钳臂11与夹持臂12之间的瓣叶。进一步的,一些实施例中,夹持臂12上设有通孔122,以减轻夹持臂12的重量,增强夹持臂12的弹性,并且利于内皮细胞的爬覆及生长。In an embodiment of the present application, the clamping reinforcement 121 is two rows of convex teeth arranged at intervals. Two rows of protruding teeth are arranged opposite to the two sides of the clamping arm 12. In addition, the included angle between the axial direction of each protruding tooth and the third surface 12d is less than or equal to 90° to further enhance the clamping force. Further, the end of the convex teeth away from the third surface 12d is a smooth arc surface, thereby avoiding damage to the valve leaflets. In this embodiment, since the clamping arm 12 is provided with convex teeth, in order to avoid the influence of the convex teeth on the coupling of the clamping arm 11 and the clamping arm 12, the width of the clamping arm 11 is smaller than the width of the clamping arm 12, so that When the clamp arm 11 is aligned with the clamp arm 12, the protruding teeth on the clamp arm 12 are located on both sides of the clamp arm 11. The first surface 112a of the clamp arm 11 is in contact with the third surface 12d of the clamp arm 12, so that The clamp arm 11 and the clamping arm 12 can more stably clamp the valve leaflets located between the clamp arm 11 and the clamping arm 12. Further, in some embodiments, the clamping arm 12 is provided with a through hole 122 to reduce the weight of the clamping arm 12, enhance the elasticity of the clamping arm 12, and facilitate the crawling and growth of endothelial cells.
请重新参阅图3至图5,延伸臂20为至少一根。延伸臂20设于钳臂11的表面或者内部。本申请一实施例中,延伸臂20为两根,分别设于两个钳臂11的表面。具体的,延伸臂20可以设于钳臂11的第一表面112a(即钳臂11的内表面)或者设于与第一表面112a相背的第二表面(即钳臂11的外表面)。一些实施例中,延伸臂20设于钳臂11的内部。具体的,钳臂11内设有从固定端11a向自由端11b方向延伸的穿孔,延伸臂20穿设于穿孔内,以使得延伸臂20设于钳臂11的内部。本实施例中,延伸臂20设于钳臂11的第二表面。具体的,钳臂11的第二表面上设有限位件14,限位件14用于限定延伸臂20的伸缩方向为沿钳臂11的固定端11a向自由端11b的方向,限制延伸臂20的径向偏移。限位件14可以为限位环、限位槽或者限位管等各种限位结构。优先的,限位件14为限位环或者限位管等,通过限位件14还能够将延伸臂20固定于钳臂11的第二表面,防止延伸臂20在运动过程中于第二表面脱离。具体的,本实施例中,限位件14为具有一定长度的管状件,延伸臂20可活动地穿设于管状件中。Please refer to FIGS. 3 to 5 again, the extension arm 20 is at least one. The extension arm 20 is provided on the surface or inside of the clamp arm 11. In an embodiment of the present application, there are two extension arms 20 which are respectively provided on the surfaces of the two clamp arms 11. Specifically, the extension arm 20 may be provided on the first surface 112a of the forceps arm 11 (ie, the inner surface of the forceps arm 11) or on a second surface opposite to the first surface 112a (that is, the outer surface of the forceps arm 11). In some embodiments, the extension arm 20 is provided inside the clamp arm 11. Specifically, the pliers arm 11 is provided with a through hole extending from the fixed end 11 a to the free end 11 b, and the extension arm 20 penetrates through the through hole, so that the extension arm 20 is disposed inside the pliers arm 11. In this embodiment, the extension arm 20 is provided on the second surface of the clamp arm 11. Specifically, a limiting member 14 is provided on the second surface of the clamp arm 11, and the limiting member 14 is used to limit the extension arm 20 in the direction from the fixed end 11a to the free end 11b of the clamp arm 11 to limit the extension arm 20. The radial offset. The limiting member 14 may be various limiting structures such as a limiting ring, a limiting groove, or a limiting tube. Preferably, the limiting member 14 is a limiting ring or a limiting tube. The limiting member 14 can also fix the extension arm 20 to the second surface of the clamp arm 11 to prevent the extension arm 20 from being on the second surface during movement. Break away. Specifically, in this embodiment, the limiting member 14 is a tubular member with a certain length, and the extension arm 20 can movably pass through the tubular member.
请参阅图13,本申请一些实施例中,延伸臂20包括相对的固定端20a以及自由端20b,固定端20a旋转固定于推杆40的远端。本申请一实施例中,固定端20a旋转固定于推杆40的远端的基座43上。延伸臂20的固定端20a位于基座43上的缺口411内。并且固定端20a上具有销钉孔114,销钉穿过销钉孔114且销钉的两端固定于缺口411的内壁,从而实现固定端20a与基座43的旋转固定。当沿轴向推动推杆40时,推杆40带动延伸臂20的末端超出钳臂11的自由端11a。具体的,当推杆40向远端进行轴向移动时,能够带动延伸臂20的末端沿钳臂11的轴向缩回;当推杆40向近端进行轴向移动时,能够带动延伸臂20的末端沿 钳臂11的轴向伸长。同时,本申请一些实施例中,由于推杆40的轴向移动能够带动钳臂11相对推杆40进行开合,从而能够实现通过轴向移动推杆40,同时控制钳臂11相对推杆40的开合以及延伸臂20沿钳臂11的轴向伸长及缩回,从而在不增加额外的手术操作步骤的前提下同时实现钳臂11相对推杆40的开合控制以及延伸臂20相对钳臂11的轴向伸长及收缩控制,降低手术难度。可以理解的是,本申请的其他实施例中,延伸臂20的伸长或者缩回以及钳臂11相对推杆40的打开或者合拢也可以不同步。例如,将钳臂11与延伸臂20连接于不同的驱动结构上,从而使得钳臂11能够与延伸臂20分开运动,以使得延伸臂20的伸长或者缩回以及钳臂11相对推杆40的打开或者合拢能够实现不同步。具体的,可以使得钳臂11的齿轮111与推杆40的齿条421进行啮合,从而通过推杆40的轴向移动实现钳臂11相对推杆40的开合。并且,设置另一推杆,并将延伸臂20与另一推杆进行连接,从而通过另一推杆驱动延伸臂20进行伸长或者缩回,即钳臂11与延伸臂20分别通过独立的推杆进行控制,从而实现延伸臂20的伸长或者缩回与钳臂11相对推杆40的打开或者合拢不同步。Please refer to FIG. 13. In some embodiments of the present application, the extension arm 20 includes a fixed end 20 a and a free end 20 b opposite to each other. The fixed end 20 a is rotatably fixed to the distal end of the push rod 40. In an embodiment of the present application, the fixed end 20 a is rotatably fixed on the base 43 at the distal end of the push rod 40. The fixed end 20 a of the extension arm 20 is located in the notch 411 on the base 43. In addition, the fixed end 20 a has a pin hole 114, the pin passes through the pin hole 114 and the two ends of the pin are fixed to the inner wall of the notch 411, so that the fixed end 20 a and the base 43 are fixed in rotation. When the push rod 40 is pushed in the axial direction, the push rod 40 drives the end of the extension arm 20 to exceed the free end 11 a of the clamp arm 11. Specifically, when the push rod 40 moves axially toward the distal end, the end of the extension arm 20 can be driven to retract along the axial direction of the clamp arm 11; when the push rod 40 axially moves toward the proximal end, the extension arm can be driven The end of 20 extends along the axial direction of the clamp arm 11. At the same time, in some embodiments of the present application, since the axial movement of the push rod 40 can drive the clamp arm 11 to open and close relative to the push rod 40, it is possible to move the push rod 40 axially while controlling the clamp arm 11 relative to the push rod 40. The opening and closing and extension arm 20 extends and retracts along the axial direction of the forceps arm 11, so as to achieve the opening and closing control of the forceps arm 11 relative to the push rod 40 and the relative extension of the extension arm 20 without adding additional surgical steps. The axial extension and contraction of the clamp arm 11 are controlled to reduce the difficulty of the operation. It can be understood that in other embodiments of the present application, the extension or retraction of the extension arm 20 and the opening or closing of the clamp arm 11 relative to the push rod 40 may also be asynchronous. For example, the pliers arm 11 and the extension arm 20 are connected to different driving structures, so that the pliers arm 11 can move separately from the extension arm 20, so that the extension arm 20 is extended or retracted and the pliers arm 11 is relative to the push rod 40. The opening or closing of the can be asynchronous. Specifically, the gear 111 of the pliers arm 11 can be meshed with the rack 421 of the push rod 40, so that the opening and closing of the pliers arm 11 relative to the push rod 40 is realized by the axial movement of the push rod 40. In addition, another push rod is provided, and the extension arm 20 is connected with another push rod, so that the extension arm 20 is driven to extend or retract through the other push rod, that is, the clamp arm 11 and the extension arm 20 pass through independent The push rod is controlled so that the extension or retraction of the extension arm 20 is not synchronized with the opening or closing of the clamp arm 11 relative to the push rod 40.
一些实施例中,瓣膜夹合器100还包括延伸臂钢套21,延伸臂20的固定端20a通过焊接或压接等方式固定于延伸臂钢套21上。延伸臂钢套21远离延伸臂20的一端位于基座43上的缺口433内。并且延伸臂钢套21远离延伸臂20的一端上具有销钉孔,缺口433的相对的两个侧壁上均具有固定孔434,销钉穿过销钉孔且销钉的两端固定于固定孔434中,从而实现延伸臂钢套21与基座43的旋转固定,进而实现延伸臂20的固定端20a与基座43旋转固定。In some embodiments, the valve clamp 100 further includes an extension arm steel sleeve 21, and the fixed end 20a of the extension arm 20 is fixed to the extension arm steel sleeve 21 by welding or crimping. The end of the extension arm steel sleeve 21 away from the extension arm 20 is located in the notch 433 on the base 43. And the extension arm steel sleeve 21 has a pin hole on one end away from the extension arm 20, and the two opposite side walls of the notch 433 have fixing holes 434. The pins pass through the pin holes and both ends of the pins are fixed in the fixing holes 434. In this way, the extension arm steel sleeve 21 and the base 43 are rotationally fixed, and the fixed end 20a of the extension arm 20 and the base 43 are rotationally fixed.
本申请中,延伸臂20伸出钳臂11是指延伸臂20的末端伸出钳臂11的自由端11b,即延伸臂20的端部位于钳臂11的自由端11b远离固定端11a的一侧;延伸臂20的末端收入钳臂11是指延伸臂20的端部收缩至钳臂11的自由端11b与固定端11a之间。推杆40向近端方向进行轴向移动时,钳臂11相对推杆40打开,同时延伸臂20伸出钳臂11。当延伸臂20伸出钳臂11时,延伸臂20相当于延长了钳臂11的长度,当钳臂11相对推杆40张开以捕获瓣叶时,延长的钳臂11能够增加承托的瓣叶长度,使得瓣叶不容易从钳臂11处滑脱,从而使得瓣膜夹合器100对瓣叶的捕获更容易,方便夹持。并且,由于钳臂11的实际长度不变,因此,瓣膜夹合器100夹持瓣叶的长度实际上并不会发生改变,避免了瓣膜夹合器100的长度过长而可能产生的问题。优选的,每个钳臂11的内表面和/或外表面均设有至少一根延伸臂20。以使得每个钳臂11的长度均可以加长,从而使得每个钳臂11均能够容易的捕获瓣叶。本实施例中,延伸臂20的整体光滑,伸出钳臂11的一端通过激光点焊形成光滑的圆头,没有毛刺、棱边、棱角等缺陷,避免对瓣叶的损伤。In this application, the extension arm 20 extending out of the clamp arm 11 means that the end of the extension arm 20 extends out of the free end 11b of the clamp arm 11, that is, the end of the extension arm 20 is located at the free end 11b of the clamp arm 11 away from the fixed end 11a. Side; the end of the extension arm 20 into the clamp arm 11 means that the end of the extension arm 20 is retracted to between the free end 11b and the fixed end 11a of the clamp arm 11. When the push rod 40 moves axially in the proximal direction, the clamp arm 11 is opened relative to the push rod 40 and the extension arm 20 extends out of the clamp arm 11 at the same time. When the extension arm 20 extends out of the forceps arm 11, the extension arm 20 is equivalent to extending the length of the forceps arm 11. When the forceps arm 11 is opened relative to the push rod 40 to capture the valve leaflets, the extended forceps arm 11 can increase the supporting capacity The length of the valve leaflet makes it difficult for the valve leaflet to slip off the forceps arm 11, thereby making it easier for the valve clamp 100 to capture the valve leaflet and facilitate clamping. In addition, since the actual length of the forceps arm 11 does not change, the length of the valve leaflet clamped by the valve clamp 100 does not actually change, which avoids possible problems caused by the valve clamp 100 being too long. Preferably, at least one extension arm 20 is provided on the inner surface and/or outer surface of each clamp arm 11. In this way, the length of each forceps arm 11 can be lengthened, so that each forceps arm 11 can easily capture the valve leaflets. In this embodiment, the extension arm 20 is smooth as a whole, and the end of the extension arm 11 is laser spot welded to form a smooth round head, without defects such as burrs, edges, corners, etc., to avoid damage to the valve leaflets.
本申请一些实施例中,延伸臂20包括延伸臂主体。延伸臂主体包括一根或者多根并排设置的支撑杆,以通过支撑杆直接承托瓣叶。支撑杆可以为实心或空心结构,也可以为单层或者多层复合结构。例如,支撑杆可以为一种材料形成的实心或者空心杆,也可以为多种不同材料的形成的内径大小不同的空心管套合得到。或者,支撑杆还可以由单根丝或者多根丝绕制而成。支撑杆的截面可以为规则的圆形或者椭圆形、月牙形、半圆形、多边形等形状,优选为圆形,易于加工同时又能避免支撑杆对瓣叶的伤害。进一步的,本实施例中,支撑杆为柔性和/或弹性的生物相容性材料制成,以适应瓣叶的解剖结构及瓣叶的活动幅度,且避免损伤瓣叶。例如可以选择金属材料、聚合物材料或者金属-聚合物复合材料制成。具体地,支撑杆由金属-高分子复合材料制成,本实施例中采用镍钛合金和PTFE制成。In some embodiments of the present application, the extension arm 20 includes an extension arm body. The extension arm body includes one or more supporting rods arranged side by side to directly support the valve leaflets through the supporting rods. The support rod can be a solid or hollow structure, or a single-layer or multi-layer composite structure. For example, the support rod may be a solid or hollow rod formed of one material, or may be a hollow tube with different inner diameters formed by multiple different materials. Alternatively, the support rod can also be wound by a single wire or multiple wires. The cross section of the support rod can be a regular circle or an ellipse, crescent, semicircle, polygon, etc., preferably a circle, which is easy to process and can avoid damage to the valve leaflets by the support rod. Furthermore, in this embodiment, the support rod is made of a flexible and/or elastic biocompatible material to adapt to the anatomical structure of the valve leaflet and the range of movement of the valve leaflet, and to avoid damage to the valve leaflet. For example, it can be made of metal material, polymer material or metal-polymer composite material. Specifically, the support rod is made of a metal-polymer composite material. In this embodiment, Nitinol and PTFE are used.
进一步的,本申请的其它实施例中,延伸臂20包括由柔性材料制成的延伸臂主体,还包 括支撑体,支撑体由刚性材料制成,例如不锈钢或钛合金等。支撑体设于延伸臂主体内部和/或外部,以增强延伸臂20的强度,使得延伸臂20具有一定的柔性以适应瓣叶的解剖结构及瓣叶的活动幅度的同时,具有一定刚性以对瓣叶进行有效的支撑。例如,一实施例中,延伸臂主体为由较柔软的材料制成柔性管,支撑体为硬度更高的材料制成的刚性杆,柔性管套设于刚性杆外以形成延伸臂20,此时,支撑体设于延伸臂主体外部。或者,本申请另一实施例中,延伸臂主体为柔性杆,支撑体为硬度更高的材料制成的刚性管,刚性管套设于柔性杆外以形成延伸臂20,此时,支撑体设于延伸臂主体的内部。或者,本申请另一实施例中,采用热缩管作为支撑体包裹在较柔软的延伸臂主体外表面,然后加热使热缩管收缩后包裹在延伸臂主体的外表面以提高支撑性,即延伸臂主体为柔性杆,刚性支撑体为热缩管,热缩管套于柔性杆外并加热收缩以同柔性杆固定,此时的支撑体设于延伸臂主体外部。或者,本申请另一实施例中,延伸臂主体由至少一根柔性丝(如,不锈钢丝)绕制而成,再将热塑性弹性体(例如,Pebax)包裹在延伸臂主体外部,然后加热使Pebax熔化后覆盖在延伸臂主体的外部,同时,部分的Pebax会通过柔性丝之间的缝隙渗入延伸臂主体内部,因此,此时的支撑体设于延伸臂主体内部和外部。Further, in other embodiments of the present application, the extension arm 20 includes an extension arm body made of a flexible material, and also includes a support body, which is made of a rigid material, such as stainless steel or titanium alloy. The support body is arranged inside and/or outside the extension arm body to enhance the strength of the extension arm 20, so that the extension arm 20 has a certain flexibility to adapt to the anatomical structure of the valve leaflet and the range of movement of the valve leaflet, while having a certain rigidity to match The valve leaflets provide effective support. For example, in one embodiment, the extension arm body is a flexible tube made of a softer material, the support body is a rigid rod made of a material with higher hardness, and the flexible tube is sleeved outside the rigid rod to form the extension arm 20. At this time, the support body is arranged outside the extension arm body. Alternatively, in another embodiment of the present application, the extension arm body is a flexible rod, the support body is a rigid tube made of a material with higher hardness, and the rigid tube is sleeved outside the flexible rod to form the extension arm 20. In this case, the support body Set inside the main body of the extension arm. Alternatively, in another embodiment of the present application, a heat-shrinkable tube is used as a support body to wrap the outer surface of the softer extension arm body, and then heated to shrink the heat-shrinkable tube and wrap it on the outer surface of the extension arm body to improve support, that is, The main body of the extension arm is a flexible rod, and the rigid support is a heat-shrinkable tube. The heat-shrinkable tube is sheathed outside the flexible rod and heated and contracted to be fixed with the flexible rod. Alternatively, in another embodiment of the present application, the extension arm body is made by winding at least one flexible wire (for example, stainless steel wire), and then a thermoplastic elastomer (for example, Pebax) is wrapped around the extension arm body, and then heated to Pebax melts and covers the outside of the extension arm body. At the same time, part of the Pebax will penetrate into the extension arm body through the gap between the flexible wires. Therefore, the support body at this time is provided inside and outside the extension arm body.
进一步的,延伸臂20至少部分由不透射X射线材料制成。例如,延伸臂主体和/或支撑体由不透射X射线材料制成,从而使得延伸臂20自瓣膜夹合器100伸出后,与瓣叶接触,延伸臂20可以伴随瓣叶的活动幅度产生相应的摆动,此时操作者可以通过X射线快速准确地判断瓣叶的位置,如果位置合理,操作者即可驱动瓣膜夹合器100夹持瓣叶,从而缩短手术时间,提高手术成功率。不透射X射线材料选自不锈钢或镍钛合金。Further, the extension arm 20 is at least partially made of an X-ray non-transmissive material. For example, the extension arm body and/or the support body are made of radiopaque material, so that after the extension arm 20 extends from the valve clamp 100 and contacts the valve leaflet, the extension arm 20 can be generated with the movement range of the valve leaflet. With corresponding swing, the operator can quickly and accurately determine the position of the valve leaflet through X-rays. If the position is reasonable, the operator can drive the valve clamp 100 to clamp the valve leaflet, thereby shortening the operation time and improving the success rate of the operation. The radiopaque material is selected from stainless steel or Nitinol.
请参阅图14a至图14e,图14a至图14e为本申请另一些实施例的延伸臂的结构示意图。这些实施例中,延伸臂20的自由端20b还设有承载部22。延伸臂20的末端超出钳臂11的自由端11b时,承载部22的宽度大于延伸臂20的直径,从而使得承载部22具有更大的承托面积,从而更好的承托瓣叶。其中,承载部22的宽度方向与钳臂11的宽度方向相同。承载部22可以为板状结构或者弹性件。如图14a所示,承载部22为板状结构,具体为平板状。如图14b至图14e所示,承载部22为弹性件,弹性件随延伸臂20收入于钳臂11时被压缩并处于压缩状态,弹性件随延伸臂20伸出钳臂11时,即延伸臂20的末端超出钳臂11的自由端时,弹性件不再受外部压迫从而舒展并处于舒展状态,舒展状态时的弹性件的面积大于压缩状态时的弹性件的面积,从而使得弹性件与瓣叶之间具有更大的接触面积,以更好地贴合瓣叶,提高延伸臂20对瓣叶的支撑性。优选的,本申请中,弹性件伸展后所在的面与钳臂11的第一表面112a之间平行,以使得弹性件伸展后与瓣叶之间有更大的接触面积,从而实现对瓣叶更好的支撑效果。具体的,第一平面112a与弹性件伸展后所在的面可以均为平面,也可以均为曲面。Please refer to FIGS. 14a to 14e. FIGS. 14a to 14e are schematic diagrams of the extension arms of other embodiments of the present application. In these embodiments, the free end 20b of the extension arm 20 is further provided with a bearing portion 22. When the end of the extension arm 20 exceeds the free end 11b of the forceps arm 11, the width of the bearing portion 22 is greater than the diameter of the extension arm 20, so that the bearing portion 22 has a larger bearing area and better supports the valve leaflets. The width direction of the supporting portion 22 is the same as the width direction of the clamp arm 11. The supporting portion 22 may be a plate-shaped structure or an elastic member. As shown in FIG. 14a, the carrying portion 22 has a plate-shaped structure, specifically a plate-shaped structure. As shown in Figures 14b to 14e, the carrying portion 22 is an elastic member. The elastic member is compressed and in a compressed state when the extension arm 20 is received in the clamp arm 11, and when the elastic member extends out of the clamp arm 11 with the extension arm 20, it extends When the end of the arm 20 exceeds the free end of the clamp arm 11, the elastic member is no longer compressed by the outside and is stretched and in a stretched state. The area of the elastic member in the stretched state is greater than the area of the elastic member in the compressed state, so that the elastic member and There is a larger contact area between the leaflets to better fit the leaflets and improve the support of the extension arm 20 to the leaflets. Preferably, in the present application, the surface on which the elastic member is stretched is parallel to the first surface 112a of the forceps arm 11, so that there is a larger contact area between the elastic member and the leaflets after the elastic member is stretched, so as to achieve alignment of the leaflets. Better support effect. Specifically, the first flat surface 112a and the surface on which the elastic member is stretched may both be flat or curved.
请参阅图14c,本申请的另一实施例中,弹性件为可变形的网笼。具体的,所述弹性件为具有一定的弹性以及张力的丝线编织形成的笼状结构。网笼收入于钳臂11内时,网笼挤压变形而处于压缩状态,并能够收入于钳臂11内。当网笼伸出钳臂11时,网笼舒展而处于舒展状态,舒展后的所述网笼的体积大于挤压时的网笼的体积,从而为延伸臂20上承托的瓣叶提供更稳定的支撑。本申请中,形成网笼的丝线可以为具有较好的生物相容性的金属丝或者具有一定弹性的高分子材料制成的丝线。本实施例中采用镍钛丝。进一步的,相较于如图14b所示实施例中的弹性件来说,本实施例的弹性件为立体的结构,能够有更加立体的显影效果,并能为延伸臂20上承托的瓣叶提供更稳定的支撑(如图16所示)。Please refer to Fig. 14c. In another embodiment of the present application, the elastic member is a deformable net cage. Specifically, the elastic member is a cage structure formed by weaving silk threads with certain elasticity and tension. When the net cage is received in the clamp arm 11, the net cage is squeezed and deformed to be in a compressed state, and can be received in the clamp arm 11. When the net cage extends out of the clamp arm 11, the net cage stretches and is in a stretched state. The volume of the net cage after expansion is larger than the volume of the net cage when squeezed, thereby providing more space for the valve leaflets supported on the extension arm 20. Stable support. In this application, the wire forming the net cage may be a metal wire with good biocompatibility or a wire made of a polymer material with a certain elasticity. In this embodiment, Nitinol wire is used. Further, compared with the elastic member in the embodiment shown in FIG. 14b, the elastic member of this embodiment has a three-dimensional structure, can have a more three-dimensional visualization effect, and can be a petal supported on the extension arm 20 The leaves provide more stable support (as shown in Figure 16).
请一并参阅图14c及图15,本实施例中,网笼包括编织网221以及分别固定于编织网221的两端的封头222以及固定管223。具体的,镍钛丝形成一个筒状的编织网221,编织网221的一端固定于封头222内。即封头222将编织网221的一个开口端收拢并固定。编织网221的另一端收拢并固定于固定管223内。固定管223背离编织网221的一端连接至延伸臂20。封头222及固定管223均可以为金属材质或者高分子塑料材质制成。本实施例中,封头222为不锈钢材质制成。Please refer to FIG. 14c and FIG. 15 together. In this embodiment, the net cage includes a woven net 221, a head 222 and a fixing tube 223 respectively fixed to both ends of the woven net 221. Specifically, the nickel-titanium wire forms a cylindrical woven mesh 221, and one end of the woven mesh 221 is fixed in the head 222. That is, the head 222 gathers and fixes an open end of the woven net 221. The other end of the woven mesh 221 is gathered and fixed in the fixing tube 223. The end of the fixing tube 223 facing away from the woven mesh 221 is connected to the extension arm 20. Both the head 222 and the fixing tube 223 can be made of metal material or polymer plastic material. In this embodiment, the head 222 is made of stainless steel.
本实施例中,网笼为中间为柱状,两头为锥形,且两头的锥形的锥角相同的结构。可以理解的是,本申请中,网笼也可以为其它的任何形状。例如,请参阅图14d及图14e,网笼可以为图14d所示的两头为锥角相同的锥形的纺锤形结构,也可以图14e所示的两头的锥角不同的结构。In this embodiment, the mesh cage has a cylindrical shape in the middle, a cone at both ends, and the cone angles of the cones at both ends are the same. It can be understood that, in this application, the net cage can also have any other shape. For example, referring to FIGS. 14d and 14e, the net cage may be a spindle-shaped structure with the same taper angle at both ends as shown in FIG. 14d, or a structure with different taper angles at both ends as shown in FIG. 14e.
请参阅图16及图17,图16所示为本申请的另一实施例的瓣膜夹合器100,图17为图16所示实施例的钳臂12的结构示意图。该实施例与图3所示实施例的差别在于:钳臂11的宽度大于夹持臂12的宽度。并且,钳臂11上设有容纳槽15,钳臂11与夹持臂12对合时,夹持臂12的凸齿121恰好位于钳臂11的容纳槽15内,使得钳臂11与夹持臂12对瓣膜的夹合效果更稳定。通过增大钳臂11的宽度,使得钳臂11的宽度大于夹持臂12的宽度,从而使得钳臂11与夹持臂12夹合瓣叶的夹合面积增加,夹合力更分散地施加在瓣叶上,减小对瓣膜的拉伤;并且,使得钳臂11的第一表面112a能够与夹持臂12的第三表面12d贴合,从而使得钳臂11贴合于推杆40时,瓣膜夹合器100的外径更小,便于瓣膜夹合器100的输送过程。本实施例中,增加钳臂11的宽度至6mm。Please refer to FIGS. 16 and 17. FIG. 16 shows a valve clamp 100 according to another embodiment of the present application, and FIG. 17 is a structural diagram of the forceps arm 12 of the embodiment shown in FIG. 16. The difference between this embodiment and the embodiment shown in FIG. 3 is that the width of the clamp arm 11 is greater than the width of the clamping arm 12. In addition, the pliers arm 11 is provided with a receiving groove 15. When the pliers arm 11 and the clamping arm 12 are aligned, the protruding teeth 121 of the clamping arm 12 are exactly located in the accommodating groove 15 of the pliers arm 11, so that the pliers arm 11 is The clamping effect of the arm 12 on the valve is more stable. By increasing the width of the clamp arm 11, the width of the clamp arm 11 is greater than the width of the clamp arm 12, so that the clamping area of the clamp arm 11 and the clamping arm 12 to clamp the leaflets is increased, and the clamping force is more dispersed. On the valve leaflets, the strain on the valve is reduced; and the first surface 112a of the clamp arm 11 can be attached to the third surface 12d of the clamping arm 12, so that when the clamp arm 11 is attached to the push rod 40, The outer diameter of the valve clamp 100 is smaller, which facilitates the delivery process of the valve clamp 100. In this embodiment, the width of the clamp arm 11 is increased to 6 mm.
进一步的,一些实施例中,钳臂11上设有通孔115,且通孔115设于容纳槽15内,通过设置通孔115有助于内皮细胞的爬覆。可以理解的是,如图18所示,一些实施例中,钳臂11上也可以没有通孔115。Further, in some embodiments, the forceps arm 11 is provided with a through hole 115, and the through hole 115 is provided in the receiving groove 15, and the through hole 115 is provided to facilitate the crawling of endothelial cells. It can be understood that, as shown in FIG. 18, in some embodiments, the pliers arm 11 may not have a through hole 115.
请参阅图19及图20,本申请还提供一种瓣膜夹合系统,瓣膜夹合系统包括推送装置及前述的瓣膜夹合器100,通过推送装置可将瓣膜夹合器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。推送装置包括用于操作者握持的操作手柄及与操作手柄远端相连、且具有一定轴向长度的推送轴,推送轴近端与操作手柄连接,推送轴的远端与瓣膜夹合器100之间可拆卸连接。具体的,推送轴包括芯轴210、套设于芯轴210外的衬管220以及套设于衬管220外的外管230。操作手柄能够分别驱动芯轴210、衬管220以及外管230进行相对移动。19 and 20, the present application also provides a valve clamping system. The valve clamping system includes a pushing device and the aforementioned valve clamping device 100. The valve clamping device 100 can be delivered to the mitral valve through the pushing device. And adjust the valve clamp 100 to the appropriate position of the mitral valve. The pushing device includes an operating handle for the operator to hold and a pushing shaft connected to the distal end of the operating handle and having a certain axial length. The proximal end of the pushing shaft is connected to the operating handle, and the distal end of the pushing shaft is connected to the valve clamp 100 Removable connection between. Specifically, the pushing shaft includes a mandrel 210, a liner 220 sleeved outside the mandrel 210, and an outer tube 230 sleeved outside the liner 220. The operating handle can respectively drive the mandrel 210, the liner 220, and the outer tube 230 for relative movement.
芯轴210的远端具有与推杆40的近端的螺纹孔412内的内螺纹相对应的外螺纹211。推送轴与瓣膜夹合器100连接时,芯轴210的远端与推杆40的近端进行螺纹连接,通过操作手柄驱动芯轴210移动,从而实现推杆40沿轴向的移动。The distal end of the mandrel 210 has an external thread 211 corresponding to the internal thread in the threaded hole 412 at the proximal end of the push rod 40. When the pushing shaft is connected to the valve clamp 100, the distal end of the mandrel 210 is threadedly connected with the proximal end of the push rod 40, and the mandrel 210 is driven to move by the operating handle, so that the push rod 40 moves in the axial direction.
外管230的远端上设有T形弹片231,用于与基座连接管60上的T型槽63进行配合,以实现外管230与基座连接管60的连接与解锁。自然状态时,T型弹片的一端与外管230的远端连接,另一端向外管230的轴线所在位置倾斜。具体的,推送轴与瓣膜夹合器100连接时,芯轴210与推杆40螺纹连接,操作手柄驱动衬管220移动,以使得衬管220伸入基座连接管60内时,衬管220顶起外管230的T形弹片231,使得T形弹片231嵌入到基座连接管60的T形槽63内,此时基座连接管60与外管230处于连接状态;当操作所述操作手柄使得衬管220离开基座连接管60内,外管230的T型弹片231处于自然状态,即向内侧变形并从T形槽63脱离,使得基座连接管60与外套管230解开锁定。A T-shaped elastic piece 231 is provided on the distal end of the outer tube 230 for mating with the T-shaped groove 63 on the base connecting tube 60 to realize the connection and unlocking of the outer tube 230 and the base connecting tube 60. In the natural state, one end of the T-shaped elastic piece is connected to the distal end of the outer tube 230, and the other end is inclined at the position of the axis of the outer tube 230. Specifically, when the push shaft is connected to the valve clamp 100, the mandrel 210 is threadedly connected with the push rod 40, and the operating handle drives the liner 220 to move, so that when the liner 220 extends into the base connecting tube 60, the liner 220 The T-shaped elastic piece 231 of the outer tube 230 is pushed up so that the T-shaped elastic piece 231 is inserted into the T-shaped groove 63 of the base connecting tube 60. At this time, the base connecting tube 60 and the outer tube 230 are in a connected state; The handle causes the liner 220 to leave the base connecting tube 60, and the T-shaped elastic piece 231 of the outer tube 230 is in a natural state, that is, deforms inwardly and detaches from the T-shaped groove 63, so that the base connecting tube 60 and the outer tube 230 are unlocked .
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: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:
第一步:将推送轴与瓣膜夹合器100进行连接。旋转推送轴的芯轴210,使得芯轴210与推杆40固定。并向远端轴向移动衬管220,以将外管230的T形弹片231顶起以使得T形弹片231嵌入到基座连接管60的T形槽63内,使得基座连接管60与外管230处于连接状态。此时,基座连接管60上的弹片62的自由端位于推杆40的环槽411内,以使得钳臂11及夹持臂12均收拢于推杆40的表面。此时,推送轴与瓣膜夹合器100的连接状态如图21及图22所示。The first step: connect the push shaft with the valve clamp 100. The mandrel 210 of the push shaft is rotated to make the mandrel 210 and the push rod 40 fixed. And axially move the liner 220 to the distal end to push up the T-shaped elastic piece 231 of the outer tube 230 so that the T-shaped elastic piece 231 is inserted into the T-shaped groove 63 of the base connecting tube 60, so that the base connecting tube 60 and The outer tube 230 is in a connected state. At this time, the free end of the elastic piece 62 on the base connecting tube 60 is located in the ring groove 411 of the push rod 40, so that the clamp arm 11 and the clamping arm 12 are both gathered on the surface of the push rod 40. At this time, the connection state of the push shaft and the valve clamp 100 is shown in FIGS. 21 and 22.
第二步:通过推送轴将与其相连的瓣膜夹合器100从左心房推进,经过二尖瓣到达左心室。Step 2: Push the valve clamp 100 connected to it from the left atrium through the push shaft, and pass through the mitral valve to the left ventricle.
第三步:向远端轴向移动衬管220,使得衬管220顶起基座连接管60上的弹片62的自由端,使得弹片62的自由端脱离环槽411。此时,推杆40能够在基座连接管60内进行轴向移动,从而推动钳臂11相对推杆40的开合以及带动延伸臂20的伸长及收缩。The third step: move the liner 220 axially to the distal end, so that the liner 220 pushes up the free end of the elastic piece 62 on the base connecting pipe 60 so that the free end of the elastic piece 62 escapes from the ring groove 411. At this time, the push rod 40 can move axially within the base connecting pipe 60 to push the jaw arm 11 to open and close relative to the push rod 40 and drive the extension and contraction of the extension arm 20.
第四步:通过操作手柄向近端移动芯轴210,从而带动与芯轴210连接的推杆40向近端方向移动,以驱动钳臂11相对推杆40张开,同时使得延伸臂20自钳臂11中伸出。Step 4: Move the mandrel 210 to the proximal end by operating the handle, thereby driving the push rod 40 connected with the mandrel 210 to move in the proximal direction to drive the pliers arm 11 to open relative to the push rod 40, and at the same time make the extension arm 20 self The clamp arm 11 extends.
第五步:调整瓣膜夹合器100的方向,并通过X射线等设备观察每个钳臂11与前叶1a和后叶1b的相对位置,使得钳臂11垂直于二尖瓣的对合线。Step 5: Adjust the direction of the valve clamp 100, and observe the relative position of each forceps arm 11 to the anterior leaflet 1a and posterior leaflet 1b through X-rays and other equipment, so that the forceps arm 11 is perpendicular to the aligning line of the mitral valve .
第六步:向近端回撤整个调整瓣膜夹合器100,使钳臂11和延伸臂20在心室侧托住瓣叶。Step 6: Withdraw the entire adjustment valve clamp 100 proximally, so that the forceps arm 11 and the extension arm 20 support the valve leaflets on the side of the ventricle.
第七步:释放夹持臂12,使得二尖瓣的前叶1a和后叶1b分别被夹持在一对钳臂11和夹持臂12之间,由此抓持瓣叶。Step 7: Release the clamping arm 12 so that the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are respectively clamped between a pair of clamp arms 11 and clamping arms 12, thereby grasping the leaflets.
第八步:向远端移动芯轴210,芯轴210带动推杆40向远端移动,从而驱动钳臂11收拢,并使得延伸臂20收入到限位件14内,即延伸臂20的末端回缩;Step 8: Move the mandrel 210 to the distal end, and the mandrel 210 drives the push rod 40 to move distally, thereby driving the pliers arm 11 to close, and the extension arm 20 is received into the stopper 14, that is, the end of the extension arm 20 Retract
第九步:外管230固定不动,衬管220向近端回撤一定的行程,此时基座连接管60的弹片62的自由端卡入到推杆40的环槽411内,以保证钳臂11始终收拢。通过操作手柄控制芯轴210旋转,使得芯轴210与推杆40之间螺纹解锁。向近端回撤衬管220和芯轴210,直至外管230的T形弹片231与基座连接管60的T形卡槽63解锁分离。此时,瓣膜夹合器100与推送轴完全分离。将推送轴撤出患者体外,瓣膜夹合器100留置于患者体内,完成二尖瓣的瓣叶缘对缘修复。Step 9: The outer tube 230 is fixed and the liner 220 is retracted to the proximal end for a certain distance. At this time, the free end of the elastic piece 62 of the base connecting tube 60 is locked into the ring groove 411 of the push rod 40 to ensure The clamp arm 11 is always closed. The mandrel 210 is controlled to rotate through the operating handle, so that the thread between the mandrel 210 and the push rod 40 is unlocked. The liner 220 and the mandrel 210 are retracted to the proximal end until the T-shaped elastic piece 231 of the outer tube 230 is unlocked and separated from the T-shaped slot 63 of the base connecting tube 60. At this time, the valve clamp 100 is completely separated from the pushing shaft. The push shaft is withdrawn from the patient's body, and the valve clamp 100 is left in the patient's body to complete the edge-to-edge repair of the mitral valve leaflet.
本申请的瓣膜夹合系统,能够实现在体外进行操作,以将瓣膜夹合器夹合瓣叶,减轻或避免“二尖瓣反流”的问题。并且,由于瓣膜夹合器能够容易的捕捉瓣叶,从而使得通过瓣膜夹合系统进行“二尖瓣反流”手术的难度大大降低,并降低手术时间。The valve clamping system of the present application can be operated outside the body to clamp the valve leaflet with the valve clamp, thereby reducing or avoiding the problem of "mitral valve regurgitation". In addition, since the valve clamp can easily capture the valve leaflets, the difficulty of performing "Mitral Regurgitation" surgery through the valve clamp system is greatly reduced, and the operation time is reduced.
以上所述,仅为本申请的具体实施方式,但本申请的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本申请揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本申请的保护范围之内。因此,本申请的保护范围应以所述权利要求的保护范围为准。The above are only specific implementations of this application, but the protection scope of this application is not limited to this. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed in this application. Should be covered within the scope of protection of this application. Therefore, the protection scope of this application should be subject to the protection scope of the claims.

Claims (22)

  1. 一种易夹持的瓣膜夹合器,其特征在于,包括:An easy-to-hold valve clamp, which is characterized in that it comprises:
    推杆;Putter
    至少两个钳臂,所述钳臂包括固定端及自由端,所述固定端与所述推杆连接,所述推杆轴向移动以带动所述钳臂以所述固定端为旋转中心相对所述推杆开合;At least two pliers arms, the pliers arms include a fixed end and a free end, the fixed end is connected to the push rod, and the push rod moves axially to drive the pliers arms to face each other with the fixed end as the center of rotation The push rod opens and closes;
    至少一根延伸臂,所述延伸臂沿所述钳臂的轴向伸长或缩回,当所述延伸臂沿钳臂的固定端向自由端方向伸长时,所述延伸臂的末端超出所述钳臂的自由端。At least one extension arm, the extension arm extends or retracts along the axial direction of the clamp arm, and when the extension arm extends in the direction of the free end along the fixed end of the clamp arm, the end of the extension arm exceeds The free end of the clamp arm.
  2. 如权利要求1所述的易夹持的瓣膜夹合器,其特征在于,所述延伸臂的伸长或缩回与所述钳臂相对所述推杆的打开或合拢同步。The easy-to-hold valve clamp of claim 1, wherein the extension or retraction of the extension arm is synchronized with the opening or closing of the forceps arm relative to the push rod.
  3. 如权利要求1或2所述的易夹持的瓣膜夹合器,其特征在于,所述推杆的远端设有齿条,所述钳臂的固定端设有齿轮,所述齿轮与所述齿条啮合。The easy-to-hold valve clamp of claim 1 or 2, wherein the distal end of the push rod is provided with a rack, the fixed end of the clamp arm is provided with a gear, and the gear is The rack is engaged.
  4. 如权利要求1或2所述的易夹持的瓣膜夹合器,其特征在于,所述推杆的远端设有基座,所述延伸臂与所述末端相背离的一端固定于所述基座上,所述推杆轴向移动以带动所述延伸臂沿所述钳臂伸长或缩回。The easy-to-hold valve clamp of claim 1 or 2, wherein the distal end of the push rod is provided with a base, and the end of the extension arm away from the distal end is fixed to the On the base, the push rod moves axially to drive the extension arm to extend or retract along the clamp arm.
  5. 如权利要求1所述的易夹持的瓣膜夹合器,其特征在于,所述延伸臂的末端设有承载部,所述延伸臂的末端超出所述钳臂的自由端时,所述承载部的宽度大于所述延伸臂的直径,所述承载部的宽度方向与所述钳臂的宽度方向相同。The easy-to-hold valve clamp of claim 1, wherein the end of the extension arm is provided with a bearing portion, and when the end of the extension arm exceeds the free end of the clamp arm, the bearing The width of the portion is greater than the diameter of the extension arm, and the width direction of the bearing portion is the same as the width direction of the clamp arm.
  6. 如权利要求5所述的易夹持的瓣膜夹合器,其特征在于,所述承载部为板状结构。The easy-to-hold valve clamp of claim 5, wherein the supporting portion is a plate-shaped structure.
  7. 如权利要求5所述的易夹持的瓣膜夹合器,其特征在于,所述承载部为弹性件,所述弹性件具有压缩状态及舒展状态,舒展状态时的所述弹性件的面积大于压缩状态时的所述弹性件的面积,所述延伸臂的末端超出所述钳臂的自由端时,所述弹性件处于舒展状态。The easy-to-hold valve clamp of claim 5, wherein the bearing portion is an elastic member, the elastic member has a compressed state and a stretched state, and the area of the elastic member in the stretched state is larger than The area of the elastic member in the compressed state. When the end of the extension arm exceeds the free end of the clamp arm, the elastic member is in a stretched state.
  8. 如权利要求7所述的易夹持的瓣膜夹合器,其特征在于,所述弹性件为可变形的网笼。8. The easy-to-hold valve clamp of claim 7, wherein the elastic member is a deformable net cage.
  9. 如权利要求1所述的易夹持的瓣膜夹合器,其特征在于,所述延伸臂活动地设于所述钳臂的表面或内部。The easy-to-hold valve clamp according to claim 1, wherein the extension arm is movably arranged on the surface or inside of the forceps arm.
  10. 如权利要求9所述的易夹持的瓣膜夹合器,其特征在于,所述延伸臂通过限位件限位于所述钳臂的表面,所述限位件用于限定所述延伸臂的伸缩方向为沿所述钳臂的固定端向自由端的方向。The easy-to-hold valve clamp of claim 9, wherein the extension arm is limited on the surface of the clamp arm by a limiting member, and the limiting member is used to limit the extension arm The telescopic direction is the direction from the fixed end to the free end of the clamp arm.
  11. 如权利要求1所述的易夹持的瓣膜夹合器,其特征在于,所述瓣膜夹合器还包括固定基座,所述固定基座包括两块相对的夹板,所述推杆位于两块所述夹板之间并相对所述夹板移动,所述钳臂的固定端位于所述两块夹板之间并与所述夹板旋转连接。The easy-to-hold valve clamp of claim 1, wherein the valve clamp further comprises a fixed base, the fixed base includes two opposing splints, and the push rods are located at two Between the two splints and move relative to the splint, the fixed end of the clamp arm is located between the two splints and is rotatably connected with the splint.
  12. 如权利要求11所述的易夹持的瓣膜夹合器,其特征在于,所述瓣膜夹合器还包括基座连接管,所述基座连接管套于所述推杆外并与所述固定基座固定。The easy-to-hold valve clamp of claim 11, wherein the valve clamp further comprises a base connecting tube, and the base connecting tube is sleeved outside the push rod and connected to the The fixed base is fixed.
  13. 如权利要求12所述的易夹持的瓣膜夹合器,其特征在于,所述推杆的远端环设有环槽,所述基座连接管上设有弹片,所述钳臂处于收拢状态时,所述弹片的一端卡入于所述环槽内。The easy-to-hold valve clamp of claim 12, wherein the distal end of the push rod is provided with a ring groove, the base connecting tube is provided with an elastic sheet, and the forceps arm is in a closed position. In the state, one end of the elastic piece is clamped into the ring groove.
  14. 如权利要求1所述的易夹持的瓣膜夹合器,其特征在于,所述瓣膜夹合器还包括夹持件,所述夹持件位于所述钳臂与所述推杆之间,所述夹持件相对所述钳臂开合以与所述钳臂配合夹持瓣叶。The easy-to-hold valve clamp of claim 1, wherein the valve clamp further comprises a clamp, and the clamp is located between the clamp arm and the push rod, The clamping member is opened and closed relative to the clamp arm to cooperate with the clamp arm to clamp the valve leaflet.
  15. 如权利要求14所述的易夹持的瓣膜夹合器,其特征在于,所述夹持件至少部分由弹性材料制成。The easy-to-hold valve clamp of claim 14, wherein the holding member is at least partially made of an elastic material.
  16. 如权利要求14所述的易夹持的瓣膜夹合器,其特征在于,所述瓣膜夹合器还包括固定基座,所述夹持件包括至少两个夹持臂,每个所述夹持臂包括相对设置的自由端及固定端,所述夹持臂的固定端固定于所述固定基座上。The easy-to-hold valve clamp of claim 14, wherein the valve clamp further includes a fixed base, the clamp includes at least two clamp arms, each of the clamps The holding arm includes a free end and a fixed end that are arranged oppositely, and the fixed end of the holding arm is fixed on the fixed base.
  17. 如权利要求16所述的易夹持的瓣膜夹合器,其特征在于,所述夹持臂包括与所述钳臂相对的夹持面,所述夹持面上设有夹持增强件。The easy-to-clamp valve clamp of claim 16, wherein the clamping arm includes a clamping surface opposite to the clamp arm, and a clamping reinforcement is provided on the clamping surface.
  18. 如权利要求17所述的易夹持的瓣膜夹合器,其特征在于,所述钳臂包括朝向所述推杆的第一表面以及与所述第一表面相对的第二表面,所述第一表面上设有向所述第二表面凹陷的凹槽,所述钳臂与所述夹持臂夹紧时所述夹持增强件位于所述凹槽内。The easy-to-hold valve clamp of claim 17, wherein the forceps arm includes a first surface facing the push rod and a second surface opposite to the first surface, and the first surface A groove recessed toward the second surface is provided on one surface, and the clamping reinforcement is located in the groove when the clamp arm is clamped with the clamping arm.
  19. 如权利要求18所述的易夹持的瓣膜夹合器,其特征在于,所述钳臂的宽度大于所述夹持臂的宽度。The easy-to-hold valve clamp of claim 18, wherein the width of the clamp arm is greater than the width of the clamp arm.
  20. 如权利要求18所述的易夹持的瓣膜夹合器,其特征在于,所述钳臂和/或夹持臂上设有多个间隔设置的开孔。The easy-to-clamp valve clamp of claim 18, wherein the clamp arm and/or the clamping arm are provided with a plurality of openings arranged at intervals.
  21. 一种瓣膜夹合系统,其特征在于,包括推送装置及权利要求1-20任一项所述的易夹持的瓣膜夹合器,所述推送装置包括操作手柄及具有一定轴向长度的推送轴,所述推送轴近端与所述操作手柄连接,所述推送轴的远端与所述瓣膜夹合器之间可拆卸连接。A valve clamping system, characterized in that it comprises a pushing device and the easy-to-hold valve clamping device of any one of claims 1-20, and the pushing device includes an operating handle and a pushing device with a certain axial length. A shaft, the proximal end of the pushing shaft is connected with the operating handle, and the distal end of the pushing shaft is detachably connected with the valve clamp.
  22. 如权利要求21所述的瓣膜夹合系统,其特征在于,所述推送轴包括活动地同轴套装在一起的芯轴、衬管及外管,所述衬管位于所述芯轴与所述外管之间;所述芯轴与所述推杆可拆卸连接,所述芯轴用于推动所述推杆沿轴向移动。The valve clamping system according to claim 21, wherein the pushing shaft comprises a mandrel, a liner and an outer tube that are movably coaxially fitted together, and the liner is located between the mandrel and the Between the outer tubes; the mandrel and the push rod are detachably connected, and the mandrel is used to push the push rod to move in the axial direction.
PCT/CN2020/101374 2019-07-12 2020-07-10 Easily operable valve clamping device and valve clamping system WO2021008461A1 (en)

Applications Claiming Priority (4)

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CN201910632959.XA CN112206017A (en) 2019-07-12 2019-07-12 Valve clamping device easy to clamp and valve clamping system
CN201921097737.4 2019-07-12
CN201910632959.X 2019-07-12
CN201921097737.4U CN211834508U (en) 2019-07-12 2019-07-12 Valve clamping device easy to clamp and valve clamping system

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