WO2021008461A1 - Dispositif de serrage de valvule facile à actionner et système de serrage de valvule - Google Patents

Dispositif de serrage de valvule facile à actionner et système de serrage de valvule 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
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English (en)
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 CN201921097737.4U external-priority patent/CN211834508U/zh
Priority claimed from CN201910632959.XA external-priority patent/CN112206017A/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2021008461A1 publication Critical patent/WO2021008461A1/fr

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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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif de serrage de valvule (100) facile à actionner et un système de serrage de valvule. Le système de serrage de valvule comprend le dispositif de serrage de valvule (100) et un dispositif de poussée. Le dispositif de serrage de valvule (100) comprend une tige de poussée (40), au moins deux bras de serrage (11) et au moins un bras d'extension (20). La tige de poussée (40) se déplace axialement de manière à entraîner les bras de serrage (11) pour qu'ils s'ouvrent et se ferment par rapport à la tige de poussée (40), et à entraîner le bras d'extension (20) pour qu'il s'étende ou se rétracte le long de la direction axiale d'un bras de serrage (11). Dans le système, le bras d'extension télescopique (20) est disposé sur la surface d'un bras de serrage (11) dans le dispositif de serrage de valvule (100), et le bras d'extension (20) s'étend hors du bras de serrage (11) au moment où le bras de serrage (11) s'ouvre par rapport à la tige de poussée (40) du dispositif de serrage de valvule (100), ce qui correspond à une augmentation de la longueur du bras de serrage (11). Le bras de serrage le plus long (11) peut présenter un meilleur effet de support sur les feuillets de valvule lorsque les feuillets de valvule sont capturés, ce qui empêche ainsi les feuillets de valvule de glisser hors de la surface du bras de serrage (11), permet une capture rapide de feuillets de valvule mobiles, réduit la difficulté de la chirurgie et améliore l'efficacité de la chirurgie.
PCT/CN2020/101374 2019-07-12 2020-07-10 Dispositif de serrage de valvule facile à actionner et système de serrage de valvule WO2021008461A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201910632959.X 2019-07-12
CN201921097737.4U CN211834508U (zh) 2019-07-12 2019-07-12 易夹持的瓣膜夹合器及瓣膜夹合***
CN201910632959.XA CN112206017A (zh) 2019-07-12 2019-07-12 易夹持的瓣膜夹合器及瓣膜夹合***
CN201921097737.4 2019-07-12

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CN113456297A (zh) * 2021-06-30 2021-10-01 上海汇禾医疗器械有限公司 夹合器械
CN113662714A (zh) * 2021-08-30 2021-11-19 上海汇禾医疗器械有限公司 夹持器械
CN114081674A (zh) * 2021-09-28 2022-02-25 四川大学华西医院 一种瓣叶分割装置
CN114848231A (zh) * 2022-05-04 2022-08-05 上海腾复医疗科技有限公司 瓣膜修复装置
CN115068167A (zh) * 2021-03-12 2022-09-20 瀚芯医疗科技(深圳)有限公司 一种可回收的瓣膜夹合装置及***
CN115105252A (zh) * 2021-03-23 2022-09-27 杭州德晋医疗科技有限公司 具有封堵功能的瓣膜夹合装置及瓣膜夹合***

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CN115068167A (zh) * 2021-03-12 2022-09-20 瀚芯医疗科技(深圳)有限公司 一种可回收的瓣膜夹合装置及***
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CN113456297A (zh) * 2021-06-30 2021-10-01 上海汇禾医疗器械有限公司 夹合器械
CN113662714A (zh) * 2021-08-30 2021-11-19 上海汇禾医疗器械有限公司 夹持器械
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CN114848231A (zh) * 2022-05-04 2022-08-05 上海腾复医疗科技有限公司 瓣膜修复装置

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