WO2019218930A1 - Dispositif de serrage de valve et système de serrage de valve - Google Patents

Dispositif de serrage de valve et système de serrage de valve Download PDF

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Publication number
WO2019218930A1
WO2019218930A1 PCT/CN2019/086254 CN2019086254W WO2019218930A1 WO 2019218930 A1 WO2019218930 A1 WO 2019218930A1 CN 2019086254 W CN2019086254 W CN 2019086254W WO 2019218930 A1 WO2019218930 A1 WO 2019218930A1
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WO
WIPO (PCT)
Prior art keywords
arm
valve
caliper
push rod
extension arm
Prior art date
Application number
PCT/CN2019/086254
Other languages
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 CN201810476710.XA external-priority patent/CN110495972A/zh
Priority claimed from CN201820739065.1U external-priority patent/CN209548144U/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 WO2019218930A1 publication Critical patent/WO2019218930A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord

Definitions

  • the invention relates to the field of medical instruments, and in particular to a valve clamp and a valve clamping system.
  • the mitral valve 1 is a one-way valve between the left atrium 2 and the left ventricle 3 of the heart.
  • the normal healthy mitral valve 1 can control blood flow from the left atrium 2 to the left ventricle 3 while avoiding blood from The left ventricle 3 flows to the left atrium 2.
  • the mitral valve includes a pair of leaflets, referred to as the anterior leaf 1a and the posterior leaf 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 completely mate to prevent blood from flowing from the left ventricle 3 to the left atrium 2.
  • the mitral valve leaflet or its related structural generator has a qualitative change or a functional change (such as chordae 4), the anterior lobe 1a and the posterior lobe 1b of the mitral valve are poorly aligned.
  • 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.”
  • the valve clipper includes a push rod, at least two clamps, and at least one extension arm.
  • One end of the clamp is connected to the push rod and is opened and closed with respect to the push rod; each of the clamps includes a first clamp arm, and the first clamp arm includes a fixed end and a free end, the fixing The end is rotatably coupled to the push rod, and the first caliper arm is opened and closed with the push rod at a fixed position of the fixed end on the push rod; the extension arm is along the first An axial extension or retraction of the caliper arm, the end of the extension arm extending beyond the free end of the first caliper arm when the extension arm is elongated toward the free end along the fixed end of the first caliper arm .
  • the valve clamping system includes a pushing device and a valve clamp
  • the pushing device includes an operating handle and a pushing shaft having a certain axial length, and the proximal end of the pushing shaft is coupled to the operating handle, the pushing shaft The distal end is detachably coupled to the valve clipper.
  • the valve clip and valve clamping system provided by the present invention, by providing an extension arm that can be extended or retracted along the axial direction of the first caliper arm, so that the first caliper arm extends when the push rod is opened
  • the end of the arm extends beyond the free end of the first caliper arm, which corresponds to increasing the length of the first caliper arm of the clamp when capturing the leaflet, and the longer first caliper arm can be used to capture the leaflet when capturing the leaflet Good support effect, avoiding the leaflet slipping off the surface of the first clamp arm, so that the active leaflet tissue can be quickly captured, the operation difficulty is reduced, and the operation efficiency is improved.
  • Figure 1 is a schematic view of the mitral valve in a normal state
  • Figure 2 is a schematic view of the mitral valve in the presence of lesions
  • FIG. 3 is a schematic structural view of a valve clamp according to an embodiment of the present invention when it is folded;
  • Figure 4 is a schematic view showing the structure of the first clamp arm of the valve clamp shown in Figure 3;
  • Figure 5 is a schematic cross-sectional view showing the first caliper arm of the valve clipper shown in Figure 3 when opened;
  • Figure 6 is a schematic view showing the position of the valve clip of the present invention at the mitral valve
  • Figure 7a is a schematic view of the mitral valve when the heart is contracted after the valve clip is clamped by the valve clamp of the present invention
  • Figure 7b is a schematic view of the mitral valve of the diastolic heart after the valve clip is clamped by the valve clamp of the present invention
  • FIG. 8 is a schematic structural view of a first clamp arm of a valve clamp according to another embodiment of the present invention.
  • FIG. 9 is a schematic structural view of an extension arm of a valve clipper according to an embodiment of the present invention.
  • FIG. 10 is a schematic structural view of an extension arm of a valve clipper according to another embodiment of the present invention.
  • FIG. 11 is a schematic structural view of an extension arm of a valve clipper according to another embodiment of the present invention.
  • FIG. 12 is a schematic structural view of a first clamp arm of a valve clamp according to another embodiment of the present invention.
  • Figure 13 is a schematic view showing the structure of the elastic member of the valve clip of Figure 12;
  • FIG. 14 is a schematic structural view of an elastic member of a valve clipper according to another embodiment of the present invention.
  • FIG. 15 is a schematic structural view of an elastic member of a valve clipper according to another embodiment of the present invention.
  • Figure 16 is a schematic illustration of the valve clip of Figure 12 with the extension arms extending and the elastic members supporting the leaflets prior to clamping the leaflets.
  • the present invention provides a valve clamp 100.
  • the valve clamp 100 includes a push rod 40, at least two clamps 10, and at least one extension arm 20.
  • the number of the clamps 10 is two, and the two clamps 10 are arranged symmetrically with the push rod 40 as an axis. Specifically, referring to FIG.
  • FIG. 7a is a schematic view showing the state of the mitral valve when the heart contracts, wherein the direction of the arrow is the direction of blood flow.
  • FIG. 7b is a schematic diagram showing the state of the mitral valve during diastole, wherein the direction of the arrow is the direction of blood flow.
  • the anterior lobe 1a and the posterior lobe 1b are fixed together only at the position where the valve clamp 100 is clamped, and the other positions of the anterior lobe 1a and the posterior lobe 1b are still normally relaxed, so that blood can enter the left ventricle from the left atrium. To ensure the normal flow of blood.
  • the valve clamp 100 of other embodiments of the present invention can also be used to reduce or treat "tricuspid regurgitation", that is, the valve clamp 10 has three clamps 10, three of which are three by three clamps 10.
  • valve clamp 100 for solving the mitral regurgitation in the embodiment of the present invention are the same, and will not be described herein. It will be appreciated that the valve clamp 100 of other embodiments of the present invention may also be applied to other minimally invasive surgical procedures where several sheets of tissue need to be clamped together, and the number of clamps 10 is actually Use the requirements to change.
  • the push rod 40 is detachably connected with the pushing device, and the operator operates the pushing device outside the body, and after the valve clamp 100 is delivered to the mitral valve, the pushing device and the push rod 40 are pushed. Separate so that the valve clip remains at the mitral valve.
  • the pusher 40 is a rod-shaped body having a lumen or a hollow tubular body made of a biocompatible material.
  • the biocompatible material is selected from the group consisting of stainless steel, cobalt alloys or titanium alloys, preferably titanium alloys.
  • the push rod 40 is round or round, and the surface of the push rod 40 is smooth, so that the push rod 40 is prevented from damaging the leaflets or hooking the chord.
  • the distal end of the push rod 40 is provided with a base 41.
  • the base 41 includes two opposite first planes and sides that connect the two first planes.
  • the side surface includes a curved surface 413 at the distal end and a second plane 412 at the proximal end and connected to the curved surface 413.
  • the distal end of the push rod 40 is vertically fixed on the second plane 412, and the area of the second plane 412 is larger than that of the push rod 40. Cross-sectional area.
  • the cross-sectional dimension of the base 41 parallel to the second plane 412 is gradually reduced from the proximal end to the distal end, that is, the shape of the base 41 may be a hemisphere, a spherical crown, a bullet shape or the like, so that the valve clamp 100 is more It is easy to advance in the body.
  • proximal refers to the direction near the operator; “distal” refers to the direction away from the operator.
  • the outer surface of the base 41 is smooth, thereby preventing the base 41 from damaging the leaflets or hooking the chordae.
  • the push rod 40 is provided with a passage 42 in the axial direction, the passage 42 is elongated, the length direction of the passage 42 is the same as the length direction of the push rod 40, and the longitudinal direction of the passage 42 is perpendicular to the two first planes of the base 41, respectively. .
  • Each of the clamps 10 includes a first clamp arm 11 and a second clamp arm 12, and the first clamp arm 11 and the second clamp arm 12 are oppositely opened and closed to clamp or loosen the first clamp arm 11 and the second clamp arm.
  • Leaflets between 12 the clamp 10 may also include only the first clamp arm 11 , and the first clamp arm 11 is opened and closed with respect to the push rod 40 to clamp or loosen the first clamp arm 11 and the push rod. Leaflets between 40.
  • Each of the first caliper arms 11 includes a fixed end 10a at the distal end and a free end 10b at the proximal end, and the fixed ends 10a of the two first caliper arms 11 are rotationally coupled.
  • the fixed ends 10a of the two first caliper arms 11 of the embodiment are rotatably connected to the push rod 40 by pins or bolts, specifically, the base 41 of the push rod 40, so that the two A caliper arm 11 is rotatably opened and closed with respect to the push rod 10.
  • Each of the second caliper arms 12 is disposed outside the push rod 40 and corresponds to a first caliper arm 11. Therefore, the first caliper arm 11 has a fixed position of the fixed end 10a on the push rod 40 as a center of rotation.
  • the second caliper arm 12 is opened and closed.
  • the two first forceps arms 11 are tightened on the surface of the push rod 40, thereby reducing the volume of the valve clamp 100, thereby being smooth Passing through the blood vessel to the mitral valve; after the valve clamp 100 is delivered to the mitral valve, the two first forceps arms 11 are opened to their respective angles with the push rod 40, so that each first The caliper arms 11 respectively support a leaflet, and then close the first caliper arm 11 and the second caliper arm 12 of the two clamps 10, thereby respectively clamping each leaflet and fixing the front leaf 1a and the back leaf 1b together.
  • the first caliper arm 11 includes a connecting section 111 and a fixing section 112.
  • the securing section 112 is for mating with the second caliper arm 12 to secure and clamp the leaflets located between the first caliper arm 11 and the second caliper arm 12.
  • One end of the connecting section 111 is connected to the fixing section 112, and the other end is connected to the base 41.
  • the connecting section 111 includes two connecting rods arranged side by side, and the connecting rods are disposed on two opposite first planes of the base 41.
  • One end of each connecting rod is connected to the base 41, and the other end is fixed to the proximal end of the fixing portion 112 so that the first caliper arm 11 is more firmly connected to the base 41.
  • the connecting section 111 may also include only one connecting rod; or, the first caliper arm 11 does not include the connecting section 111, and the fixed section 112 is directly rotatably coupled to the base 41.
  • the fixed section 112 of the first caliper arm 11 includes a first surface 112a facing the second caliper arm 12 (ie, the inner surface of the first caliper arm 11), the first surface 112a is a curved surface, and the curvature of the curved surface The direction is toward the second caliper arm 12.
  • the first surface 112a as a curved surface, the contact area and the clamping area of the first caliper arm 11 with the leaflets can be increased, thereby providing a stable clamping force and preventing the first caliper arm 11 from injuring the leaflets.
  • the first surface 112a of the curved surface can be in better contact with the surface of the round rod-shaped push rod 40 when folded relative to the push rod 40, so as to minimize the volume when the clamp 10 of the valve clamp 100 is folded, so that the valve clamp 100 is easier to transport in the body.
  • the first caliper arm 11 has a certain size specification. Specifically, the length of the first caliper arm 11 must be within a certain range. When the length of the first caliper arm 11 is too long, the first caliper arm 11 tends to clamp the excessive front blade 1a and the rear blade 1b together.
  • the two leaflets When the two clamps 10 are closed, the two leaflets are forcibly pulled toward each other and fixed together, which not only easily leads to dysfunction of the mitral valve, but also causes excessive leaflets when the heart beats and the leaflets move. Limiting the movement may also cause serious consequences such as tearing of the leaflets; when the first caliper arm 11 is too short, the clamp 10 can only clamp a small part of the leaflets, so that the leaflets are easy to slide out, and the clamping fixation effect is poor. .
  • the leaflets are relatively soft, the leaflets are easily detached from the first caliper arms 11 during the clamping process, that is, the first caliper arms 11 are not easy to support the leaflets or cooperate with the second caliper arms 12 to hold the leaflets , prolong the operation time.
  • the axial length of the first caliper arm 11 i.e., the distance from the fixed end 10a to the free end 10b
  • the width of the first caliper arm 11 is also limited to prevent the width of the first caliper arm 11 from being too narrow to damage the leaflets, and also to avoid the width of the first caliper arm 11 when the width of the first caliper arm 11 is too wide. The effect of leaf movement.
  • the width of the first caliper arm 11 i.e., the length in the direction perpendicular to the axial direction of the first caliper arm 11
  • the first caliper arm 11 should be made of a biocompatible material and have a certain flexibility and rigidity, thereby preventing the first caliper arm 11 from injuring the leaflets, and at the same time being able to Clamp the fixed leaflets.
  • the biocompatible material is selected from the group consisting of stainless steel, cobalt alloy or titanium alloy, and titanium alloy is used in this embodiment.
  • first surface 112a of the first caliper arm 11 may also be coated with an active drug, or a plurality of openings may be provided to promote endothelial cell climbing and growth of the valve tissue on the inner surface of the first caliper arm 11. Further, the first surface 112a may also be provided as a concave-convex surface having a concave-convex structure, thereby increasing the friction between the first caliper arm 11 and the leaflets, and improving the fixing ability of the clamp 10 to the leaflets.
  • the second caliper arm 12 is fixed to the outside of the push rod 10 and is disposed opposite to the first caliper arm 11, that is, when the first caliper arm 11 is gathered on the surface of the push rod 40, the first caliper arm 11 can The two caliper arms 12 are aligned.
  • the second caliper arm 12 includes a third surface 12a opposite to the first caliper arm 11.
  • the third surface 12a is provided with a clamping reinforcement 121 to increase the friction between the second caliper arm 12 and the leaflets clamped between the first caliper arm 11 and the second caliper arm 12, and the clamp 10 is improved.
  • the clamping force on the leaflets may be a structure protruding from the rib, the barb, the boss or other irregularly distributed protrusions of the third surface 12a, or may be a rough surface at least partially covering the third surface 12a to improve The clamping force of the clamp 10 on the leaflets.
  • the outer surface of the push rod 40 is covered with a gasket made of a biocompatible material having a high coefficient of friction, thereby increasing the surface roughness coefficient of the third surface 12a, thereby increasing the clamping force of the jaws 10 on the leaflets.
  • the clamping reinforcement 121 may also be a magnetic body disposed on the second caliper arm 12. At this time, a corresponding magnetic body is also disposed on the first caliper arm 11 through the first caliper arm 11 and the second caliper arm 12 The mutual magnetic attraction between them achieves the purpose of enhancing the clamping force of the clamp 10 on the leaflets.
  • the clamping reinforcements 121 are two rows of protruding teeth.
  • Two rows of convex teeth are oppositely disposed on both side edges of the second caliper arm 12. Moreover, the angle between the axial direction of each of the convex teeth and the third surface 12a is less than or equal to 90° to further enhance the clamping force of the clamp 10 on the leaflets. Further, the end of the protruding tooth away from the third surface 12a is a smooth curved surface, thereby avoiding damage to the leaflets.
  • the second caliper arm 12 is at least partially made of an elastic material such as a nickel titanium alloy.
  • the second caliper arm 12 includes a fixed section 12a at the distal end and a connecting section 12b at the proximal end, and the connecting section 12b of the second caliper arm 12 is fixedly connected with the push rod 40, and the second caliper arm 12 is The connecting section 12b is made of an elastic material.
  • the fixing portion 12a of the second caliper arm 12 may be made of a non-elastic material such as an aluminum alloy.
  • the second caliper arm 12 and the push rod 40 are disposed at an angle. Moreover, the angle between the second caliper arm 12 and the push rod 40 is greater than or equal to the angle between the first caliper arm 11 and the push rod 40 when the first caliper arm 11 is opened to the maximum state, thereby ensuring the first The clamping arm 11 and the second caliper arm 12 have a certain clamping force to clamp the leaflets between the first caliper arm 11 and the second caliper arm 12.
  • the fixed section 12a of the second caliper arm 12 is connected with the control member in the pushing device, and the fixed section 12a of the second caliper arm 12 is controlled by the control member to adjust the angle between the second caliper arm 12 and the push rod 40 and Opening and closing between the second caliper arm 12 and the first caliper arm 11.
  • the control member is an adjustment wire (not shown) made of a polymer material such as metal or PTFE. The adjustment wire passes through the fixed section 12a of the second caliper arm 12, and the second caliper arm 12 is bound to the pusher.
  • the surface of the rod 40 after the position of the first caliper arm 11 and the leaflet is adjusted, releases the control of the fixed section 12a of the second caliper arm 12 by the adjustment line, and the connecting section 12b of the second caliper arm 12 rebounds, and drives The fixed section 12a of the second caliper arm 12 connected thereto is moved away from the push rod 40 (ie, in a direction close to the first caliper arm 11), so that the second caliper arm 12 and the first caliper arm 11 are clamped at both Leaflet between.
  • the connecting segments 12b of the two second caliper arms 12 can be coupled together, or the two second caliper arms 12 can be integrally formed.
  • the two second caliper arms 12 can be U-shaped, i.e., each side of the U-shaped structure acts as a second caliper arm 12, respectively, and cooperates with a first caliper arm 11 to hold a leaflet.
  • the extension arms 20 are at least one.
  • the extension arm 20 is provided on the surface or inside of the first caliper arm 11 of the caliper 10.
  • the extension arms 20 are two, which are respectively disposed on the surfaces of the first caliper arms 11 of the two clamps 10.
  • the extension arm 20 may be disposed on the first surface 112a of the first caliper arm 11 (ie, the inner surface of the first caliper arm 11) or on the second surface opposite to the first surface 112a (ie, the first caliper arm) 11 outer surface).
  • the extension arm 20 is disposed inside the first caliper arm 11.
  • the first caliper arm 11 is provided with a through hole extending from the fixed end to the free end, and the extending arm 20 is disposed in the through hole so that the extending arm 20 is disposed on the first caliper arm 11 internal.
  • the extension arm 20 is expandable and contractible toward the free end 10b along the fixed end 10a of the first caliper arm 11 to extend or retract the first caliper arm 11. Extending the extension arm 20 of the present embodiment from the first caliper arm 11 means that the end of the extension arm 20 protrudes from the free end 10b of the first caliper arm 11, that is, the end of the extension arm 20 is located at the free end 10b away from the fixed end 10a.
  • One side; the extension arm 20 receiving the first caliper arm 11 means that the end of the extension arm 20 is contracted to between the free end 10b of the first caliper arm 11 and the fixed end 10a.
  • the extension arm 20 When the extension arm 20 extends out of the first caliper arm 11, the extension arm 20 is equivalent to extending the length of the first caliper arm 11 and is extended when the first caliper arm 11 is opened relative to the push rod 40 to capture the leaflets
  • the caliper arm 11 can increase the width of the leaflet of the support, so that the leaflet does not easily slip off from the first caliper arm 11, thereby making the clamping of the leaflet by the clamp 10 easier, and also facilitating the clamping of the valve 10 to the leaflet hold.
  • the actual length of the first caliper arm 11 does not change, the length of the cusp 10 holding the leaflet does not actually change, and the problem that the length of the caliper 10 is too long may be avoided.
  • At least one extension arm 20 is provided on the inner surface and/or the outer surface of the first caliper arm 11 of each clamp 10.
  • the length of the first caliper arms 11 of each of the tongs 10 can be lengthened so that the first caliper arms 11 of each of the tongs 10 can easily capture the leaflets.
  • the extension arm 20 is smooth overall, and one end of the extension arm 11 is formed by laser spot welding to form a smooth round head without defects such as burrs, edges, edges and the like to avoid damage to the leaflets.
  • the extension arm 20 includes an extension arm body.
  • the extension arm body includes one or more support rods arranged side by side to directly support the leaflets through the support rods.
  • the support rods may be solid or hollow structures, or may be single or multi-layer composite structures.
  • the support rod may be a solid or hollow rod formed of one material, or may be obtained by fitting hollow tubes of different inner diameters formed by a plurality of different materials.
  • the support rod may be wound from a single wire or a plurality of wires.
  • the cross section of the support rod may be a regular circular or elliptical shape, a crescent shape, a semicircular shape, a polygonal shape, or the like, preferably a circular shape, which is easy to process while avoiding damage to the leaflets by the support rod.
  • the support rod is made of a flexible and/or elastic biocompatible material to accommodate the anatomy of the leaflets and the amplitude of movement of the leaflets, and to avoid damage to the leaflets.
  • a metal material, a polymer material or a metal-polymer composite material can be selected.
  • the support rod is made of a metal-polymer composite material, and in this embodiment, a nickel-titanium alloy and PTFE are used.
  • the extension arm 20 includes an extension arm body made of a flexible material, and further includes a support body made of a rigid material such as stainless steel or titanium alloy or the like.
  • the support body is disposed 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 anatomy of the leaflet and the amplitude of movement of the leaflet, and has a certain rigidity to The leaflets are effectively supported.
  • the extension arm body is a flexible tube made of a softer material
  • the support body is a rigid rod made of a harder material
  • the flexible tube is sleeved outside the rigid rod to form the extension arm 20
  • the support body is disposed outside the extension arm body.
  • the extension arm body is a flexible rod
  • the support body is a rigid tube made of a material having a higher hardness
  • the rigid tube is sleeved outside the flexible rod to form the extension arm 20, and at this time, the support body It is provided inside the extension arm body.
  • the heat shrinkable tube is used as a support body to wrap around the outer surface of the softer extension arm body, and then heated to shrink the heat shrinkable tube and wrapped around the outer surface of the extension arm body to improve support, that is,
  • the extension arm body is a flexible rod
  • the rigid support body is a heat-shrinkable tube.
  • the heat-shrinkable tube sleeve is sleeved outside the flexible rod and is heated and contracted to be fixed with the flexible rod.
  • the support body at this time is disposed outside the extension arm body.
  • the extension arm body is wound from at least one flexible wire (eg, stainless steel wire), and a thermoplastic elastomer (eg, Pebax) is wrapped around the exterior of the extension arm body, and then heated to The Pebax is melted and covered on the outside of the main body of the extension arm, and at the same time, part of the Pebax penetrates into the inside of the extension arm main body through the gap between the flexible filaments. Therefore, the support body at this time is provided inside and outside the extension arm main body.
  • a thermoplastic elastomer eg, Pebax
  • the extension arm 20 is at least partially made of a radiopaque X-ray material.
  • the extension arm body and/or the support body are made of a radiopaque X-ray material such that after the extension arm 20 is extended from the clamp 10, it is in contact with the leaflets, and the extension arm 20 can be associated with the amplitude of movement of the leaflets.
  • the operator can quickly and accurately determine the position of the leaflets by X-rays. If the position is reasonable, the operator can drive the clamp 10 to clamp the leaflets, thereby shortening the operation time and improving the success rate of the operation.
  • the radiopaque X-ray material is selected from stainless steel or nickel titanium alloy.
  • an end of the extension arm 20 facing away from the fixed end 10a of the first caliper arm 11 is provided with an elastic member 50.
  • the elastic member 50 is compressed and compressed when the extension arm 20 is received by the first caliper arm 11, and the elastic member 50 extends beyond the first caliper arm 11 with the extension arm 20, that is, the end of the extension arm 20 exceeds the first
  • the elastic member 50 is no longer pressed by the outside to be stretched and stretched, and the area of the elastic member 50 in the stretched state is larger than the area of the elastic member 50 in the compressed state, thereby making the elastic member 50 has a larger contact area with the leaflets to better conform to the leaflets and improve the support of the extension arms 20 to the leaflets.
  • the surface on which the elastic member 50 is extended is parallel to the first surface 112a of the first caliper arm 11 so that the elastic member 50 has a larger contact area with the leaflet after being stretched, thereby Achieve better support for the leaflets.
  • the surface of the first plane 112a and the elastic member 50 may be flat or curved.
  • the elastic member 50 includes a plurality of branches, and when the elastic member 50 receives the first caliper arm 11, the plurality of branches are bundled together; when the elastic member 50 extends out of the first caliper arm 11, the plurality of branches are stretched
  • the opening is such that the area of the elastic member 50 is increased relative to when the elastic member 50 is received by the first caliper arm 11.
  • the elastic member 50 of the present embodiment has two branches extending from one end of the extension arm 20 facing away from the fixed end 10a of the first caliper arm 11. The angle a between the two branches ranges from 20° to 150°, preferably from 60° to 90°, to provide stable support for the leaflets supported on the extension arms 20.
  • the elastic member 50 is a closed elastic ring.
  • the elastic ring may be a circular, diamond, elliptical, pear-shaped, polygonal or other irregularly shaped closed structure.
  • At least one support bar 51 is disposed in the elastic ring to improve the stability of the elastic ring so that it does not deform too much when the support leaflets are deployed, and the elastic ring is kept stable to the leaflets.
  • the extending direction of the support bar is the same as the direction from the fixed end 10a to the free end 10b of the first caliper arm 11, so that the elastic ring can be easily stretched and contracted into the first caliper arm 11 after the support bar 51 is added.
  • the resilient member 50 is a deformable cage.
  • the elastic member 50 is a cage structure formed by braiding a wire having a certain elasticity and tension.
  • the net cage is received in the first caliper arm 11, the net cage is deformed by compression and is in a compressed state, so that the wire is deformed and gathered together, so that the mesh cage is reduced in size and can be used in the first tongs.
  • the cage protrudes from the first caliper arm 11
  • the cage is stretched and stretched, the wire is stretched to open the cage, and the volume of the cage after stretching is larger than the squeeze
  • the volume of the cage is then provided to provide more stable support for the leaflets supported on the extension arm 20.
  • the wire forming the cage may be a wire or a wire made of a polymer material having a certain elasticity.
  • the wire forming the cage is a nickel-titanium wire, which has good biocompatibility and can be developed under X-rays to quickly and accurately determine the position of the elastic member 50 by X-rays.
  • the elastic member 50 of the embodiment has a three-dimensional structure, can have a more three-dimensional development effect, and can be an extension arm 20
  • the upper leaflets provide more stable support (as shown in Figure 16).
  • the cage includes a woven mesh 52 and a head 53 and a fixed tube 54 respectively fixed to both ends of the woven mesh 52.
  • the nickel-titanium wire forms a tubular woven mesh 52, and one end of the woven mesh 52 is fixed in the head 53. That is, the head 53 gathers and fixes one open end of the woven mesh 52. The other end of the woven mesh 52 is gathered and fixed in the fixed tube 54.
  • One end of the fixed tube 54 facing away from the woven mesh 52 is coupled to the extension arm 20.
  • the sealing head 53 and the fixing tube 54 can be made of metal material or polymer plastic material.
  • the head 53 is made of a stainless steel material to quickly and accurately determine the position of the end of the elastic member 50 by X-ray.
  • the cage is a columnar shape in the middle, two ends are tapered, and the tapered cone angles of the two ends are the same. It can be understood that, in the present application, the cage may also be in any other shape.
  • the cage may be a tapered spindle structure having the same taper angle at both ends as shown in FIG. 14, or a structure having different taper angles at both ends as shown in FIG.
  • the extension arm 20 can be limited to the first surface 112a of the first caliper arm 11 through a limiting member 60, and the limiting member 60 is used to define the extension.
  • the direction in which the arms 20 extend and contract is in the direction of the fixed end 10a of the first caliper arm 11 toward the free end 10b, limiting the radial offset of the extension arm 20.
  • the limiting member 60 can be a variety of limiting structures such as a limiting ring, a limiting slot or a limiting tube.
  • the limiting member 60 is a limiting ring or a limiting tube.
  • the limiting member 60 can also fix the extension arm 20 to the first surface 112a of the first caliper arm 11 to prevent the extension arm 20 from being in motion.
  • the first surface 112a is detached.
  • the limiting member 60 is a hollow column member having a certain length, and the extending arm 20 is movably disposed in the column member.
  • the valve clamp 100 further includes a drive assembly 30 for controlling the opening and contraction of the first caliper arm 11 of the clamp 10 relative to the push rod 40 and the extension arm 20.
  • the drive assembly 30 includes a slider 31 and at least one set of drive rods 32.
  • the slider 31 is disposed in the push rod 40 or sleeved outside the push rod 40 and reciprocates along the axial direction of the push rod 40.
  • the slider 31 is tubular, and the slider 31 is sleeved outside the push rod 40 and reciprocates along the axial direction of the push rod 40.
  • the tube wall of the slider 31 is provided with two opposite guide holes 311. Each of the guide holes 311 penetrates through the passage 42 of the push rod 40.
  • Each of the driving rods 32 is used to connect the slider 31 with a first caliper arm 11 to drive the first caliper arm 11 to rotate by the slider 31.
  • the driving rods 32 are two groups, and the two sets of driving rods 32 are respectively disposed on the two first planes of the base 41.
  • Each set of drive rods 32 includes two drive rods 32.
  • One end of the drive rods 32 is rotatably coupled to the sliders 31, and the other end is rotatably coupled to the first caliper arms 11.
  • the connection position of the drive lever 32 on the first caliper arm 11 is located between the fixed end 10a and the free end 10b of the first caliper arm 11.
  • the slider 31 reciprocates axially along the push rod 40 to drive the drive rod 32 to rotate relative to the slider 31.
  • the drive rod 32 rotates relative to the slider 31 to drive the first clamp arm 11 to rotate relative to the push rod 40, that is, the first clamp arm is driven. 11 relative to the push rod 40 opening and closing.
  • one end of each set of driving rods 32 connected to the slider 31 is connected by bolts and pins to realize the rotational connection of the push rod 40 and the slider 31.
  • the same ends of the two sets of driving rods 32 respectively located on the first planes on both sides of the base 41 are connected by the same bolt.
  • one bolt sequentially passes through the same end of one set of driving rods 32 and one guiding hole 311 of the slider 31, and then passes through the passage 42 on the push rod 40 until it passes through the other guiding hole 311 on the slider 31.
  • the other end of the drive rod 32 is connected to the slider 31.
  • the drive lever 32 pushes the first caliper arm 11 to open and close with respect to the push rod 40.
  • the bolt connected to the slider 31 is also moved in the passage 42 in the push rod 40 in the longitudinal direction of the passage 42 (i.e., the axial direction of the push rod 40). Since the length of the passage 42 has a certain range, that is, the slider 31 also has a certain range of movement, thereby controlling the opening and closing of the first caliper arm 11 with respect to the push rod 40 at a certain angle.
  • one end of the extension arm 20 is connected to the slider 31 through the elastic rod 25, and the slider 31 is axially reciprocated along the push rod 40 to drive the elastic rod 25 to move to extend the extension arm through the elastic rod 25.
  • 20 is stretched along the first caliper arm 11.
  • the elastic rod 25 includes a first connecting section 251, a second connecting section 252, and a curved section 253 between the first connecting section 251 and the second connecting section 252.
  • One end of the first connecting portion 251 facing away from the curved portion 253 is fixedly connected with the slider 31.
  • the first connecting portion 251 is a line segment extending in the direction of the push rod 40; the end of the second connecting portion 252 facing away from the curved portion 253 is fixedly connected with the extending arm 20.
  • the extending direction of the second connecting portion 252 is the same as the extending direction of the extending arm 20, and the curved portion 253 is a curved structure with a variable curvature, usually made of an elastic material for holding the second connecting portion 252 and the second connecting portion.
  • the connecting extension arm 20 of the 252 abuts against the surface of the first caliper arm 11.
  • the base 41 is provided with a guide groove 411.
  • the curved portion 253 is disposed in the guide groove 411 and can move in the guide groove 411.
  • the elastic rod 25 is a rod-like structure having elasticity, and the elastic rod 25 is in a straight rod shape in a natural state.
  • the straight rod-shaped elastic rod 25 When the elastic rod 25 is inserted into the guide groove 411, the straight rod-shaped elastic rod 25 is bent to form a curved section 253, and the bending force of the curved section 253 is passed to maintain the second connecting section 252 and the extending arm connected to the second connecting section 252. 20 abuts against the surface of the first caliper arm 11.
  • one end of the extension arm 20 is connected to the slider 31 through the elastic rod 25 to drive the extension arm 20 to extend or retract the first caliper arm 11 by the movement of the slider 31.
  • the first caliper arm 11 is rotated to open and close with respect to the push rod 40.
  • the extension arm 20 is coupled to the slider 31, and the first caliper arm 11 is coupled to the slider 31, so that the movement of the slider 31 can simultaneously drive the extension or retraction of the extension arm 20 and the first caliper arm.
  • 11 is opened or closed relative to the push rod 40, i.e., the extension or retraction of the extension arm 20 is synchronized with the opening or closing of the first caliper arm 11 relative to the push rod 40.
  • the extension or retraction of the extension arm 20 and the opening or closing of the first caliper arm 11 relative to the push rod 40 may also be out of synchronization.
  • the first caliper arm 11 and the extension arm 20 are coupled to different drive structures such that the first caliper arm 11 can be moved separately from the extension arm 20 such that the extension arm 20 is extended or retracted and the first tong
  • the opening or closing of the arm 11 relative to the push rod 40 enables unsynchronization.
  • the first caliper arm 11 can be connected to the slider 31 through the driving rod 32.
  • another slider capable of reciprocating along the push rod 40 is placed in the push rod 40 or the push rod 40, and the extension arm 20 is connected to the other slider through the elastic rod 25 to drive the slider 31 respectively.
  • the other slide moves along the push rod 40 to effect that the extension or retraction of the extension arm 20 is not synchronized with the opening or closing of the first forceps arm 11 relative to the push rod 40.
  • a first extension arm 20 that can be telescopic is provided on the surface of the first caliper arm 11 of the first caliper 10
  • a second extension that can be extended and contracted is provided on the surface of the first caliper arm 11 of the second clamp 10.
  • the first extension arm 20 and the second extension arm 20 are both elongated, which is equivalent to the addition of the first clamp 10 and the second clamp 10, while the first clamp arm 11 is opened relative to the second clamp arm 12.
  • the length of the first caliper arm 11 enables rapid capture of the active leaflet tissue, reducing the difficulty of surgery and improving the efficiency of surgery.
  • the invention also provides a valve clamping system, the valve clamping system comprising a pushing device and the aforementioned valve clipper 100, the valve clipper 100 can be delivered to the mitral valve by a pushing device, and the valve clipper can be adjusted 100 is the appropriate location for the mitral valve.
  • the pushing device comprises 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 with the operating handle, the distal end of the pushing shaft and the valve clamping device Removable connection between. The operator pushes the valve clamp 100 to a predetermined position by the push shaft.
  • the push shaft includes a connecting shaft and a control shaft that are movably coaxially fitted together, and the connecting shaft and the push rod 40 are detachably connected, that is, the operating handle and the valve clipper 100 are connected by a connecting shaft.
  • the control shaft is coupled to the drive assembly, specifically to the connection between the control shaft and the slider 31, so as to drive the slider 31 of the drive assembly to reciprocate along the axial direction of the push rod 40 to drive the first clamp arm 11 and push The relative opening and closing between the rod 40 and the second caliper arm 12, so that the tongs 10 of the valve clamp 100 respectively hold the plurality of leaflets of the valve to achieve the purpose of narrowing the gap between the leaflets and clamping the valve .
  • the set relationship between the connecting shaft and the control shaft is determined by the set relationship between the push rod and the slider of the drive assembly.
  • the slider is disposed outside the push rod, and therefore, the control shaft sleeve is disposed outside the control shaft.
  • the pushing device of the present invention may further include other driving members.
  • the pusher device When the valve clipper is the valve clipper 200 shown in FIG. 8, the pusher device further includes an adjustment line or the like connected to the second jaw arm 12, and the adjustment line passes through the fixed section 12a of the second jaw arm 12 and is connected to On the operating handle, the relative position between the second caliper arm 12 and the first caliper arm 11 and the push rod 40 can be adjusted by operating the handle to control the adjustment line.
  • the adjustment wire is tensioned to control the fixed section 12a of the second jaw 10 such that the second jaw arm 12 is gathered over the surface of the push rod 40; when the first jaw arm 11 is located
  • the adjustment of the second caliper arm 12 by the adjustment wire is relaxed, so that the second caliper arm 12 naturally extends, so as to be clamped with the first caliper arm 11 and located at the first caliper arm 11 and the second caliper arm 12 The leaflets between.
  • valve repairing process of the mitral valve is taken as an example to illustrate the operation method of the valve clamping system of the present invention, which mainly includes the following steps:
  • the first step is to advance the valve clamp connected to it from the left atrium through the push shaft and through the mitral valve to the left ventricle. At this time, the first caliper arm 11 and the second caliper arm 12 of the valve clamp are both gathered on the surface of the push rod 40.
  • the second step adjusting the relative position of the valve clamp and the mitral valve by the push shaft, so that the two clamps 10 of the valve clamp are respectively close to the anterior leaf 1a and the posterior leaf 1b of the mitral valve.
  • the third step moving the slider 31 in the distal direction of the push rod 40 to drive the first caliper arm 11 to open relative to the push rod 40 while causing the extension arm 20 to protrude from the first caliper arm 11.
  • the fourth step adjusting the direction of the valve clamp, and observing the relative positions of each of the first caliper arms 11 and the front lobes 1a and the rear lobes 1b by means of X-ray or the like, so that the first caliper arms 11 are perpendicular to the mitral valve Matching line.
  • the fifth step the slider 31 is retracted along the proximal end of the push rod 40, thereby driving the first caliper arm 11 to be closed with respect to the second caliper arm 12 and the push rod 40, and the first caliper arm 11 is again gathered to the surface of the push rod 40.
  • the anterior blade 1a and the posterior blade 1b of the mitral valve are respectively sandwiched between the pair of first caliper arms 11 and the second caliper arms 12 located on the surface of the push rod 40, thereby respectively gripping the two leaflets .
  • Step 6 Releasing the connection between the slider 31 and the control shaft, and then releasing the connection between the push rod 40 and the push shaft, withdrawing the push shaft from the patient, leaving the valve clip in the patient, completing the mitral valve The leaf edge is clamped to the edge.
  • the step between the fourth step and the fifth step further includes the step of: releasing the control member to control the second caliper arm 12, so that The second caliper arm 12 is opened relative to the push rod 40 and cooperates with the first caliper arm 11 to clamp the leaflets located between the first caliper arm 11 and the second caliper arm 12.
  • the valve clamping system of the present invention is capable of operating in vitro to clamp the valve leaflets to reduce or avoid the problem of "mitral regurgitation". Moreover, since the valve clip can easily capture the leaflets, the difficulty of performing the "mitral regurgitation" operation through the valve clamping system is greatly reduced, and the operation time is reduced.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un dispositif de serrage de valve (100, 200) et un système de serrage de valve. Le système de serrage de valve comprend un dispositif de serrage de valve (100, 200) et un dispositif de poussée. Le dispositif de serrage de valve (100, 200) comprend une tige de poussée (40), au moins deux dispositifs de serrage (10), et au moins un bras d'extension (20). Chacun des dispositifs de serrage (10) comprend un premier bras de serrage (11) susceptible de s'ouvrir et de se fermer par rapport à un autre bras de serrage, et au moins un bras d'extension (20) est disposé de manière télescopique sur une surface du premier bras de serrage (11). La fourniture du bras d'extension télescopique (20) sur la surface du premier bras de serrage (11) du dispositif de serrage de valve (100, 200) et qui amène le bras d'extension (20) à s'étendre hors du premier bras de serrage (11) tandis que le premier bras de serrage (11) s'ouvre par rapport à la tige de poussée (40) du dispositif de serrage de valve (100, 200), est équivalent à accroître la longueur du premier bras de serrage (11) du dispositif de serrage (10), de sorte que le premier bras de serrage (11) le plus long peut mieux supporter un feuillet de valve lors de la capture du feuillet de valve, empêchant le feuillet de glisser hors de la surface du premier bras de serrage (11), capturant ainsi rapidement un feuillet de valve actif, réduisant la difficulté chirurgicale, et améliorant l'efficacité chirurgicale.
PCT/CN2019/086254 2018-05-17 2019-05-09 Dispositif de serrage de valve et système de serrage de valve WO2019218930A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201810476710.XA CN110495972A (zh) 2018-05-17 2018-05-17 瓣膜夹合器及瓣膜夹合***
CN201820739065.1 2018-05-17
CN201820739065.1U CN209548144U (zh) 2018-05-17 2018-05-17 瓣膜夹合器及瓣膜夹合***
CN201810476710.X 2018-05-17

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CN104768500A (zh) * 2012-09-06 2015-07-08 爱德华兹生命科学公司 心脏瓣膜密封装置
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WO2021008461A1 (fr) * 2019-07-12 2021-01-21 杭州德晋医疗科技有限公司 Dispositif de serrage de valvule facile à actionner et système de serrage de valvule
WO2021027588A1 (fr) * 2019-08-13 2021-02-18 杭州德晋医疗科技有限公司 Dispositif de serrage de valve réglable et système de serrage de valve

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