WO2019218930A1 - Valve clamp and valve clamping system - Google Patents

Valve clamp and valve clamping system 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
French (fr)
Chinese (zh)
Inventor
张庭超
张伟伟
郑贤章
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201820739065.1U external-priority patent/CN209548144U/en
Priority claimed from CN201810476710.XA external-priority patent/CN110495972A/en
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2019218930A1 publication Critical patent/WO2019218930A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122Clamps 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.

Abstract

A valve clamp (100, 200) and a valve clamping system. The valve clamping system comprises a valve clamp (100, 200) and a push device. The valve clamp (100, 200) comprises a push rod (40), at least two clamps (10), and at least one extension arm (20). Each of the clamps (10) comprise a first clamping arm (11) able to open and close relative to another clamp arm, and at least one extension arm (20) is telescopically disposed on a surface of the first clamping arm (11). Providing the telescopic extension arm (20) on the surface of the first clamping arm (11) of the valve clamp (100, 200) and causing the extension arm (20) to extend out of the first clamping arm (11) while the first clamping arm (11) opens relative to the push rod (40) of the valve clamp (100, 200), is equivalent to increasing the length of the first clamping arm (11) of the clamp (10), so that the longer first clamping arm (11) can better support a valve leaflet when capturing the valve leaflet, preventing the leaflet from slipping off the surface of the first clamping arm (11), thereby rapidly capturing an active valve leaflet, reducing surgical difficulty, and improving surgical efficiency.

Description

瓣膜夹合器及瓣膜夹合系统Valve clamp and valve clamping system 技术领域Technical field
本发明涉及医疗器械领域,尤其涉及一种瓣膜夹合器及瓣膜夹合系统。The invention relates to the field of medical instruments, and in particular to a valve clamp and a valve clamping system.
背景技术Background technique
请参阅图1,二尖瓣1是位于心脏左心房2与左心室3之间的单向阀,正常健康的二尖瓣1可以控制血液从左心房2流到左心室3,同时避免血液从左心室3流到左心房2。二尖瓣包括一对瓣叶,称为前叶1a及后叶1b。前叶1a及后叶1b通过腱索4固定于左心室3的内壁上。正常情况下,心脏左心室收缩时,前叶1a和后叶1b的边缘完全对合,避免血液从左心室3流到左心房2。请参阅图2,当二尖瓣的瓣叶或其相关结构发生器质性改变或功能性改变(如腱索4)部分断裂时,二尖瓣的前叶1a和后叶1b对合不良,当心脏左心室收缩时,二尖瓣1不能完全关闭,导致血液从左心室3返流至左心房2,从而引起一系列的病理生理改变,称为“二尖瓣返流”。Referring to Figure 1, 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. Referring to FIG. 2, when 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. When the left ventricle of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, causing a series of pathophysiological changes called "mitral regurgitation."
现有一种微创治疗手术,将瓣叶夹钳通过输送装置输送至二尖瓣处,再通过夹钳的相对开合同时夹住二尖瓣的前叶和后叶,使得二尖瓣的前叶与后叶固定从而达到减少二尖瓣返流的目的。但是,由于二尖瓣的两个瓣叶始终处于大幅度、大力度的开合活动状态,夹钳快速、成功地捕获活动的瓣叶组织的难度较大,使得医生需要经常花费很长的时间才能完成一台手术。There is a minimally invasive treatment procedure in which the leaflet clamp is delivered to the mitral valve through the delivery device, and then the anterior and posterior mitral cusps are clamped by the relative opening of the clamp, so that the mitral valve is The leaves and the posterior lobe are fixed to reduce the mitral regurgitation. However, since the two leaflets of the mitral valve are always in a large and large dynamic opening and closing activity, it is difficult for the clamp to quickly and successfully capture the active leaflet tissue, so that the doctor needs to take a long time. To complete an operation.
发明内容Summary of the invention
本发明的目的在于,针对上述现有技术的缺陷,提供一种瓣膜夹合器及瓣膜夹合系统,所述瓣膜夹合器的夹钳能够容易快速地捕获活动的瓣叶组织,从而降低手术难度、提高手术效率。SUMMARY OF THE INVENTION It is an object of the present invention to provide a valve clipper and a valve clamping system for the above-described drawbacks of the prior art, wherein the valve clamp can easily and quickly capture the active leaflet tissue, thereby reducing the operation. Difficulty and improve the efficiency of surgery.
所述瓣膜夹合器,包括推杆、至少两个夹钳、至少一根延伸臂。所述夹钳的一端连接到所述推杆上,并相对推杆开合;每个所述夹钳均包括第一钳臂,所述第一钳臂包括固定端及自由端,所述固定端旋转连接于所述推杆上,所述第一钳臂以所述固定端在所述推杆上的固定位置为旋转中心相对所述推杆开合;所述延伸臂沿所述第一钳臂的轴向伸长或缩回,当所述延伸臂沿所述第一钳臂的固定端向自由端方向伸长时,所述延伸臂的末端超出所述第一钳臂的自由端。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 .
所述瓣膜夹合系统包括推送装置及上述瓣膜夹合器,所述推送装置包括操作手柄及具有一定轴向长度的推送轴,所述推送轴近端与所述操作手柄连接,所述推送轴的远端与所述瓣膜夹合器之间可拆卸连接。The valve clamping system includes a pushing device and 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.
本发明提供的瓣膜夹合器及瓣膜夹合系统,通过设置可以沿所述第一钳臂的轴向伸长或缩回的延伸臂,使得第一钳臂相对所述推杆打开时,延伸臂的末端超出第一钳臂的自由端,相当于增加了夹钳的第一钳臂在捕捉瓣叶时的长度,较长的第一钳臂能够在捕捉瓣叶时对瓣叶起到较好的承托效果,避免瓣叶从第一钳臂表面滑脱,从而能够快速地捕获活动的瓣叶组织,降低手术难度、提高手术效率。The 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.
附图说明DRAWINGS
为更清楚地阐述本发明的构造特征和功效,下面结合附图与具体实施例来对其进行详细说明。In order to more clearly illustrate the structural features and advantages of the present invention, it will be described in detail below with reference to the accompanying drawings.
图1是二尖瓣正常状态时的示意图;Figure 1 is a schematic view of the mitral valve in a normal state;
图2是二尖瓣出现病变时的示意图;Figure 2 is a schematic view of the mitral valve in the presence of lesions;
图3是本发明一实施例的瓣膜夹合器收拢时的结构示意图;3 is a schematic structural view of a valve clamp according to an embodiment of the present invention when it is folded;
图4是图3所示的瓣膜夹合器的第一钳臂张开时的结构示意图;Figure 4 is a schematic view showing the structure of the first clamp arm of the valve clamp shown in Figure 3;
图5是图3所示的瓣膜夹合器的第一钳臂张开时的截面示意图;Figure 5 is a schematic cross-sectional view showing the first caliper arm of the valve clipper shown in Figure 3 when opened;
图6是本发明所述瓣膜夹合器在二尖瓣处的位置示意图;Figure 6 is a schematic view showing the position of the valve clip of the present invention at the mitral valve;
图7a是本发明所述瓣膜夹合器夹持瓣叶后,心脏收缩时二尖瓣示意图;Figure 7a is a schematic view of the mitral valve when the heart is contracted after the valve clip is clamped by the valve clamp of the present invention;
图7b是本发明所述瓣膜夹合器夹持瓣叶后,心脏舒张时二尖瓣示意图;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;
图8是本发明另一实施例的瓣膜夹合器的第一钳臂张开时的结构示意图;8 is a schematic structural view of a first clamp arm of a valve clamp according to another embodiment of the present invention;
图9是本发明一实施例的瓣膜夹合器的延伸臂的结构示意图;9 is a schematic structural view of an extension arm of a valve clipper according to an embodiment of the present invention;
图10是本发明另一实施例的瓣膜夹合器的延伸臂的结构示意图;10 is a schematic structural view of an extension arm of a valve clipper according to another embodiment of the present invention;
图11是本发明另一实施例的瓣膜夹合器的延伸臂的结构示意图;11 is a schematic structural view of an extension arm of a valve clipper according to another embodiment of the present invention;
图12是本发明另一实施例的瓣膜夹合器的第一钳臂张开时的结构示意图;12 is a schematic structural view of a first clamp arm of a valve clamp according to another embodiment of the present invention;
图13是图12的瓣膜夹合器的弹性件的结构示意图;Figure 13 is a schematic view showing the structure of the elastic member of the valve clip of Figure 12;
图14是本发明另一实施例的瓣膜夹合器的弹性件的结构示意图;14 is a schematic structural view of an elastic member of a valve clipper according to another embodiment of the present invention;
图15是本发明另一实施例的瓣膜夹合器的弹性件的结构示意图;15 is a schematic structural view of an elastic member of a valve clipper according to another embodiment of the present invention;
图16是图12的瓣膜夹合器在夹持瓣叶前,延伸臂伸出、弹性件承托瓣叶的示意图。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.
具体实施方式Detailed ways
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述。其中,附图仅用于示例性说明,表示的仅是示意图,不能理解为对本专利的限制。The technical solutions in the embodiments of the present invention will be clearly and completely described in the following with reference to the accompanying drawings. The drawings are for illustrative purposes only, and are merely schematic representations and are not to be construed as limiting.
请参阅图3至图5,本发明提供一种瓣膜夹合器100。瓣膜夹合器100包括推杆40、至少两个夹钳10,至少一个延伸臂20。本实施例中,夹钳10的数量为两个,两个夹钳10以推杆40为轴对称设置。具体的,请参阅图6,将瓣膜夹合器100置于二尖瓣的前叶及后叶的不能正常对合的位置,使得一个夹钳10夹持二尖瓣的前叶1a边缘,另一个夹钳10夹持二尖瓣的后叶1b边缘,通过将两个夹钳10收拢在一起,以将二尖瓣的前叶1a及后叶1b的不能正常对合的位置固定在一起。请参阅图7a,图7a所示为心脏收缩时二尖瓣的状态示意图,其中,箭头方向为血流方向。当心脏收缩时,前叶1a与后叶1b收拢,且前叶1a与后叶1b不能正常对合的位置A通过瓣膜夹合器100夹合(即瓣膜夹合器100的夹合位置为不能正常对合的位置A),使得不能正常对合的位置A或者部分位置收拢在一起,从而使得二尖瓣能够完全关闭或者开口的面积变小,从而减轻或治疗“二尖瓣返流”。请参阅图7b,,图7b所示为心脏舒张时二尖瓣的状态示意图,其中,箭头方向为血流方向。当心脏舒张时,前叶1a及后叶1b仅在瓣膜夹合器100夹合的位置固定在一起,前叶1a及后叶1b其它的位置仍然正常舒张,使得血液能够从左心房进入左心室,从而保证血液的正常流动。本发明的其它实施例的瓣膜夹合器100也能够用于减轻或者治疗“三尖瓣返流”,即瓣膜夹 合器100的夹钳10为三个,通过三个夹钳10将三个瓣叶固定在一起,从而减轻或者避免“三尖瓣返流”。其原理及结构与本发明实施例中用于解决二尖瓣返流的瓣膜夹合器100的原理及结构相同,在此不进行赘述。可以理解的是,本发明的其它实施例的瓣膜夹合器100还可以应用于其它需要将几个片状的组织夹合在一起的其它微创外科手术中,且夹钳10的数量根据实际使用需求进行变化。Referring to Figures 3 through 5, 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. In the present embodiment, 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. 6, the valve clamp 100 is placed in a position where the anterior and posterior mitral lobes are not normally aligned, such that one clamp 10 holds the anterior lobe 1a edge of the mitral valve, and A clamp 10 holds the edge of the posterior lobe 1b of the mitral valve, and the two clamps 10 are brought together to fix the positions of the anterior lobe 1a and the posterior lobe 1b of the mitral valve which are not normally aligned. Please refer to FIG. 7a. 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. When the heart contracts, the anterior lobe 1a and the posterior lobe 1b are gathered, and the position A in which the anterior lobe 1a and the posterior lobe 1b are not normally aligned is sandwiched by the valve clamp 100 (ie, the position of the valve clip 100 is not clamped) The position A) of the normal alignment causes the position A or the partial position of the normal alignment to be closed together, so that the mitral valve can be completely closed or the area of the opening becomes small, thereby reducing or treating the "mitral regurgitation". Please refer to FIG. 7b. 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. When the heart is dilated, 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. The leaflets are secured together to reduce or avoid "tricuspid regurgitation." The principle and structure of the 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.
请重新参阅图3至图5,推杆40与推送装置之间可拆卸连接,操作者在体外操作推送装置,将瓣膜夹合器100输送至二尖瓣处后,将推送装置与推杆40分离,使得瓣膜夹合器留在二尖瓣处。本发明一实施例中,推杆40为具有内腔的杆状体或者中空的管状体,由生物相容性材料制成。生物相容性材料选自不锈钢、钴合金或钛合金,优选为钛合金。优选的,推杆40为圆杆状或者圆管状,推杆40表面光滑,避免推杆40损伤瓣叶或钩挂腱索。为了便于推送并固定夹钳10,推杆40远端设有基座41。本实施例中,基座41包括相对的两个第一平面及连接两个第一平面的侧面。侧面包括位于远端的曲面413及位于近端、且与曲面413连接的第二平面412,推杆40的远端垂直固定于第二平面412上,第二平面412的面积大于推杆40的横截面面积。基座41的平行于第二平面412方向的截面尺寸由近端至远端逐渐减小,即基座41的形状可以为半球体、球冠、弹头形等结构,使得瓣膜夹合器100更容易在体内进行推进。这里描述的“近端”是指靠近操作者的方向;“远端”是指远离操作者的方向。基座41外表面光滑,从而避免基座41损伤瓣叶或钩挂腱索。推杆40沿轴向设有一通道42,所述通道42为长条形,通道42的长度方向与推杆40的长度方向相同,通道42的纵向分别垂直于基座41的两个第一平面。Referring back to FIG. 3 to FIG. 5, 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. In one embodiment of the invention, 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. Preferably, 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. In order to facilitate pushing and fixing the clamp 10, the distal end of the push rod 40 is provided with a base 41. In this embodiment, 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. The term "proximal" as used herein 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. .
每个夹钳10均包括第一钳臂11及第二钳臂12,第一钳臂11与第二钳臂12相对开合以夹紧或松开位于第一钳臂11与第二钳臂12之间的瓣叶。本申请的其它一些实施例中,夹钳10也可以仅包括第一钳臂11,第一钳臂11相对推杆40进行开合,以夹紧或松开位于第一钳臂11与推杆40之间的瓣叶。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. In some other embodiments of the present application, 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.
每个第一钳臂11均包括位于远端的固定端10a及位于近端的自由端10b,两个第一钳臂11的固定端10a之间旋转连接。具体的,本实施例的两个第一钳臂11的固定端10a通过销钉或螺栓等方式旋转连接于推杆40上,具体是旋转连接于推杆40的基座41上,使得两个第一钳臂11相对推杆10进行旋转开合。每个第二钳臂12均设置在推杆40的外部,且对应于一个第一钳臂11,因此,第一钳臂11以固定端10a在推杆40上的固定位置为旋转中心相对第二钳臂12开合。由此,当通过推送装置将瓣膜夹合器100输送至二尖瓣处时,两个第一钳臂11收紧于推杆40表面,从而使得瓣膜夹合器100的体积缩小,从而能够顺利的通过血管输送至二尖瓣处;当瓣膜夹合器100输送至二尖瓣后,将两个第一钳臂11打开至其分别与推杆40呈一定的角度,以便于每个第一钳臂11分别承托一片瓣叶,再将两个夹钳10的第一钳臂11与第二钳臂12闭合,从而分别夹持每片瓣叶并将前叶1a与后叶1b固定在一起。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. Specifically, 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. Thus, when the valve clamp 100 is delivered to the mitral valve by the pushing device, 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.
本实施例中,第一钳臂11包括连接段111及固定段112。固定段112用于与第二钳臂12配合以固定并夹紧位于第一钳臂11与第二钳臂12之间的瓣叶。连接段111一端连接固定段112,另一端连接基座41。连接段111包括两根并列设置的连接杆,连接杆分设于基座41相对的两个第一平面上。每根连接杆的一端连接基座41,另一端间隔固定于固定段 112的近端,以使得第一钳臂11与基座41连接的更加牢固。在本发明的其它实施例中,连接段111也可以仅包括一根连接杆;或者,第一钳臂11不包括连接段111,固定段112直接旋转连接于基座41上。In this embodiment, 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. In other embodiments of the present invention, 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.
本实施例中,第一钳臂11的固定段112包括朝向第二钳臂12的第一表面112a(即,第一钳臂11的内表面),第一表面112a为曲面,且曲面的曲率方向朝向第二钳臂12。通过将第一表面112a设置为曲面,可增加第一钳臂11与瓣叶的接触面积及夹持面积,从而提供稳定的夹持力,并能够避免第一钳臂11对瓣叶造成伤害。曲面的第一表面112a相对推杆40收拢时能够与圆杆状的推杆40的表面更好的接触,以尽量缩小瓣膜夹合器100的夹钳10收拢时的体积,使得瓣膜夹合器100更容易的在体内进行输送。为了保证稳定的夹持力并与瓣叶的大小相对应,第一钳臂11具有一定的尺寸规定。具体的,第一钳臂11的长度必须在一定范围内,当第一钳臂11的长度过长时,第一钳臂11易将过多的前叶1a和后叶1b夹在一起,当两个夹钳10闭合的时候,两个瓣叶被强行拉向彼此并固定在一起,不仅容易导致二尖瓣功能异常,并且在心脏跳动和瓣叶运动的时候,由于过多的瓣叶被限制运动,还可能导致瓣叶撕裂等严重后果;当第一钳臂11过短时,夹钳10只能夹住小部分的瓣叶,使得瓣叶容易滑出,夹合固定效果较差。并且,由于瓣叶较为柔软,在夹持过程中,瓣叶容易从第一钳臂11中滑脱,即使得第一钳臂11不易承托瓣叶或与第二钳臂12配合夹持瓣叶,延长手术时间。本发明中,第一钳臂11的轴向长度(即固定端10a至自由端10b的距离)应大于或等于4mm,优选为6-10mm。并且,第一钳臂11的宽度也有一定的限制,以避免第一钳臂11的宽度过窄而对瓣叶产生伤害,同时也避免第一钳臂11的宽度过宽时夹钳10对瓣叶运动的影响。第一钳臂11的宽度(即与第一钳臂11的轴向方向垂直的方向的长度)应大于或等于2mm,优选为4-6mm。并且,为了保证植入后的安全性,第一钳臂11应由生物相容性材料制成,并具有一定的柔性及刚性,从而避免第一钳臂11对瓣叶造成伤害,同时又能够夹紧固定瓣叶。具体地,生物相容性材料选自不锈钢、钴合金或钛合金,本实施例中采用钛合金。In this embodiment, 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. By providing 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. In order to ensure a stable clamping force and correspond to the size of the leaflets, 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. 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. . Moreover, since 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. In the present invention, the axial length of the first caliper arm 11 (i.e., the distance from the fixed end 10a to the free end 10b) should be greater than or equal to 4 mm, preferably 6-10 mm. Moreover, 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) should be greater than or equal to 2 mm, preferably 4-6 mm. Moreover, in order to ensure the safety after implantation, 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. Specifically, 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.
进一步的,第一钳臂11的第一表面112a上还可以施加活性药物,或者设置多个开口,以促进瓣膜组织在第一钳臂11的内表面上的内皮细胞爬覆及生长。进一步的,第一表面112a也可以设置为具有凹凸结构的凹凸表面,从而增加第一钳臂11与瓣叶之间的摩擦力,提高夹钳10对瓣叶的固定能力。Further, the 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.
本实施例中,第二钳臂12固定于推杆10的外部,并与第一钳臂11相对设置,即第一钳臂11收拢于推杆40表面时,第一钳臂11能与第二钳臂12对合。In this embodiment, 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.
进一步的,第二钳臂12包括第三表面12a,第三表面12a与第一钳臂11相对。第三表面12a上设有夹持增强件121,以增加第二钳臂12与夹持于第一钳臂11与第二钳臂12之间的瓣叶之间的摩擦力,提高夹钳10对瓣叶的夹持力。夹持增强件121可以是凸设于第三表面12a的凸棱、倒钩、凸台或者其它不规则分布的凸起等结构,还可以是至少部分覆盖第三表面12a的粗糙表面,以提高夹钳10对瓣叶的夹持力。例如,在推杆40外表面覆盖由摩擦系数较高的生物相容性材料制成的垫片,从而提高第三表面12a的表面粗糙系数,从而提高夹钳10对瓣叶的夹持力。夹持增强件121还可以是设置在第二钳臂12上的磁性体,此时,在第一钳臂11上也设置对应的磁性体,通过第一钳臂11与第二钳臂12之间的 相互磁性吸力,达到增强夹钳10对瓣叶的夹持力的目的。本实施例中,夹持增强件121为两列间隔设置的凸齿。两列凸齿相对设置于第二钳臂12的两侧边缘。并且,每个凸齿的轴向与第三表面12a之间的夹角小于或等于90°,以进一步增强夹钳10对瓣叶的夹持力。进一步的,凸齿远离第三表面12a的一端为光滑的弧形面,从而避免损伤瓣叶。Further, 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. The clamping reinforcement 121 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. For example, 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. In this embodiment, 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.
请参阅图8,提供本发明的另一实施例的瓣膜夹合器200,瓣膜夹合器200的结构与图5及图6所示的瓣膜夹合器100的结构基本相同,差别在于:第二钳臂12至少部分由镍钛合金等弹性材料制成。具体地,第二钳臂12包括位于远端的固定段12a及位于近端的连接段12b,且第二钳臂12的连接段12b与推杆40之间固定连接,第二钳臂12的连接段12b由弹性材料制成。第二钳臂12的固定段12a可以由铝合金等非弹性材料制成。自然状态下,第二钳臂12与推杆40之间呈角度设置。并且,第二钳臂12与推杆40之间的夹角大于或等于第一钳臂11张开至最大状态时的第一钳臂11与推杆40之间的夹角,从而保证第一钳臂11与第二钳臂12之间具有一定的夹紧力,以夹紧位于第一钳臂11与第二钳臂12之间的瓣叶。第二钳臂12的固定段12a与推送装置中的控制件进行连接,通过控制件控制第二钳臂12的固定段12a,以调整第二钳臂12与推杆40之间的角度以及第二钳臂12与第一钳臂11之间的开合。本实施例中,控制件为金属或者PTFE等高分子材料制成的调节线(图未示出),调节线穿过第二钳臂12的固定段12a,将第二钳臂12束缚于推杆40的表面,当第一钳臂11与瓣叶的位置调整好后,放开调节线对第二钳臂12的固定段12a的控制,第二钳臂12的连接段12b回弹,带动与其相连的第二钳臂12的固定段12a向远离推杆40的方向(即靠近第一钳臂11的方向)运动,使得第二钳臂12与第一钳臂11夹紧位于二者之间的瓣叶。Referring to FIG. 8, a valve clipper 200 according to another embodiment of the present invention is provided. The structure of the valve clipper 200 is substantially the same as that of the valve clipper 100 shown in FIGS. 5 and 6. The difference is: The second caliper arm 12 is at least partially made of an elastic material such as a nickel titanium alloy. Specifically, 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. In the natural state, 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. In this embodiment, 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.
可以理解的是,在其它实施例中,两个第二钳臂12的连接段12b可以连接在一起,或者两个第二钳臂12可以一体成型。由此,两个第二钳臂12可以是U形结构,即,U形结构的每一侧分别作为一个第二钳臂12,与一个第一钳臂11相配合夹持一片瓣叶。It can be understood that in other embodiments, 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. Thus, 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.
请重新参阅图3-图5,本发明中,延伸臂20为至少一根。延伸臂20设于夹钳10的第一钳臂11的表面或者内部。本实施例中,延伸臂20为两根,分别设于两个夹钳10的第一钳臂11的表面。具体的,延伸臂20可以设于第一钳臂11的第一表面112a(即第一钳臂11的内表面)或者设于与第一表面112a相背的第二表面(即第一钳臂11的外表面)。一些实施例中,延伸臂20设于第一钳臂11的内部。具体的,所述第一钳臂11内设有从固定端向自由端方向延伸的穿孔,所述延伸臂20穿设于所述穿孔内,以使得延伸臂20设于第一钳臂11的内部。Referring again to Figures 3 - 5, in the present invention, 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. In this embodiment, the extension arms 20 are two, which are respectively disposed on the surfaces of the first caliper arms 11 of the two clamps 10. Specifically, 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). In some embodiments, the extension arm 20 is disposed inside the first caliper arm 11. Specifically, 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.
延伸臂20能够沿第一钳臂11的固定端10a向自由端10b方向伸缩,以伸出或收入第一钳臂11。本实施例的延伸臂20伸出第一钳臂11是指延伸臂20的端部伸出第一钳臂11的自由端10b,即延伸臂20的端部位于自由端10b远离固定端10a的一侧;延伸臂20收入第一钳臂11是指延伸臂20的端部收缩至第一钳臂11的自由端10b与固定端10a之间。当延伸臂20伸出第一钳臂11时,延伸臂20相当于延长了第一钳臂11的长度,当第一钳臂11相对推杆40张开以捕获瓣叶时,延长的第一钳臂11能够增加承托的瓣叶宽度,使得瓣叶不容易从第一钳臂11处滑脱,从而使得夹钳10对瓣叶的捕获更容易,也更方便夹钳10对瓣叶的夹持。并且,由于第一钳臂11的实际长度不变,因此,夹钳10夹持瓣叶的长度 实际上并不会发生改变,避免了夹钳10的长度过长而可能产生的问题。优选的,每个夹钳10的第一钳臂11的内表面和/或外表面均设有至少一根延伸臂20。以使得每个夹钳10的第一钳臂11的长度均可以加长,从而使得每个夹钳10的第一钳臂11均能够容易的捕获瓣叶。本实施例中,延伸臂20的整体光滑,伸出第一钳臂11的一端通过激光点焊形成光滑的圆头,没有毛刺、棱边、棱角等缺陷,避免对瓣叶的损伤。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. 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. Moreover, since 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. Preferably, 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. In this embodiment, 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.
本发明一些实施例中,延伸臂20包括延伸臂主体。延伸臂主体包括一根或者多根并排设置的支撑杆,以通过支撑杆直接承托瓣叶。支撑杆可以为实心或空心结构,也可以为单层或者多层复合结构。例如,支撑杆可以为一种材料形成的实心或者空心杆,也可以为多种不同材料的形成的内径大小不同的空心管套合得到。或者,支撑杆还可以由单根丝或者多根丝绕制而成。支撑杆的截面可以为规则的圆形或者椭圆形、月牙形、半圆形、多边形等形状,优选为圆形,易于加工同时又能避免支撑杆对瓣叶的伤害。进一步的,本实施例中,支撑杆为柔性和/或弹性的生物相容性材料制成,以适应瓣叶的解剖结构及瓣叶的活动幅度,且避免损伤瓣叶。例如可以选择金属材料、聚合物材料或者金属-聚合物复合材料制成。具体地,支撑杆由金属-高分子复合材料制成,本实施例中采用镍钛合金和PTFE制成。In some embodiments of the invention, 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. For example, 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. Alternatively, 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. Further, in the present embodiment, 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. For example, a metal material, a polymer material or a metal-polymer composite material can be selected. Specifically, the support rod is made of a metal-polymer composite material, and in this embodiment, a nickel-titanium alloy and PTFE are used.
进一步的,本发明的其它实施例中,延伸臂20包括由柔性材料制成的延伸臂主体,还包括支撑体,支撑体由刚性材料制成,例如不锈钢或钛合金等。支撑体设于延伸臂主体内部和/或外部,以增强延伸臂20的强度,使得延伸臂20具有一定的柔性以适应瓣叶的解剖结构及瓣叶的活动幅度的同时,具有一定刚性以对瓣叶进行有效的支撑。例如,一实施例中,延伸臂主体为由较柔软的材料制成柔性管,支撑体为硬度更高的材料制成的刚性杆,柔性管套设于刚性杆外以形成延伸臂20,此时,支撑体设于延伸臂主体外部。或者,本发明另一实施例中,延伸臂主体为柔性杆,支撑体为硬度更高的材料制成的刚性管,刚性管套设于柔性杆外以形成延伸臂20,此时,支撑体设于延伸臂主体的内部。或者,本发明另一实施例中,采用热缩管作为支撑体包裹在较柔软的延伸臂主体外表面,然后加热使热缩管收缩后包裹在延伸臂主体的外表面以提高支撑性,即延伸臂主体为柔性杆,刚性支撑体为热缩管,热缩管套于柔性杆外并加热收缩以同柔性杆固定,此时的支撑体设于延伸臂主体外部。或者,本发明另一实施例中,延伸臂主体由至少一根柔性丝(如,不锈钢丝)绕制而成,再将热塑性弹性体(例如,Pebax)包裹在延伸臂主体外部,然后加热使Pebax熔化后覆盖在延伸臂主体的外部,同时,部分的Pebax会通过柔性丝之间的缝隙渗入延伸臂主体内部,因此,此时的支撑体设于延伸臂主体内部和外部。Further, in other embodiments of the present invention, 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. For example, in one embodiment, the extension arm body is a flexible tube made of a softer material, the support body is a rigid rod made of a harder material, and 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. Alternatively, in another embodiment of the present invention, the extension arm body is a flexible rod, and the support body is a rigid tube made of a material having a higher hardness, and 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. Alternatively, in another embodiment of the present invention, 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, and 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. Alternatively, in another embodiment of the invention, 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.
进一步的,延伸臂20至少部分由不透射X射线材料制成。例如,延伸臂主体和/或支撑体由不透射X射线材料制成,从而使得延伸臂20自夹钳10伸出后,与瓣叶接触,延伸臂20可以伴随瓣叶的活动幅度产生相应的摆动,此时操作者可以通过X射线快速准确地判断瓣叶的位置,如果位置合理,操作者即可驱动夹钳10夹持瓣叶,从而缩短手术时间,提高手术成功率。不透射X射线材料选自不锈钢或镍钛合金。Further, the extension arm 20 is at least partially made of a radiopaque X-ray material. For example, 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. When swinging, 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.
进一步的,请参阅图9,延伸臂20背离第一钳臂11的固定端10a的一端设有弹性件50。弹性件50随延伸臂20收入于第一钳臂11时被压缩并处于压缩状态,弹性件50随延伸臂20伸出第一钳臂11时,即所述延伸臂20的末端超出所述第一钳臂11的自由端时,所述弹性件50不再受外部压迫从而舒展并处于舒展状态,舒展状态时的弹性件50的面积 大于压缩状态时的弹性件50的面积,从而使得弹性件50与瓣叶之间具有更大的接触面积,以更好地贴合瓣叶,提高延伸臂20对瓣叶的支撑性。优选的,本发明中,弹性件50伸展后所在的面与第一钳臂11的第一表面112a之间平行,以使得弹性件50伸展后与瓣叶之间有更大的接触面积,从而实现对瓣叶更好的支撑效果。具体的,第一平面112a与弹性件50伸展后所在的面可以均为平面,也可以均为曲面。Further, referring to FIG. 9, 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 When the free end of the arm 11 is clamped, 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. Preferably, in the present invention, 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. Specifically, the surface of the first plane 112a and the elastic member 50 may be flat or curved.
在其中一个实施例中,弹性件50包括多个枝丫,弹性件50收入第一钳臂11时,多个枝丫束在一起;弹性件50伸出第一钳臂11时,多个枝丫伸展张开,使得弹性件50的面积相对于弹性件50收入第一钳臂11时增大。具体的,本实施例的弹性件50的枝丫有两根,均由延伸臂20的背离第一钳臂11的固定端10a的一端延伸出来。两根枝丫之间的角度α范围为20°-150°,优选为60°-90°,从而为延伸臂20上承托的瓣叶提供稳定的支撑。In one embodiment, 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. Specifically, 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.
请参阅图10,本发明另一实施例中,弹性件50为封闭的弹性环。其中,弹性环可以是圆形、菱形、椭圆形、梨形、多边形或者其他不规则形状的封闭结构。弹性环收入第一钳臂11时,弹性环挤压变形;弹性环伸出第一钳臂11时,弹性环舒展,舒展后的弹性环的面积大于挤压时的弹性环的面积,从而增强延伸臂20对瓣叶的支撑性。进一步的,请参阅图11,弹性环内设有至少一条支撑条51,以提高弹性环的稳定性,使其在展开支撑瓣叶时不会有太大的变形,保持弹性环对瓣叶稳定的支撑。进一步的,支撑条的延伸方向与第一钳臂11的固定端10a至自由端10b方向相同,从而使得弹性环增加支撑条51以后,仍然能够容易的伸缩于第一钳臂11中。Referring to FIG. 10, in another embodiment of the present invention, the elastic member 50 is a closed elastic ring. Wherein, the elastic ring may be a circular, diamond, elliptical, pear-shaped, polygonal or other irregularly shaped closed structure. When the elastic ring receives the first caliper arm 11, the elastic ring is pressed and deformed; when the elastic ring extends out of the first caliper arm 11, the elastic ring is stretched, and the area of the elastic ring after stretching is larger than the area of the elastic ring during pressing, thereby enhancing The support of the extension arm 20 to the leaflets. Further, referring to FIG. 11 , 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. Support. Further, 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.
请参阅图12,本发明的另一实施例中,弹性件50为可变形的网笼。具体的,所述弹性件50为具有一定的弹性以及张力的丝线编织形成的笼状结构。所述网笼收入于所述第一钳臂11内时,所述网笼挤压变形而处于压缩状态,使得丝线变形而收拢在一起,从而使得网笼的体积缩小并能够收入于第一钳臂11内。当所述网笼伸出所述第一钳臂11时,所述网笼舒展而处于舒展状态,丝线舒展开以使得网笼张开,并使得舒展后的所述网笼的体积大于挤压时的所述网笼的体积,从而为延伸臂20上承托的瓣叶提供更稳定的支撑。本申请中,形成所述网笼的丝线可以为金属丝或者具有一定弹性的高分子材料制成的丝线。本实施例中,形成所述网笼的丝线为镍钛丝,具有较好的生物相容性,且能够在X射线下显影,以能够过X射线快速准确地判断弹性件50所在的位置。进一步的,相较于如图9及图10所示实施例中的弹性件50来说,本实施例的弹性件50为立体的结构,能够有更加立体的显影效果,并能为延伸臂20上承托的瓣叶提供更稳定的支撑(如图16所示)。Referring to Figure 12, in another embodiment of the invention, the resilient member 50 is a deformable cage. Specifically, the elastic member 50 is a cage structure formed by braiding a wire having a certain elasticity and tension. When 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. Inside the arm 11. When 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. In the present application, the wire forming the cage may be a wire or a wire made of a polymer material having a certain elasticity. In this embodiment, 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. Further, compared with the elastic member 50 in the embodiment shown in FIG. 9 and FIG. 10, 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).
请一并参阅图12及图13,本实施例中,所述网笼包括编织网52以及分别固定于编织网52的两端的封头53以及固定管54。具体的,所述镍钛丝形成一个筒状的编织网52,编织网52的一端固定于所述封头53内。即所述封头53将编织网52的一个开口端收拢并固定。所述编织网52的另一端收拢并固定于所述固定管54内。所述固定管54背离所述编织网52的一端连接至延伸臂20。所述封头53及所述固定管54均可以为金属材质或者高分子塑料材质制成。本实施例中,所述封头53为不锈钢材质制成,从而通过X射线快速准确地判断弹性件50的端部所在的位置。Referring to FIG. 12 and FIG. 13 together, in the embodiment, 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. Specifically, 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. In the present embodiment, 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.
本实施例中,所述网笼为中间为柱状,两头为锥形,且两头的锥形的锥角相同的结构。可以理解的是,本申请中,所述网笼也可以为其它的任何形状。例如,请参阅图14及图 15,所述网笼可以为图14所示的两头为锥角相同的锥形的纺锤形结构,也可以图15所示的两头的锥角不同的结构。请重新参阅图3至图5,进一步的,本发明一些实施例中,延伸臂20可以通过一限位件60限位于第一钳臂11的第一表面112a,限位件60用于限定延伸臂20的伸缩方向为沿第一钳臂11的固定端10a向自由端10b的方向,限制延伸臂20的径向偏移。限位件60可以为限位环、限位槽或者限位管等各种限位结构。优先的,限位件60为限位环或者限位管等,通过限位件60还能够将延伸臂20固定于第一钳臂11的第一表面112a,防止延伸臂20在运动过程中于第一表面112a脱离。具体的,本实施例中,限位件60为具有一定长度的中空的柱状件,延伸臂20可活动地穿设于柱状件中。In this embodiment, 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. For example, referring to FIG. 14 and FIG. 15, 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. Referring to FIG. 3 to FIG. 5 again, in some embodiments of the present invention, 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. Preferably, 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. Specifically, in the embodiment, 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.
本发明一些实施例中,瓣膜夹合器100还包括驱动组件30,驱动组件30用于控制夹钳10的第一钳臂11相对推杆40开合及延伸臂20的伸长及收缩。驱动组件30包括滑块31及至少一组驱动杆32。滑块31设于推杆40内或套设于推杆40外并沿推杆40轴向往复运动。本实施例中,滑块31为管状,滑块31套设于推杆40外并沿推杆40轴向往复运动。并且,滑块31的管壁上设有相对的两个导孔311。每个导孔311均贯通至推杆40的通道42。每根驱动杆32用于连接滑块31与一个第一钳臂11,从而通过滑块31带动第一钳臂11进行旋转。本实施例中,驱动杆32为两组,两组驱动杆32分别设于基座41的两个第一平面上。每组驱动杆32包括两根驱动杆32,驱动杆32的一端与滑块31之间旋转连接,另一端与第一钳臂11之间旋转连接。并且,驱动杆32在第一钳臂11上的连接位置位于第一钳臂11的固定端10a与自由端10b之间。滑块31沿推杆40轴向往复运动以带动驱动杆32相对滑块31转动,驱动杆32相对滑块31转动以带动第一钳臂11相对推杆40转动,即,带动第一钳臂11相对推杆40开合。本实施例中,每组驱动杆32与滑块31连接的一端通过螺栓、销钉连接,以实现推杆40与滑块31的旋转连接。并且,分别位于基座41两侧的第一平面上的两组驱动杆32的同一端通过同一螺栓连接。具体的,一个螺栓依次穿过一组驱动杆32的同一端及滑块31的一个导孔311,再穿过推杆40上的通道42直至从滑块31上的另一个导孔311穿出,最后穿过另一组驱动杆32与滑块31连接的一端。当沿推杆40移动滑块31时,驱动杆32推动第一钳臂11相对推杆40开合。并且,当滑块31沿推杆40在轴向移动,与滑块31相连的螺栓也在推杆40上的通道42内沿通道42的长度方向(即推杆40的轴向)进行移动。由于通道42的长度有一定的范围,即使得滑块31也有一定的移动范围,进而控制第一钳臂11相对推杆40具有一定角度的开合。In some embodiments of the invention, 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. In this embodiment, 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. Further, 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. In this embodiment, 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. Further, 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. In this embodiment, 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. And, 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. Specifically, 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. Finally, the other end of the drive rod 32 is connected to the slider 31. When the slider 31 is moved along the push rod 40, the drive lever 32 pushes the first caliper arm 11 to open and close with respect to the push rod 40. Further, when the slider 31 is moved in the axial direction along 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.
进一步的,本实施例中,延伸臂20的一端通过弹性杆25与滑块31相连,滑块31沿推杆40进行轴向往复运动并带动弹性杆25运动,以通过弹性杆25带动延伸臂20沿第一钳臂11伸缩。本实施例中,弹性杆25包括第一连接段251、第二连接段252,以及位于第一连接段251与第二连接段252之间的弯曲段253。第一连接段251背离弯曲段253的一端与滑块31固定连接,第一连接段251为沿推杆40方向延伸的线段;第二连接段252背离弯曲段253的一端与延伸臂20固定连接,第二连接段252的延伸方向与延伸臂20的延伸方向相同,弯曲段253为曲率可变的弯曲结构,通常由弹性材料制成,用于保持第二连接段252及与第二连接段252连接的延伸臂20贴靠第一钳臂11表面。进一步的,本实施例中,基座41内设有导槽411,弯曲段253穿设于导槽411内,并能在导槽411内移动。弹性杆25为具有弹性的杆状结构,自然状态下,弹性杆25为直杆状。当弹性杆25插入导 槽411中时,直杆状的弹性杆25弯曲形成弯曲段253,通过弯曲段253的弯曲应力,以保持第二连接段252及与第二连接段252连接的延伸臂20贴靠第一钳臂11的表面。本实施例中,由于所述延伸臂20的一端通过弹性杆25与滑块31相连,以通过滑块31的运动以带动所述延伸臂20伸长或者缩回所述第一钳臂11。并且,滑块31运动时会带动第一钳臂11进行旋转,以相对于推杆40进行开合。即本实施例中,延伸臂20与滑块31连接,且第一钳臂11与滑块31连接,从而使得滑块31移动能够同时带动延伸臂20的伸长或者缩回以及第一钳臂11相对推杆40的打开或者合拢,即延伸臂20的伸长或缩回与第一钳臂11相对推杆40的打开或合拢同步。可以理解的是,本申请的其他实施例中,延伸臂20的伸长或者缩回以及第一钳臂11相对推杆40的打开或者合拢也可以不同步。例如,将第一钳臂11与延伸臂20连接于不同的驱动结构上,从而使得第一钳臂11能够与延伸臂20分开运动,以使得延伸臂20的伸长或者缩回以及第一钳臂11相对推杆40的打开或者合拢能够实现不同步。具体的,可以使得所述第一钳臂11通过驱动杆32与滑块31连接。再在推杆40内或推杆40外设能够沿推杆40往复运动的另一滑块,并将延伸臂20通过弹性杆25与所述另一滑块连接,分别驱动所述滑块31以及所述另一滑动沿推杆40移动,以实现延伸臂20的伸长或者缩回与第一钳臂11相对推杆40的打开或者合拢不同步。Further, in this embodiment, 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. In this embodiment, 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. Further, in the embodiment, 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. 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. In this embodiment, 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. Moreover, when the slider 31 moves, the first caliper arm 11 is rotated to open and close with respect to the push rod 40. That is, in the present embodiment, 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. 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 first caliper arm 11 relative to the push rod 40 may also be out of synchronization. For example, 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. Specifically, the first caliper arm 11 can be connected to the slider 31 through the driving rod 32. Then, 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. And 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.
本发明中,通过在第一夹钳10的第一钳臂11的表面设置可以伸缩的第一延伸臂20,以及在第二夹钳10的第一钳臂11表面设置可以伸缩的第二延伸臂20,使得第一钳臂11相对第二钳臂12打开的同时,第一延伸臂20及第二延伸臂20均伸长,相当于增加了第一夹钳10及第二夹钳10的第一钳臂11的长度,从而能够快速的捕获活动的瓣叶组织,降低手术难度、提高手术效率。In the present invention, 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, and 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.
本发明还提供一种瓣膜夹合系统,瓣膜夹合系统包括推送装置及前述的瓣膜夹合器100,通过推送装置可将瓣膜夹合器100输送至二尖瓣处,并调整瓣膜夹合器100于二尖瓣的适宜位置。推送装置包括用于操作者握持的操作手柄及与操作手柄远端相连、且具有一定轴向长度的推送轴,推送轴近端与操作手柄连接,推送轴的远端与瓣膜夹合器之间可拆卸连接。操作者通过推送轴将瓣膜夹合器100推送至预定位置。具体的,推送轴包括活动地同轴套装在一起的连接轴及控制轴,连接轴与推杆40之间可拆卸连接,即,操作手柄与瓣膜夹合器100之间通过连接轴连接。控制轴与驱动组件连接,具体是指控制轴与滑块31之间连接,从而通过控制轴驱动驱动组件的滑块31沿推杆40的轴向往复运动,以驱动第一钳臂11与推杆40及第二钳臂12之间的相对开合,从而使得瓣膜夹合器100的夹钳10分别夹持瓣膜的多个瓣叶,达到缩小瓣叶之间的间隙、夹合瓣膜的目的。连接轴与控制轴之间的套装关系由推杆与驱动组件的滑块之间的套装关系而决定。本实施例中,所述滑块套装于所述推杆外,因此,所述控制轴套设于所述控制轴外。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. Specifically, 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. In this embodiment, the slider is disposed outside the push rod, and therefore, the control shaft sleeve is disposed outside the control shaft.
进一步的,本发明的推送装置还可以包括其他的驱动件。当瓣膜夹合器为图8所示的瓣膜夹合器200时,推送装置还包括与第二钳臂12相连的调节线等,调节线穿过第二钳臂12的固定段12a并连接至操作手柄上,通过操作手柄控制调节线,可调节第二钳臂12与第一钳臂11及推杆40之间的相对位置。例如,当瓣膜夹合器在体内进行输送时,拉紧调节线以控制第二夹钳10的固定段12a,以使第二钳臂12收拢于推杆40表面;当第一钳臂11位于瓣叶的适当位置时,放松调节线对第二钳臂12的限制,使得第二钳臂12自然伸展, 从而与第一钳臂11配合夹紧位于第一钳臂11与第二钳臂12之间的瓣叶。Further, the pushing device of the present invention may further include other driving members. 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. For example, when the valve clip is being transported in the body, 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 When the valve leaf is in the proper position, 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.
以下以二尖瓣的瓣膜修复过程为例,说明本发明的瓣膜夹合系统的操作方法,主要包括以下步骤:Hereinafter, the 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:
第一步:通过推送轴将与其相连的瓣膜夹合器从左心房推进,经过二尖瓣到达左心室。此时,瓣膜夹合器的第一钳臂11及第二钳臂12均收拢于推杆40的表面。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.
第二步:通过推送轴调整瓣膜夹合器与二尖瓣的相对位置,使得瓣膜夹合器的两个夹钳10分别接近二尖瓣的前叶1a和后叶1b。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.
第三步:沿推杆40的远端方向移动滑块31,以驱动第一钳臂11相对推杆40张开,同时使得延伸臂20自第一钳臂11中伸出。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.
第四步:调整瓣膜夹合器的方向,并通过X射线等设备观察每个第一钳臂11与前叶1a和后叶1b的相对位置,使得第一钳臂11垂直于二尖瓣的对合线。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.
第五步:沿推杆40的近端回撤滑块31,从而驱动第一钳臂11相对于第二钳臂12及推杆40闭合,第一钳臂11再次收拢至推杆40表面,此时,二尖瓣的前叶1a和后叶1b分别被夹持在一对第一钳臂11和位于推杆40表面的第二钳臂12之间,由此分别抓持两片瓣叶。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. At this time, 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 .
第六步:解脱滑块31与控制轴之间的连接,再解脱推杆40与推送轴之间的连接,将推送轴撤出患者体外,瓣膜夹合器留置于患者体内,完成二尖瓣的瓣叶缘对缘夹持。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.
进一步的,当瓣膜夹合器为如图8所示的瓣膜夹合器200时,第四步与第五步之间还包括步骤:放开控制件对第二钳臂12的控制,使得第二钳臂12相对推杆40打开,并与第一钳臂11配合以夹紧位于第一钳臂11与第二钳臂12之间的瓣叶。Further, when the valve clipper is the valve clipper 200 as shown in FIG. 8, 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.
本发明的瓣膜夹合系统,能够实现在体外进行操作,以将瓣膜夹合器夹合瓣叶,减轻或避免“二尖瓣返流”的问题。并且,由于瓣膜夹合器能够容易的捕捉瓣叶,从而使得通过瓣膜夹合系统进行“二尖瓣返流”手术的难度大大降低,并降低手术时间。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.
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所述权利要求的保护范围为准。The above is only a specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can easily think of changes or substitutions within the technical scope of the present invention. It should be covered by the scope of the present invention. Therefore, the scope of the invention should be determined by the scope of the appended claims.

Claims (28)

  1. 一种瓣膜夹合器,其特征在于,包括:A valve clipper, comprising:
    推杆;Putt
    至少两个夹钳,其一端连接到所述推杆上,并相对推杆开合;每个所述夹钳均包括第一钳臂,所述第一钳臂包括固定端及自由端,所述固定端旋转连接于所述推杆上,所述第一钳臂以所述固定端在所述推杆上的固定位置为旋转中心相对所述推杆开合;At least two clamps, one end of which 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 fixed end is rotatably coupled to the push rod, and the first caliper arm is opened and closed with respect to the push rod with a fixed position of the fixed end on the push rod as a center of rotation;
    至少一根延伸臂,所述延伸臂沿所述第一钳臂的轴向伸长或缩回,当所述延伸臂沿第一钳臂的固定端向自由端方向伸长时,所述延伸臂的末端超出所述第一钳臂的自由端。At least one extension arm extending or retracting in an axial direction of the first caliper arm, the extension extending when the extension arm is extended toward a free end along a fixed end of the first caliper arm The end of the arm extends beyond the free end of the first caliper arm.
  2. 如权利要求1所述的瓣膜夹合器,其特征在于,所述延伸臂活动地设于所述第一钳臂的表面或内部。The valve clip of claim 1 wherein said extension arm is movably disposed on a surface or interior of said first caliper arm.
  3. 如权利要求1所述的瓣膜夹合器,其特征在于,所述延伸臂的伸长或缩回与所述第一钳臂相对所述推杆的打开或合拢同步或者不同步。The valve clip of claim 1 wherein the extension or retraction of the extension arm is synchronized or not synchronized with the opening or closing of the first jaw arm relative to the push rod.
  4. 如权利要求1所述的瓣膜夹合器,其特征在于,所述延伸臂包括延伸臂主体,所述延伸臂主体包括一根或者多根并排设置的支撑杆。The valve clip of claim 1 wherein said extension arm comprises an extension arm body, said extension arm body comprising one or more support bars disposed side by side.
  5. 如权利要求4所述的瓣膜夹合器,其特征在于,所述延伸臂还包括支撑体,所述延伸臂主体由柔性材料制成,所述支撑体由刚性材料制成,所述支撑体设于所述延伸臂主体的内部和/或外部。A valve clipper according to claim 4, wherein said extension arm further comprises a support body, said extension arm body being made of a flexible material, said support body being made of a rigid material, said support body Provided on the inside and/or outside of the extension arm body.
  6. 如权利要求5所述的瓣膜夹合器,其特征在于,所述延伸臂主体为柔性管或柔性杆,所述支撑体为刚性管或刚性杆,所述柔性管或柔性杆和所述刚性管或刚性杆同轴地套装在一起。A valve clipper according to claim 5, wherein said extension arm body is a flexible tube or a flexible rod, said support body being a rigid tube or a rigid rod, said flexible tube or flexible rod and said rigidity The tubes or rigid rods are coaxially nested together.
  7. 如权利要求5所述的瓣膜夹合器,其特征在于,所述延伸臂主体为柔性管或柔性杆,所述支撑体为热缩管,所述热缩管套于所述延伸臂主体外并加热收缩以与所述延伸臂主体固定在一起。The valve clipper according to claim 5, wherein the extension arm body is a flexible tube or a flexible rod, the support body is a heat shrinkable tube, and the heat shrinkable tube sleeve is outside the extension arm body. And heat shrinking to be fixed with the extension arm body.
  8. 如权利要求5所述的瓣膜夹合器,其特征在于,所述延伸臂主体由至少一根柔性丝绕制而成,所述支撑体由热塑性弹性体材料制成,所述热塑性弹性体材料覆盖在所述延伸臂主体外部并渗入所述延伸臂主体内部。A valve clipper according to claim 5, wherein said extension arm body is wound from at least one flexible wire, said support body being made of a thermoplastic elastomer material, said thermoplastic elastomer material Covering the outside of the extension arm body and penetrating into the interior of the extension arm body.
  9. 如权利要求1-8任一项所述的瓣膜夹合器,其特征在于,所述延伸臂至少部分由不透射X射线材料制成。The valve clip of any of claims 1-8, wherein the extension arm is at least partially made of a radiopaque X-ray material.
  10. 如权利要求1所述的瓣膜夹合器,其特征在于,所述延伸臂的末端设有弹性件,所述弹性件具有压缩状态及舒展状态,舒展状态时的所述弹性件的面积大于压缩状态时的所述弹性件的面积,所述延伸臂的末端超出所述第一钳臂的自由端时,所述弹性件处于舒展状态。The valve clipper according to claim 1, wherein the end of the extension arm is provided with an elastic member, and the elastic member has a compressed state and a stretched state, and the elastic member has a larger area than the compression state in the stretched state. The area of the elastic member in the state, when the end of the extension arm exceeds the free end of the first caliper arm, the elastic member is in a stretched state.
  11. 如权利要求10所述的瓣膜夹合器,其特征在于,所述弹性件为可变形的网笼。The valve clip of claim 10 wherein said resilient member is a deformable mesh cage.
  12. 如权利要求10所述的瓣膜夹合器,其特征在于,所述弹性件包括多个枝丫。The valve clip of claim 10 wherein said resilient member comprises a plurality of branches.
  13. 如权利要求10所述的瓣膜夹合器,其特征在于,所述弹性件为封闭的弹性环。The valve clip of claim 10 wherein said resilient member is a closed elastic ring.
  14. 如权利要求13所述的瓣膜夹合器,其特征在于,所述弹性环内设有至少一条支撑条,所述支撑条的延伸方向与所述第一钳臂的固定端至自由端方向相同。The valve clipper according to claim 13, wherein at least one support strip is disposed in the elastic ring, and the support strip extends in the same direction as the fixed end to the free end of the first caliper arm. .
  15. 如权利要求12-14任一项所述的瓣膜夹合器,其特征在于,所述第一钳臂包括朝向所述推杆的第一表面,所述弹性件所在的面与所述第一表面之间平行。A valve clipper according to any one of claims 12 to 14, wherein the first caliper arm includes a first surface facing the push rod, a face on which the elastic member is located, and the first The surfaces are parallel.
  16. 如权利要求1所述的瓣膜夹合器,其特征在于,所述第一钳臂包括朝向所述推杆的第一表面,所述第一表面为曲面,且所述曲面的曲率方向朝向所述推杆。The valve clipper of claim 1 wherein said first caliper arm includes a first surface facing said pusher, said first surface being curved, and said curved surface is oriented in a direction of curvature The putter.
  17. 如权利要求16所述的瓣膜夹合器,其特征在于,所述延伸臂通过限位件限位于所述第一表面,所述限位件用于限定所述延伸臂的伸缩方向为沿所述第一钳臂的固定端向自由端的方向。The valve clipper according to claim 16, wherein the extension arm is limited to the first surface by a limiting member, and the limiting member is configured to define a telescopic direction of the extension arm as a The fixed end of the first caliper arm is oriented in the direction of the free end.
  18. 如权利要求1所述的瓣膜夹合器,其特征在于,所述夹钳还包括第二钳臂,所述第二钳臂设于所述推杆的外部并相对所述推杆开合,从而与所述第一钳臂配合以夹持瓣叶。The valve clipper according to claim 1, wherein said clamp further comprises a second caliper arm, said second caliper arm being disposed outside said push rod and opening and closing with respect to said push rod, Thereby engaging the first caliper arm to clamp the leaflets.
  19. 如权利要求18所述的瓣膜夹合器,其特征在于,所述第二钳臂包括位于远端的固定段及位于近端的连接段,所述第二钳臂的所述连接段与所述推杆之间固定连接,所述第二钳臂的所述固定段相对所述推杆开合。A valve clipper according to claim 18, wherein said second caliper arm comprises a fixed section at the distal end and a connecting section at the proximal end, said connecting section of said second caliper arm The fixed connection between the push rods, the fixed section of the second caliper arm is opened and closed with respect to the push rod.
  20. 如权利要求19所述的瓣膜夹合器,其特征在于,所述第二钳臂至少部分由弹性材料制成。A valve clipper according to claim 19, wherein said second caliper arm is at least partially made of an elastic material.
  21. 如权利要求18所述的瓣膜夹合器,其特征在于,所述第二钳臂包括与所述第一钳臂相对的第三表面,所述第三表面上设有夹持增强件。A valve clamp according to claim 18, wherein said second caliper arm includes a third surface opposite said first caliper arm, said third surface being provided with a gripping reinforcement.
  22. 如权利要求1所述的瓣膜夹合器,其特征在于,所述瓣膜夹合器还包括驱动组件,所述驱动组件与所述第一钳臂及所述延伸臂连接,所述驱动组件推动所述第一钳臂相对所述推杆打开,并推动所述延伸臂伸出所述第一钳臂;且,所述驱动组件拉动所述第一钳臂相对所述推杆合拢,并拉动所述延伸臂收入所述第一钳臂。The valve clip of claim 1 wherein said valve clip further comprises a drive assembly coupled to said first caliper arm and said extension arm, said drive assembly urging The first caliper arm opens relative to the push rod and pushes the extension arm out of the first caliper arm; and the drive assembly pulls the first caliper arm to close with the push rod and pulls The extension arm receives the first caliper arm.
  23. 如权利要求1所述的瓣膜夹合器,其特征在于,所述驱动组件包括滑块,所述滑块设于所述推杆内或套设于所述推杆外并沿所述推杆轴向往复运动;所述延伸臂的一端通过弹性杆与所述滑块相连,所述滑块沿所述推杆轴向往复运动并带动所述弹性杆运动,以通过所述弹性杆带动所述延伸臂沿所述第一钳臂伸缩。A valve clipper according to claim 1 wherein said drive assembly includes a slider disposed within said pusher or sleeved outside said pusher and along said pusher An axial reciprocating motion; one end of the extension arm is connected to the slider through an elastic rod, the slider reciprocates axially along the push rod and drives the elastic rod to move through the elastic rod The extension arm expands and contracts along the first caliper arm.
  24. 如权利要求23所述的瓣膜夹合器,其特征在于,所述弹性杆包括第一连接段、第二连接段,以及位于所述第一连接段与所述第二连接段之间的弯曲段,所述第一连接段背离所述弯曲段的一端与所述滑块固定连接,第一连接段为沿所述推杆方向延伸的线段;所述第二连接段背离所述弯曲段的一端与所述延伸臂固定连接,所述第二连接段的延伸方向与所述延伸臂的延伸方向相同,所述弯曲段为曲率可变的弯曲结构,所述弯曲段保持所述第二连接段及与所述第二连接段连接的延伸臂贴靠所述第一钳臂表面。A valve clipper according to claim 23, wherein said elastic rod comprises a first connecting section, a second connecting section, and a bend between said first connecting section and said second connecting section a segment of the first connecting portion facing away from the curved segment is fixedly connected to the slider, the first connecting segment is a line segment extending along the push rod direction; and the second connecting portion is away from the curved portion One end is fixedly connected to the extension arm, the second connection section extends in the same direction as the extension arm, and the curved section is a curved structure with a variable curvature, and the curved section maintains the second connection The segment and the extension arm connected to the second connecting segment abut the surface of the first caliper arm.
  25. 如权利要求23所述的瓣膜夹合器,其特征在于,所述驱动组件还包括至少一组驱动杆,每组所述驱动杆包括至少两根驱动杆,所述驱动杆一端与所述滑块连接,另一端与所述第一钳臂连接,并连接于所述第一钳臂的固定端与自由端之间;所述滑块沿所述推杆进行轴向往复运动以带动所述驱动杆相对所述滑块转动,所述驱动杆转动以带动第一钳臂相对所述第二钳臂开合。The valve clip of claim 23, wherein said drive assembly further comprises at least one set of drive rods, each set of said drive rods comprising at least two drive rods, said drive rod having one end and said slide rod a block connection, the other end being coupled to the first caliper arm and coupled between the fixed end and the free end of the first caliper arm; the slider axially reciprocating along the push rod to drive the The driving rod rotates relative to the slider, and the driving rod rotates to drive the first clamping arm to open and close with respect to the second clamping arm.
  26. 一种瓣膜夹合系统,其特征在于,包括推送装置及权利要求1-19任一项所述的瓣膜夹合器,所述推送装置包括操作手柄及具有一定轴向长度的推送轴,所述推送轴近端与所述操作手柄连接,所述推送轴的远端与所述瓣膜夹合器之间可拆卸连接。A valve clamping system, comprising: a pushing device and the valve clipper according to any one of claims 1 to 19, the pushing device comprising an operating handle and a pushing shaft having a certain axial length, A proximal end of the push shaft is coupled to the operating handle, and a distal end of the push shaft is detachably coupled to the valve clip.
  27. 如权利要求26所述的瓣膜夹合系统,其特征在于,所述推送轴包括活动地同轴套装在一起的连接轴及控制轴;所述连接轴与所述推杆之间可拆卸连接,所述控制轴与所述驱动组件之间连接,所述控制轴驱动所述驱动组件沿所述推杆的轴向往复运动,以驱动所述第一钳臂与所述推杆及所述第二钳臂之间的相对开合。A valve clamping system according to claim 26, wherein said push shaft includes a connecting shaft and a control shaft that are movably coaxially fitted together; said connecting shaft being detachably coupled to said push rod, Connecting a control shaft to the drive assembly, the control shaft driving the drive assembly to reciprocate along an axial direction of the push rod to drive the first clamp arm and the push rod and the first The relative opening and closing between the two caliper arms.
  28. 如权利要求26所述的瓣膜夹合系统,其特征在于,所述推送装置包括与所述第二钳臂相连的调节线。The valve clamping system of claim 26 wherein said pushing means comprises an adjustment line coupled to said second caliper arm.
PCT/CN2019/086254 2018-05-17 2019-05-09 Valve clamp and valve clamping system WO2019218930A1 (en)

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CN201810476710.X 2018-05-17
CN201820739065.1U CN209548144U (en) 2018-05-17 2018-05-17 Valve clamping machine and valve clamping system
CN201810476710.XA CN110495972A (en) 2018-05-17 2018-05-17 Valve clamping machine and valve clamping system
CN201820739065.1 2018-05-17

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