WO2022142281A1 - Dispositif de suture de valvule - Google Patents

Dispositif de suture de valvule Download PDF

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Publication number
WO2022142281A1
WO2022142281A1 PCT/CN2021/107104 CN2021107104W WO2022142281A1 WO 2022142281 A1 WO2022142281 A1 WO 2022142281A1 CN 2021107104 W CN2021107104 W CN 2021107104W WO 2022142281 A1 WO2022142281 A1 WO 2022142281A1
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WO
WIPO (PCT)
Prior art keywords
clamping
valve
push rod
proximal end
push
Prior art date
Application number
PCT/CN2021/107104
Other languages
English (en)
Chinese (zh)
Inventor
张庭超
张伟伟
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 CN202023277009.7U external-priority patent/CN216021546U/zh
Priority claimed from CN202011602988.0A external-priority patent/CN114681131A/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2022142281A1 publication Critical patent/WO2022142281A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • the present application relates to the technical field of medical devices, in particular to a valve stapler.
  • the mitral valve is a one-way "valve" between the left atrium (abbreviated: LA) and the left ventricle (abbreviated: LV), which allows blood to flow from the left atrium to the left ventricle. See Figure 1, a normal healthy mitral valve has multiple chordae tendineae.
  • the leaflets of the mitral valve are divided into anterior leaflets and posterior leaflets.
  • the two When the left ventricle is in a diastolic state, the two are in an open state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contracted state, the chordae tendineae are stretched to ensure The valve leaflets will not be flushed to the atrium side by the blood flow, and the anterior and posterior leaflets are well closed, thereby ensuring that the blood flows from the left ventricle through the aortic valve (abbreviation: AV) to the aorta.
  • AV aortic valve
  • chorda tendinopathy is usually treated by surgically implanting sutures, which requires invasive thoracotomy, general anesthesia, and moderate hypothermic cardiopulmonary bypass as auxiliary support.
  • sutures which requires invasive thoracotomy, general anesthesia, and moderate hypothermic cardiopulmonary bypass as auxiliary support.
  • Such surgical procedures have disadvantages such as complex surgical procedures, high surgical costs, high degree of patient trauma, high risk of complications, long hospital stays, and painful recovery for patients.
  • the clamping device includes a clamping push rod, a distal end clamp and a proximal clamp for cooperating with clamping the valve leaflet, and a clamping operation mechanism connected to the proximal end of the clamping push rod.
  • the clamping operation mechanism moves from the distal end to the proximal end to close the distal end collet and the proximal end clamp, and when the clamping operation mechanism moves from the distal end to the proximal end to a predetermined position, a closing sound feedback is issued.
  • the operator can confirm whether the distal collet and the proximal collet are closed according to the audio feedback.
  • the length of the clamping push rod may be insufficient, resulting in the clamping operating mechanism unable to move to the predetermined position when the distal collet and the proximal collet clamp the valve leaflet. sound feedback.
  • the operator forcibly moves the clamping operating mechanism to the proximal end, which may cause the distal collet and the proximal collet to over-clamp the valve leaflet and thereby pinching the valve leaflet.
  • the present application provides a valve stapler.
  • the present application provides a valve stapler, which includes a pushing device and a clamping device.
  • the pushing device includes a pushing conduit;
  • the clamping device includes a clamping push rod, a proximal end collet, a distal end clamping head, a clamping operation mechanism and an elastic mechanism, the clamping push rod is movably inserted into the pushing catheter, and the proximal end
  • the collet is arranged at the distal end of the pushing catheter, the distal end collet is arranged at the distal end of the clamping push rod, the elastic mechanism is fixedly connected to the proximal end of the clamping push rod, and the clamping
  • the operating mechanism movably connects the proximal end of the clamping push rod and the elastic mechanism, and the clamping operation mechanism drives the clamping push rod to move from the distal end to the proximal end so that the distal end collet and the proximal end are connected.
  • the clamping operating mechanism compresses the elastic mechanism, so that the clamping operating mechanism is displaced proximally relative to the clamping push rod to give sound feedback.
  • the valve stapler provided by the present application is provided with an elastic mechanism.
  • the elastic mechanism can be compressed so that the clamping mechanism can be clamped.
  • the operating mechanism moves towards the proximal end relative to the clamping push rod and reaches a predetermined position to give sound feedback, so as to prevent the operator from forcibly moving the clamping operation mechanism to the proximal end in order to obtain the sound feedback, so that the distal collet and the proximal collet are excessively clamped
  • the valve leaflet is tightened and the valve leaflet is pinched, which improves the safety and reliability of the operation.
  • Figure 1 is a schematic diagram of the structure of the human heart under normal health conditions
  • Figure 2 is a schematic structural diagram of a human heart under the condition of posterior chordae tendineae rupture
  • FIG. 3 is a schematic perspective view of a valve stapler provided by an embodiment of the application.
  • FIG 4 is an exploded schematic view of the valve stapler shown in Figure 3;
  • FIG. 5 is a schematic perspective view of a suture provided by an embodiment of the present application.
  • 6a is a schematic perspective view of a probe part of a valve stapler extending out of a pushing catheter according to an embodiment of the application;
  • Fig. 6b is the enlarged schematic diagram of the partial area I of Fig. 6a;
  • FIG. 7a is a schematic perspective view of the probe of the valve stapler provided by an embodiment of the application completely located in the push catheter;
  • Fig. 7b is an enlarged schematic view of partial area II of Fig. 7a;
  • Figure 8 is an exploded schematic view of the valve stapler shown in Figure 6a;
  • Figure 9 is an exploded schematic view of the valve stapler shown in Figure 7a;
  • FIG. 10 is an exploded schematic view of a push handle provided by an embodiment of the application.
  • FIG. 11 is a schematic perspective view of a clamping operating mechanism of a clamping device provided by an embodiment of the application.
  • FIG. 12 is an exploded schematic view of a clamping operating mechanism of a clamping device provided by an embodiment of the application;
  • FIG. 13 is a schematic diagram of a puncture handle and a safety member in a locked state according to an embodiment of the application;
  • Fig. 14 is a schematic diagram of the puncture handle and the safety element in an unlocked state provided by an embodiment of the application;
  • 15 is a schematic perspective view of a puncture device and a safety piece provided by an embodiment of the application.
  • Fig. 16 is another schematic diagram of the puncture handle and the safety element in an unlocked state provided by an embodiment of the application;
  • FIG. 17 is a schematic three-dimensional schematic diagram of a fuse provided by an embodiment of the application.
  • FIG. 18 is a schematic perspective view of a clamping auxiliary device provided by an embodiment of the application.
  • FIG. 19 is a schematic perspective view of an auxiliary manipulation mechanism of a clamping auxiliary device provided by an embodiment of the application.
  • Fig. 20 is a schematic diagram of a clamping aid provided by an embodiment of the application in cooperation with a clamping device to clamp a valve leaflet;
  • 21 is a cross-sectional view of a push catheter provided by an embodiment of the application.
  • 22-33 are schematic diagrams of the implementation process of implanting sutures into valve leaflets by the valve stapler according to an embodiment of the application.
  • the expression “and/or” includes any and all combinations of the associated listed words.
  • the expression “A and/or B” may include A, may include B, or may include both A and B.
  • the position close to the operator is generally defined as the proximal end, and the position far from the operator is defined as the distal end.
  • the direction of the central axis of objects such as cylinders and tubes is defined as the axial direction.
  • Radial refers to a direction in a radial plane through the central axis, eg, a line along a diameter or radius, or a line perpendicular to the central axis.
  • an embodiment of the present application provides a valve stapler 100 for implanting a suture 60 (as shown in FIG. 5 ) into a patient's body to replace the diseased or ruptured chordae tendineae in the patient's heart ; or for implanting a plurality of sutures 60 into a patient and fixing each other to achieve edge-to-edge repair of heart valves (eg, mitral valve, tricuspid valve).
  • the valve stapler 100 includes a clamping device 10 , a puncturing device 20 , a pushing device 30 , a clamping auxiliary device 40 and a detection device 50 .
  • the pusher 30 is used to deliver the gripping device 10 to a predetermined location near the valve.
  • the gripping device 10 is used to receive the suture 60 and grip the leaflets of the valve.
  • the clamping auxiliary device 40 is used to support the lower surface of the valve leaflet and cooperate with the clamping device 10 to clamp the valve leaflet.
  • the detection device 50 is used to detect whether the clamping device 10 clamps the valve leaflets of the valve and the clamping effect on the valve leaflets.
  • the puncturing device 20 is used to puncture the valve after the holding device 10 holds the valve.
  • suture 60 includes a flexible suture body 62 .
  • Suture body 62 has opposing first and second ends. The first end and/or the second end is connected with a fixing member 64 .
  • the fixing member 64 is used for a non-removable fixed connection or a detachable fixed connection with the puncturing device 20 .
  • the fixing members 64 may be provided on both ends of the suture main body 62 , or may be provided only on one end of the suture main body 62 . In this embodiment, both ends of the suture main body 62 are provided with fixing members 64 .
  • the number of sutures 60 may be one, or two or more.
  • the material of the suture body 62 may be a polymer material or a relatively soft metal material that is compatible with the human body, preferably polyethylene terephthalate (polyethylene terephthalate, PET), expanded polytetrafluoroethylene (expanded polytetrafluoroethylene). Polytetrafluoroethylene, e-PTFE) and other polymer materials.
  • the suture body 62 is used for implantation in the heart to replace the diseased chordae tendineae in the heart, that is, one end of the suture body 62 is fixed on the valve leaflet, and the other end is fixed on the ventricular wall or the papillary muscle and other parts , to replace the diseased chordae tendineae and maintain the tension between the valve leaflets and the ventricular wall.
  • the pushing device 30 includes a pushing catheter 32 and a pushing handle 34 connected to the proximal end of the pushing catheter 32 .
  • the push handle 34 is used to manipulate the entire valve stapler 100 to be pushed distally or withdrawn proximally.
  • the push handle 34 includes a first casing 342 and a second casing 344 detachably covered on the first casing 342
  • the push conduit 32 is a tubular body with a certain axial length or a tube with an inner cavity. rod-shaped body.
  • the clamping device 10 includes a clamping pusher 12 that accommodates a suture 60, and a distal collet 14 and a proximal collet 16 for cooperating to clamp the valve leaflets.
  • the distal collet 14 is disposed at the distal end of the clamping push rod 12
  • the proximal collet 16 is disposed at the distal end of the pushing catheter 32 .
  • the clamping push rod 12 is movably inserted into the inner cavity of the push handle 34 and the push conduit 32 .
  • the clamping push rod 12 is a tubular body or a hollow rod-shaped body with a certain axial length, the cross section is preferably oval or circular, and the clamping push rod 12 is provided with a suture channel 122 in the axial direction (as shown in FIG. 4 ). shown).
  • the distal collet 14 is provided with two suture thread accommodating cavities 142 (as shown in FIG. 7 b ) communicating with the suture thread channel 122 , and the two suture thread accommodating cavities 142 respectively pass through to the clamping surface of the distal collet 14 .
  • the suture main body 62 of the suture 60 is accommodated in the suture channel 122 and the suture receiving cavity 142 .
  • the clamping surface of the distal collet 14 is further provided with two fixing cavities 144 for accommodating the two fixing members 64 of the suture 60 respectively (as shown in FIG. 7b ).
  • Each fixing cavity 144 is in axial communication with a suture receiving cavity 142 respectively.
  • the clamping device 10 further includes a clamping operation mechanism 18 and an elastic mechanism 19 connected to the proximal end of the clamping push rod 12 .
  • the clamping operation mechanism 18 is provided on the push handle 34 .
  • the clamp operating mechanism 18 is used to drive the distal collet 14 to close or disengage the proximal collet 16 .
  • the shapes of the proximal collet 16 and the distal collet 14 are consistent with the shape of the pushing catheter 32, and the distal collet 14 and the proximal collet 16 form a smooth whole after being closed, so as to facilitate pushing And reduce the damage to the patient's wound.
  • the proximal end of the clamping push rod 12 protrudes from the proximal end of the pushing catheter 32 , the elastic mechanism 19 is fixedly connected to the proximal end of the clamping push rod 12 , and the clamping operation mechanism 18 is movably connected to the proximal end of the clamping push rod 12 and the elastic mechanism 19.
  • the clamping operation mechanism 18 drives the clamping push rod 12 to move from the distal end to the proximal end to close the distal collet 14 and the proximal collet 16 , the clamping operation mechanism 18 compresses the elastic mechanism 19 so that the clamping operation mechanism 18 is opposite to each other.
  • the clamping push rod 12 is displaced towards the proximal end to give sound feedback.
  • the elastic mechanism 19 can be compressed to make the clamping operation mechanism 18 move to the predetermined position.
  • the operating mechanism 18 is displaced to the proximal end relative to the clamping push rod 12 and reaches a predetermined position to emit sound feedback, so as to prevent the operator from forcibly moving the clamping operation mechanism 18 to the proximal end in order to obtain the sound feedback, so that the distal collet 14 and the proximal end are forced to move.
  • the clamping head 16 over-clamps the valve leaflets and injures the valve leaflets, thus improving the safety and reliability of the operation.
  • the inner surface of the second housing 344 of the push handle 34 is provided with a sliding groove 345 in the axial direction (as shown in FIG. 9 and FIG. 10 ).
  • the moving piece 182 is slidably disposed in the sliding groove 345 .
  • the sliding groove 345 is used to guide and limit the movement of the sliding member 182 .
  • the elastic mechanism 19 is movably connected with the sliding member 182 , and the elastic mechanism 19 is fixedly connected with the proximal end of the clamping push rod 12 .
  • the proximal end of the clamping push rod 12 abuts against the sliding member 182 .
  • the operating assembly 184 is used to drive the sliding member 182 to slide axially along the sliding groove 345 .
  • the sliding member 182 defines a push rod installation hole 1822 , the proximal end of the clamping push rod 12 is accommodated in the push rod installation hole 1822 to abut the sliding member 182 , and the elastic mechanism 19 is partially accommodated in the push rod installation hole 1822 inside and fixedly connected with the proximal end of the clamping push rod 12 .
  • the elastic mechanism 19 and the clamping push rod 12 are partially penetrated through the push rod installation hole 1822 of the sliding member 182 to be connected, and the proximal end of the clamping push rod 12 abuts the sliding member 182 and is held in the push rod installation hole In 1822, the sliding member 182 can compress the elastic mechanism 19 so that the clamping operating mechanism 18 is displaced proximally relative to the clamping push rod 12 and reaches a predetermined position to emit sound feedback.
  • the operation assembly 184 is elastically connected with the sliding member 182, the inner surface of the push handle 34 is further provided with a guide groove 347, and the operation assembly 184 is slidably arranged in the guide groove 347 (as shown in FIG. 10 ).
  • the guide groove 347 includes a connected radial guide groove 3471 and an axial guide groove 3473 .
  • the axial guide groove 3473 is closer to the central axis of the push handle 34 than the radial guide groove 3471 .
  • the guide groove 347 is substantially an L-shaped groove structure, and the radial guide groove 3471 communicates with the proximal end of the axial guide groove 3473 .
  • the operating assembly 184 can be converted between the natural state and the compressed state. When the operating assembly 184 moves from the axial guide groove 3471 to the radial guide groove 3473, the operating assembly 184 is converted from the compressed state to the natural state, and pushes the handle 34 to generate sound. feedback.
  • both sides of the sliding member 182 are connected with operating components 184 .
  • the side of the push handle 34 is also provided with an operation through slot 348 (as shown in FIG. 9 and FIG. 10 ).
  • the operating assembly 184 includes a sliding plate 1841 , an operating member 1843 and an elastic member 1845 .
  • the sliding plate 1841 is connected to the operating member 1843 , the sliding plate 1841 is slidably disposed in the guide groove 347 , and the operating member 1843 is clamped in the operating through groove 348 and exposed to the outside of the push handle 34 .
  • the operation through groove 348 functions to limit the axial movement distance of the clamping operation mechanism 18 .
  • the movement of the operating member 1843 in the operating through slot 348 drives the sliding member 182 to move, thereby controlling the opening and closing of the distal collet 14 and the proximal collet 16 .
  • the elastic member 1845 is connected between the sliding member 182 and the sliding plate 1841. When the elastic member 1845 is converted from the compressed state to the natural state, the operating member 1843 impacts the push handle 34 to generate sound feedback, which is convenient for the operator to confirm the distal end chuck 14 Close with proximal collet 16 to hold the leaflet.
  • the clamping operating mechanism 18 further includes a mounting rod 186 , and the mounting rod 186 is connected between the sliding member 182 and the operating member 1843 .
  • the mounting rod 186 is connected between two sides of the sliding member 182 in the radial direction .
  • the operating member 1841 is connected with the mounting rods 186 .
  • the elastic piece 1845 is sleeved outside the mounting rod 186 and is arranged between the sliding piece 182 and the operating piece 1843 .
  • the sliding plate 1841 is integrated with the operating member 1843 , that is, the mounting rod 186 is also connected between the sliding member 182 and the sliding plate 1841 .
  • the operating assembly 184 is converted between the natural state and the compressed state by the deformation of the elastic member 1845 .
  • the elastic member 1845 can be a spring.
  • the sliding plate 1843 When the elastic member 1845 is converted from the natural state to the compressed state, the sliding plate 1843 can be moved from the radial guide groove 3471 to the axial guide groove 3473; when the elastic member 1845 is converted from the compressed state to the natural state, the sliding plate 1843 can be moved by the axial guide groove 3471 Move to the radial guide groove 3473, so that the operating member 1841 impacts the push handle 34 to generate an audible feedback, prompting the operator that the distal collet 14 and the proximal collet 16 have been closed.
  • the operating member 1843 includes an operating portion 1846 , a connecting portion 1847 and a feedback portion 1848 that are connected in sequence.
  • the connecting portion 1847 is penetrated through the operating through groove 348, the operating portion 1843 is located outside the push handle 34, and the feedback portion 1848 is accommodated in the inner cavity of the push handle 34.
  • the feedback portion 1848 impacts Push on the inside of the handle 34 to generate audible feedback.
  • the feedback portion 1848 extends in the axial direction, and the feedback portion 1848 can abut against the inner surface of the second housing 344 of the push handle 34 to enhance the stability of the clamping operation mechanism 18 .
  • the operation part 1846 , the connection part 1847 and the feedback part 1848 can be integrally formed, or can be separately and independently provided. The present application does not limit the structure of the operation part 1843 .
  • the sliding plate 1841 is located in the radial guide groove 3471 .
  • the operating portion 1846 is pressed by the operator, the operating member 1843 compresses the elastic member 1845, so that the sliding plate 1841 can move from the radial guide groove 3471 to the axial groove 3473.
  • the operating member 1843 is controlled to drive the sliding member 182 and the clamping pusher The rod 12 is moved distally, so that the distal collet 14 is away from the proximal collet 16 to form an open state as shown in FIG.
  • a leaflet accommodation space is formed between the distal collet 14 and the proximal collet 16 .
  • the operating member 1843 is controlled to move toward the proximal end, and the sliding plate 1841 can move from the axial guide groove 3473 to the radial guide groove 3471, at the same time, the sliding member 182 drives the clamping push rod 12 to move to the proximal end, so that the distal collet 14 approaches the proximal collet 16 to form the clamping state shown in FIG. 20 and FIG. 25 .
  • the leaflets are clamped and fixed by the clamp device 10 . Since the sliding plate 181 is in the axial guide groove 3473, the elastic member 1845 is compressed. When the sliding plate 1841 moves from the axial guide groove 3473 to the radial guide groove 3471, the elastic member 1845 returns to its natural state to generate elastic force, so that the feedback part The 1848 hits the inner side of the push handle 34 to give a "snap" audible feedback. When the operator or user hears the sound of "click", it can be determined that the distal collet 14 and the proximal collet 16 are closed to clamp the valve leaflets.
  • the length of the clamping push rod 12 may be insufficient, resulting in that when the distal collet 14 and the proximal collet 16 clamp the leaflet to close, the sliding plate 1841 cannot slide from the axial guide groove. 3473 moves to the radial guide groove 3471 to give audible feedback.
  • the operator needs to confirm whether the distal collet 14 and the proximal collet 16 are closed according to the audio feedback. Thus, in order to hear the audible feedback, the operator will forcibly move the operating member 1843 proximally.
  • the clamping push rod 12 and the sliding member 182 are elastically connected through the elastic mechanism 19, and the elastic mechanism 19 is compressed to provide a space so that the sliding plate 1841 can be operated by the operating member 1843 when the clamping push rod 12 is not long enough. It is driven to move from the axial guide groove 3473 to the radial guide groove 3471 to give sound feedback to prevent the distal collet 14 and the proximal collet 16 from over-clamping the valve leaflet and pinching the valve leaflet.
  • the elastic mechanism 19 includes a first connecting member 191 and an elastic element 193 .
  • the first connecting member 191 is movably connected with the clamping operation mechanism 18 , and specifically, is movably connected with the sliding member 182 of the clamping operation mechanism 18 .
  • the distal end of the first connecting piece 191 is fixedly connected with the proximal end of the clamping push rod 12 .
  • the proximal end of the clamping push rod 12 abuts against the clamping operation mechanism 18 , specifically the sliding member 182 of the clamping operation mechanism 18 .
  • the elastic element 193 is sleeved outside the first connecting piece 191 and is located between the proximal end of the first connecting piece 191 and the clamping operating mechanism 18 .
  • the first connector 191 includes a main body 1911 and a protruding edge 1913 disposed at the proximal end of the main body 1911 .
  • the main body 1911 is movably penetrated in the clamping operation mechanism 18 , and specifically, the main body 1911 is movably penetrated in the sliding member 182 of the clamping operation mechanism 18 .
  • the distal end of the main body 1911 is fixedly connected with the proximal end of the clamping push rod 12 .
  • the elastic element 193 is sleeved outside the main body 1911 , and the elastic element 193 is located between the protruding edge 1913 and the clamping operating mechanism 18 .
  • the proximal end of the clamping push rod 12 is accommodated in the push rod installation hole 1822, the main body 1911 and the elastic element 193 are partially accommodated in the push rod installation hole 1822, and the proximal end of the clamping push rod 12 is fixedly connected to the main body 1911 and abuts against it.
  • the sliding member 182 is held in the push rod mounting hole 1822 . Due to the existence of the protruding edge 1913, the sliding member 182 can compress the elastic element 193 when it moves from the distal end to the proximal end, so that the sliding plate 1841 can be driven by the operating member 1843 to move from the axial guide groove 3473 to the radial guide groove 3471 so as to emit sound feedback.
  • the elastic mechanism 17 further includes a second connecting member 194 for accommodating the proximal end of the clamping push rod 12 .
  • the second connecting piece 194 is fixedly connected between the distal end of the main body 1911 and the proximal end of the clamping push rod 12 , that is, the distal end of the main body 1911 is fixedly connected with the second connecting piece 194 , and the proximal end of the clamping push rod 12 is connected to the 173
  • the second connecting member 194 is fixedly connected.
  • the distal end of the first connecting member 191, the second connecting member 194, and the proximal end of the clamping push rod 12 are all provided with at least one connecting hole, and the three can be fixedly connected by means of screws or rivets.
  • connection is secured with screws.
  • the proximal end of the clamping push rod 12 is placed in the accommodating groove of the second connecting member 194 , and the screws pass through the clamping push rod 12 , the second connecting member 194 , and the first connecting member 191 in sequence to connect the three firmly.
  • the inner surface of the push handle 34 is provided with a baffle plate (not shown).
  • the elastic mechanism 17 includes a first connecting piece, and the first connecting piece is movably connected with the clamping operation mechanism 18 , and specifically, is movably connected with the sliding member 182 of the clamping operation mechanism 18 .
  • the first connecting member includes an elastic part and a connecting part. The radial dimension of the elastic portion is larger than the radial dimension of the connecting portion, the connecting portion is fixedly connected with the proximal end of the clamping push rod 12, and the proximal end of the clamping push rod 12 abuts the clamping operation mechanism 18, specifically against the clamping operation Slider 182 of mechanism 18 . Both ends of the elastic portion abut against the sliding member 182 of the clamping operating mechanism 18 and the baffle plate respectively.
  • the proximal end of the clamping push rod 12 is accommodated in the push rod installation hole 1822
  • the connecting portion of the first connecting piece is accommodated in the push rod installation hole 1822
  • the proximal end of the clamping push rod 12 is fixedly connected to the connecting portion and is It is held in the push rod mounting hole 1822 against the sliding member 182 .
  • the elastic portion of the first connecting member is located outside the push rod mounting hole 1822 and abuts against the sliding member 182 .
  • the sliding member 182 can compress the elastic part of the first connecting member when moving from the distal end to the proximal end, so that the sliding plate 1841 can be driven by the operating member 1843 to move from the axial guide groove 3473 to the radial guide groove
  • the 3471 thus gives audible feedback.
  • the puncture device 20 penetrates the inner cavity of the push handle 34 along the axial direction of the push handle 34 and is movably inserted into the push catheter 32 .
  • the puncture device 20 includes a puncture push rod 22 and a puncture needle 24 disposed at the distal end of the puncture push rod 22 .
  • the positions of the two fixing cavities 144 opened on the clamping surface of the distal collet 14 correspond to the positions of the two puncture needles 24 respectively.
  • the two fixing pieces 64 of the suture 60 are respectively accommodated in the distal collet 14 , and the proximal end of each fixing piece 64 corresponds to one puncture needle 24 , respectively.
  • the puncture needle 24 can be connected to the fastener 64 of the suture 60 after puncturing the leaflets to draw the suture body 62 proximally.
  • the puncture needle 24 and the fixing member 64 form a detachable fixed connection or a non-detachable fixed connection, for example, a screw connection, an adhesive connection, a friction connection through a rough surface, an interference fit or a snap connection.
  • the shape of the fixing member 64 matches with different connection methods.
  • the outer portion of the fixing member 64 is usually cylindrical, and the cross-sectional shape can be various shapes such as circle, ellipse, polygon, etc., preferably a circle or an ellipse;
  • the inner surface of 64 is provided with grooves or holes, and the distal end of the puncture needle 24 is provided with at least one protruding tooth or at least one ring of protruding edges for forming an interference fit or snap connection with the fixing member 64 .
  • the fixing member 64 is cylindrical, and the inner surface is radially provided with three grooves, which are engaged with the protruding teeth or protruding edges on the puncture needle 24 .
  • the puncture device 20 also includes a puncture handle 26 connected to the proximal end of the puncture push rod 22 .
  • the proximal end of the push handle 34 defines a through hole for the puncture handle 26 of the puncture device 20 to pass through, and the size of the through hole is adapted to the puncture handle 26 .
  • the puncture handle 26 is partially located in the inner cavity of the push handle 34 and partially located outside the push handle 34 .
  • the proximal end of the puncture push rod 22 protrudes from the proximal end of the push catheter 32 and is connected to the puncture handle 26 .
  • the puncture push rod 22 can be driven to move along the axial direction of the push catheter 32, thereby driving the puncture needle 24 to puncture the distal end or withdraw to the proximal end.
  • the puncture needle 24 can be driven by the puncture handle 26 to pierce the valve leaflet and connect with the fixing member 64 of the suture 60 , and the puncture needle 24 and the suture 60 are connected through the fixing member 64
  • the suture 60 is not easily separated from the puncture needle 24, and the operator can easily and quickly pull one or both ends of the suture 60 connected with the fixing member 64 to the predetermined position of the ventricular wall or papillary muscle.
  • the piercing device 20 also includes a safety member 28 .
  • the safety piece 28 is movably sleeved on the outside of the puncture handle 26 and movably worn on the push handle 34 .
  • the safety piece 28 is used to lock the puncture handle 26 to limit the axial movement of the puncture handle 26 so as to prevent the operator from accidentally triggering the puncture handle 26 when puncturing is not required.
  • the safety element 28 can interfere with the puncture handle 26 to lock the puncture handle 26 .
  • the push handle 34 is provided with an installation groove 3422 penetrating the inner and outer surfaces (as shown in FIG. 9 and FIG. 10 ). Mounting slot 3422.
  • the inner surface of the push handle 34 is provided with a support member 346 for supporting the puncture handle 26 and the puncture push rod 22 , so that the height of the puncture handle 26 in the inner cavity of the push handle 34 is fixed.
  • the support member 346 is provided with a card slot 3462 for accommodating part of the safety member 28 .
  • the safety piece 28 is in an inverted convex shape as a whole, and the safety piece 28 includes a pressing portion 282 and a connecting portion 284 that are connected and provided, and the pressing portion 282 is used for the operator to press and operate.
  • the connecting portion 284 includes a connected first connecting portion 2842 and a second connecting portion 2844 .
  • the radial dimension of the first connecting portion 2842 is smaller than that of the second connecting portion 2844 , and the first connecting portion 2842 is slidably connected to the slot 3462 .
  • the pressing portion 282 is connected to one end of the second connecting portion 2844 away from the first connecting portion 2842 .
  • the pressing portion 282 is pressed to move the safety member 28 toward the bottom surface of the card slot 3462, so that the first connecting portion 2842 fills the card slot 3462, so that the safety member 28 and the puncture handle can be released. Lock between 26.
  • the first connecting portion 2842 is provided with a first accommodating groove 281
  • the second connecting portion 2844 is provided with a second accommodating groove 283 communicating with the first accommodating groove 281
  • the radial space of the second accommodating groove 283 is larger than that of the first accommodating groove 283 .
  • the puncture handle 26 is movably inserted into the second accommodating groove 283 and fits with the clearance of the second accommodating groove 283 .
  • the puncture handle 26 is penetrated in the safety piece 28 to cooperate with the safety piece 28 , so as to reduce the space between the two, which is beneficial to the size reduction of the valve stapler 100 .
  • the side of the puncture handle 26 facing the slot 3462 is provided with an interference portion 262 , and the first protrusions 2622 and the shaft shoulders 2623 are recessed on both sides of the interference portion 262 .
  • the shaft shoulder 2623 abuts against the first connecting portion 2842, preventing the axial movement of the puncture handle 26, so that the safety member 28 locks the puncture handle 26, that is, the safety member 28 and the puncture handle 26 are locked.
  • the piercing handle 26 is in a locked state.
  • the overall radial dimension of the puncture handle 26 matches the radial dimension of the second accommodating groove 283 .
  • the shaft shoulder 2623 When the first protrusion 2622 is inserted through the second accommodating groove 283, the shaft shoulder 2623 is also located in the second accommodating groove 283, and the shaft shoulder 2623 does not abut against the first connecting portion 2842 and the second connecting portion 2844, and the puncture handle 26 can move relative to the safety piece 28 in the axial direction in the second accommodating groove 283 , that is, the safety piece 28 and the puncture handle 26 are in an unlocked state.
  • the side of the puncture handle 26 facing away from the card slot 3462 is further provided with a sliding groove 264, that is, the side of the puncturing handle 26 facing the pressing portion 282 is provided with a sliding groove 264, and the second connecting portion 2844 is also provided with a sliding groove 264.
  • a third accommodating groove 285 is provided, and the third accommodating groove 285 communicates with an end of the second accommodating groove 283 away from the first accommodating groove 281 .
  • the inner surface of the third accommodating groove 285 is provided with a second protrusion 2822 .
  • the second protrusion 2822 can move along the chute 264 to guide the movement of the puncture handle 26 relative to the safety piece 28 , thereby improving the movement of the puncture handle 26 relative to the safety piece 28 .
  • the radial space of the third accommodating groove 285 is larger than the radial space of the second accommodating groove 283 . It can be understood that the radial space of the third accommodating groove 285 may be smaller than or equal to the radial space of the second accommodating groove 283 , as long as the second protrusion 2822 can be inserted into the sliding groove 264 .
  • the third accommodating groove 285 and the second bump 2822 can be omitted.
  • the pressing portion 282 is accommodated in the installation groove 3422 , and the pressing portion 282 can be forced to drive the safety member 28 to move toward the bottom surface of the locking groove 3462 .
  • the pressing portion 282 fills the mounting groove 3422 and the surface of the pressing portion 282 facing away from the card groove 3462 is substantially flush with the outer surface of the push handle 34 .
  • the connecting portion 2842 is clamped in the card slot 3462 , and the surface of the first connecting portion 2842 facing the bottom surface of the card slot 3462 has a certain distance from the bottom surface of the card slot 3462 .
  • the first protrusion 2622 is located in the first accommodating groove 281, and the first connecting portion 2842 and the shaft shoulder 2623 prevent the puncture handle 26 from being pushed and moved distally.
  • the pressing portion 282 is pressed and forced to move toward the slot 3462, the first connecting portion 2842 fills the slot 3462, and the surface of the first connecting portion 2842 facing the bottom surface of the slot 3462 is the same as the bottom surface of the first connecting portion 2842.
  • the bottom surface of the card slot 3462 is in contact.
  • the first protrusion 2622 is separated from the first accommodating groove 281, the puncture handle 26 is integrally located in the second accommodating groove 283 and the third accommodating groove 281, the puncture handle 26 can be pushed and moved in the axial direction, the second convex
  • the block 2822 slides in the chute 264 to ensure the stability of the pushing of the puncture handle 26 .
  • the detection device 50 is used to detect whether the leaflets are clamped between the distal collet 14 and the proximal collet 16 .
  • the probe device 50 includes at least one probe 52 and a probe manipulation mechanism 54 attached to the proximal end of each probe 52 .
  • the probe 52 is movably inserted into the inner cavity of the push handle 54 and the push catheter 32 for detecting whether the clamping device 10 clamps the valve leaflets of the valve and the clamping effect on the valve leaflets.
  • the probe manipulation mechanism 54 is disposed on the push handle 34 and can move relative to the push handle 34 for driving the probe 52 to extend (moves distally) the push catheter 32 or retract (moves proximally) the push catheter 32 .
  • the detection device 50 includes two probes 52 , the two probes 52 are arranged side by side, and the distances between the two probes 52 and the clamping push rod 12 are substantially equal.
  • the axial length of probe 52 is preferably greater than the axial length of push catheter 32 .
  • the probe 52 is movably inserted into the push catheter 32 .
  • the clamping surface of the proximal collet 16 is provided with a probe outlet 162, so that the distal end of the probe 52 can be protruded from the probe outlet 162 from the pushing catheter.
  • the clamping surface of the distal end collet 14 is provided with a probe accommodating cavity 146 opposite to the probe outlet 162 for accommodating the distal end of the probe 52 .
  • the probe 52 includes a probe body having a certain length, and the probe body can be a solid or hollow structure.
  • the probe body may be made of metallic material, polymeric material or metal-polymeric material.
  • the probe body can be a solid rod-shaped or hollow tubular structure with a single-layer or multi-layer composite structure, and can also be wound from a single wire or multiple wires.
  • the probe 52 When the proximal collet 16 and the distal collet 14 are closed, if the leaflet is clamped between the proximal collet 16 and the distal collet 14 and the leaflet edge is in contact with the clamping pusher 12, the probe After the distal end of 52 passes through the clamping surface of the proximal collet 16, it will be blocked by the valve leaflet and cannot continue to advance to the distal end, indicating that the valve leaflet has a better clamping effect and can be punctured. In addition, when the distal end of the probe 52 is blocked by the valve leaflet and cannot enter the probe receiving cavity, it also indicates that the position between the leaflet edge and the suture body 62 is relatively fixed, which improves the treatment effect. Therefore, the valve leaflet clamping effect can be effectively detected by the probe 52 of the mechanical structure, and the device has a simple structure and is convenient to operate.
  • the probe manipulation mechanism 54 further includes a sliding member 542 fixedly connected to the proximal end of the probe 52 .
  • the sliding member 542 is axially slidably disposed on the push handle 34 . When the sliding member 542 slides axially, the probe 52 is driven to move in the axial direction.
  • the number of the probes 52 is two, and the number of the sliders 542 corresponds to the number of the probes 52 being two.
  • the inner surface of the second housing 344 of the push handle 34 is provided with two sliding grooves 3441 (as shown in FIG. 9 ) that are symmetrical with respect to the central axis of the push handle 34 . to move.
  • the first housing 342 is further provided with two control through grooves 3426 corresponding to the two sliding grooves 3441 one-to-one.
  • the probe control mechanism 54 further includes a control member 544 disposed on the sliding member 542, and the control member 544 is mounted on the control member.
  • the manipulation member 544 is used to drive the sliding member 542 to slide along the axial direction of the push handle 34 .
  • the two manipulation members 544 are respectively exposed from the two manipulation through grooves 3426 and clamped on the outer surface of the first housing 342 .
  • the manipulation through groove 3426 can function to limit the moving distance of the probe manipulation mechanism 54 in the axial direction.
  • the proximal end of each probe 52 is fixedly connected to the corresponding sliding member 542 respectively.
  • the operator controls the manipulation member 544 in the axial direction to drive the sliding member 542 to move in the axial direction, thereby driving the probe 52 to pass through the pushing catheter 32 . out or retract the probe 52 into the pusher catheter 32 .
  • An indication portion 5442 (as shown in FIG. 15 ) is provided on the side of the control member 544 radially toward the central axis of the push handle 34 , and an indication 341 is provided on the outer surface of the first housing 342 between the two control through grooves 3426 (as shown in Figure 10).
  • the mark 341 includes a first mark 3411 and a second mark 3412, the first mark 3411 and the second mark 3412 are two different colors, for example, the first mark 3411 is red, and the second mark 3412 is green.
  • first logo 3411 and the second logo 3412 are not limited to be colors, and the first logo 3411 and the second logo 3412 can be distinguished by other forms, for example, different letters and the like.
  • the probe manipulation mechanism 54 further includes a guide rail 546 extending radially.
  • the guide rail 546 has a guide groove 5460 , and the manipulation member 544 can be clamped in the guide groove 5460 of the guide rail 546 and move in the radial direction.
  • the manipulation through groove 3426 is L-shaped and includes an axial groove 3427 and a radial groove 3428 connecting the proximal end of the axial groove 3427 (as shown in FIG. 10 ).
  • the radial groove 3428 is provided for the manipulation member 544 to move in the radial direction.
  • the manipulation member 544 When the manipulation member 544 is in the radial groove 3428, the probe 52 is completely accommodated in the push conduit 32, and the manipulation member 544 cannot drive the sliding member 542 along the radial direction. Axial movement, so as to keep the probe 52 contained in the push catheter 32 to avoid misoperation during the operation.
  • the inner surface of the second housing 344 of the push handle 34 is provided with a positioning groove 349 (as shown in FIG. 10 ), and the probe manipulation mechanism 54 further includes a positioning member 35 and a positioning rod 548 .
  • the positioning member 35 is clamped in the positioning groove 349 .
  • the positioning member 35 defines a positioning hole 352 for the positioning rod 548 to pass through.
  • the distal end of the positioning rod 548 is fixed to the sliding member 542 .
  • the probe manipulation mechanism 54 further includes a push elastic member (such as a spring, not shown), the positioning rod 548 is inserted into the push elastic member, the proximal end of the push elastic member is accommodated in the positioning hole 352 and the distal end abuts against the push handle 34 .
  • the probe 52 When the manipulation member 544 is in the radial groove 3428, the probe 52 is completely located in the pushing catheter 32, and the positioning member 35 compresses the push elastic member; when the manipulation member 544 moves from the radial groove 3428 to the axial groove 3427, the distal end of the probe 52 It protrudes from the distal end of the pushing catheter 32 under the elastic action of the pushing elastic member.
  • the manipulation member 544 in the initial state, the manipulation member 544 is in the radial groove 3428 , the pushing elastic member on the positioning rod 548 is compressed, and the probe 52 is accommodated in the pushing conduit 32 .
  • the manipulating member 544 is moved from the radial groove 3427 to the axial groove 3428, since the pushing elastic member on the positioning rod 548 returns from the compressed state to the natural state to generate elastic force, the distal end of the probe 52 can be directly pushed out of the pushing catheter 32. roll out.
  • the valve stapler 100 further includes a clamping auxiliary device 40 .
  • the gripping aid 40 includes at least one gripping aid arm 42 (only one is exemplarily shown in FIG. 18 ) and a gripping aid 44 provided at the distal end of the gripping aid arm 42 .
  • the clamping auxiliary arm 42 is movably inserted into the pushing conduit 32 .
  • the gripping aid 42 is made of elastic and/or flexible material, and the gripping aid arm 42 is used to push the gripping aid 42 connected to it to pass through the distal end of the pushing catheter 32 or the distal end of the gripping device 10, and the gripping aid 42 is used to push the gripping aid 42 connected to it through the distal end of the pushing catheter 32 or the distal end of the gripping device 10.
  • the holding aid 42 is used for holding the leaflet in cooperation with the holding device 10 .
  • the clamping auxiliary device 40 further includes an auxiliary operating mechanism 46 connected to the proximal end of the clamping auxiliary arm 42 , and the auxiliary operating mechanism 46 is provided on the push handle 34 .
  • the proximal end of the clamping auxiliary arm 42 passes through the pushing catheter 32 and is provided with an auxiliary manipulation mechanism 46 .
  • the clamping surface of the proximal collet 16 , the side surface of the pushing catheter 32 or the side surface of the proximal collet 16 is provided with an auxiliary component outlet 321 . Therefore, the auxiliary manipulating mechanism 46 can drive the clamping auxiliary arm 42 to push the clamping aid 44 out of the distal end of the pushing catheter 32 or the distal end of the clamping device 10 .
  • An auxiliary arm accommodating cavity 328 is provided in the pushing conduit 32 along the axial direction. Before the puncturing device 20 of the valve stapler 100 is punctured, the clamping auxiliary member 44 and the clamping auxiliary arm 42 are both accommodated in the auxiliary arm accommodating cavity 328 .
  • an auxiliary part outlet 321 (as shown in FIG. 9 ) is provided on the side of the proximal collet 16 , and the auxiliary part outlet 321 communicates with the auxiliary arm receiving cavity 328 .
  • the operator pushes the auxiliary manipulation mechanism 46 to the distal end, which can drive the clamping auxiliary arm 42 to push the clamping auxiliary piece 44 to pass through the auxiliary piece outlet 321, so as to support the lower surface of the valve leaflet, stabilize the pulsating valve leaflet, and reduce the The range of motion of the valve leaflet cooperates with the clamping device 10 to clamp and fix the valve leaflet.
  • the clamping auxiliary arm 42 is a rod-shaped or tubular structure with a certain axial length, and has a certain hardness or rigidity to provide support and pushability.
  • the clamping auxiliary arm 42 may be made of a hollow or solid metal rod or a polymer material rod of a single-layer or multi-layer composite structure, and may also be wound from a single wire or multiple wires.
  • the gripping assist arm 42 may be made of a metal material, a polymer material or a metal-polymer composite material.
  • the clamping aid 44 is supported on the lower surface of the leaflet 200 and cooperates with the clamping device 10 to clamp the leaflet 200 .
  • the gripping aid 44 is made of an elastic and/or flexible material, it can accommodate the anatomy of the leaflet 200 and the range of motion of the leaflet 200 and avoid damage to the leaflet 200 .
  • the elastic material is preferably a shape memory material.
  • the gripping aid 44 may be made of a metallic material, a polymeric material or a metal-polymer composite material.
  • the clamping auxiliary member 44 is made of elastic Nitinol with shape memory function.
  • the gripping aid 44 includes a compressed state and an extended state in its natural state.
  • the clamping aid 44 When the clamping aid 44 is in a compressed state, it can be accommodated in the auxiliary arm accommodating cavity 328 of the pushing conduit 22 and pushed. After the clamping aid 44 protrudes from the outlet 321 of the aid, it is transformed into an extended state, and can be supported on the lower surface of the valve leaflet 200 to stabilize the pulsating valve leaflet 200 .
  • the clamping auxiliary member 44 is a mesh structure woven by a plurality of metal wires. The mesh structure can be further heat-set to form spherical, columnar, nested, oblate and other structures.
  • the clamping auxiliary member 44 is a woven tennis ball-shaped structure, and in the compressed state, the woven tennis-shaped structure is radially compressed and accommodated in the auxiliary arm receiving cavity 328; in the extended state, the woven tennis-shaped structure is received from the auxiliary member outlet 321 The self-expanding radially expands into a spherical shape by being pushed out.
  • the contact surface of the clamping auxiliary device 44 with the larger diameter and the valve leaflet 200 is the plane where the clamping auxiliary member 44 is located. Therefore, the contact area between the clamping auxiliary device 40 and the valve leaflet is larger, which can better adhere to the valve.
  • the valve leaflets are combined, and the supportability of the valve leaflets by the clamping auxiliary device 40 is improved.
  • the clamping auxiliary member 44 has a smooth shape, and the distal end of the clamping auxiliary member 44 can be formed into a smooth round head by a process such as laser spot welding, without defects such as burrs, edges or corners. It can be understood that the present application is not limited to the fact that the clamping auxiliary member 44 is a mesh structure.
  • the clamping auxiliary member 44 may further include a support rod or a deformation structure composed of a plurality of support rods, and the deformation structure is In an open bifurcated structure, an umbrella-shaped structure or a closed-loop structure composed of a plurality of support rods, the clamping auxiliary member 44 can be supported on the lower surface of the valve leaflet and cooperate with the clamping device 10 to clamp the valve leaflet.
  • the auxiliary operating mechanism 46 is provided on the push handle 34 .
  • the inner surface of the second casing 344 of the push handle 34 is provided with a sliding groove 3448 (as shown in FIG. 9 ), and the first casing 342 is provided with a corresponding manipulation through groove 3424 .
  • the auxiliary operating mechanism 46 includes a sliding member 462 and an operating member 464 provided on the sliding member 462 .
  • the proximal end of the clamping auxiliary arm 42 is fixedly connected with the sliding member 462 .
  • the sliding member 462 can move in the axial direction in the sliding groove 3448 .
  • the manipulation through groove 3424 can function to limit the moving distance of the auxiliary manipulation mechanism 46 in the axial direction.
  • the axial movement of the operating member 464 along the operating through groove 3424 can drive the sliding member 462 to move in the axial direction in the sliding groove 3448 , thereby pushing the clamping auxiliary arm 42 to drive the clamping auxiliary member 44 from the auxiliary arm receiving cavity 328 from the auxiliary member outlet 321
  • the clamping aid 44 is passed through or retracted into the auxiliary arm receiving cavity 328 .
  • the auxiliary operating mechanism 46 further includes a guide rail 466, the guide rail 466 is arranged on the sliding member 462, the guide rail 466 has a guide rail groove, and the operating member 464 can be clamped in the guide rail groove to move in a radial direction.
  • the manipulation through slot 3424 is substantially Z-shaped, including an axial through slot and a radial through slot connecting two ends of the axial through slot. The setting of the radial through groove of the manipulation through slot 3424 allows the manipulation member 464 to move in the radial direction. When the manipulation member 464 is in the radial through slot of the manipulation through slot 3424, the manipulation member 464 cannot drive the sliding member 462 to move axially.
  • the pushing conduit 32 is provided with a puncture push rod channel 322 , a clamping push rod channel 324 and a probe channel 326 along the axial direction.
  • the clamping push rod 12 is inserted into the clamping push rod channel 324 of the push catheter 32
  • the puncture push rod 22 is inserted into the puncture push rod channel 322 of the push catheter 32
  • the probe 52 is inserted into the probe of the push catheter 32 In the channel 326 , it is ensured that the axial directions of the clamping push rod 12 , the puncturing push rod 22 and the probe 52 are substantially parallel to the axial direction of the pushing catheter 32 .
  • the clamping push rod channel 324 is provided on one side of the pushing catheter 32 , and the two puncturing push rod channels 322 are provided on the other side of the pushing catheter 32 .
  • the probe channel 326 is disposed between the clamping push rod channel 324 and the puncturing push rod channel 322 , and the distance between the probe channel 326 and the clamping push rod channel 324 is smaller than that between the probe channel 326 and the puncturing push rod channel 322 the distance.
  • the push catheter 32 is further provided with an auxiliary arm accommodating cavity 328
  • the auxiliary arm accommodating cavity 328 is disposed between the clamping push rod channel 324 and the puncture push rod channel 322
  • the probe channel 326 is disposed between the clamping push rod channel 324 and the puncture push rod channel 322.
  • Between the push rod channel 324 and the auxiliary arm receiving cavity 328 and the distance between the probe channel 326 and the clamping push rod channel 324 is smaller than the distance between the probe channel 326 and the puncture push rod channel 322 .
  • the push catheter 32 can be an integrally formed multi-lumen tube, or the outer tube and the inner tube can be sheathed and fixed together to form the push catheter 32 with an integral structure.
  • the push catheter 32 can be made of biocompatible polymer materials (eg, polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or Polyurethane PU), metal materials (for example, stainless steel or Nitinol) or metal-polymer composite materials.
  • biocompatible polymer materials eg, polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or Polyurethane PU
  • metal materials for example, stainless steel or Nitinol
  • metal-polymer composite materials for example, stainless steel or Ni
  • the clamping operation mechanism 18 , the auxiliary operation mechanism 46 , and the probe control mechanism 54 are all provided on the push handle 34 , from the distal end to the proximal end, the clamping operation mechanism 18 , the auxiliary operation mechanism 46 , and the probe control mechanism are sequentially arranged.
  • the sliding member 182 is provided with a through hole along the axial direction for the clamping auxiliary arm 42 , the probe 52 and the puncture push rod 22 to pass through. Both sides of the sliding member 462 along the central axis of the push handle 34 are respectively provided with axial through grooves and through holes for the probe 52 and the puncture push rod 22 to pass through.
  • the sliding member 542 is provided with a support portion 5422 radially toward the central axis of the push handle 34 (as shown in FIG. 15 ).
  • the pushing device 30 further includes a sealing tube 36 communicating with the pushing catheter 32.
  • the sealing tube 36 is located in the lumen of the pushing handle 34 and is connected to the proximal end of the pushing catheter 32.
  • the puncturing device 20, the probe 52, the clip Both the push rod and the clamping auxiliary arm are movably installed in the sealing tube 36 .
  • the sealing tube 36 is provided with a Luer connector 362 for connecting to an exhaust pipe (not shown) for exhausting.
  • the sealing tube 36 is located in the inner cavity formed between the first housing 342 and the second housing 344 , and the distal side of the push handle 34 is provided with a mounting hole 3440 for mounting the luer connector 362 .
  • the outer surface of the distal end of the sealing tube 36 is threaded, and is threadedly connected with a mounting member 38 with an internal thread, so that the pushing catheter 32 and the pushing handle 34 are fixedly connected.
  • the distal end of the sealing tube 36 communicates with the proximal end of the push catheter 32, the proximal end of the sealing tube 36 is open and filled with at least one sealing member 37, and the sealing member 37 is provided with a through hole (not shown) for the puncture device 20, the probe 52. Pass through the clamping push rod and the clamping auxiliary arm.
  • the sealing member 37 includes sealing silicone.
  • the seal 37 is secured by a retaining nut 33 threaded to the proximal end of the sealing tube 36 .
  • the pushing conduit 32 is provided with a plurality of mutually separated through cavities or channels along the axial direction, and correspondingly, the sealing member 37 is also provided with a plurality of mutually separated through holes. It can be understood that the material of the sealing member 37 is not limited in this application, and the connection method of the sealing member 37 and the sealing tube 36 is not limited.
  • valve stapler 100 provided in this embodiment by taking the chordae tendineae implantation with the posterior leaflet of the mitral valve as an example.
  • the first step is to advance the valve stapler 100 into the left ventricle, and continue to advance the valve stapler 100 until both the distal collet 14 and the proximal collet 16 are located in the left atrium.
  • the operating member 1841 is controlled to move to the distal end to push the clamping push rod 12 to the distal end, so that the proximal end collet 16 is separated from the distal end collet 14 .
  • the proximal end collet 16 and the A leaflet accommodating space is formed between the distal collets 14 .
  • the manipulation member 464 to move to the distal end to drive the clamping auxiliary arm 42 to push the clamping auxiliary member 44 to pass through the auxiliary member outlet 321 .
  • the clamping auxiliary member 44 is supported on the valve leaflet.
  • the lower surface is used to assist in stabilizing the pulsating valve leaflets, keeping the relative position between the operating member 1841 and the operating member 464 unchanged, and slowly moving the entire instrument proximally until the valve leaflet enters between the proximal collet 16 and the distal collet 14.
  • the valve leaflet accommodating space formed therebetween, and the clamping aid 44 can provide a certain support force to the valve leaflet.
  • the fourth step slightly move the distal end of the valve stapler 100 until the edge of the valve leaflet contacts with the clamping push rod 12, at this time, the operating member 1841 is retracted to the proximal end, and the distal collet 14 is driven to move toward the end.
  • the proximal collet 16 is moved until the two are closed and the leaflets are clamped. If the operator finds that the valve leaflet is not effectively clamped, he can fine-tune the relative position of the distal collet 14 and the proximal collet 16 to create a certain distance between them, and then adjust the distance between the clamping push rod 12 and the valve leaflet. relative position.
  • the clamping auxiliary device 40 under the valve leaflet has a certain supporting effect on the valve leaflet, the valve leaflet can be prevented from slipping out of the clamping device 10 .
  • the fifth step keeping the position of the push handle 34 unchanged, respectively controls the two manipulation members 544 to move distally to drive the probe 52 to move distally along the axial direction of the push catheter 32; as shown in FIGS. 26a to 26c , if Poor leaflet clamping, ie, the leaflet does not completely cover the probe exit 162 on the clamping surface of the proximal collet 16, and the distal end of the probe 52 can protrude from the probe exit 162 into the distal collet
  • the probe receiving cavity 146 of the head 14 needs to repeat the operations from the second to the fourth step to re-clamp the valve leaflet; as shown in Figure 27, if the valve leaflet is in a good clamping state, that is, the valve leaflet completely covers the proximal collet
  • the probe outlet 162 on the clamping surface of the 16, the distal end of the probe 52 cannot protrude from the probe outlet 162 and enter the probe receiving cavity 146 of the distal collet 14.
  • the two control members 544
  • the sixth step press the pressing portion 282 of the safety member 28 to unlock the locked state of the puncture handle 26 .
  • the puncture handle 26 can be pushed to the distal end to drive the puncture needle 24 to move to the distal end until the puncture needle 24 passes through the leaflets 200 and forms a fixed connection with the fastener 64 of the suture 60, as shown in FIG. 30 .
  • the seventh step referring to FIGS. 31 and 32 , withdraw the puncture handle 26 so that the puncture needle 24 drives the fixing member 64 of the suture 60 and the suture body 62 connected to the fixing member 64 to pass through the valve leaflet 200 in sequence.
  • the eighth step continue to withdraw the puncture handle 26 until the fixing member 64 is withdrawn from the proximal end of the push handle 34, and then withdraw the operating member 464 to drive the clamping auxiliary member 44 to withdraw into the auxiliary arm receiving cavity 328, and withdraw the entire
  • the valve stapler 100 is installed, and the length of the suture main body 62 left in the heart is adjusted, and the two ends of the suture main body 62 are respectively fixed on the ventricular wall to complete the implantation of the suture wire 60 (as shown in FIG. 33 ).

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Abstract

Dispositif de suture de valvule (100) comprenant un dispositif de poussée (30) et un dispositif de serrage (10). Le dispositif de poussée (30) comprend un cathéter de poussée (32) ; le dispositif de serrage (10) comprend une tige-poussoir de serrage (12), une poignée proximale (16), une poignée distale (14), un mécanisme d'actionnement de serrage (18) et un mécanisme élastique (19). La tige-poussoir de serrage (12) est installée de façon mobile dans le cathéter de poussée (32) ; la poignée proximale (16) est disposée au niveau de l'extrémité distale du cathéter de poussée (32) ; la poignée distale (14) est disposée au niveau de l'extrémité distale de la tige-poussoir de serrage (12) ; le mécanisme élastique (19) est relié de manière fixe à l'extrémité proximale de la tige-poussoir de serrage (12) ; le mécanisme d'actionnement de serrage (18) est relié de façon mobile à l'extrémité proximale de la tige-poussoir de serrage (12) et au mécanisme élastique (19) ; le mécanisme d'actionnement de serrage (18) entraîne la tige-poussoir de serrage (12) pour se déplacer de l'extrémité distale à l'extrémité proximale, de telle sorte qu'après que la poignée distale (14) et la poignée proximale (16) sont fermées, le mécanisme d'actionnement de serrage (18) comprime le mécanisme élastique (19), et le mécanisme d'actionnement de serrage (18) se déplace vers l'extrémité proximale par rapport à la tige-poussoir de serrage (12) pour produire un retour sonore, ce qui permet d'empêcher que le mécanisme d'actionnement de serrage (18) soit forcé par un opérateur pour se déplacer vers l'extrémité proximale pour obtenir le retour sonore, pour amener la poignée distale (14) et la poignée proximale (16) à serrer excessivement un feuillet de valvule pour pincer le feuillet de valvule.
PCT/CN2021/107104 2020-12-29 2021-07-19 Dispositif de suture de valvule WO2022142281A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202011602988.0 2020-12-29
CN202023277009.7 2020-12-29
CN202023277009.7U CN216021546U (zh) 2020-12-29 2020-12-29 瓣膜缝合器
CN202011602988.0A CN114681131A (zh) 2020-12-29 2020-12-29 瓣膜缝合器

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Citations (7)

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Publication number Priority date Publication date Assignee Title
US20140214152A1 (en) * 2013-01-31 2014-07-31 St. Jude Medical, Inc. Method and device for heart valve repair
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