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WO2024067686A1 - Dispositif de serrage de valve mitrale et système de serrage de valve mitrale - Google Patents

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

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Publication number
WO2024067686A1
WO2024067686A1 PCT/CN2023/121974 CN2023121974W WO2024067686A1 WO 2024067686 A1 WO2024067686 A1 WO 2024067686A1 CN 2023121974 W CN2023121974 W CN 2023121974W WO 2024067686 A1 WO2024067686 A1 WO 2024067686A1
Authority
WO
WIPO (PCT)
Prior art keywords
clamping
mitral valve
control rod
assembly
distal end
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2023/121974
Other languages
English (en)
Chinese (zh)
Inventor
黄桥
谢琦宗
朱文友
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Halocinch Medical Technology Shenzhen Co Ltd
Original Assignee
Halocinch Medical Technology Shenzhen Co Ltd
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
Application filed by Halocinch Medical Technology Shenzhen Co Ltd filed Critical Halocinch Medical Technology Shenzhen Co Ltd
Publication of WO2024067686A1 publication Critical patent/WO2024067686A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor

Definitions

  • the present application relates to the technical field of medical devices, and in particular, to a mitral valve clamping device and a mitral valve clamping system.
  • the mitral valve is a part of the heart that sits between the left atrium and the left ventricle. Blood is pumped from the left atrium into the left ventricle, and when the left ventricle contracts to pump blood to the body, the mitral valve closes to prevent blood from being pumped back into the left atrium. In some patients, whether due to a genetic malformation, disease, or injury, the mitral valve does not close properly, resulting in a condition called regurgitation, in which blood is pumped into the atrium every time the heart muscle contracts. Regurgitation is a serious, often rapidly worsening condition that reduces circulation efficiency and must be corrected.
  • Mitral regurgitation is one of the most common valvular diseases today.
  • the main causes include mitral ring dilatation, chordae insufficiency, mitral myxomatous degeneration, leaflet prolapse, rheumatic heart valve disease, ischemic lesions, etc.
  • Mitral valvuloplasty and artificial valve replacement are the most effective methods for treating mitral regurgitation.
  • the operation requires extracorporeal circulation technology support, it causes great trauma to the human body. For elderly patients and patients with more complications, there is a relatively high complication and mortality rate.
  • mitral valve clamping delivers an implantable clip to the vicinity of the mitral valve through the apex of the heart, clamps and fixes the free edges of the anterior and posterior leaflets, so that the leaflets are well aligned at the end of contraction and regurgitation is reduced.
  • the present application proposes a mitral valve clamping device, which is implanted through the apex of the heart to solve the regurgitation problem caused by mitral valve insufficiency.
  • the present application provides a mitral valve clamping device, which is implanted through the apex of the heart.
  • the mitral valve clamping device comprises:
  • An upper clamping assembly comprising a flexible clamping sheet and a first support member, wherein the first support member is connected to a distal end of the flexible clamping sheet;
  • a lower clamping assembly comprises a first clamping arm, a second clamping arm and a second support member, one end of the first clamping arm and one end of the second clamping arm are rotatably connected to form a first connecting portion, the first connecting portion is connected to the second support member, and the second support member is connected to the proximal end of the flexible clamping sheet;
  • the flexible clamping piece when the first support member drives the flexible clamping piece to move toward the proximal end and approach the second support member, the flexible clamping piece is in a folded state and can form a first clamping surface and a second clamping surface, the first clamping surface cooperates with the first clamping arm and the second clamping surface cooperates with the second clamping arm to jointly clamp the mitral valve, and when the first support member drives the flexible clamping piece to move toward the distal end, the flexible clamping piece is in a straightened state.
  • the mitral valve clamping device of the present application is implanted through the apex of the left ventricle and can clamp the mitral valve.
  • the flexible clamping piece of the upper clamping assembly of the mitral valve clamping device is in an extended state and can extend between the valves of the mitral valve.
  • the first clamping surface cooperates with the first clamping arm
  • the second clamping surface cooperates with the second clamping arm to jointly clamp the mitral valve.
  • the mitral valve clamping device further comprises:
  • first drive assembly is connected to the proximal end of the lower clamping assembly
  • first drive member includes a connecting rod assembly
  • the connecting rod assembly is respectively connected to the first clamping arm, the second clamping arm and the second support member
  • the connecting rod assembly can drive the second support member to move toward the distal end or the proximal end, so that the first clamping arm and the second clamping arm are opened or closed relative to the upper clamping assembly.
  • the first drive assembly further includes a first base connected to the proximal end of the flexible clamping sheet;
  • the first clamping arm is further provided with a second connecting portion, and the second clamping arm is further provided with a third connecting portion;
  • the connecting rod assembly also includes:
  • a first control rod wherein a distal end of the first control rod is connected to the second support member, and the first base is provided with a cavity for the first control rod to pass through;
  • first connecting rod one end of which is rotatably connected to the second connecting portion, and the first connecting rod supports the first clamping arm to rotate around the first connecting portion
  • a second connecting rod one end of which is rotatably connected to the third connecting portion, and the second connecting rod supports the second clamping arm to rotate around the first connecting portion.
  • a locking structure is provided in the first base, and the locking structure is used to clamp the first control rod to prevent the relative movement between the first control rod and the first base.
  • the locking structure comprises a clamping member, the clamping member is sleeved on the first control rod, the clamping member is provided with an elastic portion capable of axial extension and contraction and the elastic portion is arranged in the mounting groove, and the clamping member is provided with a protruding end from the distal end to the proximal end;
  • the proximal outer side surface of the extended end abuts against the wall surface of the middle area of the inverted cone cavity, and the proximal inner side surface of the extended end can squeeze the first control rod.
  • a flange is provided at the distal end of the clamping member, the flange is sleeved on the outside of the first control rod, the upper end surface of the elastic portion is connected to the flange, and the lower end surface of the elastic portion is against the axial end surface of the mounting groove, or
  • the lower end surface of the elastic part is connected to the flange, and the upper end surface of the elastic part abuts against the axial end surface of the mounting groove.
  • the clamping member is provided with at least two protruding ends, and the protruding ends are arranged at equal intervals along the circumference of the first control rod.
  • the first drive assembly further includes a first traction member, a distal end of which is connected to a distal end of the clamping member, and under the action of the first traction member, the elastic portion can axially expand and contract.
  • a mitral valve clamping system is further provided, the mitral valve clamping system is used to capture and clamp the mitral valve in the left ventricle, the mitral valve clamping system comprises the mitral valve clamping device as described in any one of the above items;
  • the mitral valve clamping system further comprises:
  • An operating handle is connected to the proximal end of the catheter.
  • the mitral valve clamping system further comprises a second control rod, wherein the second control rod is disposed in the catheter, and the distal end of the second control rod is threadedly connected to the proximal end of the first control rod.
  • a guide member is provided at the side end of the catheter of the mitral valve clamping device, the extension length of the guide member to the distal end is adapted to the valve length of the mitral valve, and a guide ring is provided at the distal end of the guide member.
  • the mitral valve clamping system further comprises a second traction member, which passes through the first through hole of the first support member and the guide ring in sequence, and passes through the catheter. Reach toward the operating handle.
  • a connecting rod is provided at the distal end of the catheter, and a connecting end surface between the connecting rod and the proximal end of the first base is S-shaped in the axial direction.
  • FIG1 shows the anatomical structure of the human heart
  • FIG2 a shows a schematic diagram of a good mitral valve coaptation state of a human heart
  • FIG2 b illustrates a state in which the mitral valve of a human heart cannot fully coapt
  • FIG3 illustrates an embodiment of the mitral valve clamping device of the present application applied to a mitral valve clamping system
  • FIG4 illustrates an embodiment of the mitral valve clamping device of the present application applied to a mitral valve clamping system
  • FIG5 illustrates the folded state of the first clamping arm and the second clamping arm of the mitral valve clamping device of the present application
  • FIG6a illustrates a top view of the mitral valve clamping device of the present application, wherein the first clamping arm and the second clamping arm are in a retracted state;
  • Fig. 6b is a cross-sectional view taken along line A-A of Fig. 6a;
  • FIG. 7 illustrates an embodiment of the locking structure of the mitral valve clamping device of the present application
  • FIG8 illustrates a clamping member of the mitral valve clamping device of the present application
  • FIG9 illustrates the connection relationship between the mitral valve clamping device and the mitral valve clamping system of the present application
  • FIG10 illustrates a connecting rod assembly in the mitral valve clamping device of the present application, wherein the connecting rod assembly drives the lower clamping assembly to be in an open state;
  • FIG11 illustrates a connecting rod assembly of the mitral valve clamping device of the present application, wherein the connecting rod assembly drives the lower clamping assembly to be in a retracted state;
  • FIG12 illustrates the flexible clamping piece of the mitral valve clamping device of the present application in a folded state
  • FIG13 illustrates an embodiment of a first driving assembly of the mitral valve clamping device of the present application
  • FIG14 is a structural diagram showing the mitral valve clamping device of the present application installed in the mitral valve clamping system
  • FIG15 illustrates an axonometric view of the mitral valve clamping system of the present application
  • FIG16 illustrates a state diagram of the mitral valve clamping system of the present application in the left ventricle approaching the mitral valve
  • FIG17 is a diagram showing a state in which the mitral valve clamping system of the present application captures the mitral valve in the left ventricle;
  • FIG. 18 illustrates a state diagram of the mitral valve clamping device in the mitral valve clamping system of the present application clamping the mitral valve.
  • the reference numerals are as follows: 100. Mitral valve clipping device; 110, upper clamping assembly; 111, flexible clamping sheet; 112, first clamping surface; 113, second clamping surface; 114, first support member; 115, first penetration hole; 116, barb structure; 120, lower clamping assembly; 121, first clamping arm; 122, second connecting portion; 123, second clamping arm; 124, third connecting portion; 125, second supporting member; 126, first connecting portion; 130, first driving assembly; 131, first base; 132, mounting groove; 133, inverted cone cavity; 140, connecting rod assembly; 141, first control rod; 142, first connecting rod; 143, second connecting rod; 150, locking structure; 151, clamping member; 152, elastic portion; 153, extension end; 154, flange; 155, proximal outer side surface of the extension end; 156, proximal inner side surface of the extension end; 160, first traction member; 200, mitral valve clamping system; 210, catheter;
  • first, second, third, etc. may be used herein to describe multiple elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may only be used to distinguish one element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates otherwise, terms such as “first”, “second” and other numerical terms do not imply a sequence or order when used herein. Therefore, the first element, component, region, layer or section discussed below may be described in detail without departing from the exemplary embodiments. In the context of the teachings, it may be referred to as a second element, component, region, layer or section.
  • spatial relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as “inside”, “outside”, “inner side”, “outer side”, “below”, “below”, “above”, “above”, etc.
  • Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as “below other elements or features” or “below other elements or features” will subsequently be oriented as “above other elements or features" or “above other elements or features”. Therefore, the example term “below" can include both upper and lower orientations.
  • the device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.
  • proximal end the end of a medical device implanted in a human or animal body or a delivery system that delivers the medical device that is closer to the operator
  • distal end the end that is farther from the operator
  • proximal end and distal end of any component of a medical device or delivery system
  • proximal end and distal end of any component of a medical device or delivery system
  • proximal end and distal end of any component of a medical device or delivery system
  • the present application provides a mitral valve clamping device 100, which is implanted through the apex of the heart and can clamp the mitral valve in the left ventricle LV.
  • the mitral valve clamping device 100 includes an upper clamping component 110 and a lower clamping component 120.
  • the upper clamping component 110 and the lower clamping component 120 cooperate to capture the mitral valve LF and clamp the mitral valve.
  • the upper clamping assembly 110 includes a flexible clamping sheet 111 and a first support member 114.
  • the distal end of the flexible clamping sheet 111 is connected to the first support member 114.
  • the first support member 114 drives the flexible clamping sheet 111 to move toward the distal end, so that the flexible clamping sheet 111 is in an extended state.
  • the first support member 114 drives the flexible clamping sheet 111 to move toward the proximal end, so that the flexible clamping sheet 111 is in a folded state.
  • the flexible clamping sheet 111 in the folded state is respectively above the first clamping arm 121 and the second clamping arm 123 , and is folded in half to form two layers of the flexible clamping sheet 111 , wherein the folding line is located on the outside of the flexible clamping sheet 111 .
  • the flexible clamping piece 111 When trying to capture the valve LF, the flexible clamping piece 111 is in a vertical state. At this time, the length of the flexible clamping piece 111 reaches the maximum and the contact area with the valve LF is also large. At this time, the first support member 114 drives the flexible clamping piece 111 to move and fold, so as to efficiently complete the capture of the valve LF.
  • the lower clamping assembly 120 includes a first clamping arm 121 and a second clamping arm 123. One end of the first clamping arm 121 and one end of the second clamping arm 123 are rotatably connected. When the first clamping arm 121 and the second clamping arm 123 are opened, the first clamping arm 121 and the first clamping arm 121 cooperate with the flexible clamping sheet 111 to capture the mitral valve LF in the left ventricle LV. When the first clamping arm 121 and the second clamping arm 123 are closed, the flexible clamping sheet 111 is respectively connected with the first clamping arm 121 and the second clamping arm 123. The mitral valve is closed while the mitral valve LF is clamped together.
  • the lower clamping assembly 120 also includes a second support member 125, which is connected to the proximal end of the flexible clamping sheet 111.
  • the flexible clamping sheet 111 is in a folded state and forms a first clamping surface 112 and a second clamping surface 113, wherein the first clamping surface 112 and the first clamping arm 121 cooperate to clamp one valve LF of the mitral valve, and the second clamping surface 113 and the second clamping arm 123 cooperate to clamp the other valve LF of the mitral valve, so that the first clamping surface 112 and the second clamping surface 113 of the flexible clamping sheet 111 cooperate with the first clamping arm 121 and the second clamping arm 123 of the lower clamping assembly 120 to jointly clamp the mitral valve.
  • the mitral valve clamping device 100 When performing surgery on the mitral valve, the mitral valve clamping device 100 provided in the present application is arranged in the mitral valve clamping system 200, and the mitral valve clamping system 200 is implanted in the left ventricle LV close to the mitral valve and through the apex; wherein the proximal end of the mitral valve clamping system 200 is provided with an operating handle 220, and the operator can use the operating handle 220 to first move the first support member 114 to the distal end, so that the flexible clamping sheet 111 moves toward the distal end with the first support member 114 and is in a straight state until it extends into between the two valves LF of the mitral valve, and at the same time, the first clamping arm 121 and the second clamping arm 123 of the lower clamping assembly 120 are in an open state, gradually approaching the mitral valve in the left ventricle LV; when the flexible clamping When the sheet 111 is able to capture the valve LF of the mitral valve, the operator operates the
  • a first driving component 130 and a locking structure 150 are provided in the mitral valve clamping system 200, and the first driving component 130 is used to drive the upper clamping component 110 and the lower clamping component 120 of the mitral valve clamping device 100.
  • the first driving component 130 drives the first support member 114 to drive the flexible clamping plate 111 to move toward the distal end or the proximal end
  • the first driving component 130 drives the first clamping arm 121 and the second clamping arm 123 of the lower clamping component 120 to open or retract; when the first clamping arm 121 and the second clamping arm 123 are fully retracted, the locking structure 150 can fix the retracted first clamping arm 121 and the second clamping arm 123 so that they are continuously in a locked state.
  • a guide member 240 is provided in the mitral valve clamping system 200 , and the guide member 240 cooperates with the flexible clamping piece 111 of the mitral valve clamping device 100 in a straightened state to accurately capture the valve LF of the mitral valve.
  • the first drive assembly 130 and the locking structure 150 can be disposed in the mitral valve clamping device 100. After the mitral valve clamping system 200 completes clamping and fixing the mitral valve, the other components in the mitral valve clamping system 200 are separated from the mitral valve clamping device 100 and withdrawn from the left ventricle LV.
  • FIG1 illustrates the anatomical structure of the human heart, where LA is the left atrium, LV is the left ventricle, the mitral valve MV is located between the left atrium LA and the left ventricle LV, and the mitral valve MV has two membrane valves LF. Blood is pumped from the left atrium LA into the left ventricle LV. When the left ventricle LV contracts to pump blood into the body, the mitral valve MV closes to prevent blood from being pumped back into the left atrium LA.
  • FIG2a illustrates the state of the mitral valve of the human heart being well coapted
  • FIG2b illustrates the state of the mitral valve of the human heart not being fully coapted.
  • Figure 3 illustrates an embodiment of the mitral valve clamping device of the present application applied to the mitral valve clamping system, wherein the flexible clamping sheet 111 is in a folded state; in combination with Figure 3, the mitral valve clamping device 100 of the present application includes an upper clamping component 110 and a lower clamping component 120, in the upper clamping component 110, the distal end of the flexible clamping sheet 111 is connected to the first support member 114, and in the lower clamping component 120, the first clamping arm 121 and the second clamping arm 123 are rotatably connected; continuing to combine with Figure 12, wherein the flexible clamping sheet 111 is in a folded state, and can form a first clamping surface 112 and a second clamping surface 113, the first clamping surface 112 and the first clamping arm 121 are used to clamp one valve LF of the mitral valve, and the second clamping surface 113 and the second clamping arm 123 are used to clamp another valve LF of the mitral valve.
  • the mitral valve clamping device 100 of the present application
  • Figure 4 illustrates an embodiment of the mitral valve clamping device of the present application applied to the mitral valve clamping system, wherein the flexible clamping sheet 111 is in a straightened state; in combination with Figure 4, when the first support member 114 moves to the distal end, the flexible clamping sheet 111 is in a straightened state, and a guide member 240 is provided at the side end of the mitral valve clamping device 100, and the proximal end of the guide member 240 is connected to the catheter 210 of the mitral valve clamping system 200, and the extension length of the guide member 240 to the distal end is adapted to the length of the valve LF of the mitral valve, and the guide member 240 and the flexible clamping sheet 111 can accurately extend together between the two valves LF of the mitral valve.
  • the mitral valve clamping device 100 Since the operation is performed while the heart is beating, the mitral valve clamping device 100 needs to accurately capture and clamp the valve LF during the opening or closing of the mitral valve.
  • the guide member 240 provided in the mitral valve clamping device 100 provided in the present application can help the operator effectively complete the accurate positioning from the apex to the valve LF, thereby efficiently completing the leaflet capture.
  • a barb structure 116 is further provided on the flexible clamping sheet 111 for capturing and fixing the mitral valve LF.
  • the barb structure 116 is formed on the first clamping surface 112 and the second clamping surface 113 of the flexible clamping sheet 111 in a folded state.
  • the first clamping arm 121 and the second clamping arm 123 of the lower clamping assembly 120 are in an open state.
  • the mitral valve clamping device 100 of the present application is arranged in the mitral valve clamping system 200.
  • the guide member 240 and the flexible clamping sheet 111 can be accurately extended together between the valves LF of the mitral valve.
  • the process in which the first support member 114 drives the flexible clamping piece 111 to move toward the distal end so that the flexible clamping piece 111 is in a straightened state is as follows:
  • the first support member 114 of the mitral valve clamping device 100 of the present application is provided with a first through hole 115, and the catheter 210 of the mitral valve clamping system 200 is provided with a guide member 240, which is provided at the side end of the mitral valve clamping device 100, preferably
  • the guide member 240 may include a first guide member and a second guide member, which are symmetrically arranged on both sides of the mitral valve clamping device 100.
  • the extension length of the guide member 240 or the first guide member or the second guide member to the distal end is adapted to the valve LF length of the mitral valve.
  • a guide ring 250 may also be provided at the distal end of the guide member 240, and the guide ring 250 is used to adjust the direction of the traction member at the distal end of the guide member 240. More specifically, a first guide ring is provided at the distal end of the first guide member, and a second guide ring is provided at the distal end of the second guide member.
  • the mitral valve clamping device 100 is also provided with a second traction member 260, which passes through the first penetration hole 115, the first guide ring 250, and the second guide ring 250 in sequence, and then both ends of the second traction member 260 extend to the operating handle 220 through the catheter 210.
  • the operator continuously pulls the two ends of the second traction member 260 in the operating handle 220 of the mitral valve clamping system 200, and the second traction member 260 pulls the first support member 114 to move distally through the first through hole 115, so that the flexible clamping sheet 111 moves distally with the first support member 114 and gradually straightens.
  • Figure 5 illustrates the folded state of the first clamping arm and the second clamping arm of the mitral valve clamping device of the present application.
  • the flexible clamping sheet 111 is in a folded state, folded between the first clamping arm 121 and the second clamping arm 123.
  • Figure 6a shows a top view of the mitral valve clamping device of the present application, wherein the first clamping arm 121 and the second clamping arm 123 are in a retracted state
  • Figure 6b is an A-A cross-sectional view of Figure 6a
  • the mitral valve clamping device 100 of the present application includes an upper clamping assembly 110 and a lower clamping assembly 120, wherein, in the upper clamping assembly 110, the distal end of the flexible clamping sheet 111 is connected to the first support member 114, and the proximal end of the flexible clamping sheet 111 is connected to the second support member 125, and the second support member 125 is also connected to the first connecting portion 126, and the first connecting portion 126 is composed of one end of the first clamping arm 121 and one end of the second clamping arm 123 rotatably connected, and the first connecting portion 126 may include a rotating shaft, which is rotatably connected to one end of the first clamping arm 121 and one end of the
  • the mitral valve clamping device 100 further includes a first drive assembly 130, which includes a first base 131.
  • the distal end of the flexible clamping sheet 111 can also be connected to the first base 131, so as to better fix the flexible clamping sheet 111 at the proximal end.
  • FIG9 illustrates the connection relationship between the mitral valve clamping device of the present application and the mitral valve clamping system
  • FIG10 illustrates the connecting rod assembly in the mitral valve clamping device of the present application, wherein the connecting rod assembly 140 drives the lower clamping assembly 120 to be in an open state.
  • the first driving assembly 130 of the mitral valve clamping device 100 of the present application includes a first base 131 and a connecting rod assembly 140, wherein the connecting rod assembly 140 also includes a first control rod 141, a first connecting rod 142 and a second connecting rod 143, the distal end of the first control rod 141 is connected to the second support member 125, and the proximal end of the first control rod 141 is connected to the mitral valve clamping system 200.
  • the catheter 210 is connected, and by controlling the operating handle 220 of the mitral valve clamping system 200, the first control rod 141 can drive the second support member 125 to move toward the distal end or the proximal end.
  • the first connecting rod 142 is used to support the first clamping arm 121 to rotate around the first connecting portion 126.
  • the first clamping arm 121 is provided with a second connecting portion 122.
  • One end of the first connecting rod 142 is rotatably connected to the second connecting portion 122, and the other end of the first connecting rod 142 is rotatably connected to the first base 131.
  • the second connecting rod 143 is used to support the second clamping arm 123 to rotate around the first connecting portion 126.
  • the second clamping arm 123 is provided with a third connecting portion 124.
  • One end of the second connecting rod 143 is rotatably connected to the third connecting portion 124, and the other end of the second connecting rod 143 is rotatably connected to the first base 131.
  • the rotatable connection between one end of the first connecting rod 142 and the second connecting part 122, and the rotatable connection between the other end of the first connecting rod 142 and the first base 131 can be arranged according to specific circumstances.
  • they can be hinged, and a rotating shaft can be set in the second connecting part 122 or the first base 131, and a bearing or a bushing can be set on the first connecting rod 142, and the bearing or the bushing can rotate in cooperation with the rotating shaft.
  • a rotating shaft can be set on the first connecting rod 142, and a bearing or a bushing can be set in the second connecting part 122 or the first base 131.
  • the rotatable connection between one end of the second connecting rod 143 and the third connecting part 124, and the rotatable connection between the other end of the second connecting rod 143 and the first base 131 can be arranged according to specific circumstances.
  • they can be hinged; a rotating shaft can be set in the third connecting part 124 or the first base 131, and a bearing or a bushing can be set on the second connecting rod 143, and the bearing or the bushing can be rotated in cooperation with the rotating shaft.
  • a rotating shaft can be set on the second connecting rod 143, and a bearing or a bushing can be set in the third connecting part 124 or the first base 131.
  • the connecting rod assembly 140 in the first drive assembly 130 is respectively connected to the first clamping arm 121, the second clamping arm 123 and the second support member 125, and the first control rod 141 can drive the second support member 125 to move distally so that the first clamping arm 121 and the second clamping arm 123 are opened relative to the upper clamping assembly 110.
  • the first control rod 141 can also drive the second support member 125 to move proximally so that the first clamping arm 121 and the second clamping arm 123 are retracted relative to the upper clamping assembly 110, wherein Figure 13 illustrates an implementation scheme of the first drive assembly of the mitral valve clamping device of the present application.
  • the connecting rod assembly 140 can be specifically arranged according to the technical inspiration provided by the present application to achieve the opening or closing of the first clamping arm 121 and the second clamping arm 123 relative to the upper clamping assembly 110.
  • first drive component 130 or the connecting rod assembly 140 in the first drive component 130 can be used as a part of the mitral valve clamping device 100, and can also be arranged in the mitral valve clamping system 200. After the first drive component 130 or the connecting rod assembly 140 is connected to the mitral valve clamping device 100, the mitral valve is captured and clamped.
  • FIG. 11 illustrates a connecting rod assembly of the mitral valve clamping device of the present application, wherein the connecting rod assembly 140 drives the lower clamping assembly 120 is in a retracted state.
  • the mitral valve clamping device 100 is arranged in the mitral valve clamping system 200.
  • the proximal operating handle 220 of the mitral valve clamping system 200 can make the various components in the connecting rod assembly 140 rotate relative to each other, and support the first clamping arm 121 and the second clamping arm 123 to rotate around the first connecting portion 126.
  • the first clamping arm 121 and the second clamping arm 123 are in a completely retracted state.
  • a locking structure 150 is provided in the first base 131, and the locking structure 150 is used to clamp the first control rod 141 in the connecting rod assembly 140 to prevent the relative movement between the first control rod 141 and the first base 131 or the lower clamping assembly 120; wherein the locking structure 150 can clamp the first control rod 141 under normal conditions, and when the first control rod 141 needs to be moved, the locking structure 150 releases the first control rod 141, so that the first control rod 141 can move freely to the proximal end or the distal end.
  • the locking structure 150 can also clamp the first control rod 141 after the upper clamping assembly 110 and the lower clamping assembly 120 capture and clamp the mitral valve to prevent the first control rod from moving relative to the first base 131 or the lower clamping assembly 120, thereby preventing the lower clamping assembly 120 and the upper clamping assembly 110 from loosening.
  • the first driving assembly 130 includes a first base 131 and a first control rod 141, the first base 131 is provided with a cavity for the first control rod 141 to pass through, the distal end of the first control rod is connected to the second support member 125, and a locking structure 150 is further provided in the first base 131, the locking structure 150 is used to clamp the first control rod 141, and the locking structure 150 can prevent the first control rod 141 from axially moving relative to the first base 131 or the lower clamping assembly 120.
  • the locking structure 150 fixes the first control rod relative to the first base 131 or the lower clamping assembly 120 to prevent the first control rod from driving the lower clamping assembly 120 to move, thereby preventing the first clamping arm 121 and the second clamping arm 123 from further relative rotation, making the clamping device clamp the mitral valve more secure.
  • a locking structure 150 is further provided in the mitral valve clamping device 100. When the clamping device captures and clamps the mitral valve, it ensures that the mitral valve clamping device 100 can be more reliably maintained in a clamped state to prevent loosening.
  • a mounting groove 132 and a partially inverted cone cavity 133 are arranged in the cavity of the first base 131, and the mounting groove 132 and the inverted cone cavity 133 are arranged adjacent to each other.
  • the mounting groove 132 is arranged on the distal side, and the inverted cone cavity 133 is arranged on the proximal side.
  • the locking structure 150 also includes a clamping member 151, which has an axially retractable elastic portion 152 and an extended end 153 extending from the distal end to the proximal end.
  • the clamping member 151 is sleeved on the first control rod 141, wherein the elastic portion 152 is arranged in the mounting groove 132 of the first base 131 and can provide axial elastic force, and the extended end 153 is at least partially located in the inverted cone cavity 133.
  • the proximal outer side surface 155 of the extended end abuts against the wall surface of the middle area of the inverted cone cavity 133, and the proximal inner side surface 156 of the extended end can squeeze the first control rod 141.
  • the inner side surface 156 of the proximal end of the extended end clamps the first control rod 141, and the extended end
  • the proximal outer side surface 155 of the end abuts against the wall surface of the inverted cone cavity 133, and the inner diameter of the inverted cone cavity 133 gradually narrows from the proximal end to the distal end. Therefore, under the extrusion of the wall surface of the inverted cone cavity 133 of the first base 131 and the first control rod 141, the clamping member 151 is prevented from moving toward the distal end.
  • the proximal inner side surface 156 of the protruding end clamps the first control rod 141 and also prevents the first control rod 141 from moving toward the distal end.
  • the proximal inner side surface 156 of the protruding end no longer squeezes the first control rod 141, so that the first control rod 141 can move toward the proximal end.
  • the locking structure 150 can clamp the first control rod 141 and thereby prevent the first control rod 141 from moving relative to the first base 131.
  • the first control rod 141 no longer has the possibility of further moving in the proximal direction or the distal direction, thereby ensuring that the clamping device can stably clamp the mitral valve.
  • a flange 154 is provided at the distal end of the clamping member 151 and is sleeved on the first control rod 141.
  • the upper end surface of the elastic portion 152 of the clamping member 151 is connected to the flange 154, and the lower end surface of the elastic portion 152 is connected to the axial end surface of the mounting groove 132.
  • the elastic portion 152 Under the extrusion of the flange 154 and the axial end surface of the mounting groove 132, the elastic portion 152 is in an axial compression state to provide elastic force, so that the proximal outer surface 155 of the protruding end of the clamping member 151 abuts against the wall surface of the middle area of the inverted cone cavity 133, and the proximal inner surface 156 of the protruding end can squeeze the first control rod 141.
  • the lower end surface of the elastic portion 152 is connected to the flange 154, and the upper end surface of the elastic portion 152 is connected to the axial upper end surface of the mounting groove 132.
  • the elastic portion 152 is in an axially stretched state to provide elastic force, and can also make the proximal outer side surface 155 of the protruding end of the clamping member 151 abut against the wall surface of the middle area of the inverted cone cavity 133, and the proximal inner side surface 156 of the protruding end can squeeze the first control rod 141.
  • the elastic portion 152 of the clamping member 151 can provide elastic force regardless of being in a compressed state or in a stretched state. Relative to the first control rod 141, this elastic force is an axial traction force from the proximal end to the distal end, so that the protruding end 153 of the clamping member 151 can squeeze the inner wall surface of the inverted conical cavity 133 on the outer side of the protruding end 153 within the limited space of the inverted conical cavity 133, and can squeeze the first control rod 141 on the inner side of the protruding end 153, thereby achieving the locking of the mitral valve clamping device 100.
  • the flange 154 when the clamping member 151 and the flange 154 are two independent components, the flange 154 can be fixedly connected to the first control rod 141. In this connection mode, the first control rod 141 can drive the flange 154 to move axially from the distal end to the proximal end while overcoming the elastic force of the elastic part 152.
  • the flange 154 is a part of the clamping member 151, which is sleeved on the first control rod 141.
  • the mitral valve clamping device 100 is further provided with a first traction member.
  • the distal end of the first traction member 160 is connected to the flange 154 of the clamping member 151, or the distal end of the first traction member 160 is connected to the distal end of the protruding end 153 of the clamping member 151, and the proximal end of the first traction member 160 extends toward the operating handle 220.
  • the elastic force provided by the elastic portion 152 of the clamping member 151 can be overcome to release the squeezing or clamping of the protruding end 153 of the clamping member 151 on the first control rod 141, so that the first control rod 141 can move toward the distal end.
  • two protruding ends 153 of the clamping member 151 are provided, and the two protruding ends 153 can be symmetrically arranged on both sides of the first control rod 141, so as to better clamp the first control rod 141.
  • three protruding ends 153 of the clamping member 151 are arranged, and the three protruding ends 153 are arranged at equal intervals along the circumference of the first control rod 141.
  • the protruding ends 153 can clamp the first control rod 141 in three directions, thereby better preventing the first control rod 141 from moving.
  • the clamping member 151 provides clamping forces in two or three directions to the first control rod 141. Compared with the locking force of a single contact point and a single direction, the locking structure 150 in the mitral valve clamping device 100 of the present application will not have the risk of falling off due to loose closing or opening.
  • the flexible clamping sheet 111 can be made of nickel-titanium alloy material, and when the elastic part 152 in the clamping member 151 is set as a spring, the spring can be made of stainless steel material or nickel-titanium alloy material.
  • the biocompatible nickel-titanium alloy material or stainless steel material can better integrate with human tissue.
  • the present application also provides a mitral valve clamping system.
  • the mitral valve clamping device 100 can be delivered to the vicinity of the mitral valve of the left ventricle LV with the help of the mitral valve clamping system 200.
  • the mitral valve clamping device 100 can capture and clamp the mitral valve, and by providing a locking structure 150, the mitral valve clamping device 100 can be prevented from loosening.
  • the mitral valve clamping system 200 includes a mitral valve clamping device 100 as described in any of the above items, and also includes a catheter 210 and an operating handle 220, wherein the distal end of the catheter 210 is connected to the proximal end of the mitral valve clamping device 100, more specifically, the distal end of the catheter 210 can be connected to the proximal end of the first base 131 of the mitral valve clamping device 100; the proximal end of the catheter 210 is connected to the operating handle 220, and by controlling the operating handle 220, the mitral valve clamping device 100 is capable of capturing and clamping the mitral valve, wherein Figure 14 shows a structural diagram of the mitral valve clamping device of the present application installed in the mitral valve clamping system.
  • a guide structure is also provided. Specifically, a guide member 240 is provided at the distal end of the catheter 210, and the guide member 240 is provided at the side end of the mitral valve clamping device 100.
  • a wire ring 250 is provided at the distal end of the guide member 240, and the extension length of the guide member 240 to the distal end is adapted to the valve LF length of the mitral valve; with the aid of the guide structure, the first support member 114 of the mitral valve clamping device can be moved to the distal end, while the flexible clamping sheet 111 is in a straightened state.
  • two guide members 240 are disposed opposite to each other at the distal end of the catheter 210.
  • the guide members 240 are arranged on both sides of the mitral valve clipping device 100 , and guide rings 250 are provided at the distal ends of the two oppositely arranged guide members 240 .
  • the mitral valve clamping system also includes a second traction member 260.
  • the second traction member 260 passes through the guide ring 250 of one guide member 240, the first penetration hole 115 of the first support member 114, and the guide ring 250 of another guide member 240 in sequence, and then extends to the operating handle 220 through the catheter 210; in this embodiment, the first penetration hole 115 is also provided on the first support member 114 of the mitral valve clamping device 100, for the second traction member 260 to pass through to pull the first support member 114 to move distally.
  • a connecting rod 270 is provided at the distal end of the catheter 210, and the connecting rod 270 is connected to the proximal end of the first base 131, wherein the connecting end face can be configured to be curved.
  • the connecting end face is S-shaped in the axial direction, namely, an "S"-shaped connecting end face 271.
  • the connecting rod 270 is connected to the proximal end of the first base 131 with a curved cross-section, which can prevent the connection from loosening.
  • a second control rod 230 is arranged in the catheter 210, and the second control rod 230 is threadedly connected to the first control rod 141; when the mitral valve clamping device 100 completes the capture and clamping of the mitral valve, the first control rod 141 and the second control rod 230 can be separated more conveniently.

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  • Health & Medical Sciences (AREA)
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  • Oral & Maxillofacial Surgery (AREA)
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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

La présente demande concerne un dispositif de serrage de valve mitrale (100). Le dispositif de serrage de valve mitrale (100) est implanté à travers un apex cardiaque. Le dispositif de serrage de valve mitrale (100) comprend un ensemble de serrage supérieur (110) et un ensemble de serrage inférieur (120). L'ensemble de serrage supérieur (110) comprend une pièce de serrage flexible (111) et un premier élément de support (114). Le premier élément de support (114) est relié à l'extrémité distale de la pièce de serrage flexible (111). L'ensemble de serrage inférieur (120) comprend un premier bras de serrage (121), un second bras de serrage (123), et un second élément de support (125). Une extrémité du premier bras de serrage (121) et une extrémité du second bras de serrage (123) sont reliées de manière rotative pour former une première partie de liaison (126). La première partie de liaison (126) est reliée au second élément de support (125). Le second élément de support (125) est relié à l'extrémité proximale de la pièce de serrage flexible (111). Dans un état plié, la pièce de serrage flexible (111) peut former une première surface de serrage (112) et une seconde surface de serrage (113). La première surface de serrage (112) coopère avec le premier bras de serrage (121), et la seconde surface de serrage (113) coopère avec le second bras de serrage (123), de façon à serrer conjointement une valve mitrale. La présente demande concerne en outre un système de serrage de valve mitrale (200), comprenant ledit dispositif de serrage de valve mitrale (100).
PCT/CN2023/121974 2022-09-30 2023-09-27 Dispositif de serrage de valve mitrale et système de serrage de valve mitrale Ceased WO2024067686A1 (fr)

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CN202211215109.8 2022-09-30
CN202211215109.8A CN115517826A (zh) 2022-09-30 2022-09-30 二尖瓣夹合装置及二尖瓣夹合系统

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CN118453200A (zh) * 2024-05-31 2024-08-09 上海傲流医疗科技有限公司 一种高夹持力二尖瓣夹
CN119055409A (zh) * 2024-10-23 2024-12-03 江苏美凤力医疗科技有限公司 一种安全型双翼式二尖瓣夹合器
CN120241329A (zh) * 2025-06-05 2025-07-04 科瑞迈吉(北京)医疗科技有限公司 一种瓣膜钳夹器

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CN115517826A (zh) * 2022-09-30 2022-12-27 瀚芯医疗科技(深圳)有限公司 二尖瓣夹合装置及二尖瓣夹合系统

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CN111200995A (zh) * 2017-09-07 2020-05-26 爱德华兹生命科学公司 用于心脏瓣膜的假体间隔件装置
CN114452045A (zh) * 2021-12-28 2022-05-10 科凯(南通)生命科学有限公司 心脏瓣膜修复夹具
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CN118453200A (zh) * 2024-05-31 2024-08-09 上海傲流医疗科技有限公司 一种高夹持力二尖瓣夹
CN119055409A (zh) * 2024-10-23 2024-12-03 江苏美凤力医疗科技有限公司 一种安全型双翼式二尖瓣夹合器
CN120241329A (zh) * 2025-06-05 2025-07-04 科瑞迈吉(北京)医疗科技有限公司 一种瓣膜钳夹器

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