WO2024074089A1 - 人工腱索夹持装置以及操作器 - Google Patents

人工腱索夹持装置以及操作器 Download PDF

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Publication number
WO2024074089A1
WO2024074089A1 PCT/CN2023/117240 CN2023117240W WO2024074089A1 WO 2024074089 A1 WO2024074089 A1 WO 2024074089A1 CN 2023117240 W CN2023117240 W CN 2023117240W WO 2024074089 A1 WO2024074089 A1 WO 2024074089A1
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WO
WIPO (PCT)
Prior art keywords
clamping
plane
clamping device
artificial tendon
side wall
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Application number
PCT/CN2023/117240
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English (en)
French (fr)
Inventor
张旭升
谢琦宗
Original Assignee
瀚芯医疗科技(深圳)有限公司
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Publication date
Application filed by 瀚芯医疗科技(深圳)有限公司 filed Critical 瀚芯医疗科技(深圳)有限公司
Publication of WO2024074089A1 publication Critical patent/WO2024074089A1/zh

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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

Definitions

  • the present invention relates to the technical field of medical equipment, and in particular to an artificial tendon chord clamping device and a manipulator.
  • Mitral regurgitation is one of the most common heart valve diseases today.
  • the main causes are rheumatic heart disease, myxoid degeneration of the mitral valve, ischemic heart disease, myocardial disease, etc., which lead to lesions in the valve ring, leaflets, chordae tendineae and papillary muscles in the mitral valve structure, resulting in the inability of the mitral valve leaflets to close completely.
  • the main interventional treatment for mitral regurgitation currently includes artificial chordal implantation, in which one end of the artificial chordal tendon is fixed to the mitral valve, and the other end extends out of the heart and is sewn to the myocardium via sutures, causing damage to the myocardium. Furthermore, when the artificial chordal tendon becomes loose, the artificial chordal tendon sewn to the myocardium needs to be removed and sutured a second time, causing secondary damage to the heart myocardium.
  • the purpose of the present invention is to at least solve the problem of myocardial damage caused by one end of the artificial chord extending out of the heart being sutured to the myocardium by suture thread.
  • an artificial tendon chord clamping device includes a seat, a clamping member and an elastic member.
  • the seat includes a main body portion that abuts against the outer wall of the heart, a support portion provided on the side of the main body portion facing away from the heart, and a clamping member provided on the side of the support portion facing away from the main body portion, and the clamping member has a first clamping surface arranged toward the support portion.
  • the clamping member is movably provided on the support portion, and the clamping member and the first clamping surface have an abutting state and a separation state.
  • the elastic member is respectively connected to the main body portion and the clamping member. The elastic member applies an elastic force toward the first clamping surface to the clamping member so that the clamping member abuts against the first clamping surface.
  • the elastic member is deformed under the action of an external force and drives the clamping member to separate from the first clamping surface.
  • the clamping member and the clamping portion clamp the artificial chord, and abut against the outer wall of the heart through the seat body, so that the end of the artificial chord extending out of the heart is clamped and fixed, and there is no need to suture the heart with sutures, thereby reducing damage to the heart.
  • the artificial chord becomes loose, it is only necessary to pull the elastic member to drive the clamping member to separate from the first clamping surface, and release the elastic member after adjusting the artificial chord, so as to continue to clamp and fix the artificial chord with the clamping member and the clamping portion, without the need to suture the heart for a second time, thereby avoiding secondary damage to the heart muscle.
  • the artificial tendon clamping device according to the present invention may also have the following additional technical features:
  • the main body portion has a first plane, which is against the heart; a support plane is provided on the side of the support portion away from the main body portion, and the clamping member is slidably provided on the support plane; wherein the support plane is inclined relative to the first plane, and the first clamping surface is inclined relative to the support plane.
  • the supporting plane intersects with the first plane at a first straight line, the first clamping surface and the supporting plane are relative to a second straight line, the first straight line is parallel to the second straight line or the first straight line coincides with the second straight line.
  • the angle between the supporting plane and the first plane is a first angle
  • the angle between the first clamping surface and the first plane is a second angle
  • the first angle ranges from 10° to 60°
  • the second angle is greater than the first angle and less than 180°.
  • the clamping member includes a sliding plane and a second clamping surface.
  • the sliding plane is slidably matched with the supporting plane.
  • the second clamping surface intersects with the sliding plane and abuts against the first clamping surface.
  • the sliding plane is parallel to the supporting plane, and the second clamping surface is parallel to the first clamping surface.
  • the first clamping surface and/or the second clamping surface is configured as a rough surface.
  • the clamping portion includes a first side wall, a second side wall and a top wall.
  • the first side wall is connected to the support portion.
  • the second side wall is connected to the support portion and is arranged parallel to and spaced from the first side wall.
  • the top wall is connected to the first side wall and the second side wall respectively, and the side of the top wall facing the second clamping surface forms the first clamping surface.
  • the first side wall, the second side wall and the support plane together define a sliding channel of the clamping member, and the sliding channel extends toward the first clamping surface along the distal end of the support plane.
  • the artificial tendon chord clamping device further includes a first wire hole and a second wire hole.
  • the first wire hole is formed on the first plane and communicates with the distal end of the sliding channel.
  • the second wire hole is provided between the clamping portion and the supporting portion and communicates with the proximal end of the sliding channel.
  • the main body is further provided with a first connecting portion and a second connecting portion, the first connecting portion is located on one side of the first side wall, and the second connecting portion is located on one side of the second side wall.
  • the first side wall and the second side wall are both provided with a long hole communicating with the sliding channel;
  • the clamping member is provided with a through connecting hole;
  • the elastic member passes through the long hole and the connecting hole, and the two ends of the elastic member are respectively connected to the first connecting portion and the second connecting portion.
  • the elastic member is a rope-shaped elastic member, and the elastic member includes at least one elastic wire.
  • the main body is provided with a first avoidance groove and a second avoidance groove
  • the first avoidance groove is located between the first connecting portion and the first side wall
  • the second avoidance groove is provided between the second connecting portion and the second side wall.
  • the support portion further includes a first guide surface and a second guide surface.
  • the first guide surface is disposed correspondingly to the first avoidance groove.
  • the second guide surface is disposed correspondingly to the second avoidance groove. Both the first guide surface and the second guide surface are parallel to the support plane.
  • a mating groove is provided on the side of the support portion facing the main body portion, and the mating groove includes a first wall surface connected to the main body portion and a second wall surface connected to the first wall surface, the second wall surface is parallel to the support plane, and the angle between the second wall surface and the first wall surface is less than or equal to 90°.
  • the second wall surface is provided with a guide groove, and the guide groove extends from the proximal end of the second wall surface toward the first wall surface.
  • the second aspect of the present invention further proposes an operator for implanting the artificial tendon chord clamping device described in the technical solution of the first aspect.
  • the operator includes: a handle, a sheath, a pulling claw, a push rod and an adjustment button.
  • the proximal end of the sheath is connected to the handle.
  • the pulling claw is connected to the distal end of the sheath, and the pulling claw has a hook, and the hook can be hooked to the elastic part in the artificial tendon chord clamping device.
  • the push rod is slidably arranged in the sheath, and the distal end of the push rod can be abutted against the support part in the artificial tendon chord clamping device.
  • the adjustment button is arranged on the handle and connected to the proximal end of the push rod, and the adjustment button can push the push rod to move relative to the sheath along the length direction of the sheath.
  • FIG1 schematically shows a schematic structural diagram of an artificial tendon chord clamping device according to an embodiment of the present invention
  • FIG2 schematically shows a schematic structural diagram of an artificial tendon chord clamping device from a bottom-up perspective according to an embodiment of the present invention
  • FIG3 schematically shows a schematic structural diagram of a seat body according to an embodiment of the present invention
  • FIG4 schematically shows a schematic structural diagram of a clamping member according to an embodiment of the present invention
  • FIG5 schematically shows a schematic structural diagram of a clamping member from a left-side viewing angle according to an embodiment of the present invention
  • FIG6 schematically shows a schematic structural diagram of an artificial tendon chord clamping device from a top view according to an embodiment of the present invention
  • FIG7 schematically shows a schematic diagram of the positional relationship between the first plane, the first clamping plane and the supporting plane according to an exemplary embodiment of the present invention
  • FIG8 schematically shows a schematic structural diagram of an operator according to an embodiment of the present invention.
  • FIG9 schematically shows a schematic diagram of the implantation process of the artificial tendon chord clamping device according to an embodiment of the present invention
  • FIG10 schematically shows a partial enlarged schematic diagram of part A in FIG9 ;
  • FIG11 schematically shows a partial structural diagram of a manipulator according to an embodiment of the present invention.
  • FIG12 schematically shows a schematic diagram of the structure of a manipulator from a top view according to an embodiment of the present invention
  • FIG13 schematically shows a schematic structural diagram of an adjustment button according to an embodiment of the present invention.
  • FIG. 14 schematically shows a schematic structural diagram of a pushing component according to an embodiment of the present invention.
  • first, second, third, etc. can be used in the text 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 can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates, terms such as “first”, “second” and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.
  • 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.
  • distal and proximal are used as directional terms, which are commonly used in the field of interventional medical devices.
  • distal refers to the end away from the operator during surgery
  • proximal refers to the end close to the operator during surgery.
  • Axial refers to the direction parallel to the center of the distal end and the proximal end of the medical device. The direction of the center line; radial direction refers to the direction perpendicular to the above-mentioned axial direction.
  • an artificial tendon chord clamping device is provided.
  • the artificial tendon chord clamping device 100 comprises: a seat body 10, a clamping member 20 and an elastic member 30.
  • the seat body 10 comprises a main body 11, a support portion 12 and a clamping member 13 connected in sequence, wherein the support portion 12 is arranged on the side of the main body 11 away from the heart, the clamping member 13 is arranged on the side of the support portion 12 away from the main body 11, the clamping member 13 has a first clamping surface 1331 arranged toward the support portion 12, the clamping member 20 is arranged between the first clamping surface 1331 and the support portion 12, and the clamping member 20 can move on the support portion 12, and the clamping member 20 can approach or move away from the first clamping surface 1331, so that the clamping member 20 and the first clamping surface 1331 have abutting state and a separation state.
  • the clamping member 20 and the first clamping surface 1331 are used to clamp and fix the artificial tendon chord 300, and in the separation state, the artificial tendon chord 300 can move on the artificial tendon chord clamping device 100 to adjust the tightness.
  • the elastic member 30 is respectively connected to the main body 11 and the clamping member 20.
  • the elastic member 30 is used to provide an elastic force toward the first clamping surface 1331 to the clamping member 20.
  • the elastic member 30 drives the clamping member 20 to abut against the first clamping surface 1331.
  • the elastic member 30 is deformed under the action of the external force and drives the clamping member 20 to separate from the first clamping surface 1331.
  • the external force borne by the elastic member 30 can be either a pulling force toward the proximal direction or a pushing force toward the distal direction.
  • the clamping member 20 is closer to the proximal end relative to the first clamping surface 1331.
  • the clamping member 20 is closer to the distal end relative to the first clamping surface 1331.
  • the clamping member 20 and the clamping portion 13 clamp the artificial tendon chord 300, and abut against the outer wall of the heart through the seat 10, so that the end of the artificial tendon chord 300 extending out of the heart is clamped and fixed, and there is no need to suture the heart with sutures, thereby reducing damage to the heart.
  • the artificial tendon clamping device 100 also includes a first wire hole 141 and a second wire hole 142, the distal end of the sliding channel 14 extends to the first plane 111 and forms the first wire hole 141 on the first plane 111, and the proximal end of the sliding channel 14 extends to the proximal ends of the clamping portion 13 and the support portion 12 and forms the second wire hole between the clamping portion 13 and the support portion 12.
  • One end of the artificial tendon 300 extending out of the heart enters the sliding channel 14 through the first wire hole 141 and is clamped between the first clamping surface 1331 and the second clamping surface 22, and extends out through the second wire hole 142, so that during the surgical procedure of implanting the artificial tendon 300, the one end of the artificial tendon 300 extending out of the heart is clamped and fixed at the apex of the heart.
  • the main body 11 has a first plane 111
  • the support portion 12 is provided with a support plane 121 on the side away from the main body 11, and the clamping member 20 is slidably arranged on the support plane 121. Therefore, by tilting the first clamping surface 1331 relative to the support plane 121, when the clamping member 20 slides on the support plane 121, the clamping member 20 can have a relative displacement with the first clamping surface 1331 in a direction perpendicular to the first clamping surface 1331, so that the clamping member 20 and the first clamping surface 1331 can be transformed between the abutment state and the separation state.
  • the support plane 121 is tilted relative to the first plane 111 to facilitate the implantation operation of the artificial tendon chord clamping device 100.
  • the operation is performed through the chest opening. Since the artificial chord clamping device 100 is against the apex of the heart, generally, the apex of the heart is facing the proximal direction, and the operator has an inclination angle with the apex, when the first plane 111 is against the apex of the heart, the first plane 111 is perpendicular to the direction of the first plane 111 and faces the position of the chest opening, and the support plane 121 is inclined relative to the first plane 111, so that the second wire hole 142 can face the operator, so that the operator can capture the artificial chord 300 and clamp it on the artificial chord clamping device 100, so as to facilitate the implantation of the artificial chord clamping device 100.
  • a first operation window 104 for supporting the elastic member 30 of the push rod 204 is formed between the proximal end of the support plane 121 and the main body 11, and at the same time, a second operation window 105 for capturing or clamping the end of the artificial chord 300 extending out of the heart is formed between the support plane 121 and the first clamping plane, so that the operation window distribution during the implantation of the artificial chord clamping device 100 is more reasonable, which is conducive to reducing the difficulty of operation during the implantation of the artificial chord clamping device 100, improving the implantation efficiency of the artificial chord clamping device 100, and shortening the operation time.
  • the support plane 121 intersects with the first plane 111 at the first straight line 101, the first clamping surface 1331 and the support plane 121 are relative to the second straight line 102, and the first straight line 101 is parallel to the second straight line 102, so that the first operating window 104 between the support plane 121 and the first plane 111 and the second operating window 105 between the first clamping surface 1331 and the support plane 121 are in the same direction, both from the apex of the heart toward the direction of the chest opening, so as to facilitate the capture of the elastic member 30 and the artificial tendon 300.
  • the first straight line 101 coincides with the second straight line 102 .
  • the angle between the support plane 121 and the first plane 111 is a first angle
  • the angle between the first clamping surface 1331 and the first plane 111 is a second angle
  • the first angle ranges from 10° to 60°
  • the second angle is greater than the first angle and less than 180°.
  • the first angle can be 10°, 15°, 30°, 40°, 45°, etc.
  • the second angle can be 60°, 65°, 70°, 75°, 80°, 100°, etc.
  • the first straight line 101 coincides with the second straight line 102, the first angle is 45°, and the second angle is 90°.
  • the space of the first operation window 104 and the second operation window 105 is equal, so as to facilitate the capture of the elastic member 30 and the artificial chord.
  • the angle between the first clamping surface 1331 and the first plane 111 is 90°, so that the artificial chord can smoothly extend from the apex of the heart into the space between the clamping member 20 and the first plane 111, reducing the bending degree of the artificial chord, thereby reducing the bending damage to the artificial chord.
  • the clamping member 20 includes a sliding plane 21 and a second clamping surface 22.
  • the sliding plane 21 is slidably matched with the support plane 121. Through the sliding cooperation between the surfaces, the sliding process of the clamping member 20 on the support portion 12 is more stable.
  • the second clamping surface 22 intersects with the sliding plane 21 and abuts against the first clamping surface 1331. Through the cooperation between the first clamping surface 1331 and the second clamping surface 22, the effective clamping distance of the artificial tendon 300 is increased, and the pressure of the artificial tendon 300 in the clamped state is reduced. On the one hand, the clamping effect is made firmer, and on the other hand, the extrusion damage to the artificial tendon 300 is reduced.
  • the sliding plane 21 is parallel to the supporting plane 121
  • the second clamping surface 22 is parallel to the first clamping surface 1331, so that when the clamping member 20 slides on the supporting plane 121, the second clamping surface 22 and the first clamping surface 1331 always remain parallel, so that the pressure in each area when the second clamping surface 22 and the first clamping surface 1331 are equal, thereby avoiding excessive local pressure and causing squeezing damage to the artificial tendon 300.
  • the first clamping surface 1331 or the second clamping surface 22 is configured as a rough surface, or the first clamping surface 1331 and the second clamping surface 22 are configured as a rough surface. Both are configured with a rough surface to lock the artificial tendon 300.
  • the second clamping surface 22 is sawtooth-shaped. In other embodiments, the second clamping surface 22 is provided with a knurled pattern or a densely distributed convex point structure to increase the roughness of the second clamping surface 22 .
  • the clamping portion 13 includes a first side wall 131, a second side wall 132 and a top wall 133, the first side wall 131 and the second side wall 132 are both connected to the support portion 12, and the first side wall 131 and the second side wall 132 are arranged in parallel and spaced apart.
  • the two sides of the top wall 133 are respectively connected to the first side wall 131 and the second side wall 132, and the top wall 133, the first side wall 131, the second side wall 132 and the support plane 121 jointly define a sliding channel 14.
  • the sliding channel 14 extends toward the first clamping surface 1331 along the distal end of the support plane 121.
  • the sliding channel 14 is used to limit the sliding direction of the clamping member 20, so that the clamping member 20 can only slide along the extension direction of the sliding channel 14, thereby making the moving trajectory of the clamping member 20 more accurate, and improving the accuracy of the artificial tendon chord clamping device 100 during implantation.
  • the main body 11 is further provided with a first connection portion 112 and a second connection portion 113.
  • the first connection portion 112 is located at one side of the first side wall 131 and is spaced apart from the first side wall 131.
  • the second connection portion 113 is located at one side of the second side wall 132 and is spaced apart from the second side wall 132.
  • the first side wall 131 and the second side wall 132 are both provided with a long hole 103 communicating with the sliding channel 14.
  • the clamping member 20 is provided with a through connection hole 23.
  • the two ends of the connecting hole 23 are respectively opposite to the long holes 103 on the first side wall 131 and the second side wall 132.
  • the elastic member 30 is a rope-shaped member made of one or more elastic wires. The two ends of the elastic member 30 are respectively connected to the first connecting portion 112 and the second connecting portion 113, and the elastic member 30 passes through the long hole 103 and the connecting hole 23 in sequence. In the state without external force, the elastic member 30 is in a taut state, and the clamping member 20 is pressed against the first clamping surface 1331, so that the first clamping surface 1331 and the second clamping surface 22 are closely fitted.
  • the main body 11 is provided with a first avoidance groove 114 and a second avoidance groove 115.
  • the first avoidance groove 114 is located between the first connecting portion 112 and the first side wall 131
  • the second avoidance groove 115 is located between the second connecting portion 113 and the second side wall 132.
  • the first avoidance groove 114 and the second avoidance groove 115 are used to avoid the hook-shaped member in the operator 200 so that the hook-shaped member can grab the elastic member 30.
  • the support portion 12 further includes a first guide surface 122 and a second guide surface 123.
  • the first guide surface 122 is located on one side of the first side wall 131 and corresponds to the first avoidance groove 114.
  • the second guide surface 123 is located on one side of the second side wall 132 and corresponds to the second avoidance groove 115.
  • the first guide surface 122 and the second guide surface 123 are both parallel to the support plane 121, so that the hook-shaped member can be easily moved after grabbing the elastic member 30.
  • Supporting and guiding the movement of the hook-like member facilitates the hook-like member to exert force, and on the other hand, makes the movement of the hook-like member smoother, reduces the vibration of the artificial tendon chord clamping device 100, and improves the smoothness of the implantation process of the artificial tendon chord clamping device 100.
  • first side wall 131 and the second side wall 132 both protrude from the first guide surface 122 and the second guide surface 123, and the first connecting portion 112 and the second connecting portion 113 protrude from the main body portion 11.
  • the first side wall 131 and the first connecting portion 112, the second side wall 132 and the second connecting portion 113 can limit the position of the hook-like member, so that the hook-like member can hook the elastic wire according to the angle requirement without deviating.
  • a matching groove 124 is provided on one side of the support portion 12 facing the main body portion 11, and the matching groove 124 is used to abut and cooperate with the push rod 204 in the operator 200.
  • the distal end of the push rod 204 in the operator 200 abuts against the matching groove 124, and the matching groove 124 provides a force point for the distal end of the push rod 204.
  • the matching groove 124 includes a first wall surface 1241 connected to the main body portion 11 and a second wall surface 1242 connected to the first wall surface 1241, and the second wall surface 1242 is parallel to the support plane 121, so that the extension direction of the push rod 204 is aligned with the second wall surface 1242 to avoid the second wall surface 1242 interfering with the push rod 204.
  • the included angle between the second wall surface 1242 and the first wall surface 1241 is less than or equal to 90°, so that the distal end of the push rod 204 is confined between the first wall surface 1241 and the second wall surface 1242 , and the push rod 204 is prevented from sliding out of the matching groove 124 .
  • the second wall 1242 is provided with a guide groove 12421, which extends from the proximal end of the second wall 1242 toward the first wall 1241.
  • the contour of the guide groove 12421 matches the contour of the push rod 204.
  • the outer wall surface of the push rod 204 cooperates with the inner wall surface of the guide groove 12421, so that the push rod 204 can withstand radial force, thereby further limiting the sliding of the push rod 204 along the radial direction of the push rod 204 and improving the stability of the artificial chord clamping device 100 during the implantation process.
  • the main body 11 is wrapped with a PET film (polyester substrate), which makes the surface of the artificial tendon chord clamping device 100 softer and avoids damaging the myocardial tissue.
  • PET film polyester substrate
  • each component in the artificial tendon clamping device 100 proposed in the present invention is preferably a metal or polymer material that meets the biocompatibility requirements, such as stainless steel SUS316L, cobalt-based alloy, PEEK (polyetheretherketone), etc.
  • an operator 200 is further proposed.
  • the operator 200 is used to implant an artificial tendon chord clamping device 100 .
  • the operator uses the operator 200 to complete actions such as delivery, implantation, locking, and release of the artificial tendon chord clamping device 100 .
  • the operator 200 includes a handle 201, a sheath 202, a tension claw 203, a push rod 204 and an adjustment button. 205.
  • the proximal end of the sheath tube 202 is connected to the handle 201; the pulling claw 203 is connected to the distal end of the sheath tube 202, and the pulling claw 203 (i.e., the hook-shaped member) has a hook portion, which can be hooked to the elastic member 30 in the artificial tendon chord clamping device 100.
  • the push rod 204 is slidably arranged in the sheath tube 202, and the distal end of the push rod 204 can be abutted against the matching groove 124 on the support portion 12 of the seat body 10 in the artificial tendon chord clamping device 100.
  • the adjustment button 205 is arranged on the handle 201 and connected to the proximal end of the push rod 204, and the adjustment button 205 can push the push rod 204 to move relative to the sheath tube 202 along the length direction of the sheath tube 202.
  • the operator 200 also includes a pushing component 207 and a spring 206.
  • the pushing component 207 is welded on the pushing rod, and the spring 206 is sleeved on the push rod 204.
  • the distal end of the spring 206 is against the handle 201, and the proximal end of the spring 206 is against a side of the pushing component 207 facing the distal end.
  • the second arc surface 2071 on the pushing component 207 positioned on the lower shell of the handle 201 cooperates with the first arc surface 2052 on the adjustment button 205.
  • the adjustment button 205 When the adjustment button 205 is rotated, the adjustment button 205 rotates around the rotation axis, and the pushing component 207 and the push rod 204 connected thereto are axially moved through the first arc surface 2052, wherein the push rod 204 is positioned on the center axis. After rotating the adjustment button 205, the button position 2051 on the adjustment button 205 passes over the button position 2051 on the adjustment button 205 shell in the proximal direction.
  • the artificial tendon clamping device 100 can be connected with the manipulator at this time, and the button position 2051 can be pushed in the proximal direction so that the button position 2051 is located at the proximal end of the handle position 2011.
  • the manipulator 200 can release the artificial tendon clamping device 100.
  • the process of implanting the artificial tendon chord clamping device 100 is as follows:
  • the elastic member 30 is hooked by the tension claw 203, and the push rod 204 is pushed by the adjustment button 205, so that the outer sheath drives the tension claw 203 to move toward the proximal end relative to the push rod 204, thereby pulling the clamping member 20 apart, so that a channel is opened between the first clamping surface 1331 and the second clamping surface 22, and the channel width is D, which should be greater than or equal to the diameter of the artificial tendon 300. After the channel is opened, the artificial tendon 300 is passed through the channel.
  • the adjustment button 205 is turned to disengage the tension claw 203 from the elastic member 30, release the artificial chord clamping device 100, and complete the operation.
  • the artificial chord clamping device 100 can then apply a locking force F to the artificial chord 300 to lock and fix the artificial chord 300 at the apex of the heart.

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

Abstract

人工腱索夹持装置（100）以及操作器（200），其中，人工腱索夹持装置（100）包括：座体（10），座体（10）包括与心脏相抵的本体部（11）、设于本体部（11）背离心脏一侧的支撑部（12）、设于支撑部（12）背离本体部（11）一侧的夹持部（13），夹持部（13）具有朝向支撑部（12）设置的第一夹持面（1331）；夹持件（20），可移动地设于支撑部（12），夹持件（20）与第一夹持面（1331）之间具有抵接状态和分离状态；弹性件（30），分别与本体部（11）和夹持件（20）相连；弹性件（30）能够驱动夹持件（20）与第一夹持面（1331）抵接；弹性件（30）在外力作用下发生形变并带动夹持件（20）与第一夹持面（1331）分离。

Description

人工腱索夹持装置以及操作器 技术领域
本发明涉及医疗器械设备技术领域，尤其涉及一种人工腱索夹持装置以及操作器。
背景技术
本部分提供的仅仅是与本公开相关的背景信息，其并不必然是现有技术。
二尖瓣反流(mitral regurgitation，MR)是当今最常见的心脏瓣膜疾病之一，主要病因是风湿性心脏病、二尖瓣粘液样变性、心脏缺血性疾病、心肌病变等，导致二尖瓣结构中瓣环、瓣叶、腱索以及乳头肌发生病变，导致二尖瓣的瓣叶不能完全关闭。
现有的二尖瓣反流的主要的介入治疗方式有人工腱索植入术，人工腱索的一端固定在二尖瓣，另一端伸出心脏并通过缝合线缝在心肌上，对心肌造成伤害，并且当人工腱索会出现松弛的状况时，需要拆除缝合在心肌上的人工腱索并二次缝合，对心脏心肌造成二次伤害。
发明内容
本发明的目的是至少解决人工腱索伸出心脏的一端通过缝合线缝在心肌上造成心肌损伤的问题。
该目的是通过以下技术方案实现的：
本发明的第一方面，提出了一种人工腱索夹持装置，所述人工腱索夹持装置包括座体、夹持件和弹性件。所述座体包括与心脏的外壁相抵的本体部、设于所述本体部背离所述心脏一侧的支撑部、设于所述支撑部背离所述本体部一侧的夹持部，所述夹持部具有朝向所述支撑部设置的第一夹持面。所述夹持件可移动地设于所述支撑部，所述夹持件与所述第一夹持面之间具有抵接状态和分离状态。所述弹性件分别与所述本体部和所述夹持件相连。所述弹性件向所述夹持件施加朝向所述第一夹持面的弹性力以使所述夹持件与所述第一夹持面抵接。所述弹性件在外力作用下发生形变并带动所述夹持件与所述第一夹持面分离。
根据本发明提出的人工腱索夹持装置，在弹性件的弹性力作用下，夹持件和夹持部将人工腱索夹紧，并通过座体抵接在心脏的外壁上，从而将人工腱索伸出心脏的一端夹持固定，无需利用缝合线在心脏上缝合，减少了对心脏的损伤。并且，当人工腱索会出现松弛的状况时，仅需拉动弹性件带动夹持件与第一夹持面分离，在调整人工腱索后松开弹性件，以便于继续利用夹持件和夹持部将人工腱索夹持固定，无需对心脏进行二次缝合，避免对心脏心肌造成二次伤害。
另外，根据本发明的人工腱索夹持装置，还可具有如下附加的技术特征：
在本发明的一些实施方式中，所述本体部具有第一平面，所述第一平面与所述心脏相抵；所述支撑部背离所述本体部的一侧设有支撑平面，所述夹持件可滑动地设于所述支撑平面上；其中，所述支撑平面相对于所述第一平面倾斜设置，所述第一夹持面相对于所述支撑平面倾斜设置。
在本发明的一些实施方式中，所述支撑平面与所述第一平面相交于第一直线，所述第一夹持面与所述支撑平面相较于第二直线，所述第一直线与所述第二直线平行或所述第一直线与所述第二直线重合。
在本发明的一些实施方式中，所述支撑平面与所述第一平面的夹角值为第一角度，所述第一夹持面与所述第一平面的夹角值为第二角度，所述第一角度取值范围为10°～60°，所述第二角度大于所述第一角度且小于180°。
在本发明的一些实施方式中，所述夹持件包括滑动平面和第二夹持面。所述滑动平面与所述支撑平面滑动配合。所述第二夹持面与所述滑动平面相交并与所述第一夹持面抵接配合。所述滑动平面与所述支撑平面平行，所述第二夹持面与所述第一夹持面平行。
在本发明的一些实施方式中，所述第一夹持面和/或第二夹持面配置为粗糙面。
在本发明的一些实施方式中，所述夹持部包括第一侧壁、第二侧壁和顶壁。所述第一侧壁与所述支撑部相连。所述第二侧壁与所述支撑部相连并与所述第一侧壁平行且间隔地设置。所述顶壁分别与所述第一侧壁和第二侧壁相连，所述顶壁朝向所述第二夹持面的一侧形成所述第一夹持面。所述第一侧壁、所述第二侧壁和所述支撑平面共同限定出所述夹持件的滑动通道，所述滑动通道沿所述支撑平面的远端向所述第一夹持面延伸。
在本发明的一些实施方式中，所述人工腱索夹持装置还包括第一过线孔和第二过线孔。所述第一过线孔形成于所述第一平面并与所述滑动通道的远端连通。所述第二过线孔设于所述夹持部与所述支撑部之间并与所述滑动通道的近端连通。
在本发明的一些实施方式中，所述本体部还设有第一连接部和第二连接部，所述第一连接部位于所述第一侧壁的一侧，所述第二连接部位于所述第二侧壁的一侧。所述第一侧壁和所述第二侧壁均设有与所述滑动通道连通的长孔；所述夹持件设有贯通的连接孔；所述弹性件穿过所述长孔和所述连接孔，且所述弹性件的两端分别与所述第一连接部和所述第二连接部相连。
在本发明的一些实施方式中，所述弹性件为绳状弹性件，且所述弹性件包括至少一根弹性丝。
在本发明的一些实施方式中，所述本体部设有第一避让槽和第二避让槽，所述第一避让槽位于所述第一连接部与所述第一侧壁之间，所述第二避让槽设于所述第二连接部与第二侧壁之间。
在本发明的一些实施方式中，所述支撑部还包括第一导向面和第二导向面。所述第一导向面与所述第一避让槽对应设置。所述第二导向面与所述第二避让槽对应设置。所述第一导向面与所述第二导向面均与所述支撑平面平行。
在本发明的一些实施方式中，所述支撑部朝向所述本体部的一侧设有配合槽，所述配合槽包括与所述本体部相连的第一壁面和与所述第一壁面相连的第二壁面，所述第二壁面与所述支撑平面平行，所述第二壁面与所述第一壁面之间的夹角小于等于90°。
在本发明的一些实施方式中，所述第二壁面设有导向槽，所述导向槽自所述第二壁面的近端朝向所述第一壁面延伸。
本发明的第二方面，还提出一种操作器，用于植入第一方面技术方案中所述的人工腱索夹持装置。所述操作器包括：手柄、鞘管、拉力爪、推杆和调节按键。所述鞘管的近端与所述手柄相连。所述拉力爪与所述鞘管的远端相连，所述拉力爪具有勾部，所述勾部能够勾连于所述人工腱索夹持装置中的弹性件。所述推杆可滑动地设于所述鞘管内，所述推杆的远端能够与所述人工腱索夹持装置中的支撑部相抵。所述调节按键设于所述手柄并与所述推杆的近端相连，所述调节按键能够推动所述推杆相对于所述鞘管沿所述鞘管的长度方向移动。
附图说明
通过阅读下文优选实施方式的详细描述，各种其他的优点和益处对于本领域普通技术人员将变得清楚明了。附图仅用于示出优选实施方式的目的，而并不认为是对本发明的限制。而且在整个附图中，用相同的附图标记表示相同的部件。在附图中：
图1示意性地示出了根据本发明实施方式的人工腱索夹持装置的结构示意图；
图2示意性地示出了根据本发明实施方式的仰视视角的人工腱索夹持装置的结构示意图；
图3示意性地示出了根据本发明实施方式的座体的结构示意图；
图4示意性地示出了根据本发明实施方式的夹持件的结构示意图；
图5示意性地示出了根据本发明实施方式的左视视角的夹持件的结构示意图；
图6示意性地示出了根据本发明实施方式的俯视视角的人工腱索夹持装置的结构示意图；
图7示意性地示出了根据本发明的一个示例性实施方式的第一平面、第一夹持平面与支撑平面之间的位置关系示意图；
图8示意性地示出了根据本发明实施方式的操作器的结构示意图；
图9示意性地示出了根据本发明实施方式的人工腱索夹持装置的植入过程示意图；
图10示意性地示出了图9中A部分的局部放大示意图；
图11示意性地示出了根据本发明实施方式的操作器的局部结构示意图；
图12示意性地示出了根据本发明实施方式的俯视视角的操作器的结构示意图；
图13示意性地示出了根据本发明实施方式的调节按键的结构示意图；
图14示意性地示出了根据本发明实施方式的推送部件的结构示意图。
具体实施方式
下面将参照附图更详细地描述本公开的示例性实施方式。虽然附图中显示 了本公开的示例性实施方式，然而应当理解，可以以各种形式实现本公开而不应被这里阐述的实施方式所限制。相反，提供这些实施方式是为了能够更透彻地理解本公开，并且能够将本公开的范围完整的传达给本领域的技术人员。
应理解的是，文中使用的术语仅出于描述特定示例实施方式的目的，而无意于进行限制。除非上下文另外明确地指出，否则如文中使用的单数形式“一”、“一个”以及“所述”也可以表示包括复数形式。术语“包括”、“包含”、“含有”以及“具有”是包含性的，并且因此指明所陈述的特征、步骤、操作、元件和/或部件的存在，但并不排除存在或者添加一个或多个其它特征、步骤、操作、元件、部件、和/或它们的组合。文中描述的方法步骤、过程、以及操作不解释为必须要求它们以所描述或说明的特定顺序执行，除非明确指出执行顺序。还应当理解，可以使用另外或者替代的步骤。
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段，但是，这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出，否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。因此，以下讨论的第一元件、部件、区域、层或部段在不脱离示例实施方式的教导的情况下可以被称作第二元件、部件、区域、层或部段。
为了便于描述，可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系，这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。例如，如果在图中的装置翻转，那么描述为“在其它元件或者特征下面”或者“在其它元件或者特征下方”的元件将随后定向为“在其它元件或者特征上面”或者“在其它元件或者特征上方”。因此，示例术语“在……下方”可以包括在上和在下的方位。装置可以另外定向(旋转90度或者在其它方向)并且文中使用的空间相对关系描述符相应地进行解释。
需要说明的是，采用“远端”、“近端”作为方位词，该方位词为介入医疗器械领域惯用术语，其中“远端”表示手术过程中远离操作者的一端，“近端”表示手术过程中靠近操作者的一端。轴向，指平行于医疗器械远端中心和近端 中心连线的方向；径向，指垂直于上述轴向的方向。
如图1和图3所示，根据本发明的实施方式，提出了一种人工腱索夹持装置。
人工腱索夹持装置100包括：座体10、夹持件20和弹性件30。具体地，座体10包括依次相连的本体部11、支撑部12和夹持部13，其中，支撑部12设于本体部11背离心脏的一侧，夹持部13设于支撑部12背离本体部11的一侧，夹持部13具有朝向支撑部12设置的第一夹持面1331，夹持件20设于第一夹持面1331与支撑部12之间，并且夹持件20能够在支撑部12上移动，夹持件20能够靠近或远离第一夹持面1331，使夹持件20与第一夹持面1331之间具有抵接状态和分离状态。在抵接状态下，夹持件20与第一夹持面1331用于夹持固定人工腱索300，在分离状态下，人工腱索300能够在人工腱索夹持装置100上活动以调节松紧度。弹性件30分别与本体部11和夹持件20相连，弹性件30用于向夹持件20提供朝向第一夹持面1331的弹性力，弹性件30在为受外力作用的状态下，弹性件30驱动夹持件20抵接在第一夹持面1331上，弹性件30在外力作用下发生形变并带动夹持件20与第一夹持面1331分离。
需要说明的是，弹性件30所承受的外力既可以是朝向近端方向的拉力也可以是朝向远端方向的推力。当弹性件30承受的外力为拉力时，夹持件20相对于第一夹持面1331更加靠近近端。当弹性件30承受的外力为推力时，夹持件20相对于第一夹持面1331更加靠近远端。
本实施方式中，在弹性件30的弹性力作用下，夹持件20和夹持部13将人工腱索300夹紧，并通过座体10抵接在心脏的外壁上，从而将人工腱索300伸出心脏的一端夹持固定，无需利用缝合线在心脏上缝合，减少了对心脏的损伤。并且，当人工腱索300会出现松弛的状况时，仅需拉动弹性件30带动夹持件20与第一夹持面1331分离，在调整人工腱索300后松开弹性件30，以便于继续利用夹持件20和夹持部13将人工腱索夹持固定，无需对心脏进行二次手术，避免对心脏心肌造成二次伤害。
在本发明的一些实施方式中，请结合图2至图6所示，人工腱索夹持装置100还包括第一过线孔141和第二过线孔142，滑动通道14的远端延伸至第一平面111并在第一平面111上形成第一过线孔141，滑动通道14的近端延伸至夹持部13和支撑部12的近端并在夹持部13和支撑部12之间形成第二过线孔 142。人工腱索300伸出心脏的一端通过第一过线孔141进入滑动通道14内被夹持于第一夹持面1331和第二夹持面22之间，并通过第二过线孔142伸出，以便于在植入人工腱索300的手术过程中，将人工腱索300伸出心脏的一端夹持固定在心尖位置处。
在本实施方式中，请结合图1、图2、图3和图6所示，本体部11具有第一平面111，支撑部12背离本体部11的一侧设有支撑平面121，夹持件20以可滑动地方式设置在支撑平面121上，因此，通过第一夹持面1331相对于支撑平面121倾斜设置，使得夹持件20在支撑平面121上滑动时，在垂直于第一夹持面1331的方向上夹持件20能够与第一夹持面1331具有相对位移，从而实现夹持件20与第一夹持面1331能够在抵接状态和分离状态之间转变。还需要说明的是，支撑平面121相对于第一平面111倾斜设置，以便于人工腱索夹持装置100的植入操作。
请结合图1和图7所示，在人工腱索夹持装置100植入手术过程中，手术中是通过胸腔开口进行。由于人工腱索夹持装置100抵靠在心脏的心尖位置处，一般地，一般地，心脏心尖的朝向近端方向，并且操作者与心尖的位置具有一个倾斜角度，因此当第一平面111抵靠在心脏的心尖位置时，第一平面111垂直于第一平面111的方向朝向胸腔开口的位置，而使支撑平面121相对于第一平面111倾斜，使第二过线孔142能够正对操作者，以便于操作者捕捉人工腱索300，并将其夹持在人工腱索夹持装置100上，以利于人工腱索夹持装置100的植入。
具体地，在植入过程中，一方面需要向弹性件30施加拉力，使弹性件30带动夹持件20与第一夹持面1331分离，同时还需要捕捉人工腱索300伸出心脏的一端并穿过夹持件20与第一夹持面1331之间，由于手术采用小切口，操作空间有限，支撑部12等结构极遮挡或干涉人工腱索300伸出心脏的一端。因此，通过支撑平面121相对于第一平面111倾斜设置，使得支撑平面121的近端与本体部11之间形成用于支撑推杆204的弹性件30的第一操作窗口104，同时支撑平面121与第一夹持平面之间形成捕捉或夹取人工腱索300伸出心脏一端的第二操作窗口105，使人工腱索夹持装置100植入过程中的操作窗口分配更加合理，有利于降低人工腱索夹持装置100植入时的操作难度，提高人工腱索夹持装置100植入效率，缩短手术时间。
进一步地，支撑平面121与第一平面111相交于第一直线101，第一夹持面1331与支撑平面121相较于第二直线102，第一直线101与第二直线102平行，使支撑平面121与第一平面111之间的第一操作窗口104和第一夹持面1331与支撑平面121之间的第二操作窗口105朝向一致，均由心脏的心尖朝向胸腔开口的方向，以方便捕捉弹性件30，以及人工腱索300。
或者，在其他实施方式中，第一直线101与第二直线102重合。
在本发明的一些实施方式中，支撑平面121与第一平面111的夹角值为第一角度，第一夹持面1331与第一平面111的夹角值为第二角度，第一角度取值范围为10°～60°，第二角度大于第一角度且小于180°。可理解地，第一角度可以是10°、15°、30°、40°、45°等。第二角度可以是60、65°、70°、75°、80°、100°等。
在一个示例性地实施方式中，第一直线101与第二直线102重合，第一角度为45°，第二角度为90°。本实施方式中，由于支撑平面121与第一平面111之间的夹角以及支撑平面121与第一夹持面1331之间的夹角均为45°，使得第一操作窗口104和第二操作窗口105的空间均等，以方便捕捉弹性件30，以及人工腱索。还需说明的是，第一夹持面1331与第一平面111的夹角值90°，使得人工腱索能够自心脏的心尖处顺畅地伸入夹持件20与第一平面111之间，减少人工腱索的弯折程度，从而减轻对人工腱索的弯折损伤。
本实施方式中，请结合图3和图5所示，夹持件20包括滑动平面21和第二夹持面22，滑动平面21与支撑平面121滑动配合，通过面与面之间的滑动配合，使夹持件20在支撑部12上滑动的过程更加稳定，第二夹持面22与滑动平面21相交并与第一夹持面1331抵接配合，通过第一夹持面1331与第二夹持面22的配合增大人工腱索300的有效夹持距离，并减小人工腱索300被夹持状态下的压强，一方面使夹持效果更为牢固，另一方面，降低对人工腱索300的挤压损伤。其中，滑动平面21与支撑平面121平行，第二夹持面22与第一夹持面1331平行，使夹持件20在支撑平面121上滑动时，第二夹持面22与第一夹持面1331始终保持平行状态，使第二夹持面22与第一夹持面1331相抵时的各区域的压力相等，从而避免局部压力过大导致对人工腱索300的挤压损伤。
需要说明的是，如图5所示，为增加对人工腱索300的锁定力，第一夹持面1331或第二夹持面22配置为粗糙面，或者第一夹持面1331和第二夹持面22 均配置为粗糙面，以锁紧人工腱索300。
在一个示例性的实施方式中，如图5所示，第二夹持面22呈锯齿状。在其他实施方式中，第二夹持面22设置滚花纹路或者密布凸点结构以增加第二夹持面22的粗糙度。
在本发明的一些实施方式中，如图1和图6所示，夹持部13包括第一侧壁131、第二侧壁132和顶壁133，第一侧壁131和第二侧壁132均与支撑部12相连，且第一侧壁131和第二侧壁132平行且间隔地设置。顶壁133的两侧分别与第一侧壁131和第二侧壁132相连，顶壁133、第一侧壁131、第二侧壁132和支撑平面121共同限定出滑动通道14。滑动通道14沿支撑平面121的远端向第一夹持面1331延伸。本实施方式中，滑动通道14用于限定夹持件20的滑动方向，使夹持件20仅能够沿滑动通道14的延伸方向滑动，从而使夹持件20的移动轨迹更加精确，提高人工腱索夹持装置100植入过程中的精准程度。
在本发明的一些实施方式中，如图1、图4和图6所示，本体部11还设有第一连接部112和第二连接部113，第一连接部112位于第一侧壁131的一侧，且第一连接部112与第一侧壁131间隔设置，第二连接部113位于第二侧壁132的一侧，且第二连接部113与第二侧壁132间隔设置。第一侧壁131和第二侧壁132均设有与滑动通道14连通的长孔103，夹持件20设有贯通的连接孔23，
连接孔23的两端分别与第一侧壁131和第二侧壁132上的长孔103相对。弹性件30为由一根或多根弹性丝制成的绳状件。弹性件30的两单分别与第一连接部112和第二连接部113相连，且弹性件30依次穿过长孔103和连接孔23。在未受外力的状态下，弹性件30处于绷紧状态，并使夹持件20压抵在第一夹持面1331上，以使第一夹持面1331与第二夹持面22紧密贴合。
进一步地，本体部11设有第一避让槽114和第二避让槽115，第一避让槽114位于第一连接部112与第一侧壁131之间，第二避让槽115设于第二连接部113与第二侧壁132之间，第一避让槽114和第二避让槽115用于对操作器200中的勾爪状件进行避让，以便于勾爪状件抓取弹性件30。
进一步地，如图1所示，支撑部12还包括第一导向面122和第二导向面123，第一导向面122位于第一侧壁131的一侧并与第一避让槽114相对应，第二导向面123位于第二侧壁132的一侧并与第二避让槽115相对应，第一导向面122与第二导向面123均与支撑平面121平行，以便于勾爪状件在抓取弹性件30后 支撑并引导勾爪状件的移动，一方面便于勾爪状件发力，另一方面，使勾爪状件的移动更为平顺，减少人工腱索夹持装置100的颤动，提高人工腱索夹持装置100植入过程的平顺度。
需要说明的是，第一侧壁131和第二侧壁132均凸出于第一导向面122和第二导向面123，第一连接部112和第二连接部113凸出于本体部11设置，第一侧壁131和第一连接部112、第二侧壁132和第二连接部113能够对勾爪状件的位置进行限位，使勾爪状件能够按照角度要求勾取弹性丝，不会偏离。
在本发明的一些实施方式中，如图3所示，支撑部12朝向本体部11的一侧设有配合槽124，配合槽124用于与操作器200中的推杆204抵接配合，在植入过程中，操作器200中的推杆204的远端抵靠在配合槽124中，配合槽124为推杆204的远端提供着力点。其中，配合槽124包括与本体部11相连的第一壁面1241和与第一壁面1241相连的第二壁面1242，第二壁面1242与支撑平面121平行，使推杆204的延伸方向与第二壁面1242一直，以避免第二壁面1242干涉推杆204。第二壁面1242与第一壁面1241之间的夹角小于等于90°，使推杆204的远端被第一壁面1241和第二壁面1242限值于两者之间，并避免推杆204滑出配合槽124。
进一步地，如图3所示，第二壁面1242设有导向槽12421，导向槽12421自第二壁面1242的近端朝向第一壁面1241延伸，导向槽12421的轮廓与推杆204的轮廓相匹配，在植入过程中，通过推杆204的外壁面与导向槽12421内壁面的配合，使推杆204能够承受径向方向的力，以进一步限值推杆204沿推杆204径向方向的滑动，提高人工腱索夹持装置100植入过程中的稳定性。
本体部11包裹有PET膜(聚酯基片)，让人工腱索夹持装置100表面更柔和，避免伤害心肌组织。
需要说明的是，本发明中提出的人工腱索夹持装置100中各部件的材质优选为符合生物相容性要求的金属或者高分子材料，例如不锈钢SUS316L、钴基合金、PEEK(聚醚醚酮)等。
根据本发明的实施方式，如图8所示，还提出一种操作器200，操作器200用于植入人工腱索夹持装置100，术者通过操作器200的使用，完成对人工腱索夹持装置100的输送、植入、锁定、释放等动作。
操作器200包括：手柄201、鞘管202、拉力爪203、推杆204和调节按键 205。
具体地，请结合图8至图10所示，鞘管202的近端与手柄201相连；拉力爪203与鞘管202的远端相连，拉力爪203(即为上述勾爪状件)具有勾部，勾部能够勾连于人工腱索夹持装置100中的弹性件30。推杆204可滑动地设于鞘管202内，推杆204的远端能够与人工腱索夹持装置100中的座体10的支撑部12上的配合槽124相抵。调节按键205设于手柄201并与推杆204的近端相连，调节按键205能够推动推杆204相对于鞘管202沿鞘管202的长度方向移动。
请结合图11至图14所示，操作器200还包括推送部件207和弹簧206，推送部件207焊接在推送棒上，弹簧206套设于推杆204上，并且弹簧206的远端与手柄201相抵，弹簧206的近端与推送部件207朝向远端的一侧面相抵，定位在手柄201的下壳上推送部件207上的第二圆弧面2071与调节按键205上的第一圆弧面2052配合，当旋转调节按键205，调节按键205绕旋转轴旋转，通过第一圆弧面2052对推送部件207及其连接的推杆204进行轴向运动，其中推杆204被定位于中心轴上。旋动调节按键205后，调节按键205上的按键卡位2051向近端方向越过调节按键205壳上的按键卡位2051，调节按键205被卡在手柄201壳的手柄卡位2011的远端之后，此时可以将人工腱索夹持装置100与操控器连接在一起，向近端方向推过按键卡位2051，使按键卡位2051位于手柄卡位2011的近端时，操控器200则可以解脱人工腱索夹持装置100。
在植入人工腱索夹持装置100的过程如下：
(1)、通过拉力爪203勾拉住弹性件30，通过调节按键205推动推杆204，使外鞘带动拉力爪203相对于推杆204朝向近端移动，从而将夹持件20拉开，使第一夹持面1331和第二夹持面22之间打开一个通道，道宽度为D，D应大于或等于人工腱索300的直径。当打开通道后，将人工腱索300穿引过通道。
(2)保持按压调节按键205的状态，可自由调节人工腱索300的长度，确定最终需要植入的长度，取消按压状态，在弹性件30的弹性力作用下，夹持件20朝向顶壁133移动，且第一夹持面1331与第二夹持面22相抵将人工腱索夹持固定，锁定长度。
(3)再次确定长度后，拨动调节按键205，使拉力爪203与弹性件30脱离，释放人工腱索夹持装置100，完成操作。人工腱索夹持装置100即可以对人工腱索300施加锁紧力F，将人工腱索300锁紧固定于心尖部位。
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以权利要求的保护范围为准。

Claims (15)

  1. 一种人工腱索夹持装置，其特征在于，所述人工腱索夹持装置包括：
    座体，所述座体包括与心脏的外壁相抵的本体部、设于所述本体部背离所述心脏一侧的支撑部、设于所述支撑部背离所述本体部一侧的夹持部，所述夹持部具有朝向所述支撑部设置的第一夹持面；
    夹持件，可移动地设于所述支撑部，所述夹持件与所述第一夹持面之间具有抵接状态和分离状态；
    弹性件，分别与所述本体部和所述夹持件相连；
    所述弹性件向所述夹持件施加朝向所述第一夹持面的弹性力以使所述夹持件与所述第一夹持面抵接；所述弹性件在外力作用下发生形变并带动所述夹持件与所述第一夹持面分离。
  2. 根据权利要求1所述的人工腱索夹持装置，其特征在于，所述本体部具有第一平面，所述第一平面与所述心脏相抵；所述支撑部背离所述本体部的一侧设有支撑平面，所述夹持件可滑动地设于所述支撑平面上；
    其中，所述支撑平面相对于所述第一平面倾斜设置，所述第一夹持面相对于所述支撑平面倾斜设置。
  3. 根据权利要求2所述的人工腱索夹持装置，其特征在于，所述支撑平面与所述第一平面相交于第一直线，所述第一夹持面与所述支撑平面相较于第二直线，所述第一直线与所述第二直线平行或所述第一直线与所述第二直线重合。
  4. 根据权利要求3所述的人工腱索夹持装置，其特征在于，所述支撑平面与所述第一平面的夹角值为第一角度，所述第一夹持面与所述第一平面的夹角值为第二角度，所述第一角度的取值范围为10°～60°，所述第二角度大于所述第一角度且小于180°。
  5. 根据权利要求2至4中任一项所述的人工腱索夹持装置，其特征在于，所述夹持件包括：
    滑动平面，与所述支撑平面可滑动配合；
    第二夹持面，与所述滑动平面相交并与所述第一夹持面抵接配合；
    其中，所述滑动平面与所述支撑平面平行，所述第二夹持面与所述第一夹持面平行。
  6. 根据权利要求5所述的人工腱索夹持装置，其特征在于，所述第一夹持面和/或第二夹持面配置为粗糙面。
  7. 根据权利要求5所述的人工腱索夹持装置，其特征在于，所述夹持部包括：
    第一侧壁，与所述支撑部相连；
    第二侧壁，与所述支撑部相连并与所述第一侧壁平行且间隔地设置；
    顶壁，分别与所述第一侧壁和第二侧壁相连，所述顶壁朝向所述第二夹持面的一侧形成所述第一夹持面；
    其中，所述第一侧壁、所述第二侧壁和所述支撑平面共同限定出所述夹持件的滑动通道，所述滑动通道沿所述支撑平面的远端向所述第一夹持面延伸。
  8. 根据权利要求7所述的人工腱索夹持装置，其特征在于，所述人工腱索夹持装置还包括：
    第一过线孔，形成于所述第一平面并与所述滑动通道的远端连通；
    第二过线孔，设于所述夹持部与所述支撑部之间并与所述滑动通道的近端连通。
  9. 根据权利要求7所述的人工腱索夹持装置，其特征在于，
    所述本体部还设有第一连接部和第二连接部，所述第一连接部位于所述第一侧壁的一侧，所述第二连接部位于所述第二侧壁的一侧；
    所述第一侧壁和所述第二侧壁均设有与所述滑动通道连通的长孔；
    所述夹持件设有贯通的连接孔；
    所述弹性件穿过所述长孔和所述连接孔，且所述弹性件的两端分别与所述第一连接部和所述第二连接部相连。
  10. 根据权利要求9所述的人工腱索夹持装置，其特征在于，所述弹性件为绳状弹性件，且所述弹性件包括至少一根弹性丝。
  11. 根据权利要求9所述的人工腱索夹持装置，其特征在于，所述本体部设有第一避让槽和第二避让槽，所述第一避让槽位于所述第一连接部与所述第一侧壁之间，所述第二避让槽设于所述第二连接部与第二侧壁之间。
  12. 根据权利要求11所述的人工腱索夹持装置，其特征在于，所述支撑部还包括：
    第一导向面，与所述第一避让槽对应设置；
    第二导向面，与所述第二避让槽对应设置；
    所述第一导向面与所述第二导向面均与所述支撑平面平行。
  13. 根据权利要求2所述的人工腱索夹持装置，其特征在于，所述支撑部朝 向所述本体部的一侧设有配合槽，所述配合槽包括与所述本体部相连的第一壁面和与所述第一壁面相连的第二壁面，所述第二壁面与所述支撑平面平行，所述第二壁面与所述第一壁面之间的夹角小于等于90°。
  14. 根据权利要求13所述的人工腱索夹持装置，其特征在于，所述第二壁面设有导向槽，所述导向槽自所述第二壁面的近端朝向所述第一壁面延伸。
  15. 一种操作器，用于植入如权利要求1-14中任一项所述的人工腱索夹持装置，其特征在于，所述操作器包括：
    手柄；
    鞘管，所述鞘管的近端与所述手柄相连；
    拉力爪，与所述鞘管的远端相连，所述拉力爪具有勾部，所述勾部能够勾连于所述人工腱索夹持装置中的弹性件；
    推杆，可滑动地设于所述鞘管内，所述推杆的远端能够与所述人工腱索夹持装置中的支撑部相抵；
    调节按键，设于所述手柄并与所述推杆的近端相连，所述调节按键能够推动所述推杆相对于所述鞘管沿所述鞘管的长度方向移动。
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