Locking Structure and External Anchor of Left Ventricular Volume Reduction Device

Abstract

The present invention discloses a locking structure, an external anchor and a left ventricular volume reduction device. The locking structure has a locking unit, and the locking unit has: a locking member that can be pressed against a tie rod, the locking member being a three-pronged rack assembly, one prong of the rack assembly being a rack; a squeezing member that can press the locking member onto the tie rod, the squeezing member being a gear, and the gear can be rotatably engaged with the rack of the rack assembly back and forth to achieve locking and unlocking. By improving the structure of the locking structure, the present invention further reduces the risk of the external anchor slipping off the tie rod, and retrieves the external anchor by unlocking the locking structure; moreover, the locking structure and the tie rod operate locking and unlocking in the same direction, which is very convenient.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a locking structure and an external anchor of a left ventricular volume reduction device. Background Art

[0002] Left ventricular aneurysm (LVA) is a common complication after myocardial infarction. It is caused by the fact that after myocardial infarction in the left ventricle, part of the ventricular muscle becomes ischemic and necrotic. Since the necrotic ventricular muscle loses its contractile function, when the patient's heart contracts, this part of the necrotic myocardium will bulge outwards, thus leading to the occurrence of ventricular aneurysm. Due to the compensatory effect of the heart, the heart continuously enlarges by a certain volume, and then heart failure, pulmonary congestion and other conditions occur.

[0003] Left ventricular volume reduction is a transcatheter ventricular augmentation system, which can be used to solve the problem of scar tissue in patients with ischemic cardiomyopathy after myocardial infarction. The left ventricular volume reduction device delivers multiple pairs of anchors (including internal anchors and external anchors) into the body. They can clamp the left ventricle and allow other surgical instruments to enter the heart through a small incision on the body surface. This minimally invasive system can also be used in traditional open-chest surgery to achieve ventricular repair. In the prior art, the principle of combining the internal and external anchors is through a tie rod connection between the internal and external anchors. One end of the tie rod is fixed to the internal anchor, and the other end of the tie rod is locked by the locking structure of the external anchor. At the same time, in the prior art, the control direction of locking and unlocking the external anchor is perpendicular to the tie rod, and a special instrument is required to cooperate with the locking structure in the direction perpendicular to the tie rod, which not only increases the difficulty of the operation, is extremely inconvenient, but also requires more invasive measures for the patient, which is not conducive to the health of the patient. Therefore, it is necessary to develop a more integrated and stable external anchor (especially the locking structure) to solve the above problems. Summary of the Invention

[0004] One object of the present invention is to provide a locking structure for a left ventricular volume reduction device with a completely different structure.

[0005] The locking structure of the left ventricular volume reduction device of the present invention has a locking unit, and the locking unit has:

[0006] A locking member that can be pressed against the tie rod. The locking member is a three-pronged rack assembly, and one prong of the rack assembly is a rack;

[0007] A squeezing member that can press the locking member against the tie rod. The squeezing member is a gear, and the gear can rotate back and forth meshingly with the rack of the rack assembly to achieve locking and unlocking.

[0008] Preferably, the locking unit further has:

[0009] A starting member for extruding or relieving pressure on a starting extrusion member, the starting member being a screw, the threads of the screw being engaged in the tooth grooves of the gear, and the gear being rotated by rotating the screw.

[0010] Preferably, one end face of the rack assembly is a tooth-shaped surface that can be pressed against the tie rod.

[0011] Preferably, the locking structure further has a housing, and the locking unit is disposed inside the housing:

[0012] The two opposite first shell walls of the housing respectively have gear support holes, the axis of the gear has a gear shaft, and both ends of the gear shaft are respectively fixed in the gear support holes;

[0013] The two opposite second shell walls of the housing respectively have screw support holes, and both ends of the screw are rotatably disposed in the screw support holes.

[0014] Preferably,

[0015] The locking structure further has a U-shaped limiting groove for limiting the gear assembly, which is fixed inside the housing, and one side of the gear assembly is limited in the U-shaped limiting groove.

[0016] Preferably,

[0017] The two opposite first shell walls of the housing respectively have rack support holes, or rack shaft holes are provided on the two opposite side walls of the limiting groove. A rack shaft is disposed through the three-way connection of the rack assembly, and both ends of the rack shaft are respectively fixed in the rack support holes or the rack shaft holes.

[0018] Preferably,

[0019] A rack shaft is disposed through the three-way connection of the rack assembly;

[0020] One fork of the rack assembly is two parallel and spaced racks, and both ends of the gear are respectively rotationally engaged with the two racks to achieve locking and unlocking; the screw is located between the two racks, the threads of the screw are engaged in the tooth grooves at the middle position of the gear, and the gear is rotated by rotating the screw;

[0021] The other two forks of the rack assembly are a folded locking bottom block. The locking bottom block has a half-lock block that can be pressed against the tie rod after rotation and a half-balance block that does not touch the tie rod after rotation. The half-lock block and the half-balance block are fixedly connected together with the fold line as the boundary to form the other two forks of the rack assembly, and one end of the two racks is also fixed to both ends of the fold line.

[0022] Preferably,

[0023] The semi-lock block is connected to the side of the tooth of the rack, and the semi-balance block is connected to the side of the rack without teeth.

[0024] Or,

[0025] The semi-lock block is connected to the side of the rack without teeth, and the semi-balance block is connected to the side of the tooth of the rack.

[0026] Preferably,

[0027] The included angle formed by the semi-lock block and the rack is an obtuse angle;

[0028] The included angle formed by the semi-balance block and the rack is a right angle or an acute angle.

[0029] Preferably,

[0030] Rack chutes are respectively provided in two opposite first shell walls of the housing. Rack sliders are respectively fixed on both sides of the rack assembly, and the rack sliders are respectively slidably arranged in the rack chutes.

[0031] Preferably,

[0032] One fork of the rack assembly is two parallel and spaced racks. Both ends of the gear are respectively meshed and connected with the two racks to drive the two racks to slide along the axial direction of the rack to achieve locking and unlocking; the screw is located between the two racks, and the thread of the screw is clamped in the tooth groove at the middle position of the gear, and the gear is rotated by rotating the screw;

[0033] The other two forks of the rack assembly are a folded locking bottom block. The locking bottom block has two semi-lock blocks that simultaneously squeeze the tie rod after sliding. The two semi-lock blocks are fixedly connected together with the folded edge as the boundary, constituting the other two forks of the rack assembly. One ends of the two racks are also fixed at both ends of the folded edge.

[0034] Preferably, tie rod holes are respectively provided at corresponding positions on two opposite second shell walls of the housing, i.e., on the same shell wall as the screw support hole, where the locking member locks the tie rod.

[0035] Another object of the present invention is to provide an external anchor for a left ventricular volume reduction device, having:

[0036] A flat cuboid-shaped external anchor body;

[0037] A locking structure, characterized in that: the locking structure is the locking structure for the left ventricular volume reduction device of the present invention, and the locking structure is fixedly arranged at the central position of one side surface of the external anchor body.

[0038] Preferably, the external anchor body has:

[0039] A contact surface that can abut against the outer wall of the left ventricle; and

[0040] A non-contact surface opposite to the contact surface, and the locking structure is fixed at the central position of the non-contact surface.

[0041] Preferably, a through locking hole is provided at the central position of the outer anchor main body, the tie rod is passed through the locking hole, and the second shell wall of the outer shell of the locking structure is fixedly arranged at the locking hole position of the outer anchor main body.

[0042] Another object of the present invention is to provide a left ventricular volume reduction device, which includes:

[0043] A tie rod;

[0044] An inner anchor, which is passed through the head end of the tie rod;

[0045] An outer anchor, which is passed through the proximal section on the tie rod, and is characterized in that the outer anchor is the outer anchor for the left ventricular volume reduction device described in the present invention.

[0046] Preferably, the tie rod has a square connection section, a guiding section and a needle head section connected in sequence, the inner anchor is passed through the head end of the square connection section, and the outer anchor is passed through the proximal section of the square connection section.

[0047] Preferably, a stranding hole is provided at the head end of the square connection section, and the stranding hole can be passed through the tie rod shaft on the inner anchor.

[0048] Preferably, the guiding section and the needle head section respectively have wire guiding channels communicating with each other axially at the center.

[0049] Preferably, a guiding hole for guiding the wire into the wire guiding channel is provided at the head end of the guiding section close to the square connection section.

[0050] Preferably, the inner anchor has:

[0051] A contact surface that can abut against the ventricular septum of the right ventricle; and

[0052] A non-contact surface opposite to the contact surface, and characterized in that at least one side edge of the non-contact surface extends towards the middle direction of the non-contact surface to extend a barb substantially parallel to the non-contact surface, and a guiding cavity for providing guidance to the snare is formed in the space between the barb and the non-contact surface.

[0053] Preferably, two opposite side edges of the non-contact surface respectively extend towards the middle direction of the non-contact surface to extend the barbs substantially parallel to the non-contact surface.

[0054] Preferably, there is a certain distance between two barbs on two opposite sides of the non-contact surface, and the distance forms a barb opening for the snare to enter the guiding cavity.

[0055] Preferably, the end point of the guiding cavity stops at the center of the side end of the inner anchor.

[0056] Preferably, near the end point of the guiding cavity, the barb has a guiding bump protruding from the guiding cavity for indicating the guiding end point.

[0057] Preferably, the shape of the barb is U-shaped.

[0058] Preferably, the main body of the inner anchor is cuboid-shaped.

[0059] Preferably, the axial center of the inner anchor has a wire guiding cavity for a guide wire to pass through.

[0060] Preferably, the side end of the inner anchor is a spherical end face.

[0061] Preferably, the contact surface of the inner anchor has a tie rod groove along the axial direction for accommodating and limiting the tie rod.

[0062] Preferably, in the middle of the contact surface of the inner anchor, there are a hinge part located on both sides of the tie rod groove and a tie rod shaft spanning the tie rod groove for passing through the tie rod, and both ends of the tie rod shaft are respectively fixed in the middle of the hinge part.

[0063] Preferably, the cross-section of the inner anchor is I-shaped.

[0064] The positive and progressive effects of the present invention are as follows:

[0065] 1. By improving the structure of the locking structure, the present invention provides a brand-new locking structure, reduces the risk of the outer anchor slipping off the tie rod, and retrieves the outer anchor by unlocking the locking structure.

[0066] 2. The control direction for locking and dissociating the outer anchor of the present invention is in the same direction as the tie rod, greatly reducing the difficulty of operating the locking and unlocking.

[0067] 3. By providing a locking structure with a toothed surface on the outer anchor, the present invention improves the grasping force between the outer anchor and the tie rod through the toothed surface, thereby reducing the risk of the outer anchor falling off in the body.

[0068] 4. By providing barbs on the non-contact surface of the inner anchor, the present invention can hook the snare. Thus, when the operation fails or the inner anchor needs to be removed subsequently, it is only necessary to hook the barbs on the inner anchor with the snare to pull the inner anchor out of the body from the delivery sheath, without the need for thoracotomy. It has the function of secondary interventional retrieval, increasing the error tolerance rate of the operation, reducing the economic burden on patients, avoiding high-risk operations such as open-heart surgery, and benefiting patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0069] Figure 1 is a three-dimensional structural schematic diagram of the left ventricular volume reduction device of the present invention;

[0070] Figure 2 is a structural schematic diagram of the tie rod 10 of the present invention;

[0071] Figures 3A to 3D is a structural schematic diagram of the retrievable inner anchor of the present invention;

[0072] Figure 3E is a schematic diagram of the retrieval process of the retrievable inner anchor of the present invention;

[0073] Figures 4A to 4B is a structural schematic diagram of the outer anchor of the present invention;

[0074] Figures 5A to 5C is a structural schematic diagram of the locking structure of the present invention;

[0075] Figures 5D to 5F is a structural schematic diagram of another exemplary locking structure of the present invention;

[0076] Figures 6A to 6D is a structural schematic diagram of the implantation process of the left ventricular volume reduction device of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0077] In order to make the technical means, creative features, achieved purposes and functions of the present invention easy to understand, the present invention will be further described below with reference to specific illustrations.

[0078] In the field of interventional medical devices, "distal" is defined as the end far from the operator during the operation, and "proximal" is defined as the end close to the operator during the operation.

[0079] In the present invention, unless otherwise clearly defined and limited, terms such as "installation", "connection", "linkage", "fixation" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal communication of two components or the interaction relationship between two components, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0080] The lock release member referred to in the present invention refers to a device that can lock or unlock the locking structure in the conveying device.

[0081] As Figure 1 shown, the left ventricular volume reduction device of the present invention includes a tie rod 10, an inner anchor 20, and an outer anchor 30. The inner anchor 20 can be hinged to the distal end of the tie rod 10; the outer anchor 30 is inserted through the tie rod 10. The left ventricular volume reduction device provided by the present invention embeds the inner and outer anchors into the ventricular wall and sutures the redundant scar tissue to help the heart restore its previous shape and function.

[0082] The tie rod of the present invention can be an ordinary tie rod in the prior art, such as Figure 4A shown, a straight rod; it can also be a three-section type. As Figure 2 described, the tie rod 10 has a square connection section 11, a guiding section 12, and a needle section 13 from the distal end to the proximal end. The square connection section 11, the guiding section 12, and the needle section 13 are integrally formed in the order from the distal end to the proximal end. The proximal needle section 13 is made of a high-hardness metal such as stainless steel or a polymer material. The distal end of the connection section 11 has a stranded hole 111. The guiding section 12 and the axial center of the needle 13 section respectively have a wire guide channel that communicates with each other. The head end of the guiding section 12 close to the connection section 11 has a guiding hole 121 for the wire to penetrate into the wire guide channel. The tie rod 10 can be made of a polymer material such as stainless steel, platinum-iridium alloy, or PEEK.

[0083] The inner anchor of the present invention can be an inner anchor in any structural form in the prior art, as long as it can be disposed on the right ventricular septum of the heart. However, in order to reduce the surgical risk of thoracotomy after the implantation surgery of the heart volume reduction device fails or the patient needs to remove the left ventricular volume reduction device in the later stage, the present invention Figures 3A to 3EA sample retrievable inner anchor 20 is provided. The main body of the retrievable inner anchor 20 is generally cuboid-shaped, having two faces, one being the contact face 21 and the other being the non-contact face 22. The contact face 21 refers to the face that fits against the interventricular septum of the right ventricle of the heart after implantation; the non-contact face 22 refers to the face that will not stick to the heart after implantation, that is, the face opposite to the contact face 21. The axial center of the inner anchor 20 has a guide wire cavity 213 for the guide wire to pass through when the inner anchor is delivered during the operation. The cross-section of the guide wire cavity 23 can be square, circular, or any other hollow inner cavity of any shape as long as it allows the guide wire to pass through. Preferably, it is a circular through hole. The side end of the inner anchor 20 can be any smooth curved surface shape, preferably a spherical end face, which is beneficial for the inner anchor 21 to smoothly enter the delivery sheath and reduce the delivery resistance. The contact face 21 can abut against the interventricular septum of the right ventricle. The contact face 21 can be without a tie rod groove as in the prior art. During the delivery of the inner anchor, the tie rod 10 closely adheres to the contact face 21. In order to reduce the size of the delivery sheath, a better way is to axially provide a tie rod groove 211 on the contact face 21. During the delivery of the inner anchor, the tie rod 10 is accommodated in the tie rod groove 211, reducing the volume of the inner anchor and the tie rod during the delivery process; at the same time, the tie rod groove 211 also limits the tie rod 10, and the tie rod 10 is constrained in the tie rod groove 211 to regulate the movement of the tie rod 10 and avoid damage to the heart tissue. The tie rod 10 can be pivotally connected to the middle of the contact face 21. Preferably, it is in a non-detachable manner. For example, in the middle of the contact face 21, there are hinge parts 212 located on both sides of the tie rod groove 211 and a tie rod shaft 213 for passing through the tie rod 10 across the tie rod groove 211. The two ends of the tie rod shaft 213 are respectively fixed in the middle of the hinge parts 212. The hinge parts 212 serve as the support points for the two ends of the tie rod shaft 213, and the tie rod shaft 213 cannot be removed from the hinge parts 212. The hinge hole 111 of the tie rod 10 is passed through the tie rod shaft 213 on the inner anchor 20.

[0084] The non-contact surface 22 of the retrievable inner anchor 20 faces away from the contact surface 21. At least one side of the non-contact surface 22 extends a barb 221 substantially parallel to the non-contact surface 22 toward the middle of the non-contact surface 22, which is conducive to the snare 91 capturing the inner anchor 20. A better way is that the two opposite sides of the non-contact surface 22 respectively extend barbs 221 substantially parallel to the non-contact surface 22 toward the middle of the non-contact surface 22, and both sides have barbs, which is more conducive to the snare 91 capturing the inner anchor 20. The barbs 221 extend from both sides of the non-contact surface 22, so that the cross section of the inner anchor is I-shaped. The I-shaped cross section is conducive to the snare wire being accumulated in the cavity of the I-shaped cross section of the inner anchor when the snare 91 drives the inner anchor 20 to be withdrawn, thereby reducing the resistance to withdrawing the inner anchor 20. The barb 221 may be in the shape of a long plate, but the shape of the barb may be U-shaped, which reduces the endothelial attachment growth of the inner anchor 20 in the body and facilitates subsequent recovery. The space between the barb 221 and the non-contact surface 22 forms a guide cavity 222 that can provide guidance for the snare 91. The recyclable inner anchor 20 is provided with a barb 221 on one side of the inner anchor for the snare 91 to hook and pull, so that the inner anchor 20 is pulled back from the delivery sheath to complete the recovery of the inner anchor 20, and no additional open-heart surgery is required to remove the inner anchor. In the case where the barbs 221 extend from both opposite sides of the non-contact surface 22, there is a certain distance between the two barbs 221 on the two opposite sides of the non-contact surface 22, that is, the two barbs 221 are not butted together, and at this time, the distance forms a barb opening 223 that can capture the snare 91 to enter the guide cavity 222. At this time, the guide cavity 222 extends from the barb opening 223 as the starting point along the straight line parallel to the non-contact surface 22 of the inner anchor. When it extends to the side end position of the inner anchor 20 but has not yet reached, the guide cavity 222 begins to bend and extend in the direction of the axis of the inner anchor 20, and finally the guide cavity 222 ends at the axis of the side end of the inner anchor 20, that is, the guide cavity 222 ends at the guide wire cavity 23 at the axial center. Such a setting can make the snare 91 hung in the guide cavity 222 be located at the center of the inner anchor 20 when the inner anchor is recovered, which is beneficial to the movement guidance of the snare 91. When the snare captures the inner anchor 20, it is located at the center of the inner anchor 20, which is beneficial to the entry of the inner anchor 20 into the delivery sheath. In addition, the barb 221 has a guide protrusion 224 protruding from the guide cavity 222 at the end point of the guide cavity 222 to indicate the end point of the guide. When the snare 91 moves to this position, in combination with the external imager, the snare completes the capture of the inner anchor 20, and the corresponding operation of withdrawing the snare 91 can be performed. The inner anchor 20 of this example can be integrally formed. The inner anchor material can be made of one or more combinations of metal materials with good biocompatibility and toughness such as stainless steel, titanium, nickel-titanium alloy, etc. The contact surface of the inner anchor or the entire inner anchor can also be covered with a polyester coating or surface coating treatment, so that the coating can buffer the contact between the inner anchor and the heart tissue, and at the same time can increase the speed of endothelialization and reduce the corresponding inflammatory response.

[0085] The outer anchor of the present invention can be an outer anchor of any structure in the prior art, which is used to exclude the left ventricular scar structure. For example Figures 4A to 4B As shown, one structural form of the outer anchor, such as outer anchor 30, is generally in the shape of a flat cuboid, and has an outer anchor body 30a. The outer anchor body also has two sides, a contact surface and a non-contact surface. The contact surface can abut against the outer wall of the left ventricle, and the non-contact surface faces away from the contact surface. A through locking hole 30b is provided at the center of the outer anchor body 30a, and the locking hole 30b is for passing through the tie rod 10. The outer anchor material can be made of one or a combination of metal materials with good biocompatibility and toughness, such as stainless steel, titanium, nitinol, cobalt-chromium alloy, platinum-iridium alloy, etc. The contact surface of the outer anchor or the entire outer anchor body can also be covered with a polyester coating or surface coating treatment. The coating structure buffers the contact between the outer anchor and the heart tissue, and at the same time can increase the speed of endothelialization and reduce the corresponding inflammatory reaction.

[0086] In order to strengthen the firmness of the outer anchor 30 locked on the tie rod 10, a locking structure is provided on the non-contact surface at the position of the locking hole 30b of the outer anchor body 30a. The locking structure of the present invention can be any structure that can tightly lock the outer anchor 30 and the tie rod 10 together. The locking structure exemplified in the present invention at least has a locking member and a squeezing member. In a preferred case, there may also be a reset member, or there may further be a cam, or there may further be a housing. The structures such as the locking member, the squeezing member, the reset member, and the housing can be various, as long as it is a structure that can lock the locking member on the tie rod, it is feasible. Any squeezing member that can squeeze the locking member on the tie rod 10 is also feasible. The reset member is a structure that can release the locking relationship of the locking member from the tie rod and release the locking member, and it is all feasible.

[0087] A locking structure exemplified in the present invention has a locking unit and a housing. The locking unit of the present invention can be a locking unit in the prior art, or a locking unit in the applicant's prior patent application. See applications CN2022104104038 and CN2022104103800. This patent application has a locking member, a squeezing member, a pair of reset members, and a cam. The present invention patent application includes all the technical contents of the above patent applications.

[0088] For example Figures 5A to 5CAs shown, the present invention also exemplifies a locking structure with a simple structure that is controlled in the same direction as the tie rod 10. This locking structure can also be unlocked to recover the outer anchor and the inner anchor. Since the locking structure of this example operates in the same direction as the tie rod 10, it is very convenient to perform locking and unlocking operations. The locking structure of the present invention also has a locking unit, and the locking unit has: a locking member that can be pressed against the tie rod 10, a squeezing member that can press the locking member against the tie rod 10, an activating member that activates the squeezing member to perform squeezing or pressure release, and a housing.

[0089] The locking member of this example is a three-pronged rack assembly 31, that is, the rack assembly 31 has three forks, which is approximately Y-shaped when viewed from the side, but not completely Y-shaped. One of the forks of the rack assembly 31 is two parallel and spaced racks 311. Since the two racks 311 are viewed from the side, only one rack can be seen, so it is called a fork. One side of the rack 311 has a plurality of teeth and tooth grooves arranged at intervals, which are called tooth side edges. The teeth and tooth grooves are perpendicular to the length direction of the rack. The other opposite side of the rack 311 has no teeth and is straight, which is called the non-tooth side edge. The other two forks of the rack assembly 31 are combined into a folded locking bottom block 312, half of which is a half locking block 312a, and the other half is a half balancing block 312b. After the half-locking block 312a rotates, it can press against the tie rod 10; the half-balancing block 312b will not touch the tie rod 10 during and after the rotation, which plays a balancing role. The half-locking block 312a and the half-balancing block 312b are fixedly connected together with the folded edge as the boundary, that is, they are connected as a whole, forming the other two forks of the rack assembly 31, and one end of the two racks 311 is also fixed at both ends of the folded edge and is spaced a certain distance apart. In one example, the half-locking block 312a is connected to the tooth side of the rack 311, and the half-balancing block 312b is connected to the non-tooth side of the rack 311; the angle formed by the half-locking block 312a and the rack 311 is an obtuse angle, so that the half-locking block 312a directly approaches the tie rod 10, and directly squeezes the tie rod 10 with a slight rotation. The angle formed by the half-balancing block 312b and the rack 311 is a right angle or an acute angle, so it is far away from the tie rod 10, and it will not touch and squeeze the tie rod 10 even if it rotates. In another example not shown in the figure, the half locking block 312a and the half balancing block 312b are set at the opposite positions. The half locking block 312a is connected to the non-tooth side of the rack 311, and the half balancing block 312b is connected to the tooth side of the rack 311. The angle formed by the half locking block 312a and the rack 311 is an obtuse angle, so that the half locking block 312a directly approaches the tie rod 10, and directly squeezes the tie rod 10 with a slight rotation. The angle formed by the half balancing block 312b and the rack 311 is a right angle or an acute angle, which is far away from the tie rod 10, and will not touch and squeeze the tie rod 10 even if it rotates. The main body of the rack assembly 31 is penetrated with a rack shaft 313 at the center position of the trident, that is, the folded edge position, and the rack shaft 313 is perpendicular to the rack 311 in space, so it is equivalent to being perpendicular to the half locking block 312a and the half balancing block 312b, so the three can rotate around the rack shaft 313. In a preferred example, one end surface of the half locking block 312a of the rack assembly 31 is a toothed surface (not shown) that can be pressed against the tie rod. The toothed surface is pressed against the flat surface of the tie rod 10 to achieve a tighter engagement.

[0090] In this example, the compression piece that compresses the locking piece on the tie rod 10 is a gear 32, and the body is a cylindrical shape. The axis of the gear 32 body has a gear shaft 321, which is parallel to the rack shaft 313. The side surface of the gear 32 body has teeth and tooth grooves arranged at intervals, and the direction of the teeth and tooth grooves is the same as the axis of the body. The teeth and tooth grooves at both ends of the gear 32 are respectively meshed with the tooth grooves and teeth on the two racks 311, so that when the gear 32 rotates, it can be rotated back and forth with the rack 311 to engage and connect. During the rotation process, since the rack assembly 31 has a rack shaft 313, the rack assembly 31 rotates with the rack shaft 313 as the center, thereby driving the half-locking block 312a to rush toward and squeeze the tie rod 10 to achieve the locking function. When the gear 32 rotates in the opposite direction, the half-locking block 312a leaves the tie rod 10, and the unlocking function is achieved.

[0091] In this example, the starting member for realizing the driving or starting function is a screw 33, and the shape of the screw 33 in this example is no different from that of an ordinary screw. The surface of the screw 33 is covered with spirally extending threads, and the threads are composed of a number of spaced screw teeth and screw grooves. The screw 33 is located between the two racks 311, and the screw teeth of the screw 33 are stuck in the tooth grooves in the middle of the gear 32, so the teeth of the gear 32 are also stuck in the screw grooves of the screw 33. When the screw 33 is rotated, the gear 32 will be started to rotate, and the rotating gear 32 will drive the rack assembly 31 to rotate so that the half-locking block 312a squeezes and locks the tie rod 10; rotating the screw 33 in the opposite direction will unlock the tie rod 10. In order to facilitate the rotation of the screw 10, a linear groove is provided on one end face of the screw 10.

[0092] In this example, the locking structure further has a housing 34, and a locking unit is built inside the housing 34. Gear support holes (not shown in the figure) are respectively provided on two opposite first shell walls of the housing. Both ends of the gear shaft 321 of the gear 32 are respectively fixed in the gear support holes of the housing 34 to provide support for the gear shaft 321. Screw support holes 342 are respectively provided on two opposite second shell walls of the housing 34. Both ends of the screw 33 are rotatably arranged in the screw support holes 342 to provide support for the screw 33. Rack support holes 343 are respectively provided on two opposite first shell walls of the housing 34. Both ends of the rack shaft 313 of the rack assembly 31 are respectively fixed in the rack support holes 313 to provide support for the rack shaft 313. The locking structure further has a U-shaped limiting groove 35 for limiting the gear assembly 31, which is fixed inside the housing 34. The shape of the limiting groove 35 is generally a U-shaped groove surrounded by two side plates and a bottom plate. One side of the gear assembly 31, that is, the locking bottom block 312 part, is limited in the U-shaped limiting groove 35, and a rack shaft hole 351 can be provided on the limiting groove 35. One of the rack shaft hole 351 and the rack support hole can be provided, or both can be provided. The tie rod 10 is parallelly penetrated through the bottom of the limiting groove 35. Tie rod holes 344 are respectively provided on two opposite second shell walls of the housing 34 at positions corresponding to the locking member locking the tie rod 10. The two side openings of the limiting groove 35 are aligned with the tie rod holes 344 so that the tie rod 10 can be inserted. The tie rod holes 344 and the screw support holes 342 are both on the second shell wall, that is, on the same side, so it is convenient to operate the locking and unlocking in the same direction.

[0093] One of the second shell walls of the housing 34 of the locking structure, which has the tie rod hole 344, is aligned with the lock hole 30b at the central position of the outer anchor main body 30a of the outer anchor. The housing of the locking structure is fixed at the position of the lock hole 30b on the non-contact surface of the outer anchor through the second shell wall of the housing. Therefore, the tie rod 10 can conveniently pass through the locking structure and the outer anchor 30.

[0094] In another example of the locking structure of the present invention, as Figures 5D to 5FAs shown, different from the above example, the rack assembly 38 of this example is a symmetrical Y-shaped structure, that is, one of the forks of the rack assembly 38 is two parallel and spaced racks 381, and only one rack can be seen from the side of the two racks 381, so it is called a fork. One side of the rack 381 has a plurality of teeth and tooth grooves arranged at intervals, which is called the tooth side, and the teeth and tooth grooves are perpendicular to the length direction of the rack 381. The other opposite side of the rack 381 has no teeth and is straight, which is called the non-tooth side. The other two forks of the rack assembly 38 are combined into a folded locking bottom block 382, ​​and the two half blocks of the locking bottom block 382 are both half locking blocks 382a. The side of the rack assembly 38 has two rack sliders 383, and the two racks 381 slide along the length direction of the rack to achieve locking and unlocking, and the two half locking blocks 382a can be pressed against the tie rod 10. The two half-locking blocks 382a are fixedly connected together with the folded edge as the boundary, that is, they are integrally connected, forming the other two forks of the rack assembly 38. One end of the two racks 381 is also fixed at both ends of the folded edge and is spaced a certain distance apart. The two half-locking blocks 382a are symmetrically arranged with the rack 381 as the symmetry line, so the angles formed between the two half-locking blocks 382a and the rack 381 are equal. In a preferred example, one side end face of the half-locking block 382a of the rack assembly 38 is a toothed surface (not shown) that can be pressed against the tie rod, and the toothed surface is pressed on the flat surface of the tie rod 10, which can be more tightly engaged. With respect to the structure of the rack assembly 38 in this example, since the two racks 381 of the rack assembly 38 have rack sliders 383 on both sides, respectively. Correspondingly, different from the housing 34, rack slide grooves 353 are respectively provided in the two opposite first shell walls of the housing 35, but no rack support holes are provided, and the rack sliders 383 on both sides of the rack assembly 38 are respectively slidably disposed in the rack slide grooves 353. The other structures on the housing 35 are the same as those on the housing 34, and are not described in detail here.

[0095] like Figures 6A to 6D As shown, the implantation process of the left ventricular volume reduction device of the present invention is as follows:

[0096] The proximal needle section 13 on the tie rod 10 or other puncture parts are used to complete the puncture of the left ventricular scar and the ventricular septum, enter the puncture sheath, establish a channel between the right ventricle and the epicardial area, withdraw the dilator in the puncture sheath, enter the J-type guide wire 92 along the puncture sheath, and use the snare 91 that enters the delivery device to complete the capture of the J-type guide wire 92, keep the snare 91 tightly bound to the J-type guide wire 92, withdraw the snare 91, and pull the J-type guide wire 92 into the inner cavity of the delivery device 90, and then out of the proximal end of the delivery device.

[0097] Adjust the puncture sheath so that the distal end of the puncture sheath enters the distal inner cavity of the delivery device 90. Outside the body, insert the J-shaped guide wire 92 into the proximal needle segment 13 on the tie rod 10, and then insert the tie rod 10 along the J-shaped guide wire 92 into the tie rod 10 connected to the inner anchor. Keep the J-shaped guide wire 92 stationary and push the tie rod 10 so that the proximal end of the tie rod 10 sequentially enters the inner cavity of the delivery device 90, the distal inner cavity of the puncture sheath, the distal end of the delivery device 90, the right ventricle, the left ventricle, and the epicardial region. When the proximal end of the tie rod 10 exits the epicardium, the J-shaped guide wire 92 can be withdrawn, and pulling the tie rod 10 can complete the insertion of the inner anchor 20.

[0098] Confirm the position of the inner anchor 20 through fluoroscopy of the imager. When the inner anchor 20 approaches the position of the right ventricular septum, withdraw the distal end of the puncture sheath to the left ventricle, and at the same time retract the delivery device 90 so that the inner anchor 20 can be released at the position of the right ventricular septum.

[0099] Cut the square connecting section 11 at the connection between the square connecting section 11 and the guiding section 12, adjust the locking structure of the outer anchor 30 to make it in the released state, and insert the outer anchor 30 along the square connecting section 11 to ensure that the contact surface of the outer anchor 30 contacts the scar tissue in the epicardial region.

[0100] Shorten the distance between the inner anchor and the outer anchor, while maintaining an appropriate compression force on the heart, which should not be too large or too small. The optimal force is 1 - 6 N. Operate the external locking part to lock the locking structure, and cut the redundant square connecting section 11 to complete the implantation of the left ventricular volume reduction device. Combining with the anatomical structure and actual needs of the patient's heart, repeat the above steps to implant multiple pairs of anchors, generally 2 - 4 pairs.

[0101] When the operation fails or the patient needs to remove the left ventricular volume reduction device, etc., insert the delivery device 90 along the right jugular vein, withdraw the dilator in the delivery device 90, insert the snare 91 along the delivery device 90, with the support of the imager, use the snare to capture the barb opening 223 on the inner anchor 20, successfully capture the barb 221 of the inner anchor 20, tighten the snare 91. When the snare 91 contacts the guiding bump 224 and the imager prompts that the snare has completed the capture of the inner anchor, use the external locking part to release the locking of the outer anchor 30 on the tie rod 10, keep the snare tightly binding the inner anchor 20, and complete the entry of the inner anchor 20 into the delivery device 90 while withdrawing the snare, and then withdraw the delivery device 90 to complete the interventional recovery of the inner anchor 20.

[0102] The left ventricular volume reduction device provided by the present invention uses a minimally invasive incision on the left anterior chest and an interventional right internal jugular vein as the surgical approach. Under the condition of non-stop heart beating, after using a guide wire to shuttle back and forth in the heart to "lay tracks", like tightening a pocket, two anchors are accurately placed at the edge of the ventricular aneurysm, one on the left and one on the right, one inside and one outside, attacking from both sides, so that the ventricular aneurysm is folded and clamped, the scar area of the left ventricle and the right ventricle are folded together, a series of anchors are embedded into the ventricular wall, and the redundant scar tissue is sutured to help the heart restore its previous shape and function. The left ventricle of the patient is reshaped to be close to the normal shape and size, the ventricle is reshaped, and the heart function is helped to be improved, as well as the patient's symptoms and quality of life. The left ventricular volume reduction device of the present invention has the function of retrievable intervention, avoiding open heart surgery when the left ventricular volume reduction device needs to be removed during or after the operation. The retrievable method reduces the secondary injury to the patient during the operation and reduces the economic burden on the patient and his family.

[0103] The above has shown and described the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments. What is described in the above embodiments and the specification only illustrates the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of the present invention claimed is defined by the appended claims and their equivalents.

Claims

1. A locking structure for a left ventricular volume reduction device, characterized in that The locking structure has a locking unit, and the locking unit has: A locking member that can be pressed against the tie rod. The locking member is a three-pronged rack assembly, and one prong of the rack assembly is a rack; A squeezing member that can press the locking member against the tie rod. The squeezing member is a gear, and the gear can be rotatably engaged with the rack of the rack assembly back and forth to achieve locking and unlocking; An actuating member for actuating the squeezing member to perform squeezing or pressure relief. The actuating member is a screw, and the thread of the screw is engaged in the tooth groove of the gear, and the gear is rotated by rotating the screw; A rack shaft is inserted through the three-pronged connection of the rack assembly; One prong of the rack assembly is two parallel and spaced racks, and both ends of the gear are respectively rotatably engaged with the two racks back and forth to achieve locking and unlocking; the screw is located between the two racks, and the thread of the screw is engaged in the tooth groove at the middle position of the gear, and the gear is rotated by rotating the screw; The other two prongs of the rack assembly are a folded locking bottom block. The locking bottom block has a half-lock block that can be pressed against the tie rod after rotation and a half-balance block that does not touch the tie rod after rotation. The half-lock block and the half-balance block are fixedly connected together with the folded edge as the boundary, constituting the other two prongs of the rack assembly, and one end of the two racks is also fixed at both ends of the folded edge.

2. The locking structure for the left ventricular volume reduction device according to claim 1, characterized in that, One side end face of the rack assembly is a tooth-shaped surface that can be pressed against the tie rod.

3. The locking structure for the left ventricular volume reduction device according to claim 1, characterized in that The locking structure also has a housing, and the locking unit is built in the housing: Gear support holes are respectively provided on two opposite first shell walls of the housing. The axis of the gear has a gear shaft, and both ends of the gear shaft are respectively fixed in the gear support holes; Screw support holes are respectively provided on two opposite second shell walls of the housing, and the screw is rotatably inserted through the screw support holes.

4. The locking structure for a left ventricular volume reduction device according to claim 3, wherein The locking structure also has a U-shaped limiting groove for limiting the rack assembly, which is fixed in the housing, and one side of the rack assembly is limited in the U-shaped limiting groove.

5. The locking structure for a left ventricular volume reduction device according to claim 4, wherein Rack support holes are respectively provided on two opposite first shell walls of the housing, or rack shaft holes are provided on two opposite side walls of the limiting groove. A rack shaft is inserted through the three-pronged connection of the rack assembly, and both ends of the rack shaft are respectively fixed in the rack support holes or the rack shaft holes.

6. The locking structure for a left ventricular volume reduction device according to claim 1, wherein The half-lock block is connected to the tooth side of the rack, and the half-balance block is connected to the non-tooth side of the rack; Or, The half-lock block is connected to the non-tooth side of the rack, and the half-balance block is connected to the tooth side of the rack.

7. The locking structure for a left ventricular volume reduction device according to claim 6, wherein The included angle formed by the half-lock block and the rack is an obtuse angle; The included angle formed by the half-balance block and the rack is a right angle or an acute angle.

8. The locking structure for a left ventricular volume reduction device according to claim 3, wherein rack chutes are respectively provided in two opposite first shell walls of the housing, a rack slider is fixedly provided on each of two sides of the rack assembly, and the rack sliders are respectively slidably arranged in the rack chutes.

9. The locking structure for a left ventricular volume reduction device according to claim 1, wherein one fork of the rack assembly is two parallel and spaced racks, two ends of the gear are respectively meshed and connected with the two racks to drive the two racks to slide along the axial direction of the rack to achieve locking and unlocking; the screw rod is located between the two racks, and the thread of the screw rod is clamped in the tooth groove at the middle position of the gear, and the gear is rotated by rotating the screw rod; the other two forks of the rack assembly are a folded locking bottom block, the locking bottom block has two half locking blocks that simultaneously press the tie rod after sliding, and the two half locking blocks are fixedly connected together with the folded edge as the boundary, constituting the other two forks of the rack assembly, and one ends of the two racks are also fixed at both ends of the folded edge.

10. The locking structure for a left ventricular volume reduction device according to claim 3, characterized in that Tie rod holes are respectively provided at corresponding positions on two opposite second shell walls of the housing, i.e., on the same shell wall as the screw rod support hole, where the locking member locks the tie rod.

11. An external anchor for a left ventricular volume reduction device, comprising: an external anchor body in the shape of a flat cuboid; A locking structure, characterized in that: the locking structure is the locking structure for a left ventricular volume reduction device according to any one of claims 1 to 10, and the locking structure is fixedly arranged at the central position of one side surface of the external anchor body.

12. The outer anchor for a left ventricular volume reduction device according to claim 11, wherein The external anchor body has: a contact surface that can abut against the outer wall of the left ventricle; and a non-contact surface opposite to the contact surface, and the locking structure is fixed at the central position of the non-contact surface.

13. The outer anchor for a left ventricular volume reduction device according to claim 12, characterized in that A through lock hole is provided at the central position of the external anchor body, the lock hole is for passing through the tie rod, and the second shell wall of the housing of the locking structure is fixedly arranged at the lock hole position of the external anchor body.

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