An implant device and its loading and unloading tool assembly

Abstract

The present invention relates to the field of medical devices, and particularly to an implant device and its loading and unloading tool assembly. The implant device includes a first component, a second component, and a lateral connection structure; circumferential limiting structures are provided on the first component and the second component; the lateral connection structure is used to axially limit the first component and the second component. The loading and unloading tool assembly sequentially includes a rotation operation part, a rotation force transmission part, and a first guide part from the right end to the left end. The implant device and its loading and unloading tool assembly provided by the present invention can achieve free combination and repeated disassembly and assembly of components of various specifications according to the actual needs of patients, can avoid misoperation by doctors, and have better safety, stronger convenience, a wider adjustable range of axial spacing, and higher flexibility compared with similar products on the market.

Description

[0001] The present invention belongs to the field of medical devices, and particularly relates to an implanting device and its loading and unloading tool assembly. Background Art

[0002] Currently, existing medical intervention products include an integral structure and a split structure. For the integral structure, the components of the product adopt axial cooperation. During the process of the implanting device being received into the sheath tube, rotated, and the cable being disengaged in the reverse direction, loosening is likely to occur easily, increasing the surgical risk. Moreover, during the cooperation of the components of the product, repeated disassembly and assembly and personalized adjustment cannot be effectively achieved. The anti-loosening structures adopted all achieve this through local deformation or displacement, and the degree of damage to the device is uncontrollable, causing the product to lose its original shape. Also, due to the small size of the implanting device, performing local deformation or displacement in a limited space increases the difficulty of surgical operation. It is very difficult for the auxiliary tool to hold the implanting device in place, and it may even damage adjacent components. According to user feedback, this anti-disengagement structure through local deformation or displacement will not be adopted by customers. For the split structure, the centering during the axial assembly of the components of the product is relatively poor, and the product bulges in the radial direction, which will affect the process of being received into the sheath.

[0003] Patent CN112022246A provides a left atrial appendage occluder and its usage method. The left atrial appendage occluder includes an anchoring portion, a connecting portion, and a covering portion that are sequentially connected along the axial direction. Among them, the anchoring portion includes a first support mesh that can radially contract and a first fixing element. A plurality of anchoring elements for grasping the left atrial appendage tissue are provided on the outer peripheral surface of the first support mesh. The first fixing element is detachably connected to the connecting portion, enabling the anchoring portion to be separately placed at the left atrial appendage. The covering portion includes a second support mesh that can radially contract and a second fixing element. The second fixing element is installed at one end of the second support mesh away from the connecting portion. Pushing device connection positions are respectively provided at one ends of the first fixing element and the second fixing element away from the first support mesh.Through the specific structures and connection relationships of the anchoring part, the connecting part and the covering part, the present invention achieves the purpose of flexible use of the instrument and improves the adaptability of the left atrial appendage occluder to left atrial appendages of various shapes. However, the patent still has the following disadvantages: 1) There are two usage forms of the occluder in this patent: using only its anchoring part alone, or using the combination of the anchoring part, the connecting part and the covering part. For some flat and shallow-shaped atrial appendages clinically, a double-disk occluder is suitable, and there are certain restrictions on the overall height of the occluder. However, in the design of this patent, the anchoring part and the covering part cannot be directly connected and must be transitioned through the connecting part in the middle, increasing the distance between the anchoring part and the covering part, thus having certain limitations in terms of the applicable range; 2) The connecting part in this patent only realizes the combined disassembly of the anchoring part and the covering part through a threaded connection, which has certain design drawbacks: Although the assembly of each component can be achieved through the rotation of the threaded structure, and in one implementation of this patent, the components are mutually locked through a resistance element, it brings difficulties to the operation of repeated loading and unloading. For example, when the user finishes assembling and then finds that a temporary replacement of the specification is needed, the current design is very difficult to disassemble repeatedly, or the disassembly resistance is large and not easy to operate; 3) In one implementation of this patent, the connecting part is provided with a clamping element, and one end of it can be rotatably installed in the spherical cavity of the connecting part to realize the angle adjustment between the anchoring part and the covering part. The design drawbacks brought by this rotatable method mainly include: First, the rotatable connection mechanism involves the mutual movement and cooperation of multiple parts, which is difficult to manufacture, and the rotation angle cannot be accurately controlled. After being implanted into the human body, due to the relative rotation between the anchoring part and the covering part, the user cannot accurately grasp the precise release position of the occluder during the operation, and at the same time, the covering part is extremely likely to shake, posing a certain challenge to the sealing effectiveness of the left atrial appendage; Second, this movable design has extremely high requirements for the fatigue performance of the occluder. After implantation, along with the continuous beating of the heart, the movable connecting part may cause the risk of fatigue fracture and failure; 4) In one implementation of this patent, the connecting part is provided with an elastic element to realize the axial telescoping or relative bending between the anchoring part and the covering part. This design has the following disadvantages: The accuracy of axial telescoping and stretching or relative bending cannot be controlled, that is, the size of axial telescoping cannot be quantitatively controlled, and the telescoping and stretching ranges are limited; 5) The structure of the connecting part in this patent is complex, especially in the implementation method involving a hollow tube supported by an elastic metal tube in the middle of the connecting part. Due to the large gaps between the connecting units, these gaps may become the source of stress corrosion, affecting the long-term corrosion resistance of the occluder.

[0004] Patent CN107233117B provides a left atrial appendage occluder, which includes an occluding disc, a fixing disc and a connecting device. The occluding disc is used to occlude the left atrial appendage; the fixing disc is used to fix the left atrial appendage occluder on the left atrial appendage, and barbs are provided on the fixing disc; the connecting device connects the occluding disc and the fixing disc, and the connecting device includes a detachable adjustment structure. The detachable adjustment structure includes a first component and a second component that is separated or combined with the first component. The first component and the second component can move relative to each other. The first component is connected to the occluding disc, and the second component is connected to the fixing disc. The adjustment of the depth / length of the left atrial appendage occluder can be achieved through the relative movement between the first component and the second component, so as to adapt to left atrial appendages with different depths; the detachable adjustment structure can be selectively connected to fixing discs of different sizes to adapt to left atrial appendages with different shapes. Although this patent relates to a detachable left atrial appendage occluder, it still has the following disadvantages: 1) Fixing discs of different sizes are detachable. Although a detachable structure is designed, no anti-loosening device or structure after the fixing disc is reassembled is designed. Therefore, the detachable nature in such designs means looseness, which will pose a safety hazard in actual use; 2) The relative movement of the threaded structure is used to achieve height adjustment for each component of the left atrial appendage occluder in this patent, and it is not reliable in actual operation. During the surgical process, with the retraction and release sheath and pulling movement of the left atrial appendage occluder by the delivery steel cable, the components of the occluder will also rotate accordingly, resulting in the failure of height adjustment and thus bringing the hidden danger of implantation failure; 3) The height adjustment member and the occluder are of an integral structure, and the range of adjustable height is limited; 4) In one implementation of this patent, the length / depth of the left atrial appendage occluder can be adjusted by the insertion depth between the external spline structure and the internal spline structure, or the insertion depth between the clamping part and the buckling part, but the problem of loosening after insertion is not solved.

[0005] Patent CN106466196A discloses a split left atrial appendage occluder, comprising a separately arranged anchoring device and a sealing disc. One of the anchoring device and the sealing disc is provided with a cylindrical first connector, and the other is provided with a second connector that cooperates with the cylindrical wall of the first connector to achieve a detachable connection. The first and second connectors can adopt a stopper hole and a hook for cooperation, or they can also adopt an interference fit method simultaneously or separately. The detachable left atrial appendage occluder provided by this patent can adjust the distance between the anchoring device and the sealing disc according to the shape of the left atrial appendage, so that the sealing disc can completely block the left atrium from the left atrial appendage. The connection between the first and second connectors is achieved by using a hook and a stopper hole to cooperate. First, an anchoring device of appropriate size is released in the body, so that the anchoring device is fixed in a position near the opening inside the left atrial appendage. Then, a sealing disc of appropriate size is selected for release. During the release of the sealing disc, the hook extends into the stopper hole. When the sealing disc tends to detach from the left atrial appendage, the hook hooks the stopper hole to prevent it from detaching. Although this patent involves an adjustable-distance left atrial appendage occluder, it still has the following shortcomings: 1) The connector has great resistance during the process of being retracted into the sheath, and may even get stuck in the sheath, making it impossible to use a delivery sheath with a smaller sheath diameter; 2) The connector relies solely on the structural design of the hook and the limiting hole, and the force transmission is poor; 3) During the release of the product, the design of the barb is prone to entanglement, and even the anchoring device and the sealing disc are prone to falling off, which leads to failure to release, resulting in a design defect; 4) The design of the connector makes it impossible to accurately guarantee the accuracy of height adjustment; 5) The barb design of the connector is prone to breakage risk. As a force-bearing component, the barb will break during the pushing process of the delivery system and the process of retracting and releasing the sheath of the product, resulting in implantation failure; and after implantation into the human body, the barb part is also prone to fatigue failure due to long-term force, thereby causing breakage.

[0006] Therefore, the implant device and its assembly and disassembly tool assembly provided by the present invention can realize the free combination and repeated disassembly and assembly of components of various specifications according to the actual needs of the patient, which can avoid the doctor's misoperation. Compared with similar products on the market, it is safer, more convenient, has a wider range of adjustable axial spacing, and is more flexible. Summary of the Invention

[0007] In view of the above and others, an object of the present invention is to overcome the deficiencies of the prior art.

[0008] According to an embodiment of the application of cardiac left atrial appendage occluder surgery, the present invention can provide an implant device and its loading and unloading tool assembly for patients with structural heart disease who need interventional treatment, which can solve the problems of repeated disassembly between different specifications of implant devices, high disassembly resistance, easy loosening of components, inconvenience in operation, and misoperation, thereby ensuring the safety, convenience, and flexibility of the product.

[0009] According to one aspect of the present invention, an implant device includes a first component, a second component, and a lateral connection structure; circumferential limiting structures are provided on the first component and the second component; the lateral connection structure is used to axially limit the first component and the second component.

[0010] In one embodiment, the first component includes a three-dimensional reticular structure, and the second component includes a stent structure or a reticular structure.

[0011] In one embodiment, the circumferential limiting structure includes one or more positioning bosses and positioning grooves matching the positioning bosses.

[0012] In one embodiment, the positioning bosses are non-centrally symmetric about the central axis of the implant device.

[0013] In one embodiment, the positioning bosses are located on the circumferential outer side of the distal region of the first component, and the positioning grooves are circumferentially located in the proximal region of the second component; alternatively, an axial groove is provided on the circumferential inner side of the distal region of the first component, and the positioning bosses matching the axial groove are provided on the axial inner side of the second component.

[0014] In one embodiment, the lateral connection structure includes an intermediate connector, one or more first groups of lateral holes, and a second group of lateral holes matching the first group of lateral holes; the first group of lateral holes and the second group of lateral holes form a radial fitting region; the radial fitting region includes a first-size hole and a second-size hole; the first-size hole and the second-size hole have different sizes.

[0015] In one embodiment, the lateral connection structure includes an intermediate connector, one or more first groups of lateral holes, and a second group of lateral holes matching the first group of lateral holes; the first group of lateral holes are axially arranged in the distal region of the first component, and the second group of lateral holes are axially arranged in the proximal region of the second component; after the first component and the second component are limited by the circumferential limiting structure, the first group of lateral holes and the second group of lateral holes form a radial fitting region; the intermediate connector passes through and is connected to the radial fitting region to complete axial positioning.

[0016] In one embodiment, the distal region of the first component is a cylindrical body or a polyhedron, and the proximal region of the second component is a chamber structure matching the cylindrical body or the polyhedron. After the cylindrical body or the polyhedron axially passes through the chamber structure and achieves circumferential positioning, the first group of lateral holes and the second group of lateral holes form a radial fitting region.

[0017] In one embodiment, the intermediate connecting member is provided with an axial through hole, and includes a fixed connection portion, a limiting member, and a second guiding member; the limiting member is located at the right end of the intermediate connecting member; alternatively, the limiting member is located between the fixed connection portion and the second guiding member; a fitting connection structure is formed between the right end region of the radial fitting region and the right end region of the fixed connection portion, and the fitting connection structure includes one or more combinations of threads and snap fits; when the limiting member is located at the right end of the intermediate connecting member, the limiting member abuts against the right end region of the first component or the second component.

[0018] In one embodiment, when the limiting member is located between the fixed connection portion and the second guiding member, the radial fitting region sequentially includes a first-sized hole and a second-sized hole from right to left; the aperture of the first-sized hole is larger than the aperture of the second-sized hole, so that a limiting portion is formed between the first-sized hole and the second-sized hole; both the first-sized hole and the second-sized hole are through holes; alternatively, the first-sized hole is a through hole and the second-sized hole is a blind hole.

[0019] According to another aspect of the present invention, a loading and unloading tool assembly for an implant device, the tool assembly sequentially includes a rotation operation portion, a rotation force transmission member, and a first guiding member from right to left.

[0020] In one embodiment, the rotation force transmission member is of a straight slot structure or a cross slot structure.

[0021] In one embodiment, an elastic component is provided in the rotation operation portion, and when the first guiding member abuts against the left end of the blind hole, the elastic component causes the intermediate connecting member to continue to move leftward.

[0022] In one embodiment, an anti-detachment structure is provided at the left end of the first guiding member, and when the intermediate connecting member is pre-mounted on the tool assembly, the anti-detachment structure prevents the intermediate connecting member from detaching.

[0023] In one embodiment, when the second-sized hole is a through hole, the left end of the first guiding member enters the first-sized hole from right to left and reaches the left end region or outside the left end region of the second-sized hole, and at this time, the left end of the second guiding member cooperates with the right end of the second-sized hole. When the tool assembly is operated to drive the second guiding member to continue to move leftward, at the same time, the rotation operation portion drives the intermediate connecting member to rotate circumferentially through the rotation force transmission member to form the fitting connection structure, and the limiting member abuts against the limiting portion.

[0024] In one embodiment, when the positioning boss is located on the circumferential outer side of the distal region of the first component, the outermost dimension L1 from the positioning boss to the central axis of the implanting instrument, the inner diameter L2 of the second component, and the outermost dimension L3 from the first component to the central axis of the implanting instrument satisfy the mathematical relationship: L2 < L1 ≤ L3.

[0025] In one embodiment, when the second-sized hole is a through-hole, the axial length L4 of the first guide member, the axial length L5 of the first-sized hole, the axial length L6 of the second guide member, the outer diameter D1 of the first guide member, the outer diameter D2 of the second guide member, the inner diameter D3 of the first-sized hole, the inner diameter D4 of the second-sized hole, and the outer diameter D5 of the limiting member satisfy the mathematical relationships: L4 > L5, L6 > L5; D1 < D2 ≤ D4 < D3; D4 < D5 < D3; D3 ≤ 2D4.

[0026] In one embodiment, when the second-sized hole is a blind hole, the axial length L of the first guide member 01 , the axial length L of the first-sized hole 02 , the axial length L of the second guide member 03 , the axial length L of the second-sized hole 04 , and the axial length L of the limiting member 05 satisfy the mathematical relationship: L 01 + L 03 ≤ L 04 , L 05 < L 02 .

[0027] In one embodiment, the tool assembly and the intermediate connecting member form a detachable connection structure through the rotational force transmission member, and the radial dimension of the left end region of the rotational operation portion decreases in the direction approaching the first guide member.

[0028] In one embodiment, the implant device includes a first component, a second component, an intermediate component, and an intermediate connecting member; circumferential limiting structures that cooperate with each other are provided between the first component and the intermediate component, and between the second component and the intermediate component; the first component and the intermediate component, and the second component and the intermediate component form lateral connecting structures that cooperate with each other with the intermediate connecting member, and both the circumferential limiting structure and the lateral connecting structure are detachable connecting structures; wherein, after the circumferential limiting structure enables the first component and the intermediate component, and the second component and the intermediate component to achieve quick positioning through sliding cooperation or circumferential rotation, the first component, the second component, and the intermediate component are in a state ready for assembly; after the tool component drives the intermediate connecting member to be assembled with the first component, the second component, and the intermediate component to form the lateral connecting structure, part or all of the intermediate connecting member is built into the first component, the second component, or the intermediate component; by replacing intermediate components with different height specifications, the distance between the first component and the second component can be adjusted.

[0029] In one embodiment, both the columnar body and the chamber structure are rotational body structures.

[0030] In one embodiment, the first set of lateral holes and the second set of lateral holes have a certain angle with the central axis of the implant device.

[0031] In one embodiment, multiple metal wires of the first component converge into a first connecting member from the proximal end to the distal end, and the distal end of the first connecting member is fixedly connected to the proximal end of the columnar body or the polyhedron.

[0032] In one embodiment, an internal thread is provided in the right-end region of the first-size hole, and an external thread that mates with the internal thread is provided in the right-end region of the fixed connection portion. The number of turns of both the internal thread and the external thread is at least two.

[0033] In one embodiment, the rotation operation portion sequentially includes a rotation abutting member, a hand-held member, and a mating member from the right end to the left end; the left-end region of the mating member is an arc-shaped structure, and its radial dimension decreases in the direction away from the hand-held member; an axial slot is provided at the right end of the fixed connection portion; the first guide member passes through the axial through-hole of the intermediate connecting member and drives part of the rotation force transmission member to axially insert into the slot, so that the rotation force transmission member drives the intermediate connecting member to rotate circumferentially.

[0034] In one embodiment, the implant device includes a first component, a second component, an intermediate connecting member, and an intermediate component located between the first component and the second component; the number of the intermediate connecting members is one; a first set of lateral holes is axially provided in a distal region of the first component, a second set of lateral holes is axially provided in a proximal region of the second component, a third set of lateral holes that cooperate with the first set of lateral holes is provided in a proximal region of the intermediate component, and a fourth set of lateral holes that cooperate with the second set of lateral holes is provided in a distal region of the intermediate component; after the first component, the second component, and the intermediate component cooperate with each other, at this time, the first set of lateral holes and the third set of lateral holes are radially overlapped and cooperated to form a first radially cooperating region, and the second set of lateral holes and the fourth set of lateral holes are radially overlapped and cooperated to form a second radially cooperating region; the tool component drives the intermediate connecting member to pass through and be connected to the first radially cooperating region and the second radially cooperating region.

[0035] In one embodiment, the implant device can be loaded into the body through a catheter, and the diameter of the catheter is within 14F.

[0036] In one embodiment, the wall thickness h of the chamber structure satisfies the mathematical relationship: 0.1 mm ≤ h ≤ 0.3 mm.

[0037] In one embodiment, the intermediate connecting member and the first component and the second component are threadedly connected and snap-connected to form a detachable connection structure.

[0038] In one embodiment, the left end face or the right end face of the intermediate connecting member is an arc structure, and the arc structure forms a limiting member.

[0039] In one embodiment, the circumferential limiting structure is located in the proximal region of the lateral connecting structure.

[0040] Compared with the prior art, the advantages of the present invention at least include the following:

[0041] 1. At present, most medical intervention products are of integral structure and split structure. For the integral structure, axial mating connection is used between the components of the product. This connection method cannot achieve disassembly, assembly and personalized adjustment. Moreover, the product specifications between components cannot be effectively replaced according to the patient's anatomical form, and it is difficult to repeatedly disassemble. The components occupy a large space volume, are not convenient to operate, and are prone to looseness between components, which is likely to cause doctors' misoperation, thus posing a safety hazard. For the split structure, the centering during the axial assembly of the components of the product is relatively poor, and the product protrudes in the radial direction, which will affect the process of inserting into the sheath. Different from the prior art, in an embodiment of the present invention, the implant device includes a first component, a second component, and a lateral connection structure; circumferential limiting structures are provided on the first component and the second component; the lateral connection structure is used for axially limiting the first component and the second component; the loading and unloading tool assembly includes a rotation operation part, a rotation force transmission part, and a first guide part in sequence from the right end to the left end; the structure is simple, the implant device occupies a small space in the sheath tube, and according to the actual needs of patients, free combination and repeated disassembly of various specification parts of the implant device can be realized. The disassembly and assembly are quick and convenient, reducing the interference factors during the operation, providing a wide surgical operation vision and a large operation space, avoiding doctors' misoperation, and improving the surgical safety. Compared with similar products on the market, it has better safety, stronger convenience, a wider adjustable range of axial spacing, and higher flexibility.

[0042] 2. Different from the prior art, in an embodiment of the present invention, the circumferential limiting structure includes one or more positioning bosses and positioning grooves matching the positioning bosses; the positioning bosses are non-centrally symmetric about the central axis of the implant device; the radial fitting region sequentially includes a first-size hole and a second-size hole from the right end to the left end; the lateral connection structure includes an intermediate connector, one or more first-group lateral holes, and a second-group lateral holes matching the first-group lateral holes; the first-group lateral holes and the second-group lateral holes form the radial fitting region; the radial fitting region includes the first-size hole and the second-size hole; the first-size hole and the second-size hole are different in size; the aperture of the first-size hole is larger than that of the second-size hole, the left end of the first guide member passes from the right end to the left end into the first-size hole and reaches the left-end region or outside the left-end region of the second-size hole. At this time, the left end of the second guide member is fitted with the right end of the second-size hole. Operate the tool assembly to drive the second guide member to continue moving leftward. At the same time, after the rotation operation part drives the intermediate connector to rotate circumferentially through the rotation force transmission member to form the fitting connection structure, the limiting member abuts against the limiting part. Such a design can ensure the accurate positioning of the fitting position and direction of the first component and the second component, which is convenient and fast, enabling the first-size hole and the second-size hole in the first-group lateral holes and the second-group lateral holes to be quickly fitted, avoiding the problems of repeated assembly and poor positioning effect of the two. Throughout the process, the first guide member and the second guide member provide guiding and positioning functions for loading the intermediate connector into the radial fitting region, and the operation is simple and fast.

[0043] 3. Different from the prior art, in an embodiment of the present invention, the tool assembly and the intermediate connector form a detachable connection structure through the rotation force transmission member, and the radial dimension of the left-end region of the rotation operation part decreases in the direction close to the first guide member; and the rotation force transmission member is of a straight-shaped structure or a cross-shaped structure. Such a design can not only ensure that when the operator operates near the implant device, the tool assembly does not touch the implant device, but also ensure that the operator can easily hold and disassemble the tool at the rotation operation part, avoiding surgical mistakes.

[0044] 4. Different from the prior art, in an embodiment of the present invention, the maximum dimension of the rotation force transmission member is smaller than the minimum peripheral dimension of the external thread; such a design can ensure that the rotation force transmission member or the multi-pyramid structure touches the external thread when rotating forward, avoiding the possibility of the failure of the cooperation between the external thread and the internal thread.

[0045] 5. Different from the prior art, in an embodiment of the present invention, an elastic component is provided in the rotation operation part. When the first guide member abuts against the left end of the blind hole, the elastic component makes the intermediate connector continue to move leftward along the axis, and the operation is simple, convenient and fast. Brief Description of the Drawings

[0046] Figures 1a - 1d This is a schematic diagram of the overall state of the tool component assembling and implanting device in the first embodiment of the present invention.

[0047] Figures 2a - 2d This is a sectional view of the tool component assembling and implanting device in the first embodiment of the present invention.

[0048] Figures 3a - 3d This is a schematic diagram of the state where the second-sized hole in the implanting device is a blind hole in the second embodiment of the present invention.

[0049] Figure 3e This is a schematic diagram of the state where the tool component has an elastic component in the second embodiment of the present invention.

[0050] Figures 4a - 4d This is a schematic diagram of the process of the positioning boss and the positioning groove cooperating in the implanting device in the first embodiment of the present invention.

[0051] Figure 5 This is a schematic diagram of the state where the left end of the first guide member has an anti-disengagement structure in various embodiments of the present invention.

[0052] Figures 6a - 6b This is a schematic diagram of the intermediate component in the third embodiment of the present invention.

[0053] Figures 7a - 7b This is a schematic diagram of the state where the tool component assembles the implanting device in the third embodiment of the present invention.

[0054] Figure 7c This is a schematic diagram of the implanting device in the third embodiment of the present invention.

[0055] Figures 8a - 8b This is a schematic diagram of the state when the limiting member is located between the fixed connection part and the second guide member in one embodiment of the present invention.

[0056] Figures 9a - 9c This is a schematic diagram of the state when the limiting member is located at the right end of the intermediate connecting member in one embodiment of the present invention.

[0057] Figures 10a - 10c This is a schematic diagram of the state where the first component includes a three-dimensional reticular structure and the second component includes a stent structure or a reticular structure in the first embodiment of the present invention.

[0058] The names of the parts referred to by the numbers in the drawings are as follows: 1 - implant device, 11 - first component, 111 - first group of lateral holes, 112 - cylindrical body, 113 - positioning boss, 114 - first connecting member, 12 - second component, 121 - second group of lateral holes, 122 - chamber structure, 123 - positioning groove, 13 - intermediate component, 131 - third group of lateral holes, 132 - fourth group of lateral holes, 2 - radial mating region, 21 - first - sized hole, 211 - internal thread, 22 - second - sized hole, 23 - limiting portion, 24 - first radial mating region, 25 - second radial mating region, 3 - intermediate connecting member, 31 - fixed connecting portion, 311 - external thread, 312 - slot, 32 - limiting member, 33 - second guiding member, 4 - tool assembly, 41 - rotating operation portion, 411 - rotating contact member, 412 - hand - held portion, 413 - mating member, 42 - rotating force transmission member, 43 - first guiding member, 5 - anti - detachment structure, 6 - elastic component. Detailed implementation manners

[0059] The invention will be further described in detail below with reference to the drawings and embodiments.

[0060] In the present invention, the proximal end refers to the end closer to the surgeon along the release direction of the implant device, and the distal end refers to the end farther from the surgeon along the release direction of the implant device; in the present invention, the left end refers to the left end of the surgeon along the release direction of the implant device, and the right end refers to the right end of the surgeon along the release direction of the implant device.

[0061] Embodiment 1:

[0062] In this embodiment, as Figures 1a - 1d and Figures 2a - 2d shown, an implant device 1 includes a first component 11, a second component 12, and a lateral connection structure; circumferential limiting structures are provided on the first component 11 and the second component 12; the lateral connection structure is used to axially limit the first component 11 and the second component 12.

[0063] In this embodiment, as Figures 10a - 10c shown, the first component 11 includes a three - dimensional reticulated structure, the second component 12 includes a stent structure or a reticulated structure, the first component 11 includes a three - dimensional reticulated structure, and the second component 12 includes a stent structure or a reticulated structure.

[0064] In this embodiment, as Figures 2a - 2d and Figures 4a - 4d shown, the circumferential limiting structure includes one or more positioning bosses 113 and positioning grooves 123 that match the positioning bosses 113.

[0065] In this embodiment, the positioning boss 113 is non-centrally symmetric about the central axis of the implant device 1.

[0066] In this embodiment, the positioning boss 113 is located on the circumferential outer side of the distal region of the first component 11, and the positioning groove 123 is circumferentially located in the proximal region of the second component 12.

[0067] In this embodiment, the outermost dimension L1 of the positioning boss 113 to the central axis of the implant device 1, the inner diameter L2 of the second component 12, and the outermost dimension L3 of the first component 11 to the central axis of the implant device 1 satisfy the mathematical relationship: L2 < L1 ≤ L3. Such a design can ensure that during the cooperation between the first component 11 and the second component 12, the positioning boss 113 can accurately and effectively cooperate with the positioning groove 123, avoiding scratching the sheath tube wall when retracting and deploying the sheath.

[0068] In this embodiment, the lateral connection structure includes an intermediate connector 3, one or more first groups of lateral holes 111, and a second group of lateral holes 121 that cooperate with the first group of lateral holes 111; the first group of lateral holes 111 and the second group of lateral holes 121 form a radial cooperation area 2; the radial cooperation area 2 includes a first-size hole 21 and a second-size hole 22; the first-size hole 21 and the second-size hole 22 have different sizes.

[0069] In this embodiment, as Figures 1a - 1d shown, the lateral connection structure includes an intermediate connector 3, one or more first groups of lateral holes 111, and a second group of lateral holes 121 that cooperate with the first group of lateral holes 111; the first group of lateral holes 111 are axially arranged in the distal region of the first component 11, and the second group of lateral holes 121 are axially arranged in the proximal region of the second component 12; after the first component 11 and the second component 12 are limited by the circumferential limiting structure, the first group of lateral holes 111 and the second group of lateral holes 121 form a radial cooperation area; the intermediate connector 3 is inserted into and connected to the radial cooperation area 2 to complete axial positioning.

[0070] In this embodiment, as Figures 1a - 1d shown, the distal region of the first component 11 is a cylindrical body 112, and the proximal region of the second component 12 is a chamber structure 122 that cooperates with the cylindrical body 112. After the cylindrical body 112 axially enters the chamber structure 122 and achieves circumferential positioning, the first group of lateral holes 111 and the second group of lateral holes 121 form the radial cooperation area 2.

[0071] In this embodiment, as Figure 1a and Figure 2aAs shown, the intermediate connecting member 3 is provided with an axial through hole, which includes a fixed connecting portion 31, a limiting member 32, and a second guiding member 33. The limiting member 32 is located between the fixed connecting portion 31 and the second guiding member 33; a right-end region of the radial fitting region 2 and a right-end region of the fixed connecting portion 31 form a fitting connection structure, and the fitting connection structure includes one or more combinations of threads and buckles.

[0072] In another embodiment, as Figures 8a - 8b shown, the limiting member 32 is located between the fixed connecting portion 31 and the second guiding member 33.

[0073] In this embodiment, as Figure 1b and Figure 2a shown, the right-end region of the radial fitting region 2 is provided with an internal thread 211, and the right-end region of the fixed connecting portion 31 is provided with an external thread 311 that mates with the internal thread 211. The number of turns of both the internal thread 211 and the external thread 311 is at least two turns.

[0074] In another embodiment, as Figures 9a - 9c shown, the intermediate connecting member 3 is provided with an axial through hole, which includes a fixed connecting portion 31, a limiting member 32, and a second guiding member 33. The limiting member 32 is located at the right end of the intermediate connecting member 3, and the limiting member 32 abuts against the right-end region of the second component 12.

[0075] In this embodiment, as Figures 1a - 1d shown, the tool assembly 4 sequentially includes a rotation operation portion 41, a rotation force transmission member 42, and a first guiding member 43 from the right end to the left end. The tool assembly 4 and the intermediate connecting member 3 form a detachable connection structure through the rotation force transmission member 42. The radial dimension of the left-end region of the rotation operation portion 41 decreases in a direction approaching the first guiding member 43; and the rotation force transmission member 42 has a cross-shaped structure.

[0076] In this embodiment, as Figures 1a - 1d shown, the rotation operation portion 41 sequentially includes a rotation contact member 411, a hand-held member 412, and a fitting member 413 from the right end to the left end; the left-end region of the fitting member 413 has an arc-shaped structure, and its radial dimension decreases in a direction away from the hand-held member 412; the right end of the fixed connecting portion 31 is provided with an axial slot 312; the first guiding member 43 passes through the axial through hole of the intermediate connecting member 3 and axially inserts a part of the rotation force transmission member 42 into the slot 312, so that the rotation force transmission member 42 drives the intermediate connecting member 3 to rotate circumferentially.

[0077] In this embodiment, as Figure 1aAs shown, when the limiting member 32 is located between the fixed connection portion 31 and the second guiding member 33, the radial fitting region 2 sequentially includes a first-sized hole 21 and a second-sized hole 22 from the right end to the left end; the aperture of the first-sized hole 21 is larger than that of the second-sized hole 22, so that a limiting portion 23 is formed between the first-sized hole 21 and the second-sized hole 22; both the first-sized hole 21 and the second-sized hole 22 are through holes.

[0078] In this embodiment, as Figures 2a - 2d shown, when the second-sized hole 22 is an axial through hole, the left end of the first guiding member 43 enters the first-sized hole 21 from the right end to the left end under the drive of the tool assembly 4 and reaches the left end region or outside the left end region of the second-sized hole 22. At this time, the left end of the second guiding member 33 cooperates with the right end of the second-sized hole 22. Operate the tool assembly 4 to drive the second guiding member 33 to continue moving to the left end. At the same time, after the rotating operation portion 41 drives the intermediate connecting member 3 to rotate circumferentially through the rotating force transmission member 42 to form the fitting connection structure, the limiting member 32 abuts against the limiting portion 23; wherein, the axial length L4 of the first guiding member 43, the axial length L5 of the first-sized hole 21, the axial length L6 of the second guiding member 33, the outer diameter D1 of the first guiding member 43, the outer diameter D2 of the second guiding member 33, the inner diameter D3 of the first-sized hole 21, the inner diameter D4 of the second-sized hole 22, and the outer diameter D5 of the limiting member 32 satisfy the mathematical relationships: L4 > L5, L6 > L5; D1 < D2 ≤ D4 < D3; D4 < D5 < D3; D3 ≤ 2D4.

[0079] In this embodiment, as Figure 5 shown, an anti-detachment structure 5 is provided at the left end of the first guiding member 43. When the intermediate connecting member 3 is pre-installed on the tool assembly 4, the anti-detachment structure 5 prevents the intermediate connecting member 3 from detaching.

[0080] In this embodiment, both the columnar body 112 and the chamber structure 122 are rotary body structures.

[0081] In this embodiment, the first group of lateral holes 111 and the second group of lateral holes 121 have a certain angle with the central axis of the implanting instrument 1.

[0082] In this embodiment, multiple metal wires of the first component 11 converge into a first connecting member 114 from the proximal end to the distal end, and the distal end of the first connecting member 114 is fixedly connected to the proximal end of the columnar body 112.

[0083] In this embodiment, the implanting instrument 1 can be loaded into the body through a catheter, and the diameter of the catheter is within 14F.

[0084] In this embodiment, the wall thickness h of the chamber structure 122 satisfies the mathematical relationship: 0.1 mm ≤ h ≤ 0.3 mm.

[0085] In this embodiment, when the tool assembly 4 is assembled to the implantation device 1, as Figure 1b shown, the circumferential limiting structure is located in the proximal region of the lateral connection structure.

[0086] Embodiment Two:

[0087] The difference from Embodiment One is that:

[0088] In this embodiment, as Figures 3a - 3d shown, the first-sized hole 21 is a through hole, and the second-sized hole 22 is an axial blind hole.

[0089] In this embodiment, as Figures 3a - 3d shown, when the second-sized hole 22 is an axial blind hole and the tool assembly 4 drives the intermediate connecting member 3 to pass through and connect to the radial mating region 2, the distal end of the first guide member 43 passes through the first-sized hole 21 and reaches the proximal end of the second-sized hole 22; wherein, the axial length L of the first guide member 43 01 , the axial length L of the first-sized hole 21 02 , the axial length L of the second guide member 33 03 , the axial length L of the second-sized hole 22 04 , the axial length L of the limiting member 32 05 satisfies the mathematical relationship: L 01 + L 03 ≤ L 04 , L 05 < L 02 .

[0090] In this embodiment, as Figure 3e shown, an elastic component 6 is provided in the rotation operation part 41. When the first guide member 43 abuts against the left end of the blind hole, the elastic component 6 causes the intermediate connecting member 3 to continue to move axially to the left end.

[0091] Embodiment Three:

[0092] The difference from Embodiment One is that:

[0093] In this embodiment, as Figures 6a - 6b and Figures 7a - 7cAs shown, an implant device 1 that can be quickly disassembled and reassembled and its tool assembly 4, including an implant device 1 and a tool assembly 4 for repeatedly disassembling and reassembling the implant device 1. The implant device 1 includes a first component 11, a second component 12, an intermediate component 13, and an intermediate connector 3. Circumferential limiting structures that cooperate with each other are provided between the first component 11 and the intermediate component 13, and between the second component 12 and the intermediate component 13. Lateral connection structures that cooperate with each other are formed between the first component 11 and the intermediate component 13, and between the second component 12 and the intermediate component 13 and the intermediate connector 3. The circumferential limiting structures and the lateral connection structures are both detachable connection structures. Among them, after the circumferential limiting structure enables the first component 11 and the intermediate component 13, and the second component 12 and the intermediate component 13 to achieve quick positioning through sliding fit or circumferential rotation, the first component 11, the second component 12, and the intermediate component 13 are in a state ready for assembly. After the tool assembly 4 drives the intermediate connector 3 to be assembled with the first component 11, the second component 12, and the intermediate component 13 to form the lateral connection structure, part or all of the intermediate connector 3 is built into the first component 11, the second component 12, or the intermediate component 13.

[0094] In this embodiment, as Figures 6a - 6b and Figures 7a - 7c shown, the implant device 1 includes a first component 11, a second component 12, an intermediate connector 3, and an intermediate component 13 located between the first component 11 and the second component 12. The number of intermediate connectors 3 is one. A first set of lateral holes 111 is provided axially in the distal region of the first component 11, a second set of lateral holes 121 is provided axially in the proximal region of the second component 12, a third set of lateral holes 131 that cooperate with the first set of lateral holes 111 is provided in the proximal region of the intermediate component 13, and a fourth set of lateral holes 132 that cooperate with the second set of lateral holes 121 is provided in the distal region of the intermediate component 13. After the first component 11, the second component 12, and the intermediate component 13 cooperate with each other, at this time, the first set of lateral holes 111 and the third set of lateral holes 131 overlap radially and cooperate to form a first radial cooperation region 24, and the second set of lateral holes 121 and the fourth set of lateral holes 132 overlap radially and cooperate to form a second radial cooperation region 25. The tool assembly 4 drives the intermediate connector 3 to pass through and connect to the first radial cooperation region 24 and the second radial cooperation region 25.

[0095] The above content is only an exemplary embodiment of the present invention. For those of ordinary skill in the art, based on the idea of the present invention, there can be changes in the specific implementation manner and application scope. The content of this specification should not be construed as a limitation to the present invention.

Claims

1. An implantable device comprising a first component, a second component, and a lateral connection structure; characterized in that: A circumferential limiting structure is provided on the first component and the second component; the lateral connection structure is used to axially limit the first component and the second component; the first component includes a three-dimensional mesh structure, and the second component includes a bracket structure or a mesh structure; The circumferential limiting structure includes one or more positioning bosses and a positioning groove matching the positioning bosses; The lateral connection structure includes an intermediate connection member, one or more first groups of lateral holes, and a second group of lateral holes matching the first group of lateral holes; the first group of lateral holes and the second group of lateral holes form a radial matching area; the radial matching area includes a first size hole and a second size hole; the first size hole and the second size hole are different in size; The first group of lateral holes is axially arranged in the distal region of the first component, and the second group of lateral holes is axially arranged in the proximal region of the second component; after the first component and the second component are limited by the circumferential limiting structure, the first group of lateral holes and the second group of lateral holes form a radial matching area; the intermediate connecting member is passed through and connected to the radial matching area to complete axial positioning; The distal region of the first component is a cylindrical body or a polyhedron, and the proximal region of the second component is a chamber structure that cooperates with the cylindrical body or the polyhedron. The cylindrical body or the polyhedron axially passes into the chamber structure and realizes circumferential positioning; The intermediate connecting member is provided with an axial through hole, which includes a fixed connection part, a limit member, and a second guide member; the limit member is located at the right end of the intermediate connecting member; or, the limit member is located between the fixed connection part and the second guide member; the right end area of the radial fitting area and the right end area of the fixed connection part form a fitting connection structure, and the fitting connection structure includes one or more combinations of threads and snaps; when the limit member is located at the right end of the intermediate connecting member, the limit member is tightly against the right end area of the first component or the second component.

2. An implant device according to claim 1, characterized in that: The positioning boss is non-centrally symmetrical about the central axis of the implant instrument.

3. An implant device according to claim 2, characterized in that: The positioning boss is located on the circumferential outer side of the distal end area of the first component, and the positioning groove is located on the circumferential outer side of the proximal end area of the second component; or, an axial groove is provided on the circumferential inner side of the distal end area of the first component, and the positioning boss that cooperates with the axial groove is provided on the axial inner side of the second component.

4. An implant device according to claim 1, characterized in that: When the limiting member is located between the fixed connection portion and the second guide member, the radial matching area includes a first size hole and a second size hole from the right end to the left end in sequence; the aperture of the first size hole is larger than the aperture of the second size hole, so that a limiting portion is formed between the first size hole and the second size hole; the first size hole and the second size hole are both through holes; or, the first size hole is a through hole and the second size hole is a blind hole.

5. A tool assembly for mounting and dismounting an implant device according to any one of claims 1 to 4, characterized in that: The tool assembly includes the implant device according to any one of claims 1 to 4, and the tool assembly includes a rotation operating part, a rotation force transmission part, and a first guide part from the right end to the left end.

6. The implant device assembly according to claim 5, wherein: The rotation force transmission member is a straight-line structure or a cross-shaped structure.

7. The implant device assembly according to claim 5, wherein: An elastic component is provided in the rotating operating portion. When the first guide member abuts against the left end of the blind hole, the elastic component causes the intermediate connecting member to continue to move toward the left end.

8. The implant device assembly according to claim 5, wherein: An anti-slip structure is provided at the left end of the first guide member, and when the intermediate connecting member is pre-installed on the tool assembly, the anti-slip structure prevents the intermediate connecting member from falling off.

9. The implant device assembly according to claim 5, wherein: When the second-size hole is a through hole, the left end of the first guide member passes into the first-size hole from the right end to the left end and reaches the left end area or outside the left end area of the second-size hole. At this time, the left end of the second guide member cooperates with the right end of the second-size hole, and the tool assembly is operated to drive the second guide member to continue to move to the left end. At the same time, the rotating operating part drives the intermediate connecting member to rotate circumferentially through the rotational force transmission member to form the matching connection structure, and the limiting member is tightly pressed against the limiting part.

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