An implantable device with optional assembly

Abstract

The present invention relates to an implantable device that can be optionally assembled, comprising: a first component and a second component, or comprising: a first component, a second component and an intermediate component, the first component is a three-dimensional mesh structure and / or a support structure, the second component has a support structure, the support structure of the second component is non-mesh, and has at most one layer of wave structure, the distal end of the first component is provided with a first connector, the proximal end of the second component is provided with a second connector, the first connector and the second connector are provided with at least one mutually matched connecting mechanism, the intermediate component can quantitatively adjust the axial spacing between the first component and the second component, and realize the connection of the first component and the second component after optional matching; the connecting mechanism is provided with an anti-release structure, and the anti-release structure realizes two functions through local deformation or displacement: one is used to prevent the relative axial or circumferential loosening of the first component and the second component, or the first component, the second component and the intermediate component after the connection, and the other is to use auxiliary tools to quickly disassemble the two or three components when the two or three components are connected. The present invention has a wide range of application, high safety, strong convenience, and realizes the free disassembly and assembly of components of various specifications.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to an implant device which can be optionally assembled. Background Art

[0002] Under the current market situation, most medical interventional products are integrated structures, and the components of the products are fixedly connected, which cannot be disassembled and personalized. Taking the left atrial appendage occluder as an example, its structure consists of two major components: the occluder disc and the anchoring frame. The two components are fixedly connected and cannot be disassembled, and the specifications and sizes of the occluder are limited. In clinical use, the actual specifications of the selected left atrial appendage occluder need to be determined according to the patient's left atrial appendage anatomical morphology. Due to the limited specifications of existing left atrial appendage occluder products, it is difficult to achieve a perfect fit between the patient and the device. Therefore, although the current structural design can meet the conventional needs of most patients, for some special patients, especially those with deep left atrial appendages and great differences in the sizes of the anchoring area and the opening area, conventional occluders can no longer be used. If a customized design is adopted, the manufacturer needs to re-produce and manufacture according to the actual needs of the patient, which undoubtedly increases the time cost.

[0003] Patent CN112022246A discloses a left atrial appendage occluder, comprising an anchoring part, a connecting part and a covering part connected in sequence along the axial direction, wherein the anchoring part comprises a radially shrinkable first supporting net and a first fixing element, the first fixing element is detachably connected to the connecting part, so that the anchoring part can be placed separately at the left atrial appendage; the covering part comprises a radially shrinkable second supporting net and a second fixing element, the second fixing element is installed at one end of the second supporting net away from the connecting part, and the first fixing element and the second fixing element are respectively provided with a pushing device connection position at one end away from the first supporting net.This patent achieves flexible use of the device and improves the adaptability of the left atrial appendage occluder through the specific structure and connection relationship of the anchoring part, the connecting part and the covering part, but still has the following disadvantages: 1) The occluder in this patent has two usage forms: using its anchoring part alone, or using the anchoring part, the connecting part and the covering part in combination. For some flat and shallow atrial appendages in clinical practice, the double-disc occluder is suitable, and there is a certain limit 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 an intermediate transition must be made through the connecting part, which increases the distance between the anchoring part and the covering part, thereby making it There are certain limitations in the scope of application; 2) The connection part in this patent only realizes the combined disassembly of the anchoring part and the covering part by means of threaded connection, which has certain design disadvantages: although the assembly of various components can be realized by the rotation of the threaded structure, and one embodiment of this patent realizes the mutual locking of components through a resistance element, it brings difficulties to the repeated disassembly operation. For example, when the user completes the assembly, it is found that the specifications need to be temporarily changed. The current design is difficult to disassemble repeatedly, or the disassembly resistance is large, which is not convenient for operation; 3) In one embodiment of this patent, the connection part is provided with a clamping element, one end of which can be rotatably mounted on the ball of the connection part The angle adjustment between the anchoring part and the covering part is realized in the shaped cavity. The design disadvantages brought by this rotatable method are mainly as follows: first, the naturally rotatable connection mechanism involves the mutual activity and coordination of multiple parts, which is difficult to manufacture, and the rotation angle cannot be accurately controlled. After implantation 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 surgery. At the same time, the covering part is very easy to shake, which brings certain challenges to the effectiveness of left atrial appendage occlusion; secondly, this movable design has extremely high requirements on the fatigue performance of the occluder. After implantation, as the heart continues to beat, the movable connection part There is a risk of fatigue fracture failure; 4) In one embodiment of the patent, an elastic element is provided at the connection part to achieve axial expansion and contraction or relative bending between the anchoring part and the covering part. This design has the following disadvantages: the accuracy of the axial expansion and contraction or relative bending cannot be controlled, that is, the size of the axial expansion and contraction cannot be quantitatively controlled, and the expansion and contraction range is limited; 5) The connection part of the patent has a complex structure, especially in the embodiment of a hollow tube supported by an elastic metal pipe in the middle of the connection part. Due to the large gaps between the connection 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 disk, a fixing disk and a connecting device, wherein the occluding disk is used to occlude the left atrial appendage; the fixing disk is used to fix the left atrial appendage occluder on the left atrial appendage, and the fixing disk has a barb; the connecting device connects the occluding disk and the fixing disk, and the connecting device includes a detachable adjustment structure, the detachable adjustment structure includes a first component and a second component separated from or combined with the first component, the first component and the second component can make relative movement, the first component is connected to the occluding disk, and the second component is connected to the fixing disk. The depth / length of the left atrial appendage occluder can be adjusted by the relative movement between the first component and the second component, so as to adapt to left atrial appendages of different depths; the detachable adjustment structure can choose to connect fixing disks of different sizes to adapt to left atrial appendages of different shapes. Although this patent involves a detachable left atrial appendage occluder, it still has the following disadvantages: 1) Fixed disks of different sizes are detachable. Although a detachable structure is designed, there is no anti-detachment device or structure after the fixed disk is reassembled. Therefore, the detachability in this type of design means that it can be loosened, which will cause safety hazards in actual use; 2) The various components of the left atrial appendage occluder in this patent use the relative movement of the threaded structure to achieve height adjustment, which is not reliable in actual operation. During the operation, the delivery steel cable retracts and releases the sheath and pulls the left atrial appendage occluder, and the various components of the occluder will also rotate, causing the height adjustment to fail, thereby bringing the risk of implantation failure; 3) The height adjustment member and the occluder are an integrated structure, and the height adjustment range is limited; 4) In one embodiment of the 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 card and the buckle part, but the problem of loosening after insertion is not solved.

[0005] Patent CN210990532 U provides a left atrial appendage occluder, including a cover sheet, a connecting mechanism and a packing column, the connecting mechanism includes a proximal connecting piece fixed to the cover sheet, a distal connecting piece fixed to the packing column, an intermediate connecting piece fixed between the proximal connecting piece and the distal connecting piece, and an elastic element located in the intermediate connecting piece, the intermediate connecting piece has at least two connecting sections that are axially clamped, and an annular adjustment groove formed at the clamping position of two adjacent connecting sections, the annular adjustment groove allows the adjacent two connecting sections to have an axial gap formed between the two adjacent connecting sections along the axial direction, and a circumferential gap formed between the two adjacent connecting sections along the circumferential direction. The intermediate connecting piece has a certain degree of bendability and axial scalability, so that the angle and axial distance between the cover sheet and the packing column are adjustable, thereby enabling the left atrial appendage occluder to adapt to left atrial appendage cavities of various shapes and reduce the occurrence of residual shunts. Although this patent involves a retractable and angle-adjustable left atrial appendage occluder, it still has the following disadvantages: 1) The retractable range is small. Although it is designed to be retractable, the retractable length range is too small and cannot meet the needs of special cases during actual use; 2) There are many small parts in the intermediate connecting piece structure, and the height and angle cannot be directionally adjusted, which poses a risk of implantation failure during the operation.

[0006] Patent CN111419302 A provides a left atrial appendage occluder, including: an anchoring mechanism; a covering mechanism, which is provided with a through hole; a connector body, which passes through an adjustable left atrial appendage occluder through hole and is fixed to an adjustable left atrial appendage occluder anchoring mechanism, and a gap is provided between an adjustable left atrial appendage occluder connector body and an adjustable left atrial appendage occluder through hole; an elastic gripping portion, which is arranged on at least one of an inner wall of an adjustable left atrial appendage occluder through hole and an adjustable left atrial appendage occluder connector body; an operating mechanism; in this patent, the connector body and the covering mechanism are connected by the elastic gripping portion, and when the operating mechanism deforms the elastic gripping portion, the covering mechanism can freely adjust its position, thereby realizing free adjustment of the distance between the covering mechanism and the anchoring mechanism during surgery, and the covering mechanism and the anchoring mechanism can conform to the shape of the human left atrial appendage to present a required angle, thereby achieving a good occluding effect. Although this patent involves an adjustable-distance left atrial appendage occluder, it still has the following shortcomings: 1) The design of the distance adjustment mechanism has a great impact on the occluding disc of the left atrial appendage occluder, and there are potential quality risks to the product during the pushing process in the sheath; 2) The distance adjustment conditions are harsh, and the operation needs to be performed under clear imaging during the operation, which is difficult and the operation process is complicated; 3) The adjustable-distance component structure is only theoretical, with low actual feasibility and no guarantee of practicality.

[0007] Patent CN106466196A discloses a split left atrial appendage occluder, including a split anchoring device and a sealing disk, one of which 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 connector and the second connector can adopt a matching method of a limiting hole and a hook, or can also adopt an interference fit method simultaneously or separately. The detachable left atrial appendage occluder provided by the patent can adjust the spacing between the anchoring device and the sealing disk according to the shape of the left atrial appendage, so that the sealing disk can completely block the left atrium and the left atrial appendage. The connection between the first connector and the second connector is achieved by matching the hook with the limiting hole. First, an anchoring device of appropriate specifications is released in the body, so that the anchoring device is fixed at a position adjacent to the opening inside the left atrial appendage, and then a sealing disk of appropriate specifications is selected for release. During the release of the sealing disk, the hook extends into the limiting hole. When the sealing disk has a tendency to detach from the left atrial appendage, the hook hooks the limiting hole to prevent detachment. Although this patent involves an adjustable-distance left atrial appendage occluder, it still has the following shortcomings: 1) There is great resistance when the connector is put into the sheath, and it may even get stuck, 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 limit hole, and the force transmission is poor; 3) During the release of the product, the design of the hook is prone to entanglement, and even the anchoring device and the sealing disk are prone to fall off, which leads to failure to release, and there is a design defect; 4) The design of the connector makes it impossible to accurately guarantee the accuracy of height adjustment; 5) The design of the connector's hook is prone to breakage risk. As a force-bearing component, the hook will break during the delivery system's pushing process and the product's sheath retraction and release process, resulting in implantation failure; and after implantation into the human body, the hook part is prone to fatigue failure due to long-term stress, thereby causing breakage.

[0008] Therefore, the present invention relates to an implant device with optional assembly, which can realize the free combination and repeated disassembly and assembly of components of various specifications according to the actual needs of patients. Compared with similar products on the market, it has better safety, greater convenience, a wider adjustable range of axial spacing, and higher flexibility. Summary of the invention

[0009] The purpose of the present invention is to overcome the deficiencies of the prior art and provide an implantable device with optional assembly, which enables free optional combination and repeated disassembly and assembly of components of various specifications. Compared with similar products on the market, it has better safety, greater convenience and higher flexibility.

[0010] The object of the present invention is achieved through the following technical solutions:

[0011] The first aspect of the present invention provides an implant device that can be optionally assembled, including: a first component and a second component, or including a first component, a second component and an intermediate component, the first component is a three-dimensional mesh structure and / or a support structure, the second component has a support structure, the support structure is non-mesh, and has at most one layer of corrugated structure, the distal end of the first component is provided with a first connector, the proximal end of the second component is provided with a second connector, the first connector and the second connector are provided with at least one connecting mechanism that cooperates with each other, the intermediate component can quantitatively adjust the axial spacing between the first component and the second component to achieve the connection of the first component and the second component after optional matching, the connecting mechanism is provided with an anti-release structure, and the anti-release structure realizes two functions through local deformation or displacement: one is to prevent the relative axial or circumferential loosening of the first component and the second component, or the first component, the second component and the third component after connection, and the other is to quickly disassemble the two or the three components with the help of auxiliary tools when the two or the three are connected.

[0012] Preferably, the first component is a mesh structure with two ends constrained and a drum-shaped middle, and the second component includes a bracket structure surrounded by a plurality of elastic skeletons diverging outward from a center piece, and the elastic skeletons gather in the center piece area to form a plurality of U-shaped grooves, and the U-shaped grooves are outside the distal end of the center piece; wherein, the first connecting member is a hollow bolt, and the hollow bolt is provided with a through hole, and the through hole is used to fix the first component, and the second connecting member is a T-shaped nut provided with a convex nail, and the convex nail of the T-shaped nut is inserted into the U-shaped groove, so that the proximal end surface of the T-shaped nut is located in the center piece or flush with the proximal end surface of the center piece, and the T-shaped nut is relatively fixed to the center piece, thereby forming a built-in thread, and the connecting mechanism is a threaded structure formed by the cooperation of the hollow bolt and the T-shaped nut, so as to realize the fixed connection between the first connecting member and the second connecting member;

[0013] Alternatively, the first connecting member is a buckle, the distal end of the buckle is provided with a multi-claw structure, the multi-claw structure is elastic, the proximal end of the buckle is provided with a countersunk hole, the countersunk hole is used to fix the first component, the second connecting member is a buckle groove, the buckle groove is matched with the multi-claw structure, the distal end of the buckle groove is a cylinder with a convex nail, the convex nail of the buckle groove is inserted into the U-shaped groove of the center member, the connecting mechanism is a buckle fixing structure formed by the multi-claw structure and the buckle groove, so as to realize the fixed connection between the first connecting member and the second connecting member;

[0014] Alternatively, the first connecting member is a convex shaft, the proximal end of the convex shaft is provided with a countersunk hole and a transverse threaded hole, the countersunk hole is used to fix the first component, the second connecting member is a concave shaft, the proximal end of the concave shaft is provided with a transverse through hole, the transverse through hole and the transverse threaded hole are coaxial, the distal end of the concave shaft is a cylinder provided with a convex nail, the convex nail of the concave shaft is inserted into the U-shaped groove of the center member; the connecting mechanism is a splicing structure formed by the distal end of the convex shaft and the proximal end of the concave shaft, the splicing structure forms an interference fit or a transition fit, and realizes the fixed connection between the first connecting member and the second connecting member;

[0015] Alternatively, the first connecting member is a pressure spring shaft, which is composed of a stepped shaft and a spring with different diameters, the proximal end diameter of the stepped shaft is larger than the distal end diameter, the outer surface of the distal end of the stepped shaft is provided with a transverse hole groove, the spring is arranged in the transverse hole groove, one end of the spring is fixed inside the transverse hole groove, and the other end of the spring is connected to a limiting component, in a natural state, most of the surface of the limiting component is exposed to the stepped shaft, the proximal end of the stepped shaft is provided with a countersunk hole, and the countersunk hole is used to fix the first component, the second connecting member is a positioning shaft, the proximal end of the positioning shaft is a countersunk hole matched with the stepped shaft, the outer surface of the proximal end of the positioning shaft is provided with a limiting hole groove, the shape of the limiting hole groove corresponds to the limiting component, and the space size of the limiting hole groove can accommodate the limiting component, the distal end of the positioning shaft is a cylinder provided with a convex nail, the convex nail of the positioning shaft is inserted into the U-shaped groove of the center piece, and the connecting mechanism is a composite structure formed by the cooperation of the limiting component and the limiting hole groove, so as to realize the fixed connection between the first connecting member and the second connecting member;

[0016] Alternatively, the first connecting member is a stepped column, a countersunk hole is provided on the proximal surface of the stepped column, and the countersunk hole is used to fix the first component; the second connecting member is a circular ring column, and the circular ring column is integrally processed with the proximal end of the center member; the proximal end of the circular ring column and the distal end of the stepped column are elastic and constitute a mutually cooperating snap-fitting structure, which is the connecting mechanism, and the connecting mechanism realizes a fixed connection between the first connecting member and the second connecting member.

[0017] Preferably, when the first connecting member is the hollow bolt and the second connecting member is the T-shaped nut, the anti-release structure is realized in the form of mechanical clamping. At this time, a plurality of non-threaded areas are provided on the outer surface of the stud of the hollow bolt. When the hollow bolt and the T-shaped nut cooperate with each other, a three-dimensional cavity is formed in the gap between the non-threaded area and the T-shaped nut. The auxiliary tool is used to clamp a specific position on the center piece corresponding to the three-dimensional cavity, so as to indirectly cause mechanical deformation of the three-dimensional cavity, thereby preventing relative axial and circumferential loosening between the first component and the second component. At the same time, the auxiliary tool is used to clamp a non-specific position of the center piece to restore the three-dimensional cavity to its original state, thereby realizing separation of the first connecting member and the second connecting member, and enabling the first component and the second component to be fixedly connected and repeatedly disassembled.

[0018] Alternatively, when the first connecting member is the buckle and the second connecting member is the buckle groove, the anti-release structure is a buckle-fitting structure formed between the elastic multi-claw structure and the buckle groove, and when the first connecting member cooperates with the second connecting member, the multi-claw structure is embedded in the buckle groove under the action of elasticity to achieve a fixed connection and prevent relative axial and circumferential looseness between the first component and the second component; a hollow area is formed between the buckle and the buckle groove, and the auxiliary tool is inserted into the hollow area and squeezes the multi-claw structure to make the multi-claw structure detach from the buckle groove under the action of external force, thereby achieving separation of the first connecting member and the second connecting member, and enabling the first component and the second component to be fixedly connected and repeatedly disassembled.

[0019] Alternatively, when the first connecting member is the convex shaft and the second connecting member is the concave shaft, the anti-release structure is a screw. When the convex shaft and the concave shaft are matched, the screw and the transverse threaded hole are threadedly matched to achieve an anti-release function to prevent relative axial and circumferential loosening between the first component and the second component. The auxiliary tool is used to release the screw from the transverse threaded hole to separate the first connecting member from the second connecting member, so that the first component and the second component can be fixedly connected and repeatedly disassembled.

[0020] Alternatively, when the first connecting member is the pressure spring shaft and the second connecting member is the positioning shaft, the anti-release structure is a spring matching structure. In the matching state, the limiting component exposes the limiting hole groove, thereby achieving fixation of the first connecting member and the second connecting member in all directions, preventing relative axial and circumferential loosening between the first component and the second component, and using the auxiliary tool to push the limiting component laterally into the transverse hole groove of the first connecting member to achieve separation of the first connecting member and the second connecting member, so that the first component and the second component can be fixedly connected and repeatedly disassembled.

[0021] Alternatively, when the first connecting member is the stepped column and the second connecting member is the annular column, the anti-release structure is an elastic protrusion structure arranged on the buckling structure, and the elastic protrusion structure plays a limiting and anti-release role in a natural state to prevent relative axial and circumferential loosening between the first component and the second component. The auxiliary tool can be used to elastically deform the elastic protrusion structure to achieve separation of the first connecting member and the second connecting member, so that the first component and the second component can be fixedly connected and repeatedly disassembled.

[0022] Preferably, the intermediate component is used to increase the axial spacing between the first component and the second component, and the spacing length is a multiple of 0.5 mm; the proximal end and the distal end of the intermediate component are respectively provided with connecting mechanisms that cooperate with the first connecting member and the second connecting member, and the connecting mechanism is provided with the anti-release structure.

[0023] Preferably, the intermediate component is one or more intermediate elements sleeved on the first connecting member and / or the second connecting member, and the axial length of the intermediate element is a multiple of 0.5 mm, which is used to increase the axial distance between the first component and the second component.

[0024] Preferably, the implant device has a non-circular rotationally symmetrical structure or an eccentric structure, and the intermediate component is a direction adjusting member for adjusting the relative angle between the first component and the second component on the circumference and the axial height between the first component and the second component, and the axial height is a single or multiple times the feed depth between the first component and the second component; when the feeding method is threaded feeding, the circumferential rotation angle is defined as ω, the pitch is defined as P, and the feed depth is (360°-ω) / 360°×P; when the feeding method is step type or tooth type, the feed depth is a single or multiple times the height of a single step or the height of the tooth pitch.

[0025] Preferably, the axial components of the implant device are at a certain angle, and the direction adjustment member is used to adjust the axial relative angle between the first component and the second component. The plane where the proximal end of the direction adjustment member is located is defined as α1, and the plane where the distal end of the direction adjustment member is located is defined as α2. The angle θ between the directions α1 and α2 is the bending angle of the direction adjustment member, and the angle θ satisfies the following mathematical relationship: 0°<θ<90°.

[0026] Preferably, the first connecting member and the second connecting member are made of metal or polymer material with elasticity or shape memory, and the intermediate component is made of metal or polymer material with rigidity, elasticity or shape memory.

[0027] Preferably, the connecting mechanism is provided with a guide structure, which is a micro-magnet provided at the distal end of the first connecting member and the proximal end of the second connecting member. The micro-magnet is fixed in an embedded or coated manner and has oppositely charged properties, so as to realize rapid alignment of the first component and the second component. The total volume of the micro-magnet does not exceed 60 mm 3 , with magnetic resonance imaging (MRI) compatibility.

[0028] In a second aspect, the present invention also provides a kit, comprising the above-mentioned implant device, wherein the kit comprises several first components of different specifications, several second components of different specifications, several intermediate components of different specifications and the auxiliary tool, wherein the specifications include the diameters of the first component and the second component, the height of the intermediate component and the bending angle of the intermediate component, and one end of the auxiliary tool is detachably connected to the intermediate component, the first connecting member and the second connecting member, and according to instructions, quick matching, disassembly and assembly connection between the first components of different specifications and the second components of different specifications, or between the first components of different specifications, the intermediate components of different specifications and the second components of different specifications can be achieved.

[0029] Compared with the prior art, the present invention has the following outstanding advantages:

[0030] 1. The present invention provides an implant device with optional assembly, which is respectively provided with a connecting mechanism in which a first connecting member and a second connecting member cooperate with each other, and an anti-release structure is provided in the connecting mechanism. The anti-release structure can realize repeated disassembly of components of different specifications through local deformation or displacement, and prevent relative axial or circumferential loosening between the first component and the second component, thereby improving safety.

[0031] 2. The present invention provides an implant device with optional assembly, in which the U-shaped groove is outside the distal end of the center piece, and the connecting mechanism is a threaded structure composed of a hollow bolt and a T-shaped nut, which has the following advantages: a) the convex nail of the T-shaped nut is inserted into the U-shaped groove, so that the proximal surface of the T-shaped nut is located in the center piece or flush with the proximal surface of the center piece, and the T-shaped nut is relatively fixed to the center piece to form an internal thread, so that the first connecting member and the second connecting member are connected seamlessly, while most of the prior art connects the proximal surface of the second connecting member by welding, etc., to form a separate extended additional structure, which increases the height of the first component and the second component, making it unsuitable for situations where there are restrictions on the overall height of the device, such as the left atrial appendage with a flat and shallow opening, and the existence of the welding point is likely to affect the fatigue performance of the product; b) the hollow bolt with a non-threaded area cooperates with the T-shaped nut to form a three-dimensional cavity, which can not only achieve fixation through local deformation to improve the safety of the product, but also achieve repeated assembly through auxiliary tools to improve practical flexibility.

[0032] 3. The present invention provides an implant device that can be optionally assembled, and its connection mechanism provides a variety of different forms, such as a snap-on fixing structure, an inserting structure, a composite structure, a buckling structure, etc., without a complicated matching structure, excellent anti-fatigue performance, and the internal structure of the connection mechanism is not directly exposed to the blood. At the same time, the outer surface of the connection mechanism has no obvious gaps, strong corrosion resistance, good safety, and easy operation.

[0033] 4. The present invention provides an implant device with optional assembly, which is equipped with intermediate components of various specifications. The operator can meet the different needs of patients and achieve personalized customization by matching the intermediate components according to the structural characteristics of the part to be implanted in the patient's body.

[0034] 5. The present invention provides an implant device with optional assembly, and the connecting mechanism is provided with a guide structure. Since the parts involved in the present invention are all tiny precision parts, the operator can use the guide structure to achieve rapid alignment of different components during assembly, thereby achieving the purpose of rapid assembly of the first component and the second component, saving assembly time and reducing the preoperative instrument preparation cycle.

[0035] 6. The present invention provides an optionally assembled intermediate component of an implantable device, which is a direction adjustment component that can adjust the circumferential relative angle or axial relative angle between the first component and the second component. It is suitable for devices with non-circular rotationally symmetrical structures or eccentric structures, or situations where there are requirements for the axial angle of the device.

[0036] 7. The present invention provides an implantable device that can be optionally assembled, which is a kit package. The kit package includes various specifications of a first component, a second component and an intermediate component, and contains auxiliary tools. According to the actual situation of the patient, the operator can respond immediately online according to real-time instructions, select different components, and realize the selection and assembly connection of components of different specifications, thereby realizing personalized customization of the product. In particular, for some lesions with special anatomical structures, product components can be flexibly selected to match the optimal product solution, thereby greatly reducing the patient's waiting time for surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 A schematic diagram of an assemblable implantable device in which both the first component and the second component are disc-shaped structures in the present invention;

[0038] Figure 2 This is a schematic diagram of an assembleable implantable device in which the first component is a mesh structure and the second component is a support structure in the present invention;

[0039] Figure 3 It is a schematic diagram of a connecting mechanism and an anti-release structure in an assemblable implantable device of the present invention;

[0040] Figure 4 A schematic diagram of an assemblable implant device according to the present invention having an intermediate component;

[0041] Figure 5 It is a schematic diagram of the first connecting member of the assemblable implant device of the present invention as a hollow bolt in the first embodiment;

[0042] Figure 6 A schematic diagram of a second connecting member being a T-shaped nut in the first embodiment of the assemblable implant device of the present invention;

[0043] Figure 7 A three-dimensional view of the hollow bolt and the T-shaped nut after being matched in the first embodiment of the assemblable implant device of the present invention;

[0044] Figure 8 A schematic diagram of a hollow bolt provided with a non-threaded area in a first embodiment of an assemblable implant device of the present invention;

[0045] Figure 9a A top view of the hollow bolt and the T-shaped nut after being matched in the first embodiment of the assemblable implant device of the present invention, showing a schematic diagram of the three-dimensional cavity formed by the gap between the non-threaded area and the T-shaped nut;

[0046] Figure 9b A top view of the hollow bolt and the T-shaped nut after being matched in the first embodiment of the assemblable implant device of the present invention, showing a schematic diagram of the anti-release structure being an elastic gasket;

[0047] Fig.10 A three-dimensional view of the second embodiment of the assemblable implant device of the present invention in which the first connecting member is a buckle;

[0048] Fig.11 for Fig.10 A partial cross-sectional view of

[0049] Fig.12 A three-dimensional view of the second connecting member of the assemblable implant device of the present invention as a buckle groove;

[0050] Fig.13 for Fig.12 A partial cross-sectional view of

[0051] Fig.14 A three-dimensional view of the buckle and buckle groove of the assemblable implant device of the second embodiment of the present invention after being matched;

[0052] Fig.15a It is a partial cross-sectional view of the buckle and the buckle groove after the buckle is matched in the second embodiment of the assemblable implant device of the present invention, at which time the buckle and the buckle groove are in a fixed connection state;

[0053] Fig.15b for Fig.15a Schematic diagram of the deformation of the multi-claw structure in the buckle under the action of external force after the middle buckle and the buckle groove are matched;

[0054] Fig.15c for Fig.15b Schematic diagram of the buckle and buckle groove being separated after the multi-claw structure is deformed;

[0055] Fig.16 A three-dimensional view of the first connecting member of the third embodiment of the assemblable implant device of the present invention, which is a convex-shaped shaft;

[0056] Fig.17 for Fig.16 A partial cross-sectional view of

[0057] Fig.18 A three-dimensional view of the second connecting member of the third embodiment of the assemblable implant device of the present invention, which is a concave-shaped shaft;

[0058] Fig.19 for Fig.18 A partial cross-sectional view of

[0059] Fig. 20 A three-dimensional view of the assembled implant device of the third embodiment of the present invention after the convex shaft, the concave shaft and the screw are matched;

[0060] Fig.21 for Fig. 20 A partial cross-sectional view of

[0061] Fig. 22 A three-dimensional view of the first connecting member of the fourth embodiment of the assemblable implant device of the present invention, which is a pressure spring shaft;

[0062] Fig.23 for Fig. 22 A partial cross-sectional view of

[0063] Fig.24 A three-dimensional view of the second connecting member as a positioning axis in the fourth embodiment of the assemblable implant device of the present invention;

[0064] Fig.25 for Fig.24 A partial cross-sectional view of

[0065] Fig.26 A three-dimensional view of the pressure spring shaft and the positioning shaft after being matched in the fourth embodiment of the assemblable implant device of the present invention;

[0066] Fig. 27 It is a partial cross-sectional view of the fourth embodiment of the assemblable implant device of the present invention after the pressure spring shaft and the positioning shaft are matched, at which time the pressure spring shaft and the positioning shaft are in a fixed connection state;

[0067] Fig.28 for Fig. 27 Schematic diagram of the separation of the pressure spring shaft and the positioning shaft under the action of external force after the pressure spring shaft and the positioning shaft are matched;

[0068] Fig.29 It is a schematic diagram of the buckling structure in the fifth embodiment of the assemblable implant device of the present invention;

[0069] Fig.30a and 30b They are respectively a cross-sectional view and a three-dimensional view of the guide rail column in the fifth embodiment of the assemblable implant device of the invention;

[0070] Fig.31a It is a schematic diagram of the guide groove ring in the fifth embodiment of the assemblable implant device of the present invention;

[0071] Fig.31b It is a schematic diagram of the cooperation between the guide rail column and the guide groove ring in the fifth embodiment of the assemblable implant device of the present invention;

[0072] Fig.32a and 32b They are respectively a cross-sectional view and a three-dimensional view of the spring column in the fifth embodiment of the assemblable implant device of the present invention;

[0073] Fig.33a It is a schematic diagram of the notch ring in the fifth embodiment of the assemblable implant device of the present invention;

[0074] Figure 33bIt is a schematic diagram of the cooperation between the spring column and the notch ring in the fifth embodiment of the assemblable implant device of the present invention;

[0075] Fig.34a and 34b They are respectively a cross-sectional view and a three-dimensional view of the first connecting member provided with a micro-magnet in the tenth embodiment of the assemblable implant device of the present invention;

[0076] Fig.35a A cross-sectional view of a second connecting member provided with a micro-magnet in a tenth embodiment of the assemblable implant device of the present invention;

[0077] Fig.35b It is a cross-sectional view of the micro-magnet provided after the first connecting member and the second connecting member are combined in the tenth embodiment of the assemblable implant device of the present invention;

[0078] Fig.36a It is a schematic diagram of an intermediate element in the seventh embodiment of the assemblable implant device of the present invention;

[0079] Fig.36b It is a schematic diagram of the intermediate element being sleeved on the first connecting member and the second connecting member in the seventh embodiment of the assemblable implant device of the present invention;

[0080] Fig.37 It is a schematic diagram of an implant device provided with a direction adjustment member in Embodiment 8 of the assemblable implant device of the present invention;

[0081] Fig.38a and 38b It is a schematic diagram of another implant device provided with a direction adjustment member in the ninth embodiment of the assemblable implant device of the present invention;

[0082] Fig.39 A partially hollowed-out tubular direction adjusting member in Embodiment 8 of the assemblable implant device of the present invention;

[0083] Among them, 1 is an implant device, 2 is an auxiliary tool, 10 is a first component, 11 is a second component, 12 is a first connecting member, 13 is a second connecting member, 14 is an intermediate component, 100 is a connecting mechanism, 120 is a hollow bolt, 121 is a buckle, 122 is a convex shaft, 123 is a pressure spring shaft, 124 is a stepped column, 130 is a T-shaped nut, 131 is a buckle groove, 132 is a concave shaft, 133 is a spring shaft, 134 is a spring shaft, 135 is a spring shaft, 136 is a spring shaft, 137 is a spring shaft, 138 is a spring shaft, 139 is a spring shaft, 140 is a spring shaft, 141 is a spring shaft, 142 is a spring shaft, 143 is a spring shaft, 144 is a spring shaft, 145 is a spring shaft, 146 is a spring shaft, 147 is a spring shaft, 148 is a spring shaft, 149 is a spring shaft, 150 is a spring shaft, 151 is a spring shaft, 152 is a spring shaft, 153 is a spring shaft, 154 is a spring shaft, 155 is a spring shaft, 156 is a spring shaft, 157 is a spring shaft, 158 is a spring shaft, 159 is a spring shaft, 160 is a spring shaft, 161 is a spring shaft, 162 is a spring shaft, 163 is a spring shaft, 164 is a spring shaft, 165 is a spring shaft, 166 is a spring shaft, 167 is a spring shaft, 168 is a spring shaft, 169 is a spring shaft, 170 is a spring shaft, 171 is a spring shaft, 172 is a spring shaft, 1 is a positioning shaft, 134 is a circular column, 140 is a direction adjustment member, 150 is an intermediate element, 200 is an anti-release structure, 1101 is a center piece, 1102 is a U-shaped groove, 1201 is a through hole, 1210 is a multi-claw structure, 1211 is a countersunk hole, 1220 is a transverse threaded hole, 1231 is a stepped shaft, 1232 is a spring, 1241 is a guide column, 1242 is a spring column, 1301 is a convex nail, 13 10 is a cylinder, 1302 is a hollow area, 1320 is a transverse through hole, 1331 is a limiting hole groove, 1341 is a guide groove ring, 1342 is a notch ring, 1001 is a threaded structure, 1002 is a buckle fixing structure, 1003 is a splicing structure, 1004 is a composite structure, 1005 is a guide structure, 1006 is a buckle structure, 2001 is a three-dimensional cavity, 2002 is a buckle matching structure, 2003 is a screw thread structure, 1004 is a composite structure, 1005 is a guide structure, 1006 is a buckle structure, 2001 is a three-dimensional cavity, 2002 is a buckle matching structure, 2003 is a screw thread structure, 1002 is a screw thread structure, 1003 ... It is a screw structure, 2004 is a spring matching structure, 2006 is an elastic protrusion structure, 10011 is a non-threaded area, 10012 is an elastic gasket, 10051 is a micro magnet, 12311 is a transverse hole groove, 12321 is a limiting component, 10061 is a slide rail structure, 10062 is a spring structure, 12411 is a guide rail, 12421 is a spring, 13411 is a guide groove, and 13421 is a notch. DETAILED DESCRIPTION

[0084] The technical solution proposed by the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer according to the following description and claims. It should be noted that the drawings are all in a very simplified form and are not in precise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In particular, due to the different contents to be highlighted in each drawing, different proportions are often used.

[0085] In order to more clearly describe the implantable device with optional assembly provided by the present invention, the terms "distal end" and "proximal end" are defined herein, and the above terms are conventional terms in the field of interventional medical devices. Specifically, "proximal end" refers to the end close to the operator during the operation, especially when the implantable device is crimped and loaded in the delivery system, and "distal end" refers to the end away from the operator during the operation, especially when the implantable device is crimped and loaded in the delivery system.

[0086] The assemblable implant device 1 provided by the present invention comprises: a first component 10 and a second component 11, or comprises: a first component 10, a second component 11 and an intermediate component 14, wherein the first component 10 is a three-dimensional mesh structure and / or a support structure, and the second component 11 has a support structure, and the support structure of the second component 11 is non-mesh and has at most one layer of corrugated structure, respectively. Figure 1 and Figure 2 As shown, a first connecting member 12 is provided at the distal end of the first component 10, and a second connecting member 13 is provided at the proximal end of the second component 11. The first connecting member 12 and the second connecting member 13 are provided with at least one connecting mechanism 100 that cooperates with each other. The intermediate component 14 can be quantitatively adjusted to realize the axial spacing between the first component 10 and the second component 11, so as to realize the connection of the first component 10 and the second component 11 after selection. The connecting mechanism 100 is provided with an anti-release structure 2005. The anti-release structure 200 realizes two functions through local deformation or displacement: one is to prevent the relative axial or circumferential loosening of the first component 10 and the second component 11, or the first component 10, the second component 11 and the intermediate component 14 after connection; the other is to quickly disassemble the two or three components with the aid of auxiliary tools when the two or three are in a connected state.

[0087] The purpose of the present invention can be further achieved by the following technical solutions:

[0088] In one embodiment, the present invention provides an optionally assembled implantable device 1, including an arterial / venous filter, an atrial septum / ventricular septal defect / patent foramen ovale occluder, a left atrial appendage occluder, etc. The following embodiments mainly take the left atrial appendage occluder as an example.

[0089] In one embodiment, the present invention provides an optionally assembled implant device 1, which is composed of a first component 10 and a second component 11. The first component 10 is a mesh structure with two ends constrained and a drum-shaped middle. The second component 11 includes a bracket structure surrounded by multiple elastic skeletons that diverge outward from a center piece 1101. The elastic skeletons gather in the center piece 1101 area to form multiple U-shaped grooves 1102. The U-shaped grooves 1102 are outside the distal end of the center piece 1101, such as Figure 2-4 shown.

[0090] Specifically, in the first embodiment, the first connecting member 12 is a hollow bolt 120, and the hollow bolt 120 is provided with a through hole 1201. Figure 5 As shown, the through hole 1201 is used to fix the first component 10; the second connecting member 13 is a T-shaped nut 130 provided with a protruding nail 1301, as shown in FIG. Figure 6As shown, the protruding nail 1301 of the T-shaped nut 130 can be inserted into the U-shaped groove 1102, so that the proximal end surface of the T-shaped nut 130 is located in the center piece 1101 or is flush with the proximal end surface of the center piece 1101, and the T-shaped nut 130 is relatively fixed to the center piece 1101, thereby forming an internal thread. The connecting mechanism 100 is a threaded structure 1001 composed of a hollow bolt 120 and a T-shaped nut 130. Figure 5 and Figure 6 As shown, the first connecting member 12 and the second connecting member 13 are fixedly connected, as shown in FIG. Figure 7 The advantage of this design is that the first connecting member 12 and the second connecting member 13 can be matched with each other through threads, and the operation is simple.

[0091] In this embodiment, further preferably, the anti-release structure 200 of the first connecting member 12 and the second connecting member 13 is realized by mechanical clamping. At this time, the outer surface of the stud of the hollow bolt 120 is provided with a plurality of non-threaded areas 10011, such as Figure 8 As shown, when the hollow bolt 120 and the T-shaped nut 130 cooperate with each other, the gap between the non-threaded area 10011 and the T-shaped nut 130 forms a three-dimensional cavity 2001. The auxiliary tool is used to clamp the specific position on the center piece 1101 corresponding to the three-dimensional cavity 2001, which indirectly causes mechanical deformation of the three-dimensional cavity 2001, thereby preventing the first component 10 and the second component 11 from being loosened in the axial and circumferential directions. Figure 9a As shown; at the same time, auxiliary tools are used to clamp the non-specific position of the center piece 1101, so that the three-dimensional cavity 2001 is restored to its original state, the first connecting piece 12 is separated from the second connecting piece 13, and the first component 10 and the second component 11 are fixedly connected and repeatedly disassembled.

[0092] Furthermore, the anti-release structure 200 is realized by the cooperation of the elastic gasket 10012 and the three-dimensional cavity 2001. The elastic gasket 10012 is located inside the three-dimensional cavity 2001 of the hollow bolt 120. Figure 9b As shown, when the hollow bolt 120 and the T-shaped nut 130 are matched, the elastic gasket 10012 is squeezed and slightly deformed, and a reverse force is formed to limit the relative movement of the hollow bolt 120 and the T-shaped nut 130, thereby forming an anti-release effect.

[0093] Furthermore, the first connecting member 12 and the second connecting member 13 are made of metal or polymer material having elasticity or shape memory.

[0094] In the second embodiment, the first connecting member 12 is a buckle 121, the distal end of the buckle 121 is provided with a multi-claw structure 1210, the multi-claw structure 1210 is elastic, and the proximal end of the buckle 121 is provided with a countersunk hole 1211, and the countersunk hole 1211 is used to fix the first component 10. Fig.10 and Fig.11 The second connecting member 13 is a buckle groove 131, the buckle groove 131 and the multi-claw structure 1210 cooperate to connect, the buckle groove 131 is provided with a cylindrical stud 1301 at the distal end 1310, such as Fig.12 and Fig.13 As shown, the protruding nail 1301 of the buckle groove 131 can be inserted into the U-shaped groove of the center piece 1101. At this time, the connecting mechanism 100 is a buckle fixing structure composed of the buckle 121 and the buckle groove 131, so as to realize the fixed connection between the first connecting member 12 and the second connecting member 13. Fig.14 shown.

[0095] In the present embodiment, it is further preferred that the anti-release structure 200 of the first connecting member 12 and the second connecting member 13 is a snap-fitting structure 2002 formed between the elastic multi-claw structure 1210 and the snap-fitting groove 131. When the first connecting member 12 is matched with the second connecting member 13, the multi-claw structure 1210 is embedded in the snap-fitting groove 131 under the action of elasticity to achieve a fixed connection, thereby preventing relative axial or circumferential loosening between the first component 10 and the second component 11. A hollow area 1302 is formed between the buckle 121 and the snap-fitting groove 131. An auxiliary tool is inserted into the hollow area 1302 and squeezes the multi-claw structure 1210, so that the multi-claw structure 1210 is separated from the snap-fitting groove 131 under the action of an external force, thereby achieving separation of the first connecting member 12 from the second connecting member 13, and enabling the first component 10 and the second component 11 to achieve a fixed connection and repeated disassembly, such as Figures 15a to 15c The advantages of this design are that the buckle structure is simple in design, easy to assemble, does not loosen when buckled, and has high safety. In a preferred embodiment, the number of claws of the elastic multi-claw structure 1210 is between 2 and 4.

[0096] In the third embodiment, the first connecting member 12 is a convex shaft 122, and a countersunk hole 1211 and a transverse threaded hole 1220 are provided at the proximal end of the convex shaft 122. The countersunk hole 1211 is used to fix the first component 10. Fig.16 and Fig.17 As shown, the second connecting member 13 is a concave shaft 132. Fig.18 and Fig.19 As shown, the proximal end of the concave shaft 132 is provided with a transverse through hole 1320, and the transverse through hole 1320 and the transverse threaded hole 1220 are coaxial, and the distal end of the concave shaft 132 is a cylinder 1310 provided with a convex nail 1301, and the convex nail 1301 of the concave shaft 132 can be inserted into the U-shaped groove of the center piece 1101. At this time, the connecting mechanism 100 is a splicing structure 1003 formed by the distal end of the convex shaft 122 and the proximal end of the concave shaft 132. The splicing structure 1003 forms an interference fit or a transition fit to achieve a fixed connection between the first connecting member 12 and the second connecting member 13, as shown in FIG. Fig. 20 and Fig.21 shown.

[0097] In this embodiment, it is further preferred that the anti-release structure 200 of the first connecting member 12 and the second connecting member 13 is a screw 2003. When the convex shaft 122 and the concave shaft 132 are matched, the screw 2003 and the transverse threaded hole 1220 are threadedly matched to achieve an anti-release function to prevent relative axial and circumferential loosening between the first component 10 and the second component 11. The screw 2003 is released from the transverse threaded hole 1220 by using an auxiliary tool to separate the first connecting member 12 from the second connecting member 13, so that the first component 10 and the second component 11 can be fixedly connected and repeatedly disassembled, such as Fig. 20 and Fig.21 The advantages of this design are that the connection mechanism 100 of the plug-in structure 1003 is easy to operate, has a high degree of fit, and is anti-release through the screws 2003, which is highly reliable. In a preferred embodiment, the plug-in structure 1003 is in the shape of a cylinder, a square, a polygon, or a combination of one or more of the above.

[0098] In the fourth embodiment, the first connecting member 12 is a pressure spring shaft 123, and the pressure spring shaft 123 is composed of a stepped shaft 1231 and a spring 1232 of unequal diameters. The proximal diameter of the stepped shaft 1231 is larger than the distal diameter. A transverse hole groove 12311 is provided on the outer surface of the distal end of the stepped shaft 1231, and a spring 1232 is provided in the transverse hole groove 12311. One end of the spring 1232 is fixed inside the transverse hole groove 12311, and the other end of the spring 1232 is connected to the limiting component 12321, such as Fig. 22 and Fig.23 As shown, in the natural state, most of the surface of the limiting component 12321 is exposed on the stepped shaft 1231, and a countersunk hole 1211 is opened at the proximal end of the stepped shaft 1231. The countersunk hole 1211 is used to fix the first component 10. The second connecting member 13 is a positioning shaft 133. The proximal end of the positioning shaft 133 is a countersunk hole 1211 that can cooperate with the stepped shaft 1231. The outer surface of the proximal end of the positioning shaft 133 is provided with a limiting hole groove 1331. The shape of the limiting hole groove 1331 corresponds to the limiting component 12321, and the space size of the limiting hole groove 1331 can accommodate the limiting component 12321. The distal end of the positioning shaft 133 is a cylinder 1310 provided with a convex nail 1301, as shown in FIG. Fig.24 and Fig.25 As shown, the protruding nail 1301 of the positioning shaft 133 can be inserted into the U-shaped groove of the center piece 1101. At this time, the connecting mechanism 100 is a composite structure 1004 composed of the limiting component 12321 and the limiting hole groove 1331, so as to realize the fixed connection between the first connecting member 12 and the second connecting member 13. Fig.26 and Fig. 27 shown.

[0099] In this embodiment, further preferably, the anti-release structure 200 of the first connecting member 12 and the second connecting member 13 is a spring matching structure 2004. In the matching state, the limiting component 12321 exposes the limiting hole groove 1331, thereby achieving the fixation of the first connecting member 12 and the second connecting member 13 in all directions, preventing the first component 10 and the second component 11 from being loosened in the axial direction or circumferential direction. Fig.26 and Fig. 27 As shown, at this time, the limiting component 12321 is pushed into the horizontal hole 12311 of the first connecting member 12 by an auxiliary tool to separate the first connecting member 12 from the second connecting member 13, so that the first component 10 and the second component 11 can be fixedly connected and repeatedly disassembled, as shown in FIG. Fig.28 As shown, the advantages of this design are that the structure of the composite mechanism is compact and simple, the pressure spring shaft 123 does not loosen when it is matched, the safety is high, and the replacement is convenient. In a preferred embodiment, the shape of the limiting component 12321 is spherical, ellipsoidal, square or irregular, preferably spherical, such as Fig. 22 and Fig.23 shown.

[0100] In the fifth embodiment, the first connecting member 12 is a stepped column 124, and the proximal surface of the stepped column 124 is provided with a countersunk hole 1211, and the countersunk hole 1211 is used to fix the first component 10. The second connecting member 13 is a circular column 134, and the circular column 134 is integrally processed with the proximal end of the center member 1101. The proximal end of the circular column 134 and the distal end of the stepped column 124 are elastic and form a mutually matching buckling structure 1006. The buckling structure 1006 is the connecting mechanism 100, and the connecting mechanism 100 realizes the fixed connection between the first connecting member 12 and the second connecting member 13, such as Fig.29 shown.

[0101] In this embodiment, it is further preferred that the anti-release structure 200 of the first connecting member 12 and the second connecting member 13 is an elastic protrusion structure 2006 arranged on the buckling structure 1006. The elastic protrusion structure 2006 plays a limiting and anti-release role in a natural state to prevent relative axial and circumferential loosening between the first component 10 and the second component 11. The elastic protrusion structure 2006 can be elastically deformed by using auxiliary tools to achieve separation of the first connecting member 12 and the second connecting member 13, so that the first component 10 and the second component 11 can be fixedly connected and repeatedly disassembled.

[0102] In one embodiment, if Figure 4As shown, the intermediate component 14 is used to increase the axial spacing between the first component 10 and the second component 11, and the length of the axial spacing is a multiple of 0.5 mm. The proximal end and the distal end of the intermediate component 14 are respectively provided with a connecting mechanism 100 that cooperates with the first connecting member 12 and the second connecting member 13, and the connecting mechanism 100 is provided with an anti-release structure 200.

[0103] Preferably, the intermediate component 14 has different height specifications, so as to achieve effective height adjustment between the first group 10 and the second component 11, and the effective height adjustment range is 0.5-10 mm. The advantage of this design is that the surgeon can select different specifications of the intermediate components 14 according to the patient's own characteristics, so as to achieve personalized selection of multiple specifications of the spacing between different components of the product.

[0104] In one embodiment, the intermediate component 14 is one or more intermediate elements 150 sleeved on the first connecting member 12 and / or the second connecting member 13, and the axial length of the intermediate element 150 is a multiple of 0.5 mm, which is used to increase the axial spacing between the first component 10 and the second component 11. Fig.36a and 36b shown.

[0105] In one embodiment, the implant device 1 has a non-circumferential rotationally symmetrical structure or an eccentric structure, and the intermediate component 14 is a direction adjustment member 140 to adjust the relative angle between the first component 10 and the second component 11 on the circumference and the axial height between the first component 10 and the second component 11, such as Fig.37 As shown. The axial height is a single or multiple feed depth between the first component 10 and the second component 11. When the feed mode is thread feed, the circumferential rotation angle is defined as ω, the pitch is P, and the feed depth formula is (360°-ω) / 360°×P. When the feed mode is step-type or tooth-type or other forms, the feed depth is a single or multiple single step height or tooth pitch or the height of its form. The advantage of this design is that it meets the needs of patients and realizes the personalized selection of angles between different components of the product.

[0106] In one embodiment, the components of the implant device 1 are axially at a certain angle. At this time, the direction adjustment member 140 is used to adjust the axial relative angle between the first component 10 and the second component 11. The plane where the proximal end of the direction adjustment member 140 is located is defined as α1, and the plane where the distal end of the direction adjustment member 140 is located is defined as α2. The angle θ between the directions α1 and α2 is the bending angle of the direction adjustment member 140. The angle θ satisfies the following mathematical relationship: 0°<θ<90°; further, the angle θ satisfies the following mathematical relationship: 10°≤θ≤45°, such as Fig.38a and 38b shown.

[0107] In a preferred embodiment, the direction adjusting member 140 is in the shape of a partially hollowed-out tube. Fig.39 shown.

[0108] In one embodiment, the first connecting member 12 and the second connecting member 13 are made of metal or polymer material with elasticity or shape memory, and the intermediate component 14 is made of metal or polymer material with rigidity, elasticity or shape memory.

[0109] In one embodiment, the connecting mechanism 100 is provided with a guide structure 1005, which is a micro-magnet 10051 provided at the distal end of the first connecting member 12 and the proximal end of the second connecting member 13. The micro-magnet 10051 is fixed in an embedded or coated manner and has oppositely charged properties, so as to realize rapid alignment of the first component 10 and the second component 11. The total volume of the micro-magnet 10051 does not exceed 60 mm 3 , with MRI compatibility, such as Figures 34a to 35b shown.

[0110] In one embodiment, a kit is provided, including the above-mentioned assemblable implant device 1, the kit including a plurality of first components 10 of different specifications, a plurality of second components 11 of different specifications, a plurality of intermediate components 14 of different specifications and an auxiliary tool, the specifications including the diameter of the first component 10 and the second component 11, the height of the intermediate component 14 and the bending angle of the intermediate component 14, one end of the auxiliary tool is detachably connected to the intermediate component 14, the first connector 12 and the second connector 13, and according to instructions, the matching and assembly connection between the first components 10 of different specifications and the second components 11 of different specifications, or the quick matching, disassembly and assembly connection between the first components 10 of different specifications, the intermediate components 14 of different specifications and the second components 11 of different specifications are achieved. The advantage of this design is that it enables personalized customization of products based on various components as standard parts. In particular, for some lesions with special anatomical structures, product components can be flexibly selected to match the best product solution, greatly reducing the long waiting time for patients to place orders directly with manufacturers for customization in order to use the best products until the surgeon obtains them, especially including the various processing time, sterilization time and transportation time required for manufacturers to produce products, providing sufficient guarantee for patients to use the most suitable products as soon as possible.

[0111] The present invention will be further described in detail below with reference to the accompanying drawings and a number of specific embodiments.

[0112] Embodiment 1:

[0113] The present embodiment provides an implantable device 1 that can be optionally assembled, comprising: a first component 10 and a second component 11, or comprising: a first component 10, a second component 11 and an intermediate component 14, wherein the first component 10 is a three-dimensional mesh structure and / or a support structure, and the second component 11 has a support structure, which is non-mesh and has at most one layer of corrugated structure, respectively. Figure 1 and Figure 2 As shown, a first connecting member 12 is provided at the distal end of the first component 10, and a second connecting member 13 is provided at the proximal end of the second component 11. The first connecting member 12 and the second connecting member 13 are provided with at least one connecting mechanism 100 that cooperates with each other. The intermediate component 14 can quantitatively adjust the axial distance between the first component 10 and the second component 11 to realize the connection of the first component 10 and the second component 11 after selection; the connecting mechanism 100 is provided with an anti-release structure 2005, and the anti-release structure 200 realizes two functions through local deformation or displacement: one is to prevent the relative axial or circumferential loosening of the first component 10 and the second component 11, or the first component 10, the second component 11 and the intermediate component 14 after connection; the other is to quickly disassemble the two or three with the help of auxiliary tools when the two or three are in a connected state.

[0114] In this embodiment, Figure 2 As shown, an implantable device 1 that can be optionally assembled is composed of a first component 10 and a second component 11, wherein the first component 10 is a mesh structure with two ends constrained and a drum-shaped middle, and the second component 11 includes a bracket structure surrounded by multiple elastic skeletons that diverge outward from a center piece 1101, and the elastic skeletons gather in the center piece 1101 area to form multiple U-shaped grooves 1102, and the U-shaped grooves 1102 are outside the distal end of the center piece 1101, such as Figure 4 As shown; the first connecting member 12 is a hollow bolt 120, and the hollow bolt 120 is provided with a through hole 1201, as Figure 5 As shown, the through hole 1201 is used to fix the first component 10, and the second connecting member 13 is a T-shaped nut 130 provided with a protruding nail 1301, as shown in FIG. Figure 6 As shown, the protruding nail 1301 of the T-shaped nut 130 can be inserted into the U-shaped groove 1102, so that the proximal end surface of the T-shaped nut 130 is located in the center piece 1101 or flush with the proximal end surface of the center piece 1101. The T-shaped nut 130 is relatively fixed to the center piece 1101 by mechanical matching, deformation extrusion, gluing, snap-fit, spring clips, etc. to form an internal thread. At this time, the connecting mechanism 100 is a threaded structure 1001 composed of the hollow bolt 120 and the T-shaped nut 130. Figure 5 and Figure 6 As shown, the first connecting member 12 and the second connecting member 13 are fixedly connected, as shown in FIG. Figure 7 shown.

[0115] In this embodiment, the anti-release structure 200 of the first connecting member 12 and the second connecting member 13 is realized by mechanical clamping. At this time, the outer surface of the stud of the hollow bolt 120 is provided with a plurality of non-threaded areas 10011, such as Figure 8 As shown, when the hollow bolt 120 and the T-shaped nut 130 cooperate with each other, the gap between the non-threaded area 10011 and the T-shaped nut 130 forms a three-dimensional cavity 2001. The auxiliary tool is used to clamp the specific position on the center piece 1101 corresponding to the three-dimensional cavity 2001, which indirectly causes mechanical deformation of the three-dimensional cavity 2001, thereby preventing the first component 10 and the second component 11 from being loosened in the axial and circumferential directions. Figure 9a As shown; at the same time, auxiliary tools are used to clamp the non-specific position of the center piece 1101, so that the three-dimensional cavity 2001 is restored to its original state, the first connecting piece 12 is separated from the second connecting piece 13, and the first component 10 and the second component 11 are fixedly connected and repeatedly disassembled.

[0116] In this embodiment, the anti-release structure 200 is realized by the cooperation of the elastic gasket 10012 and the three-dimensional cavity 2001. The elastic gasket 10012 is located inside the three-dimensional cavity 2001 of the hollow bolt 120. Figure 9b As shown, when the hollow bolt 120 and the T-shaped nut 130 are matched, the elastic gasket 10012 is squeezed and slightly deformed, and a reverse force is formed to limit the relative movement of the hollow bolt 120 and the T-shaped nut 130, thereby forming an anti-release effect.

[0117] In this embodiment, the first connecting member 12 and the second connecting member 13 are made of metal or polymer material having elasticity or shape memory.

[0118] Embodiment 2:

[0119] This embodiment is based on the first embodiment, and the difference lies in that the first connecting member 12, the second connecting member 13, the connecting mechanism 100 and the anti-release structure 200 in the second embodiment are different from those in the first embodiment.

[0120] The present embodiment provides an assemblable implantable device 1, wherein the first connecting member 12 is a buckle 121, a multi-claw structure 1210 is provided at the distal end of the buckle 121, and the multi-claw structure 1210 is elastic, and a countersunk hole 1211 is provided at the proximal end of the buckle 121, and the countersunk hole 1211 is used to fix the first component 10, such as Fig.10 and Fig.11 As shown, the second connecting member 13 is a buckle groove 131, which is linked with the multi-claw structure 1210, and the far end of the buckle groove 131 is a cylinder 1310 with a convex nail 1301. Fig.12 and Fig.13As shown, the protruding nail 1301 of the buckle groove 131 can be inserted into the U-shaped groove of the center piece 1101. At this time, the connecting mechanism 100 is a buckle fixing structure composed of the buckle 121 and the buckle groove 131, so as to realize the fixed connection between the first connecting member 12 and the second connecting member 13. Fig.14 shown.

[0121] In this embodiment, the anti-release structure 200 of the first connecting member 12 and the second connecting member 13 is a snap-fitting structure 2002 formed between the elastic multi-claw structure 1210 and the snap-fitting groove 131. When the first connecting member 12 is matched with the second connecting member 13, the multi-claw structure 1210 is embedded in the snap-fitting groove 131 under the action of elasticity to achieve a fixed connection, thereby preventing relative axial or circumferential loosening between the first component 10 and the second component 11. A hollow area 1302 is formed between the buckle 121 and the snap-fitting groove 131. An auxiliary tool is inserted into the hollow area 1302 and squeezes the multi-claw structure 1210, so that the multi-claw structure 1210 is separated from the snap-fitting groove 131 under the action of an external force, thereby achieving separation of the first connecting member 12 and the second connecting member 13, so that the first component 10 and the second component 11 are fixedly connected and repeatedly disassembled, such as Figures 15a to 15c The advantage of this design is that the buckle structure is simple in design, easy to assemble, does not loosen when buckled, and has high safety.

[0122] In this embodiment, the number of claws of the elastic multi-claw structure 1210 is four.

[0123] Embodiment three:

[0124] This embodiment is based on the first embodiment, and the difference lies in that the first connecting member 12, the second connecting member 13, the connecting mechanism 100 and the anti-release structure 200 in the third embodiment are different from those in the first embodiment.

[0125] The present embodiment provides an assembleable implantable device 1, wherein the first connecting member 12 is a convex shaft 122, and a countersunk hole 1211 and a transverse threaded hole 1220 are provided at the proximal end of the convex shaft 122, and the countersunk hole 1211 is used to fix the first component 10, such as Fig.16 and Fig.17 As shown, the second connecting member 13 is a concave shaft 132. Fig.18 and Fig.19As shown, the proximal end of the concave shaft 132 is provided with a transverse through hole 1320, and the transverse through hole 1320 and the transverse threaded hole 1220 are coaxial, and the distal end of the concave shaft 132 is a cylinder 1310 provided with a convex nail 1301, and the convex nail 1301 of the concave shaft 132 can be inserted into the U-shaped groove of the center piece 1101. At this time, the connecting mechanism 100 is a splicing structure 1003 formed by the distal end of the convex shaft 122 and the proximal end of the concave shaft 132. The splicing structure 1003 forms an interference fit or a transition fit to achieve a fixed connection between the first connecting member 12 and the second connecting member 13, as shown in FIG. Fig. 20 and Fig.21 shown.

[0126] In this embodiment, the anti-release structure 200 of the first connecting member 12 and the second connecting member 13 is a screw 2003. When the convex shaft 122 and the concave shaft 132 are matched, the screw 2003 and the transverse threaded hole 1220 are threadedly matched to achieve an anti-release function to prevent relative axial and circumferential loosening between the first component 10 and the second component 11. The screw 2003 is released from the transverse threaded hole 1220 by using an auxiliary tool to separate the first connecting member 12 from the second connecting member 13, so that the first component 10 and the second component 11 can be fixedly connected and repeatedly disassembled. Fig. 20 and Fig.21 shown.

[0127] Embodiment 4:

[0128] This embodiment is based on the first embodiment, and the difference lies in that the first connecting member 12, the second connecting member 13, the connecting mechanism 100 and the anti-release structure 200 in the fourth embodiment are different from those in the first embodiment.

[0129] The present embodiment provides an assemblable implantable device 1, wherein the first connecting member 12 is a pressure spring shaft 123, and the pressure spring shaft 123 is composed of a stepped shaft 1231 and a spring 1232 of unequal diameters, wherein the proximal diameter of the stepped shaft 1231 is greater than the distal diameter, and a transverse hole groove 12311 is provided on the outer surface of the distal end of the stepped shaft 1231, and a spring 1232 is provided in the transverse hole groove 12311, wherein one end of the spring 1232 is fixed inside the transverse hole groove 12311, and the other end of the spring 1232 is connected to a limiting component 12321, such as Fig. 22 and Fig.23As shown, in the natural state, most of the surface of the limiting component 12321 is exposed on the stepped shaft 1231, and a countersunk hole 1211 is opened at the proximal end of the stepped shaft 1231. The countersunk hole 1211 is used to fix the first component 10. The second connecting member 13 is a positioning shaft 133. The proximal end of the positioning shaft 133 is a countersunk hole 1211 that can cooperate with the stepped shaft 1231. The outer surface of the proximal end of the positioning shaft 133 is provided with a limiting hole groove 1331. The shape of the limiting hole groove 1331 corresponds to the limiting component 12321, and the space size of the limiting hole groove 1331 can accommodate the limiting component 12321. The distal end of the positioning shaft 133 is a cylinder 1310 provided with a convex nail 1301, as shown in FIG. Fig.24 and Fig.25 As shown, the protruding nail 1301 of the positioning shaft 133 can be inserted into the U-shaped groove of the center piece 1101. At this time, the connecting mechanism 100 is a composite structure 1004 composed of the limiting component 12321 and the limiting hole groove 1331, so as to realize the fixed connection between the first connecting member 12 and the second connecting member 13. Fig.26 and Fig. 27 shown.

[0130] In this embodiment, the first connecting member and the second connecting member 13 anti-release structure 200 is a spring matching structure 2004. In the matching state, the limiting component 12321 exposes the limiting hole 1331, thereby achieving the fixation of the first connecting member 12 and the second connecting member 13 in all directions, preventing the first component 10 and the second component 11 from being loosened in the axial direction or circumferential direction. Fig.26 and Fig. 27 As shown, at this time, the limiting component 12321 is pushed into the horizontal hole 12311 of the first connecting member 12 by an auxiliary tool to separate the first connecting member 12 from the second connecting member 13, so that the first component 10 and the second component 11 can be fixedly connected and repeatedly disassembled, as shown in FIG. Fig.28 shown.

[0131] In this embodiment, the limiting component 12321 is in a spherical shape.

[0132] Embodiment five:

[0133] This embodiment is based on the first embodiment, and the difference lies in that the first connecting member 12, the second connecting member 13, the connecting mechanism 100 and the anti-release structure 200 in the fifth embodiment are different from those in the first embodiment.

[0134] The present embodiment provides an assemblable implantable device 1, wherein the first connecting member 12 is a stepped column 124, and a countersunk hole 1211 is provided on the proximal surface of the stepped column 124, and the countersunk hole 1211 is used to fix the first component 10, and the second connecting member 13 is a circular column 134, and the circular column 134 is integrally processed with the proximal end of the center member 1101, and the proximal end of the circular column 134 and the distal end of the stepped column 124 are elastic and form a mutually matching buckling structure 1006, and the buckling structure 1006 is the connecting mechanism 100, and the connecting mechanism 100 realizes the fixed connection between the first connecting member 12 and the second connecting member 13, such as Fig.29 shown.

[0135] In this embodiment, the anti-release structure 200 of the first connecting member 12 and the second connecting member 13 is an elastic protrusion structure 2006 arranged on the buckling structure 1006. The elastic protrusion structure 2006 plays a limiting and anti-release role in a natural state, preventing relative axial and circumferential loosening between the first component 10 and the second component 11. The elastic protrusion structure 2006 can be elastically deformed by using auxiliary tools to achieve the separation of the first connecting member 12 and the second connecting member 13, so that the first component 10 and the second component 11 can be fixedly connected and repeatedly disassembled.

[0136] In a preferred embodiment, the step column 124 is a guide column 1241, which is a cylinder provided with a guide rail 12411 and a countersunk hole 1211, the guide rail 12411 is on the outer circumferential surface of the distal end of the guide column 1241, the countersunk hole 1211 is in the proximal surface of the guide column 1241, and the countersunk hole 1211 is used to fix the first component 10, such as Fig.30a and 30b As shown, the annular column 134 is a guide groove ring 1341, and the guide groove ring 1341 is provided with a guide groove 13411. The shape of the guide groove 13411 corresponds to the guide rail 12411. The space size of the guide groove 13411 can accommodate the guide rail 12411. The guide groove ring 1341 is integrally processed with the proximal end of the center piece 1101, as shown in FIG. Fig.31a As shown, the buckle structure 1006 is a slide rail structure 10061 formed by the cooperation of the guide rail 12411 and the guide groove 13411, which realizes the fixed connection between the first connecting member 12 and the second connecting member 13. The elastic protrusion structure 2006 is an embedded structure on the slide rail structure 10061. In the matched state, the top surface of the guide rail 12411 is higher than the top surface of the guide groove 13411, and the guide rail 12411 is embedded in the guide groove 13411 to realize the anti-release function. Fig.31b shown.

[0137] In another preferred embodiment, the step column 124 is a spring column 1242, the outer circumferential surface of the spring column 1242 is provided with a spring 12421, and the proximal end of the spring column 1242 is provided with a countersunk hole 1211, and the countersunk hole 1211 is used to fix the first component 10. Fig.32a and 32b As shown, the annular column 134 is a notch ring 1342, and the notch ring 1342 is provided with a notch 13421 on the circumference. The notch ring 1342 and the proximal end of the center piece 1101 are integrally processed, as shown in FIG. Fig.33a As shown, the spring piece column 1242 can be inserted into the notch ring 1342 at the back. At this time, the buckling structure 1006 is a spring piece structure 10062 formed by the spring piece 12421 and the notch 13421, so as to achieve the fixed connection between the first connecting member 12 and the second connecting member 13. At this time, the elastic protrusion structure 2006 is an embedded structure formed by the spring piece 12421 and the notch 13421. In the matched state, one end of the spring piece 12421 is convex and embedded in the notch 13421 of the notch ring 1342, so as to achieve the anti-release function. Figure 33b shown.

[0138] Embodiment six:

[0139] This embodiment is based on the first embodiment. The difference between the seventh embodiment and the first embodiment is that the implant device 1 in this embodiment includes an intermediate component 14 .

[0140] The intermediate component 14 in this embodiment is used to increase the axial distance between the first component 10 and the second component 11. Figure 4 As shown, the axial spacing length is a multiple of 0.5 mm, and the proximal end and the distal end of the intermediate component 14 are respectively provided with a connecting mechanism 100 that cooperates with the first connecting member 12 and the second connecting member 13, and the connecting mechanism 100 is provided with an anti-release structure 200.

[0141] Embodiment seven:

[0142] This embodiment is based on the sixth embodiment. The difference between the seventh embodiment and the first embodiment is that the intermediate component 14 in this embodiment is an intermediate element 150 .

[0143] In this embodiment, the intermediate component 14 is one or more intermediate elements 150 sleeved on the first connecting member 12 and / or the second connecting member 13. The axial length of the intermediate element 150 is a multiple of 0.5 mm, which is used to increase the axial spacing between the first component 10 and the second component 11. Fig.36a and 36b shown.

[0144] Embodiment eight:

[0145] This embodiment is based on the seventh embodiment, and the structural design of the intermediate component 14 involved in the eighth embodiment is different from that in the seventh embodiment.

[0146] In this embodiment, the implant device 1 is a non-circumferential rotationally symmetrical structure or an eccentric structure, and the intermediate component 14 is a direction adjustment member 140 to adjust the relative angle between the first component 10 and the second component 11 on the circumference and the axial height between the first component 10 and the second component 11. Fig.37 The axial height is a single or multiple feed depth between the first component 10 and the second component 11. When the feed mode is thread feed, the circumferential rotation angle is defined as ω, the pitch is defined as P, and the feed depth is defined as (360°-ω) / 360°×P. When the feed mode is a step type or a tooth type or other forms, the feed depth is a single or multiple single step height or tooth pitch or the height of its form.

[0147] Embodiment nine:

[0148] This embodiment is based on the eighth embodiment, and the structural design of the intermediate component 14 involved in the ninth embodiment is different from that in the eighth embodiment.

[0149] In this embodiment, the components of the implant device 1 are axially at a certain angle. At this time, the direction adjustment member 140 is used to adjust the axial relative angle between the first component 10 and the second component 11. The plane where the proximal end of the direction adjustment member 140 is located is defined as α1, and the plane where the distal end of the direction adjustment member 140 is located is defined as α2. The angle θ between the directions α1 and α2 is the bending angle of the direction adjustment member 140. The angle θ satisfies the following mathematical relationship: 0°<θ<90°; further, the angle θ satisfies the following mathematical relationship: 10°≤θ≤45°, such as Fig.38a and 38b shown.

[0150] In this embodiment, the direction adjusting member 140 is in the shape of a partially hollow tube. Fig.39 shown.

[0151] Embodiment ten:

[0152] This embodiment is based on the first embodiment. The connection mechanism 100 involved in the tenth embodiment is provided with a guide structure 1005. The guide structure 1005 is a micro magnet 10051 provided at the distal end of the first connection member 12 and the proximal end of the second connection member 13. The micro magnet 10051 is fixed by an embedded structure or a coating type and has opposite sex attraction, so as to realize the rapid alignment of the first component 10 and the second component 11. The total volume of the micro magnet 10051 does not exceed 60mm. 3 , with MRI compatibility, such as Figures 34a to 35b shown.

[0153] Embodiment eleven:

[0154] The present embodiment provides a kit, which includes a plurality of first components 10 of different specifications, a plurality of second components 11 of different specifications, a plurality of intermediate components 14 of different specifications, and an auxiliary tool. The specifications include the diameters of the first components 10 and the second components 11, the height of the intermediate component 14, and the bending angle of the intermediate component 14. One end of the auxiliary tool is detachably connected to the intermediate component 14, the first connecting member 12, and the second connecting member 13. According to real-time instructions during use, the operator can immediately respond to achieve the selection and assembly connection between the first components 10 of different specifications and the second components 11 of different specifications, or the quick selection, disassembly and assembly connection between the first components 10 of different specifications, the intermediate components 14 of different specifications, and the second components 11 of different specifications. The advantage of this design is that it enables personalized customization of products based on various components as standard parts. In particular, for some lesions with special anatomical structures, product components can be flexibly selected to match the best product solution, greatly reducing the long waiting time for patients to place orders directly with manufacturers for customization in order to use the best products until the surgeon obtains them, especially including the various processing time, sterilization time and transportation time required for manufacturers to produce products, providing sufficient guarantee for patients to use the most suitable products as soon as possible.

[0155] The specific embodiments of the present invention are described in detail above, but they are only examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions made to the present invention are also within the scope of the present invention. Therefore, the equalization changes and modifications made without departing from the spirit and scope of the present invention should be included in the scope of the present invention.

Claims

1. An implantable device (1) that can be optionally assembled, comprising: A first component (10) and a second component (11), or comprising: a first component (10), a second component (11) and an intermediate component (14), characterized in that the first component (10) is a three-dimensional mesh structure and / or a support structure, the second component (11) has a support structure, the support structure of the second component (11) is non-mesh and has at most one layer of wave structure, the first component (10) is provided with a first connecting piece (12) at the distal end, the second component (11) is provided with a second connecting piece (13) at the proximal end, the first connecting piece (12) and the second connecting piece (13) are provided with at least one connecting mechanism (100) that cooperates with each other, and the intermediate component (14) is provided with a first connecting piece (12) and a second connecting piece (13) that cooperate with each other. 4) The axial spacing between the first component (10) and the second component (11) can be quantitatively adjusted to realize the connection of the first component (10) and the second component (11) after selection; the connection mechanism (100) is provided with an anti-release structure (200), and the anti-release structure (200) realizes two functions through local deformation or displacement: one is to prevent the first component (10) and the second component (11), or the first component (10), the second component (11) and the intermediate component (14) from being loosened in the relative axial and circumferential directions after being connected; the other is to enable the two or the three to be quickly disassembled with the aid of auxiliary tools when the two or the three are in a connected state; The first component (10) is a mesh structure with two ends constrained and a drum-shaped middle. The second component (11) includes a support structure surrounded by a plurality of elastic skeletons radiating outward from a central piece (1101). The elastic skeletons gather in the region of the central piece (1101) to form a plurality of U-shaped grooves (1102). The U-shaped grooves (1102) are outside the distal end of the central piece (1101); wherein: The first connecting member (12) is a hollow bolt (120), and the hollow bolt (120) is provided with a through hole (1201), and the through hole (1201) is used to fix the first component (10), and the second connecting member (13) is a T-shaped nut (130) provided with a convex nail (1301), and the convex nail (1301) of the T-shaped nut (130) is inserted into the U-shaped groove (1102), so that the proximal end surface of the T-shaped nut (130) is located in the center member (1101) or is in contact with the center member (1101). 1), the proximal end surface of the T-shaped nut (130) is flush with the central piece (1101), the T-shaped nut (130) is relatively fixed to the central piece (1101), thereby forming an internal thread; the connecting mechanism (100) is a threaded structure (1001) formed by the hollow bolt (120) and the T-shaped nut (130), realizing the fixed connection between the first connecting piece (12) and the second connecting piece (13); the distal end cross-sectional area of ​​the hollow bolt (120) is smaller than the proximal end inner cavity cross-sectional area of ​​the T-shaped nut (130), forming a guide structure (1005); Alternatively, the first connecting member (12) is a buckle (121), a multi-claw structure (1210) is provided at the distal end of the buckle (121), the multi-claw structure (1210) is elastic, a countersunk hole (1211) is provided at the proximal end of the buckle (121), the countersunk hole (1211) is used to fix the first component (10), and the second connecting member (13) is a buckle groove (131), the buckle groove (131) is connected in cooperation with the multi-claw structure (1210), The distal end of the snap groove (131) is a cylinder (1310) provided with a convex nail (1301), and the convex nail (1301) of the snap groove (131) is inserted into the U-shaped groove (1102) of the center piece (1101). The connecting mechanism (100) is a snap-fit ​​fixing structure (1002) formed by the cooperation of the multi-claw structure (1210) and the snap groove (131), so as to realize the fixed connection between the first connecting piece (12) and the second connecting piece (13); Alternatively, the first connecting member (12) is a convex shaft (122), the proximal end of the convex shaft (122) is provided with a countersunk hole (1211) and a transverse threaded hole (1220), the countersunk hole (1211) is used to fix the first component (10), and the second connecting member (13) is a concave shaft (132), the proximal end of the concave shaft (132) is provided with a transverse through hole (1320), the transverse through hole (1320) and the transverse threaded hole (1220) are coaxial, and the distal end of the concave shaft (132) is provided with a A cylinder (1310) with a convex nail (1301), wherein the convex nail (1301) of the concave shaft (132) is inserted into the U-shaped groove (1102) of the center piece (1101); the connecting mechanism (100) is an inserting structure (1003) formed by the distal end of the convex shaft (122) and the proximal end of the concave shaft (132), wherein the inserting structure (1003) forms an interference fit or a transition fit to achieve a fixed connection between the first connecting piece (12) and the second connecting piece (13); Alternatively, the first connecting member (12) is a pressure spring shaft (123), and the pressure spring shaft (123) is composed of a stepped shaft (1231) and a spring (1232) of unequal diameters. The proximal diameter of the stepped shaft (1231) is greater than the distal diameter. The outer surface of the distal end of the stepped shaft (1231) has a transverse hole groove (12311), and the spring (1232) is arranged in the transverse hole groove (12311). One end of the spring (1232) is fixed inside the transverse hole groove (12311), and the other end of the spring (1232) is connected to a limiting component (12321). In a natural state, most of the surface of the limiting component (12321) is exposed to the stepped shaft (1231). The proximal end of the stepped shaft (1231) is provided with a countersunk hole (1211), and the countersunk hole (1211) is used to fix the first component (10). The second connecting member (12) 3) is a positioning shaft (133), the proximal end of the positioning shaft (133) is a countersunk hole (1211) matched with the stepped shaft (1231), the outer surface of the proximal end of the positioning shaft (133) is provided with a limiting hole groove (1331), the shape of the limiting hole groove (1331) corresponds to the limiting component (12321), and the space size of the limiting hole groove (1331) can accommodate the limiting component (12321), the positioning shaft (13 3) is a cylinder (1310) provided with a convex nail (1301), the convex nail (1301) of the positioning shaft (133) is inserted into the U-shaped groove (1102) of the center piece (1101), and the connecting mechanism (100) is a composite structure (1004) formed by the limiting component (12321) and the limiting hole groove (1331), so as to realize the fixed connection between the first connecting piece (12) and the second connecting piece (13); Alternatively, the first connecting member (12) is a stepped column (124), the proximal surface of the stepped column (124) is provided with a countersunk hole (1211), the countersunk hole (1211) is used to fix the first component (10), the second connecting member (13) is a circular column (134), the circular column is the proximal end of the center member (1101) processed in one piece, the proximal end of the circular column (134) and the distal end of the stepped column (124) are elastic, and form a mutually matching buckling structure (1006), the buckling structure (1006) is the connecting mechanism (100), and the connecting mechanism (100) realizes the fixed connection between the first connecting member (12) and the second connecting member (13); When the first connecting member (12) is the hollow bolt (120) and the second connecting member (13) is the T-shaped nut (130), the anti-release structure (200) is implemented in the form of mechanical clamping. At this time, the outer surface of the stud of the hollow bolt (120) is provided with a plurality of non-threaded areas (1001). When the hollow bolt (120) and the T-shaped nut (130) cooperate with each other, the gap between the non-threaded areas (1001) and the T-shaped nut (130) forms a three-dimensional cavity (2001). The auxiliary tool (2) is used to clamp the center member ( 1101) at a specific position corresponding to the three-dimensional cavity (2001), thereby indirectly causing mechanical deformation of the three-dimensional cavity (2001), thereby preventing relative axial and circumferential loosening between the first component (10) and the second component (11); at the same time, the auxiliary tool (2) is used to clamp the non-specific position of the center piece (1101) to restore the three-dimensional cavity (2001) to its original state, thereby realizing the separation of the first connecting piece (12) and the second connecting piece (13), so that the first component (10) and the second component (11) can be fixedly connected and repeatedly disassembled; Alternatively, when the first connecting member (12) is the buckle (121) and the second connecting member (13) is the buckle groove (131), the anti-release structure (200) is a buckle fitting structure (2002) formed between the elastic multi-claw structure (1210) and the buckle groove (131), and when the first connecting member (12) and the second connecting member (13) are fitted, the multi-claw structure (1210) is embedded in the buckle groove (131) under the action of elasticity to achieve a fixed connection, thereby preventing the first component (10) and the second connecting member (13) from being released. Relative axial and circumferential looseness occurs between the second component (11); a hollow area (1302) is formed between the buckle (121) and the buckle groove (131); the auxiliary tool (2) is inserted into the hollow area (1302) and squeezes the multi-claw structure (1210), so that the multi-claw structure (1210) is separated from the buckle groove (131) under the action of external force, thereby realizing the separation of the first connecting member (12) and the second connecting member (13), so that the first component (10) and the second component (11) are fixedly connected and repeatedly disassembled; Alternatively, when the first connecting member (12) is the convex shaft (122) and the second connecting member (13) is the concave shaft (132), the anti-release structure (200) is a screw (2003). When the convex shaft (122) and the concave shaft (132) are matched, the screw (2003) and the transverse threaded hole (1220) are threadedly matched to achieve an anti-release function, thereby preventing the first component (10) and the second component (11) from being loosened in the axial and circumferential directions. The auxiliary tool (2) is used to release the screw (2003) from the transverse threaded hole (1220), thereby achieving separation of the first connecting member (12) and the second connecting member (13), so that the first component (10) and the second component (11) can be fixedly connected and repeatedly disassembled. Alternatively, when the first connecting member (12) is the pressure spring shaft (123) and the second connecting member (13) is the positioning shaft (133), the anti-release structure (200) is a spring matching structure (2004). In the matching state, the limiting component (12321) exposes the limiting hole groove (1231), thereby achieving the fixation of the first connecting member (12) and the second connecting member (13) in all directions, preventing the first component (10) and the second component (11) from being loosened in the axial and circumferential directions. The limiting component (12321) is pushed into the transverse hole groove (12311) of the first connecting member (12) by using the auxiliary tool (2), thereby achieving the separation of the first connecting member (12) and the second connecting member (13), so that the first component (10) and the second component (11) can be fixedly connected and repeatedly disassembled. Alternatively, when the first connecting member (12) is the stepped column (124) and the second connecting member (13) is the annular column (134), the anti-release structure (200) is an elastic protrusion structure (2006) arranged on the buckling structure (1006), and the elastic protrusion structure (2006) has a limiting and anti-release function in a natural state to prevent relative axial and circumferential loosening between the first component (10) and the second component (11). The auxiliary tool (2) can be used to elastically deform the elastic protrusion structure (2006) to separate the first connecting member (12) from the second connecting member (13), so that the first component (10) and the second component (11) can be fixedly connected and repeatedly disassembled.

2. An implantable device (1) with optional assembly according to claim 1, characterized in that: The intermediate component (14) has different specifications and is used to increase the axial spacing between the first component (10) and the second component (11), and the length of the axial spacing is a multiple of 0.5 mm; the proximal end and the distal end of the intermediate component (14) are respectively provided with a connecting mechanism (100) that cooperates with the first connecting member (12) and the second connecting member (13), and the connecting mechanism (100) is provided with the anti-release structure (200).

3. An implantable device (1) with optional assembly according to claim 2, characterized in that: The intermediate component (14) is one or more intermediate elements (150) sleeved on the first connecting member (12) and / or the second connecting member (13), and the axial length of the intermediate element (150) is a multiple of 0.5 mm, and is used to increase the axial distance between the first component (10) and the second component (11).

4. An implantable device (1) with optional assembly according to claim 2, characterized in that: The implant device (1) has a non-circumferential rotationally symmetrical structure or an eccentric structure, and the intermediate component (14) is a direction adjusting member (140) for adjusting the relative angle between the first component (10) and the second component (11) on the circumference and the axial height between the first component (10) and the second component (11), wherein the axial height is a single or multiple times the feed depth between the first component (10) and the second component (11); when the feed mode is thread feed, the circumferential rotation angle is defined as ω, and the pitch is defined as P, and the feed depth is (360°-ω) / 360°×P; when the feed mode is step-type or tooth-type, the feed depth is a single or multiple times the height of a single step or the height of the tooth pitch.

5. The implant device (1) according to claim 4, characterized in that The components of the implant device (1) are axially arranged at a certain angle, and the direction adjustment member (140) is used to adjust the axial relative angle between the first component (10) and the second component (11). The plane where the proximal end of the direction adjustment member (140) is located is defined as α1, and the plane where the distal end of the direction adjustment member (140) is located is defined as α2. The angle θ between the directions α1 and α2 is the bending angle of the direction adjustment member (140), and the angle θ satisfies the following mathematical relationship: 0°<θ<90°.

6. An implantable device (1) with optional assembly according to claim 1, characterized in that: The first connecting member (12) and the second connecting member (13) are made of metal or polymer material with elasticity or shape memory, and the intermediate component (14) is made of metal or polymer material with rigidity or elasticity or shape memory.

7. An implantable device (1) with optional assembly according to claim 1, characterized in that: The connecting mechanism (100) is provided with a guide structure (1005), and the guide structure (1005) is a micro-magnet (10051) provided at the distal end of the first connecting member (12) and the proximal end of the second connecting member (13). The micro-magnet (10051) is fixed in an embedded or coated manner and has an oppositely charged attraction property, so as to realize the rapid alignment of the first component (10) and the second component (11). The total volume of the micro-magnet (10051) does not exceed 60 mm 3 , with NMR compatibility.

8. A kit comprising an optionally assembled implant device (1) according to any one of claims 1 to 7, characterized in that: The kit comprises a plurality of first components (10) of different specifications, a plurality of second components (11) of different specifications, a plurality of intermediate components (14) of different specifications and the auxiliary tool (2), wherein the specifications comprise the diameters of the first component (10) and the second component (11), the effective height of the intermediate component (14) and the bending angle of the intermediate component (14); one end of the auxiliary tool (2) is detachably connected to the intermediate component (14), the first connecting member (12) and the second connecting member (13); according to real-time instructions during use, the operator can immediately respond to realize quick matching, disassembly and assembly connection between the first components (10) of different specifications and the second components (11) of different specifications, or between the first components (10) of different specifications, the intermediate components (14) of different specifications and the second components (11) of different specifications.

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