Implanting instrument capable of being selectively assembled

Abstract

The invention relates to an implantable instrument capable of being selectively assembled, which comprises a first component and a second component, or comprises the first component, the second component and a middle component, the first component is of a three-dimensional net structure and / or a support structure, the second component is provided with a support structure, the support structure of the second component is not net-shaped and is provided with at most one layer of waveform structure, and the middle component is provided with at least one layer of waveform structure. A first connecting piece is arranged at the far end of the first assembly, a second connecting piece is arranged at the near end of the second assembly, the first connecting piece and the second connecting piece are provided with at least one connecting mechanism matched with each other, the middle assembly can quantitatively adjust the axial distance between the first assembly and the second assembly, and connection of the first assembly and the second assembly after selection and matching is achieved. The connecting mechanism is provided with an anti-disengaging structure, and the anti-disengaging structure achieves two functions through local deformation or displacement: one function is used for preventing relative axial or circumferential looseness after the first assembly and the second assembly are connected or the first assembly, the second assembly and the middle assembly are connected, and the other function is used for preventing the first assembly and the second assembly from loosening in the relative axial or circumferential direction after the first assembly, the second assembly and the middle assembly are connected. And the two or the three can be quickly disassembled by auxiliary tools. The device is wide in application range, high in safety and high in convenience, and free disassembly and assembly of parts of various specifications are achieved.

Description

technical field [0001] The invention relates to the technical field of medical devices, and particularly designs an implantable device that can be optionally assembled. Background technique [0002] In the current market situation, most medical interventional products have an integrated structure, and the components of the product are fixedly connected, which cannot be disassembled and adjusted individually. Taking the left atrial appendage occluder as an example, its structure consists of two major components: the occlusion disc and the anchoring frame. The two components are fixedly connected and cannot be disassembled, and the size of the occluder is limited. In clinical use, the actual specifications of the selected LAA occluder should be determined according to the anatomical shape of the patient's LAA. Due to the limited product specifications of the existing LAA occluder, it is difficult to achieve a perfect fit between the patient and the device. Therefore, although...

AI Technical Summary

Problems solved by technology

This patent realizes the 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 there are still the following disadvantages: 1) The occluder in this patent has two One form of use: that is, the anchoring part is used alone, or the anchoring part, the connecting part and the covering part are used in combination. For some clinically flat and shallow auricles, it is suitable for double-disc occluders, and the overall height of the occluder There are certain restrictions, but 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, so that it has a certain range of application Limitations; 2) The connecting part in this patent only realizes the combination and disassembly of the anchoring part and the covering part through threaded connection, which has certain design drawbacks: although the assembly of various parts can be realized through the rotation of the threaded structure, and a part of the patent This embodiment realizes mutual locking of parts through resistance elements, but it brings a difficulty to repeated disassembly operations. For example, after the user assembles, he finds that the specifications need to be temporarily replaced. The current design is difficult to disassemble repeatedly, or the disassembly resistance is large. , which is not easy to operate; 3) In one embodiment of this patent, the connecting part is provided with a clamping element, one end of which is rotatably installed in the spherical cavity of the connecting part to realize the angle adjustment between the anchoring part and the covering part, The design disadvantages brought by this rotatable method mainly include: firstly, the naturally rotatable connection mechanism involves the mutual cooperation of multiple parts, which is difficult to manufacture, and the rotation angle cannot be precisely controlled. The covering parts can be rotated relative to each other, and the user cannot accurately grasp the precise release position of the occluder during the operation. 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 The movable design has extremely high requirements on the fatigue performance of the occluder. After implantation, with the continuous beating of the heart, the movable connection part may cause the risk of fatigue fracture failure; 4) In one embodiment of this patent, the connection part An elastic element is provided to achieve axial expansion or relative bending between the anchoring part and the covering part. This design has the following disadvantages: the accuracy of axial expansion and stretching or relative bending cannot be controlled, that is, the size of the axial expansion cannot be quantitatively controlled , and the stretching and stretching range is limited; 5) The structure of the connecting part of this patent is complex, especially the implementation of the hollow tube supported by elastic metal pipes in the middle of the connecting part. Since there are large gaps between the connecting units, these gaps May become a source of stress corrosion and affect the long-term corrosion resistance of the occluder

Although this patent relates to a detachable left atrial appendage occluder, it still has the following disadvantages: 1) The fixed plates of different sizes are detachable. Although the detachable structure is designed, the anti-off after the fixed plate is reassembled is not designed. device or structure, so detachable in this type of design means that it can be loosened, which will cause safety hazards in actual use; 2) The components of the left atrial appendage occluder in this patent use the relative movement of the thread structure to realize The height adjustment is not reliable in the actual operation process. During the operation, with the retraction, release sheath and pulling movement of the delivery cable to the left atrial appendage occluder, the components of the occluder will also rotate accordingly. 3) The height adjustment part and the occluder are integrated structure, and the range of height adjustable conditions is limited; 4) In one embodiment of this patent, the external spline structure The insertion depth with the internal spline structure, or the insertion depth between the clamping part and the fastening part can adjust the length / depth of the LAA occluder, but it does not solve the problem of loosening after insertion

Although this patent relates to a left atrial appendage occluder with scalability and adjustable angles, it still has the following disadvantages: 1) the telescopic range is small. Satisfies special cases; 2) There are many small parts in the structure of the intermediate connector, and the height and angle cannot be directional adjusted to control the height and angle, and there is a hidden danger of implantation failure during the operation

Although this patent relates to the left atrial appendage occluder with adjustable distance, it still has the following disadvantages: 1) the design of the distance adjustment mechanism has a great influence on the occluder disk of the left atrial appendage occluder, and during the pushing process in the sheath tube There are hidden dangers to the quality of the product; 2) The conditions for distance adjustment are harsh, and the operation needs to be performed when the intraoperative imaging is very clear, which is difficult and the operation process is complicated; 3) The structure of the adjustable distance components is only theoretical, and the actual Feasibility is low and practicality cannot be guaranteed

Although this patent relates to a left atrial appendage occluder with an adjustable distance, it still has the following disadvantages: 1) The connector has a large resistance during the sheathing process, or even gets stuck in the sheath, which makes it impossible to use a delivery device with a small sheath diameter. Sheath tube; 2) The connector simply relies on the structural design of the hook and the limit hole, and the force transmission is poor; 3) The product is released, and the design of the hook is easy to cause entanglement, and even the anchoring device and the sealing plate It is easy to fall off, which leads to inability to release, and there are design defects; 4) The design of the connector makes it impossible to accurately guarantee the accuracy of height adjustment. , during the pushing process of the delivery system and the process of retracting and releasing the sheath of the product, the barb will be broken, resulting in implantation failure; after implanting in the human body, the barbed part is also prone to fatigue failure due to long-term stress, resulting in fracture

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