Anchoring device with multiple locking structures and conveying system thereof

Abstract

The invention relates to the field of medical instruments, in particular to an anchoring device with multiple locking structures, comprising a main anchoring component configured to be embedded in tissue to provide main anchoring force; an auxiliary anchoring component configured to provide an auxiliary anchoring force, the auxiliary anchoring component comprising a reinforcing element disposed at a distal end of the auxiliary anchoring component and configured to compress or anchor a tissue surface, the auxiliary anchoring component operably coupled with the main anchoring component, capable of adjusting a relative distance between the reinforcing element and the main anchoring component, the reinforcing element is tightly attached to the tissue; the auxiliary anchoring component not only can provide auxiliary anchoring force, but also can adjust the relative distance between the reinforcing element and the main anchoring component, so that it is ensured that the reinforcing element can be tightly attached to the tissue, and the anchoring device has triple anchoring force; that is, the anchoring force of the anchoring device can be remarkably enhanced through the main anchoring force provided by the main anchoring component, the auxiliary anchoring force provided by the auxiliary anchoring component and the pressing force provided by the reinforcing element which is tightly attached to the surface of the tissue.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an anchoring device with multiple locking structures and its delivery system. Background Technology

[0002] Minimally invasive transcatheter treatment of cardiovascular diseases is gradually becoming a major treatment method. For example, coronary stents, heart valves, occluders, large vessel stents, and other cardiovascular implantable devices need to be delivered to the desired location on the body via a delivery device, and then fixed after reaching the target location. Fixation of heart valve prostheses is particularly important. Currently, the fixation of aortic and pulmonary valves mainly relies on the radial support force of the valve stent, using clamps or protrusions and depressions on the valve stent to utilize the anatomical structure and characteristics for fixation. The fixation of mitral and tricuspid valves mainly adds auxiliary fixation devices to the radial support force, such as barbs, hooks, leaflet clamps, annular clamps, apical fixation sutures, and fixation rods. However, due to the complex anatomical structure of the mitral and tricuspid valves, relying solely on the radial support of the valve stent and other auxiliary fixation devices can significantly impact the valve annulus, hindering the heart's diastolic and systolic movements and failing to effectively solve the fixation problem. Furthermore, for minimally invasive transcatheter products, the limitations of catheter diameter and performance make it difficult to create effective and flexible structures on the implantation device for fixation to the target anatomical structure.

[0003] For example, patent application CN202120566797.7 discloses an anchoring mechanism for use in cardiac implants. The anchoring mechanism includes a puncture member, an anchoring member, and a clamping member. The anchoring member is disposed within the puncture member. Both the clamping member and the needle member have a preset shape. During anchoring, after the puncture member is inserted into the target position, the anchoring member and the clamping member return to their preset shapes. The puncture member is first inserted into the heart tissue. When the needle member extends out from the channel of the puncture member, it can contact the heart tissue for anchoring. At the same time, it avoids premature bending of the needle member, ensuring the depth of the needle member in the heart tissue, thereby ensuring its anchoring force and avoiding the risk of the anchoring mechanism being pulled away from the heart tissue. Meanwhile, the clamping member on the puncture member ensures a fixed connection between the anchoring mechanism and the anchored area, preventing the anchoring mechanism from falling off the anchored area. In this patented solution, the anchor and the clamping member are limited by the tail of the anchor, resulting in a fixed and unadjustable distance between them. However, in actual operation, due to the lack of visualization during the procedure, the depth of the anchor inserted into the tissue is uncontrollable. When the anchor is not inserted deep enough, the clamping member will not be able to contact the tissue surface, and the clamping member will lose its further anchoring function. When the anchor is not inserted deep enough, its anchoring force will also be insufficient.

[0004] In summary, while existing anchoring devices incorporate clamping elements to further enhance anchoring force, the fixed distance between the clamping and anchoring elements, coupled with the uncontrollable depth of the anchoring element's penetration into the tissue, means that the clamping element fails to adhere to the tissue surface when the anchoring depth is insufficient, thus negating its anchoring function. Therefore, improvements to the anchoring device are needed to ensure the effective operation of the designed multi-anchoring structure and to further enhance the anchoring force to meet clinical needs. Summary of the Invention

[0005] This application is made in view of the above and other ideas.

[0006] One of the purposes of this application is to overcome the shortcomings of the prior art. For example, although the existing anchoring device is designed with a clamping member to further increase the anchoring force, the distance between the clamping member and the anchoring member is fixed, and the depth of the anchoring member into the tissue is uncontrollable. When the depth of the anchoring member into the tissue is insufficient, the clamping member cannot adhere to the tissue surface. Therefore, this application provides an anchoring device with a multi-locking structure.

[0007] The technical solution adopted to solve the technical problem of the present invention is to provide an anchoring device with a multi-locking structure, including a main anchoring component configured to be embedded in tissue to provide a main anchoring force; an auxiliary anchoring component configured to provide an auxiliary anchoring force; and the auxiliary anchoring component including a reinforcing element disposed at the distal end of the auxiliary anchoring component and configured to press or anchor the tissue surface; wherein the auxiliary anchoring component is operably coupled to the main anchoring component and the relative distance between the reinforcing element and the main anchoring component can be adjusted to ensure that the reinforcing element is in close contact with the tissue; the auxiliary anchoring component can adjust the relative distance between the reinforcing element and the main anchoring component so that it can ensure that regardless of the depth to which the main anchoring component is embedded in the tissue, the reinforcing element can be pressed tightly against the tissue surface by adjusting the auxiliary anchoring component, thereby enabling the entire anchoring device to have a triple anchoring effect, namely: the main anchoring force provided by the main anchoring component, the auxiliary anchoring force provided by the auxiliary anchoring component, and the pressing force of the reinforcing element against the tissue surface.

[0008] As a further improvement of the present invention, the auxiliary anchoring component includes a threaded shaft portion configured to penetrate into tissue to provide auxiliary anchoring force, and the threaded shaft portion is axially movable relative to the main anchoring component to adjust the relative distance between the clamping member and the main anchoring component.

[0009] As a further improvement of the present invention, the main anchoring component includes an anchoring needle structure and a connecting thread, the anchoring needle structure being configured to be anchored in the tissue in the form of a ship's anchor, and the connecting thread engaging with the auxiliary anchoring component.

[0010] As a further improvement of the present invention, the threaded shaft portion engages with the main anchoring component through the connecting thread, so that rotating the threaded shaft portion can drive the reinforcing element to move axially; the engagement between the threaded shaft portion and the connecting thread not only makes the connection between the main anchoring component and the auxiliary anchoring component stable and tight, but also allows the threaded shaft portion to provide auxiliary anchoring force after it is inserted into the tissue, further stabilizing the anchoring device in conjunction with the anchoring needle.

[0011] As a further improvement of the present invention, the reinforcing element is a disc-shaped structure, or the reinforcing element includes a plurality of deployable clamping plates, and the reinforcing element is disposed at the tail of the auxiliary anchoring component for adhering to the tissue surface.

[0012] In a preferred embodiment, the tip of the reinforcing element may also be configured to be sharp to penetrate into the tissue and provide a corresponding anchoring force.

[0013] As a further improvement of the present invention, the anchoring needle structure has a preset shape. When loaded, the anchoring needle structure is stretched into a straight line. When released, the anchoring needle structure folds over and forms an anchor-shaped structure to penetrate the tissue.

[0014] As a further improvement of the present invention, an anchoring device delivery system is also provided for delivering and manipulating the anchoring device as described above, comprising: an outer sheath assembly configured to releasably receive the anchoring device, and the distal end of the outer sheath assembly having a puncture portion; and a drive mechanism operatively connected to an auxiliary anchoring component of the anchoring device, configured to control rotation of the auxiliary anchoring component to adjust the relative distance between the reinforcing element and the main anchoring component.

[0015] As a further improvement of the present invention, the driving mechanism includes a driving tube and an inner core tube, wherein the distal end of the driving tube is provided with a detachable connecting structure for engaging with the auxiliary anchoring component; the inner core tube passes through the driving tube and can move axially therein; wherein, when the inner core tube is in a first position, it can maintain the engagement state between the connecting structure and the auxiliary anchoring component; when the inner core tube moves to a second position near its proximal end, the connecting structure is released, thereby separating the driving tube from the auxiliary anchoring component.

[0016] As a further improvement of the present invention, the connection structure is an S-shaped snap-fit ​​structure.

[0017] Compared with the prior art, the advantages of the technical solution of this application include at least the following: In existing technologies, although anchoring devices are designed with clamping elements to further increase anchoring force, the distance between the clamping element and the anchoring element is fixed, while the depth of the anchoring element's penetration into the tissue is uncontrollable. When the anchoring element's penetration depth is insufficient, the clamping element cannot adhere to the tissue surface, causing the clamping element to lose its further anchoring function. According to a concept of this application, the auxiliary anchoring component can not only provide auxiliary anchoring force but also adjust the relative distance between the reinforcing element and the main anchoring component to ensure that the reinforcing element can adhere tightly to the tissue. In this way, the anchoring device has triple anchoring force: the main anchoring force provided by the main anchoring component, the auxiliary anchoring force provided by the auxiliary anchoring component, and the clamping force provided by the reinforcing element adhering to the tissue surface, which can significantly enhance the anchoring force of the anchoring device.

[0018] According to one concept of this application, the auxiliary anchoring component includes a threaded shaft portion that engages with a connecting thread. When the threaded shaft portion rotates along the connecting thread into the tissue, it can provide an auxiliary anchoring force and adjust the relative distance between the clamping element and the anchoring needle structure to ensure that the reinforcing element can fit tightly against the tissue surface.

[0019] The embodiments of this application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0020] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figure 1 This is a schematic diagram of the anchoring device of the present invention installed in a conveying system.

[0021] Figure 2 This is a schematic diagram of the anchoring device of the present invention when it is released.

[0022] Figure 3 This is a schematic diagram of the anchoring device of the present invention.

[0023] The features represented by the numbers in the attached diagram are as follows: 1-Main anchoring component, 11-Anchoring needle structure, 12-Connecting thread, 2-Auxiliary anchoring component, 21-Threaded shaft, 3-Reinforcing element, 31-Pressure plate, 4-Outer sheath assembly, 41-Punch section, 5-Drive mechanism, 51-Drive tube, 511-Connecting structure, 52-Inner core tube. Detailed Implementation

[0024] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0025] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0026] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0027] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0028] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0029] Example 1: As Figure 1 , Figure 2 , Figure 3As shown, an anchoring device with a multi-locking structure includes a main anchoring component 1 configured to be embedded in tissue to provide a primary anchoring force; an auxiliary anchoring component 2 configured to provide an auxiliary anchoring force; and the auxiliary anchoring component 2 includes a reinforcing element 3 disposed at the distal end of the auxiliary anchoring component 2 and configured to press or anchor the tissue surface. The auxiliary anchoring component 2 is operably coupled to the main anchoring component 1 and can adjust the relative distance between the reinforcing element 3 and the main anchoring component 1 to ensure that the reinforcing element 3 adheres tightly to the tissue. The auxiliary anchoring component 2 not only provides an auxiliary anchoring force but also adjusts the relative distance between the reinforcing element 3 and the main anchoring component 1 to ensure that the reinforcing element 3 adheres tightly to the tissue. Thus, the anchoring device possesses triple anchoring force: the primary anchoring force provided by the main anchoring component 1, the auxiliary anchoring force provided by the auxiliary anchoring component 2, and the pressing force provided by the reinforcing element 3 adhering to the tissue surface, which significantly enhances the anchoring force of the anchoring device.

[0030] In this embodiment, as Figure 3 As shown, the auxiliary anchoring component 2 includes a threaded shaft portion 21, which is configured to penetrate into the tissue to provide auxiliary anchoring force. Furthermore, the threaded shaft portion 21 is axially movable relative to the main anchoring component 1 to adjust the relative distance between the clamping member and the main anchoring component 1.

[0031] In this embodiment, the main anchoring component 1 includes an anchoring needle structure 11 and a connecting thread 12. The anchoring needle structure 11 is configured to be anchored in the tissue in the form of an anchor, and the connecting thread 12 is connected to the auxiliary anchoring component 2.

[0032] In this embodiment, the threaded shaft 21 engages with the main anchoring component 1 via the connecting thread 12, so that rotating the threaded shaft 21 can drive the reinforcing element 3 to move axially. The engagement between the threaded shaft 21 and the connecting thread 12 not only makes the connection between the main anchoring component 1 and the auxiliary anchoring component 2 stable and tight, but also allows the threaded shaft 21 to provide auxiliary anchoring force after it is inserted into the tissue, further stabilizing the anchoring device in conjunction with the anchoring needle.

[0033] In this embodiment, the reinforcing element 3 is a disc-shaped structure, or the reinforcing element 3 includes a plurality of deployable clamping plates 31. The reinforcing element 3 is disposed at the tail of the auxiliary anchoring component 2 for adhering to the tissue surface.

[0034] In this embodiment, as Figure 1 and Figure 2 As shown, the anchoring needle structure 11 has a preset shape. When loaded, the anchoring needle structure 11 is stretched into a straight line. When released, the anchoring needle structure 11 folds over and forms an anchor-shaped structure that embeds itself into the tissue.

[0035] In this embodiment, as Figure 1 As shown, an anchoring device delivery system is also provided for delivering and manipulating the aforementioned anchoring device, comprising: an outer sheath assembly 4 configured to releasably accommodate the anchoring device, and the distal end of the outer sheath assembly 4 having a puncture portion 41; and a drive mechanism 5 operatively connected to an auxiliary anchoring component 2 of the anchoring device, configured to control the rotation of the auxiliary anchoring component 2 to adjust the relative distance between the reinforcing element 3 and the main anchoring component 1.

[0036] In this embodiment, the driving mechanism 5 includes a driving tube 51 and an inner core tube 52. The driving tube 51 has a detachable connecting structure 511 at its distal end for engaging with the auxiliary anchoring component 2. The inner core tube 52 passes through the driving tube 51 and can move axially within it. When the inner core tube 52 is in a first position, it can maintain the engagement state between the connecting structure 511 and the auxiliary anchoring component 2. When the inner core tube 52 moves to a second position near its proximal end, the connecting structure 511 is released, thereby separating the driving tube 51 from the auxiliary anchoring component 2.

[0037] In this embodiment, the connection structure 511 is an S-shaped snap-fit ​​structure.

[0038] In this embodiment, during operation, the puncture part 41 is pre-inserted into the tissue. Then, the driving tube 51 is pushed to make the anchoring needle structure 11 extend out of the outer sheath assembly 4, return to the preset shape, and insert into the tissue. The driving tube 51 is further rotated so that the threaded shaft part 21 rotates downward along the connecting thread 12 and inserts into the tissue. When the resistance of the operator's rotation operation increases, the reinforcing element 3 has been pressed against the tissue surface. At this time, the inner core tube 52 can be pulled out to release the connecting structure 511. Then, the delivery system is withdrawn to complete the anchoring.

[0039] The foregoing description of the embodiments described above is provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed. Clearly, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. An anchoring device with multiple locking structures, characterized in that: Includes a main anchoring component configured to be embedded in the tissue to provide the primary anchoring force; An auxiliary anchoring component is configured to provide an auxiliary anchoring force, and the auxiliary anchoring component includes a reinforcing element disposed at the distal end of the auxiliary anchoring component and configured to press against or anchor a tissue surface; wherein the auxiliary anchoring component is operatively coupled to the main anchoring component and is capable of adjusting the relative distance between the reinforcing element and the main anchoring component to ensure that the reinforcing element adheres to or penetrates the tissue.

2. The anchoring device with multiple locking structures according to claim 1, characterized in that: The auxiliary anchoring component includes a threaded shaft portion configured to penetrate into tissue to provide auxiliary anchoring force, and the threaded shaft portion is axially movable relative to the main anchoring component to adjust the relative distance between the clamping member and the main anchoring component.

3. The anchoring device with multiple locking structures according to claim 2, characterized in that: The main anchoring component includes an anchoring pin structure and a connecting thread. The anchoring pin structure is configured to be anchored in the tissue in the form of an anchor. The connecting thread is connected to the auxiliary anchoring component.

4. The anchoring device with multiple locking structures according to claim 3, characterized in that: The threaded shaft engages with the main anchoring component via the connecting thread, such that rotating the threaded shaft can drive the reinforcing element to move axially.

5. An anchoring device with multiple locking structures according to claim 1, characterized in that: The reinforcing element is a disc-shaped structure, or the reinforcing element includes multiple deployable clamping plates. The reinforcing element is disposed at the tail of the auxiliary anchoring component for adhering to the tissue surface.

6. An anchoring device with a multiple locking structure according to claim 3, characterized in that: The anchoring needle structure has a preset shape. When loaded, the anchoring needle structure is stretched into a straight line. When released, the anchoring needle structure folds over and forms an anchor-shaped structure to penetrate the tissue.

7. An anchoring device conveying system for conveying and manipulating the anchoring device as claimed in claim 1, characterized in that, include: An outer sheath assembly configured to releasably receive the anchoring device, and the distal end of the outer sheath assembly is provided with a puncture portion; And a drive mechanism operably connected to an auxiliary anchoring component of the anchoring device, configured to control the rotation of the auxiliary anchoring component to adjust the relative distance between the reinforcing element and the main anchoring component.

8. The anchoring device conveying system with multiple locking structures according to claim 7, characterized in that: The puncture portion is configured to pre-puncture the target tissue and form a channel for the anchoring device to pass through.

9. The anchoring device conveying system with multiple locking structures according to claim 7, characterized in that: The driving mechanism includes a driving tube and an inner core tube. The driving tube has a detachable connecting structure at its distal end for engaging with the auxiliary anchoring component. The inner core tube passes through the driving tube and can move axially within it. When the inner core tube is in a first position, it maintains the engagement between the connecting structure and the auxiliary anchoring component. When the inner core tube moves to a second position near its proximal end, the connecting structure is released, thereby separating the driving tube from the auxiliary anchoring component.

10. The anchoring device conveying system with multiple locking structures according to claim 9, characterized in that: The connection structure is an S-shaped snap-fit ​​structure.

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