A method of using an interventional valve delivery system

Abstract

This application relates to a method of using an interventional valve delivery system, comprising the following steps: determining the difference between the distal and proximal ends of the output face of the delivery system in a direction parallel to the axial direction of the delivery system, based on the characteristics of the lesion site; installing the interventional valve into the delivery system; controlling the delivery system to deliver the interventional valve to the lesion site and releasing the interventional valve. Using the method of this application, during the release of the interventional valve, the distal end of the output face provides support to the interventional valve, preventing excessive bending of the valve towards the distal side and ensuring that the end face of the interventional valve remains nearly parallel to the valve annulus, thereby ensuring the accuracy of the valve's alignment with the annulus. Furthermore, based on the characteristics of the lesion site, the difference between the distal and proximal ends can be adjusted, thereby adjusting the supporting effect of the distal and proximal ends on the interventional valve during release, ensuring good implantation accuracy for various valve annulus types.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a method of using an interventional valve delivery system. Background Technology

[0002] Interventional valves are usually implanted into the human body through a delivery system. However, due to the limitations of the delivery system's entry point or access channel, it is difficult to ensure that the angle between the rivet part of the interventional valve and the implantation point (such as the valve annulus) is consistent during implantation, resulting in an unsatisfactory implantation position. Summary of the Invention

[0003] The purpose of this application is to provide a method of using an interventional valve delivery system to solve the problem of inconsistent angles between the anchoring part of the interventional valve and the implantation point in the human body in the prior art.

[0004] This application provides a method of using an interventional valve delivery system, comprising the following steps:

[0005] The difference between the farthest and nearest ends of the output face of the delivery system in the axial direction parallel to the delivery system is determined based on the characteristics of the lesion site.

[0006] An interventional valve is installed into the delivery system. One end of the interventional valve has a pre-release portion and a post-release portion, with the pre-release portion facing the side where the nearest end is located and the post-release portion facing the side where the farthest end is located.

[0007] The delivery system is controlled to deliver the interventional valve to the patient site and then release the interventional valve.

[0008] In one possible implementation, the installation of the interventional valve into the delivery system specifically includes:

[0009] The interventional valve includes a main body, one end of which is provided with an inflow end and the other end of which is provided with an outflow end. A first direction perpendicular to the end face of the inflow end forms a first angle with the center line of the main body, so that the inflow end has a high point and a low point in the direction extending along the center line of the main body, and the side of the interventional valve with the high point is oriented toward the side where the nearest end of the delivery system is located.

[0010] The outflow end of the interventional valve is installed into the delivery system prior to the inflow end.

[0011] In one possible implementation, the inflow end includes a front ring and a rear ring, wherein the maximum distance between the front ring and the centerline of the main body is greater than the maximum distance between the rear ring and the centerline of the main body;

[0012] The front ring includes the high point.

[0013] In one possible implementation, the end face of the outflow end is parallel to the end face of the inflow end.

[0014] In one possible implementation, the difference is 0 to 1 times the diameter of the conveying system.

[0015] In one possible implementation, the end face of the output end of the conveying system is a plane.

[0016] In one possible implementation, the end face of the output end of the delivery system includes an arcuate protrusion disposed at the edge of the output end between the farthest end and the nearest end, and the arcuate protrusion protrudes in the direction of the interventional valve release.

[0017] In one possible implementation, the inflow end of the interventional valve is circular, elliptical, or D-shaped.

[0018] In one possible implementation, the diseased site is characterized by an angle between the valve annulus and the direction in which the delivery system releases the interventional valve implantation.

[0019] The technical solution provided in this application can achieve the following beneficial effects:

[0020] The method of the interventional valve delivery system provided in this application creates a height difference at the output end of the delivery system by forming an oblique structure on the end face. During valve release, the distal portion of the end face provides support to the valve, preventing excessive bending of the valve towards the distal side. This allows the valve to be released along the axial direction of the delivery system, ensuring that the valve end face remains nearly parallel to the valve annulus, thus guaranteeing accurate positioning of the valve. Furthermore, the difference between the distal and proximal ends of the output end face can be adjusted according to the characteristics of the lesion site, thereby regulating the support provided by these ends during valve release and ensuring good implantation accuracy for various valve annulus types.

[0021] It should be understood that the above general description and the following detailed description are merely exemplary and do not limit this application. Attached Figure Description

[0022] Figure 1 A flowchart of the interventional valve implantation method provided in the embodiments of this application;

[0023] Figure 2 This is a schematic diagram of the interventional valve structure;

[0024] Figure 3 A schematic diagram of the conveying system at the output end (I);

[0025] Figure 4 This is a schematic diagram of the interventional valve being installed in the delivery system in the forward orientation.

[0026] Figure 5 This is a schematic diagram of the interventional valve being delivered to the valve annulus in an orthogonally mounted state within the delivery system.

[0027] Figure 6 This is a schematic diagram of the interventional valve being installed in reverse in the delivery system.

[0028] Figure 7 This is a schematic diagram of the interventional valve being delivered to the valve annulus in a reverse-mounted configuration within the delivery system.

[0029] Figure 8 A schematic diagram of the interventional valve being installed in reverse in the delivery system after the distance difference between the farthest and nearest ends has been reduced;

[0030] Figure 9 Schematic diagram (II) of the conveying system located at the output end.

[0031] Figure label:

[0032] 1-Interventional valve;

[0033] 11-Main body;

[0034] 12-Inflow end;

[0035] 121-Front Ring;

[0036] 121a - First release site;

[0037] 122-Rear Ring;

[0038] 122a - Post-release site;

[0039] 13-Outflow end;

[0040] 2-Conveying system;

[0041] 21-Output terminal;

[0042] 211 - Farthest point;

[0043] 212 - Nearest end;

[0044] 213 - Arc-shaped convex part;

[0045] H1 - Distance;

[0046] H2 - Distance;

[0047] 3-Lobe ring;

[0048] A-Centerline;

[0049] B-axis;

[0050] C - First direction.

[0051] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. Detailed Implementation

[0052] To better understand the technical solution of this application, the embodiments of this application will be described in detail below with reference to the accompanying drawings.

[0053] It should be understood that the described embodiments are merely some, not all, of the embodiments in this application. All other embodiments obtained by those skilled in the art based on the embodiments in this application without inventive effort are within the scope of protection of this application.

[0054] The terminology used in the embodiments of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The singular forms “a,” “the,” and “the” used in the embodiments of this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise.

[0055] It should be understood that the term "and / or" used in this article is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Additionally, the character " / " in this article generally indicates that the preceding and following related objects have an "or" relationship.

[0056] It should be noted that the directional terms such as "upper," "lower," "left," and "right" described in the embodiments of this application are used to describe the angles shown in the accompanying drawings and should not be construed as limiting the embodiments of this application. Furthermore, in the context, it should be understood that when it is mentioned that an element is connected "upper" or "lower" to another element, it can be directly connected to the other element "upper" or "lower," or indirectly connected to the other element "upper" or "lower" through an intermediate element.

[0057] When the body's native valves, such as the mitral or tricuspid valves, become diseased, interventional valves are generally needed to replace the diseased native valves to ensure normal bodily function. Interventional valves are typically delivered into the body via a delivery system. Externally, the interventional valve can be contained within the delivery system. Before implantation, a hole is made at the apex of the heart or similar site. The delivery system containing the interventional valve is then moved through this hole to the implantation location. The delivery system can then be controlled to release the interventional valve, allowing it to expand and anchor at the diseased site, thus completing the implantation procedure.

[0058] However, existing delivery systems typically have an output end face that is perpendicular to the system's axis. In contrast, the two ends of the interventional valve in the release direction are not parallel to the delivery system's end face but are tilted at a certain angle. This causes the end face of the interventional valve to not be released simultaneously during release. Instead, the portion of the end face closer to the delivery system's output end is released first. This portion expands preferentially after being released from the delivery system, and this expanded portion is squeezed towards the unreleased side, causing the interventional valve to bend to one side. Consequently, the end face of the interventional valve cannot maintain a relatively close parallel state with the original valve annulus, resulting in inaccurate anchoring of the interventional valve.

[0059] like Figure 1 As shown in the figure, this application provides an interventional valve implantation method, which includes the following steps:

[0060] Step S1: Determine the distance H1 difference between the farthest end 211 and the nearest end 212 of the output end 21 of the delivery system 2 in the direction parallel to the axis of the delivery system 2, based on the characteristics of the lesion site. Here, both the nearest end 212 and the farthest end 211 are referenced to the user; that is, the end on the end face that is relatively closer to the user is the nearest end 212, and the end that is relatively farther from the user is the farthest end 211.

[0061] like Figure 3 As shown, in this embodiment, the delivery system 2 has a channel for receiving the interventional valve 1, which is generally a cylindrical channel. The end face of the output end 21 of the delivery system 2 is not a plane perpendicular to the axis B of the delivery system 2, but forms a certain angle with the axis B, presenting an inclined state, so that the end face of the output end 21 of the delivery system 2 forms a nearest end 212 and a farthest end 211 along the axial direction of the delivery system 2, and a certain distance difference is formed between the nearest end 212 and the farthest end 211.

[0062] The characteristics of the lesion site include the angle between the annulus 3 and the direction in which the delivery system 2 releases the interventional valve 1 for implantation. The plane containing the annulus 3 can form a certain angle with the direction in which the delivery system 2 releases the interventional valve 1. Ideally, this angle is 90°, meaning the plane containing the annulus 3 is perpendicular to the direction in which the delivery system 2 releases the interventional valve 1. However, because the annulus 3 and other tissues in the human body vary from person to person, the plane containing the annulus 3 and the direction in which the delivery system 2 releases the interventional valve 1 cannot be guaranteed to be absolutely perpendicular. This will cause the position of the interventional valve 1 to not reliably match the annulus 3 after release, resulting in a positional error. If this error is too large, it will affect the normal function of the interventional valve 1, and may even prevent the reliable anchoring of the interventional valve 1, causing it to fall off.

[0063] In this embodiment, by forming an oblique structure on the end face of the output end 21 of the delivery system 2, a height difference can be created at the output end 21. When the interventional valve 1 is released, the part of the end face located at the farthest end 211 can provide support for the interventional valve 1, preventing the interventional valve 1 from bending excessively to the farthest end 211. This relatively enables the interventional valve 1 to be released along the axial direction of the delivery system 2, ensuring that the end face of the interventional valve 1 remains nearly parallel to the valve annulus 3, thereby ensuring the accuracy of the alignment between the interventional valve 1 and the valve annulus 3. Furthermore, based on the characteristics of the lesion site, the difference between the farthest end 211 and the nearest end 212 of the end face of the output end 21 of the delivery system 2 can be adjusted, thereby adjusting the supporting effect of the farthest end 211 and the nearest end 212 on the interventional valve 1 during release, ensuring good implantation accuracy for various valve annulus 3.

[0064] Step S2: Install the interventional valve 1 into the delivery system 2. One end of the interventional valve 1 has a pre-release part and a post-release part, with the pre-release part facing the side where the nearest end 212 is located and the post-release part facing the side where the farthest end 211 is located.

[0065] It is understandable that, such as Figure 2 As shown, the interventional valve 1 has an inflow end 12 and an outflow end 13. The diameter of the inflow end 12 is larger than the diameter of the outflow end 13. The inflow end 12 and the outflow end 13 are inclined relative to their own central axis. That is, when the interventional valve 1 is constricted in the delivery system 2, the end faces of the inflow end 12 and the outflow end 13 are not perpendicular to the axial direction of the delivery system 2, but form a certain angle with the axial direction of the delivery system 2.

[0066] When the interventional valve 1 is installed in the delivery system 2, either the inflow end 12 or the outflow end 13 of the interventional valve 1 can be installed first. The specific installation posture of the interventional valve can be adjusted according to actual needs. In this embodiment, when the interventional valve 1 is in the delivery system 2, the example is that its inflow end 12 is closer to the output end 21 of the delivery system 2 than its outflow end 13.

[0067] The aforementioned first release portion 121a and subsequent release portion 122a are opposite sides of the inflow end 12 in the radial direction. When the interventional valve 1 is released, the inflow end 12 of the interventional valve 1 is released first relative to the outflow end 13. However, since the end face of the inflow end 12 is inclined, it can be understood that, given the design that the end face of the output end 21 of the delivery system 2 is a plane perpendicular to the axial direction of the delivery system 2, different positions on the end face of the inflow end 12 of the interventional valve 1 will not be released simultaneously. That is, the portion on the end face of the inflow end 12 that is closer to the output end 21 of the delivery system 2 along the axial direction is released first. This causes the interventional valve 1 to bend more and more towards the end released after the inflow end 12 during the release process, resulting in a deviation in the implantation position.

[0068] In this embodiment, such as Figure 6 and Figure 7 As shown, the interventional valve 1 is installed in a reversed state in the delivery system 2. Specifically, by making the portion of the inflow end 12 of the interventional valve (based on its state in the delivery system) closer to the output end 21 of the delivery system (the first release portion 121a) face the side where the nearest end 212 of the output end 21 of the delivery system is located, and making the portion of the inflow end 12 of the interventional valve further away from the output end 21 of the delivery system (the second release portion 122a) face the side where the farthest end 211 of the output end 21 of the delivery system is located, when the interventional valve 1 begins to be released, the first release portion 121a is preferentially released from the aforementioned nearest end 212, and the second release portion 122a can be supported by the aforementioned farthest end 211, thus limiting the excessive bending of the interventional valve 1 towards the side of the second release portion 122a during the release process. This allows the interventional valve 1 to be released along an axis close to the delivery system 2, thereby ensuring that the interventional valve 1 can be adapted to the position of the valve annulus 3 and ensuring the accuracy of the implantation position.

[0069] In addition, such as Figure 4 and Figure 5As shown, if the release part 121a is first directed toward the side where the farthest end 211 of the output end 21 of the delivery system 2 is located, and then the release part 122a is directed toward the side where the nearest end 212 of the output end 21 of the delivery system 2 is located, so that the interventional valve 1 is in a forward-mounted state in the delivery system 2, it will cause the interventional valve 1 to bend more easily toward the side of the release part 122a. This application embodiment does not limit this.

[0070] Step S3: Control the delivery system 2 to deliver the interventional valve 1 to the patient site and release the interventional valve 1.

[0071] Specifically, step S2 includes:

[0072] Step S21: The interventional valve 1 includes a main body 11, such as... Figure 2 As shown, one end of the main body 11 is provided with an inflow end 12, and the other end of the main body 11 is provided with an outflow end 13. A first direction C perpendicular to the end face of the inflow end 12 forms a first angle with the center line of the main body 11, so that the inflow end 12 has a high point and a low point in the direction extending along the center line of the main body 11, and the side of the interventional valve 1 with the high point faces the side where the nearest end 212 of the delivery system 2 is located.

[0073] In the conventional delivery system 2, when the interventional valve 1 is installed, the end with the higher point is released first during the release process, and it gradually bends towards the end with the lower point, resulting in an ineffective fit between the final implantation posture and the valve annulus 3. In this embodiment, by aligning the side of the interventional valve 1 with the side containing the higher point towards the nearest end 212 of the delivery system 2, the higher end of the interventional valve 1 is released first from the side containing the nearest end 212 of the output end 21 of the delivery system 2. Meanwhile, the lower end of the interventional valve 1 is supported by the farthest end 211 of the output end 21 of the delivery system 2, preventing excessive bending towards the lower end. This ensures that the interventional valve 1 is gradually released along an axis close to the delivery system 2 throughout the entire release process, guaranteeing the implantation accuracy of the interventional valve 1 and thus ensuring the effective fit between the interventional valve 1 and the valve annulus 3.

[0074] Step S22: Install the outflow end 13 of the interventional valve 1 into the delivery system 2, prioritizing the inflow end 12.

[0075] Specifically, such as Figure 2 As shown, in order to better adapt to the human body's native valve, the inflow end 12 of the interventional valve 1 includes an anterior ring 121 and a posterior ring 122. The maximum distance between the anterior ring 121 and the center line of the main body 11 is greater than the maximum distance between the posterior ring 122 and the center line of the main body 11. The anterior ring 121 includes the aforementioned high point.

[0076] Of course, the inflow end 12 and outflow end 13 of the interventional valve 1 can also be circular, elliptical or D-shaped.

[0077] Specifically, the end face of the outflow end 13 is parallel to the end face of the inflow end 12. This facilitates blood flow between the inflow end 12 and the outflow end 13 of the interventional valve 1.

[0078] Specifically, the difference between the farthest end 211 and the nearest end 212 along the axial direction of the delivery system 2 is 0 to 1 times the diameter of the delivery system 2. That is, when the difference between the farthest end 211 and the nearest end 212 is 1 times the diameter of the delivery system 2 (i.e., the difference between the farthest end 211 and the nearest end 212 is equal to the diameter of the delivery system 2), the angle between the line connecting the farthest end 211 and the nearest end 212 and the radial direction of the delivery system 2 is 45°; when the difference between the farthest end 211 and the nearest end 212 is 0 times the diameter of the delivery system 2 (i.e., the difference between the farthest end 211 and the nearest end 212 is 0), the end face of the output end 21 of the delivery system 2 is a plane perpendicular to the axis of the delivery system 2. In this embodiment, the difference between the farthest end 211 and the nearest end 212 along the axial direction of the delivery system 2 is 0.2 to 1 times the diameter of the delivery system 2. Within this range, it can be ensured that the interventional valve 1 can adapt to valve annulus 3 in various different states. The angle between the inflow end 12 and the plane of the valve annulus 3 during the release of the interventional valve 1 can be adjusted by changing the difference between the distal end 211 and the proximal end 212. This ensures that the implantation position of the interventional valve 1 matches the valve annulus 3, guaranteeing implantation accuracy. Specifically, ensuring that the difference between the distal end 211 and the proximal end 212 is within one time the diameter of the delivery system 2 avoids that an excessively large difference could obstruct the release of the interventional valve 1.

[0079] Furthermore, within this numerical range, such as Figure 6 and Figure 8 As shown, Figure 6 and Figure 8 The interventional valve 1 and delivery system 2 shown are installed in the same way, the difference being that... Figure 8 The difference in distance H2 between the farthest end 211 and the nearest end 212 shown is less than Figure 6 The distance H1 difference between the distal end 211 and the proximal end 212 shown in the figure, since H2 is less than H1, reduces the height at which the distal end 211 supports the interventional valve 1, thus... Figure 8 Interventional valve 1 relative to Figure 6 The interventional valve 1 is more likely to bend towards the most distal side 211 to adapt to the valve annulus 3 in different states.

[0080] In one specific implementation, the end face of the output end 21 of the conveying system 2 is a plane. This plane is inclined relative to the axis of the conveying system 2, so that the plane has the aforementioned nearest end 212 and farthest end 211. This plane can be formed by a cutting process.

[0081] In another specific implementation, such as Figure 9 As shown, the end face of the output end 21 of the delivery system 2 includes an arc-shaped protrusion 213. The arc-shaped protrusion 213 is disposed on the edge of the output end 21 between the farthest end 211 and the nearest end 212, and the arc-shaped protrusion 213 protrudes in the direction of release of the interventional valve 1. This arc-shaped protrusion 213 can guide and constrain the interventional valve 1 during the release process, so that when the interventional valve 1 begins to be released from the position of the nearest end 212, it will not deviate excessively to the sides of the nearest end 212 and the farthest end 211, further ensuring the release state and implantation position accuracy of the interventional valve 1.

[0082] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A method of using an interventional valve delivery system, characterized in that, Includes the following steps: The difference (H1) between the farthest end (211) and the nearest end (212) of the end face of the output end (21) of the delivery system (2) in the axial direction of the delivery system (2) is determined according to the characteristics of the lesion site; An interventional valve (1) is installed into the delivery system (2). One end of the interventional valve (1) has a first release portion (121a) and a second release portion (122a). The first release portion (121a) is oriented toward the side where the nearest end (212) is located, and the second release portion (122a) is oriented toward the side where the farthest end (211) is located. When the interventional valve (1) is released, the end face of the output end (21) located at the farthest end (211) provides support to the interventional valve (1) and prevents the interventional valve (1) from bending excessively toward the farthest end (211). The installation of the interventional valve (1) into the delivery system (2) specifically includes: The interventional valve (1) includes a main body (11), one end of which is provided with an inflow end (12), and the other end of which is provided with an outflow end (13). A first direction (C) perpendicular to the end face of the inflow end (12) forms a first angle with the center line (A) of the main body (11), so that the inflow end (12) has a high point and a low point in the direction extending along the center line (A) of the main body (11), and the side of the interventional valve (1) with the high point faces the side where the nearest end (212) of the delivery system (2) is located. The outflow end (13) of the interventional valve (1) is installed into the delivery system (2) prior to the inflow end (12); The inflow end (12) includes a front ring (121) and a rear ring (122), and the maximum distance between the front ring (121) and the center line (A) of the main body (11) is greater than the maximum distance between the rear ring (122) and the center line (A) of the main body (11); The front ring (121) includes the high point; The end face of the outflow end (13) is parallel to the end face of the inflow end (12).

2. The method of using the interventional valve delivery system according to claim 1, characterized in that, The difference is 0.2 to 1 times the diameter of the conveying system.

3. The method of using the interventional valve delivery system according to claim 1, characterized in that, The output end (21) of the conveying system has a flat surface.

4. The method of using the interventional valve delivery system according to claim 1, characterized in that, The end face of the output end (21) of the delivery system includes an arcuate protrusion (213), which is disposed at the edge of the output end (21) between the farthest end (211) and the nearest end (212), and the arcuate protrusion (213) protrudes in the direction of release of the interventional valve (1).

5. The method of using the interventional valve delivery system according to claim 1, characterized in that, The inflow end (12) of the interventional valve (1) is circular, elliptical or D-shaped.

6. The method of using the interventional valve delivery system according to claim 1, characterized in that, The features of the affected site include the angle between the valve annulus (3) and the direction in which the delivery system (2) releases the interventional valve (1) for implantation.

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