A method of making an aortic valve anchor

Abstract

The application relates to a manufacturing method of an aortic valve anchor, which comprises the following steps: cutting a base plate into an anchor semi-finished product in a planar unfolded state, and then cooperating with a shaping tool and heat treatment to axially stretch the anchor semi-finished product to form an anchor finished product in a three-dimensional state. The method omits the previous heat treatment step, reduces multiple shaping steps and heat treatment steps of a traditional shaping tool, directly stretches and shapes the final anchor, simplifies the process, avoids the instability caused by the traditional multiple heat treatment process and outward extension and shaping clamping, has small heat deformation, avoids the obstruction of the poor node formed at the bottom end of the positioning sinus of the anchor during implantation, improves the forming quality and use effect of the anchor, simultaneously reduces the manufacturing cost, and is favorable for improving the production efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a method for manufacturing an aortic valve anchor. Background Technology

[0002] Aortic valve anchors are components that position and anchor the valve during implantation. Due to the highly complex anatomy of the heart, the structure and contour of the anchor must be carefully designed to ensure effective support and long-term service after implantation. Current technologies, such as 3D laser cutting, are limited by the size of the laser cutting machine's fixtures and its cutting power. Generally, only smaller diameter tubing can be used initially for cutting, and the cut parts are then gradually shaped into the desired product structure through heat treatment. In existing technologies, shaping molds are typically used to extend the tubing outwards. During the heat treatment process, the outward extension requires the assembly and disassembly of shaping molds of different sizes according to the design dimensions, affecting production efficiency. Multiple shaping and resetting processes are complex and introduce instability. As the shaping size increases, the anchoring component undergoes irregular deformation, and the arc transition portion does not transition in the same direction as the straight rod. This creates a node between the arc portion of the anchoring component at the sinus base and the straight rod. During implantation and release, this node obstructs the anchoring component, preventing it from moving effectively down the vessel wall to the sinus base during valve implantation. Furthermore, the multiple heat treatments and shaping processes easily lead to deformation errors during the manufacturing of the anchoring component, resulting in poor molding quality and unsatisfactory performance. Summary of the Invention

[0003] Therefore, the technical problem to be solved by the present invention is that the multiple heat treatment and shaping processes can easily lead to deformation errors in the manufacturing process of the anchoring parts, resulting in poor molding quality and unsatisfactory performance.

[0004] This invention provides a method for manufacturing an aortic valve anchor, comprising the following steps:

[0005] S1: An anchoring semi-finished product formed by cutting the substrate into a planar unfolded state, which includes the following steps;

[0006] S11: Establish a model of the planar unfolded state of the aortic valve anchor;

[0007] S12: Select the substrate according to the model dimensions;

[0008] S13: Input the model into the cutting machine to cut the substrate to obtain a semi-finished anchor part in a planar unfolded state.

[0009] S2: Perform heat treatment and shaping operations on the semi-finished anchor components, including the following sub-steps:

[0010] S21: Perform the first heat treatment on the semi-finished anchoring parts;

[0011] S22: The anchoring component semi-finished product undergoes a second heat treatment. At the same time, the anchoring component semi-finished product undergoing the second heat treatment is limited and stretched to form a three-dimensional anchoring component through a shaping fixture.

[0012] Optionally, in step S21, the temperature of the first heat treatment is 470 to 490°C, and the holding time is 8 to 12 minutes.

[0013] Optionally, in step S22, the shaping temperature of the second heat treatment is 510 to 530°C, and the holding time is 13 to 17 minutes.

[0014] Optionally, the substrate is a shape memory alloy.

[0015] Optionally, in step S2: the shaping fixture includes a first fixture and a second fixture, the first fixture and the anchoring component semi-finished product are abutted together, the anchoring component semi-finished product is sleeved on the outside of the first fixture, the first fixture is used to limit and shape the inner side of the anchoring component semi-finished product; the second fixture is abutted together on the outer side of the anchoring component semi-finished product, the second fixture is used to limit and shape the outer side of the anchoring component semi-finished product;

[0016] The first tooling and the second tooling have a sliding state in which they move relative to each other under the action of external force.

[0017] Optionally, the anchoring component semi-finished product is provided with a first connecting portion and a second connecting portion that are staggered and spaced apart;

[0018] The first tooling is provided with a first positioning part, which is installed on the outer wall surface of the first tooling facing the anchoring part semi-finished product. The second tooling is provided with a second positioning part. The first positioning part is detachably connected to the first connecting part. The second positioning part is located on the side of the second tooling facing the anchoring part semi-finished product. The second positioning part is movably connected to the second connecting part.

[0019] In the sliding state, the first positioning part abuts against the first connecting part, and the second positioning part abuts against the second connecting part, so that the first connecting part and the second connecting part move away from each other, and the anchoring part semi-finished product is stretched to form a three-dimensional anchoring part.

[0020] Optionally, the anchoring component semi-finished product is configured as a triangular structure, with three of each of the first and second connecting parts.

[0021] Optionally, the first tooling is configured as a cylindrical structure, comprising a first body and a second body, wherein the outer diameter of the first body is larger than the outer diameter of the second body, and the first connecting portion is disposed on the first body; and / or

[0022] The second tooling is configured as an arc-shaped plate structure, and the second tooling is distributed in a ring around the outside of the anchoring component semi-finished product.

[0023] Optionally, the axial direction of any tooling is collinear with the axial direction of the anchoring component semi-finished product.

[0024] Optionally, the first connecting portion is provided with at least one connecting hole.

[0025] The technical solution provided by this invention has the following advantages:

[0026] 1. The manufacturing method provided by this invention involves cutting a substrate into a planar unfolded anchoring component semi-finished product, and then using shaping tooling and heat treatment in conjunction with axial stretching to form a three-dimensional anchoring component finished product. This method omits the initial heat treatment step, reduces the multiple shaping and heat treatment steps of traditional shaping tooling, and directly stretches the final anchoring component, simplifying the process and avoiding the instability caused by traditional multiple heat treatment processes and outward extension and shaping clamping. It also results in minimal thermal deformation, preventing the formation of undesirable nodes at the positioning sinus base during anchoring component implantation, thus effectively preventing the anchoring component from failing to move smoothly down the vessel wall to the desired sinus base during valve implantation. This manufacturing method effectively improves the forming quality and performance of the anchoring component, while reducing manufacturing costs and increasing production efficiency.

[0027] 2. The manufacturing method provided by the present invention involves a first heat treatment temperature of 470 to 490°C and a holding time of 8 to 12 minutes. The first heat treatment eliminates the residual stress left in the anchoring part semi-finished product after cutting, prevents the anchoring part semi-finished product from undergoing undesirable fracture during subsequent shaping, improves the plasticity, optimizes the subsequent stretching and shaping, and helps to improve the molding quality.

[0028] 3. In the manufacturing method provided by the present invention, the shaping fixture in step S2 includes a first fixture and a second fixture. The first fixture and the anchoring component semi-finished product are abutted together, and the anchoring component semi-finished product is sleeved outside the first fixture. The first fixture is used to limit and shape the inner side of the anchoring component semi-finished product. The second fixture is abutted together on the outer side of the anchoring component semi-finished product, and the second fixture is used to limit and shape the outer side of the anchoring component semi-finished product. The first fixture and the second fixture have a sliding state that moves away from each other under the action of external force. By abutting and limiting the inner and outer sides of the anchoring component semi-finished product respectively by the first fixture and the second fixture, the anchoring component semi-finished product is deformed into the required three-dimensional structure along the desired direction.

[0029] 4. The manufacturing method provided by the present invention includes a semi-finished anchor component with staggered first and second connecting portions; a first tooling with a first positioning portion and a second tooling with a second positioning portion; the first positioning portion is detachably connected to the first connecting portion, and the second positioning portion is located on the side of the second tooling facing the semi-finished anchor component, and is movably connected to the second connecting portion. When the first and second toolings slide relative to each other, the first positioning portion abuts against the first connecting portion, and the second positioning portion abuts against the second connecting portion, causing the first and second connecting portions to move away from each other, thus stretching the semi-finished anchor component to form the desired three-dimensional anchor component. The limiting and shaping effects of the first and second positioning portions on the outer contour of the anchor component improve the forming quality of the anchor component. Attached Figure Description

[0030] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0031] Figure 1 This is a schematic diagram illustrating the operation of the aortic valve anchoring component during manufacturing, as provided in an embodiment of the present invention.

[0032] Figure 2 This is a schematic diagram illustrating the testing process during the fabrication of the aortic valve anchor provided in an embodiment of the present invention.

[0033] Figure 3 This is a schematic diagram of the structure of the anchoring component semi-finished product provided in the embodiments of the present invention;

[0034] Figure 4 This is a schematic diagram of the structure of the first tooling provided in an embodiment of the present invention;

[0035] Figure 5 This is a schematic diagram of the structure of the second tooling provided in an embodiment of the present invention;

[0036] Figure 6 This is a structural schematic diagram of the anchoring component provided in an embodiment of the present invention;

[0037] Explanation of reference numerals in the attached figures:

[0038] 1-Anchoring component semi-finished product; 11-First connecting part; 12-Second connecting part;

[0039] 2-First tooling; 21-First positioning part; 22-First body; 23-Second body;

[0040] 3-Second tooling; 31-Second positioning part;

[0041] 4-Finished anchoring components. Detailed Implementation

[0042] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0043] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0044] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0045] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0046] Example 1

[0047] This embodiment provides a method for manufacturing an aortic valve anchor, including the following steps:

[0048] S1: An anchoring semi-finished product 1, which is formed by cutting the substrate into a planar unfolded state, includes the following steps;

[0049] S11: Based on the aortic valve shape required by the patient, establish a model of the planar unfolded state of the aortic valve anchor.

[0050] S12: Select a substrate according to the model size; wherein the substrate is configured as a shape memory alloy part, and the substrate is set as a nickel-titanium alloy plate.

[0051] S13: Input the model into the cutting machine to cut the substrate to obtain the anchor semi-finished product 1 in the plane unfolded state;

[0052] S2: Perform heat treatment and shaping operations on the anchoring component semi-finished product 1, including the following sub-steps:

[0053] S21: The anchoring component semi-finished product 1 is subjected to a first heat treatment at a temperature of 470 to 490°C and a holding time of 8 to 12 minutes.

[0054] S22: The anchoring component semi-finished product 1 undergoes a second heat treatment. Simultaneously, a shaping fixture is used to limit and stretch the anchoring component semi-finished product 1 during the second heat treatment to form a three-dimensional anchoring component. The shaping temperature of the heat treatment is set to 510 to 530℃, and the holding time is 13 to 17 minutes.

[0055] In step S21, the first heat treatment eliminates the residual stress formed in the anchoring part semi-finished product 1 after cutting, preventing the anchoring part semi-finished product 1 from undergoing undesirable fracture during subsequent shaping. At the same time, it improves the plasticity. The heat treatment softens the structure of the anchoring part, which optimizes the subsequent stretching and shaping, making it easier to assemble the anchoring part with the shaping tooling during subsequent shaping, thus improving the molding quality.

[0056] In step S22, the two-dimensional planar unfolded part is shaped into the required three-dimensional shape of the anchoring part. This is achieved through the use of shaping tooling. Considering the characteristics of nickel-titanium material and parameters such as the Af temperature of the anchoring part after shaping, the shaping temperature is set to 510 to 530℃ so that the nickel-titanium alloy plate can be fully deformed with the shaping tooling.

[0057] In step S13, the cutting machine can be a laser cutting machine or a wire cutting machine with two-dimensional planar cutting function.

[0058] In this embodiment, the final shape of the anchoring part is first obtained by planar cutting. Then, the planar unfolded part is heat-treated and shaped. This allows the arc transition part at the bottom of the positioning ring sinus of the anchoring part to transition in the same direction as the straight rod, thereby solving the problem of irregular deformation at the bottom of the positioning sinus due to expansion and extension during the manufacturing process of existing anchoring parts, and avoiding the problem that the arc part at the bottom of the positioning sinus of the anchoring part cannot transition in the same direction as the straight rod.

[0059] Compared to existing manufacturing methods, this embodiment cuts the substrate into a planar unfolded anchoring component semi-finished product 1, and then uses shaping tooling and heat treatment in conjunction with axial stretching of the anchoring component semi-finished product 1 to form a three-dimensional anchoring component finished product 4. This eliminates the need for the initial heat treatment step, reduces the multiple shaping and heat treatment steps of traditional shaping tooling, simplifies the process, avoids the instability caused by traditional multiple heat treatment processes and shaping clamping, and prevents the formation of undesirable nodes at the positioning sinus base during anchoring component implantation. Therefore, it effectively prevents the anchoring component from failing to move smoothly down the vessel wall to the desired sinus base during valve implantation. This manufacturing method effectively improves the molding quality and performance of the anchoring component.

[0060] Example 2

[0061] This embodiment provides a shaping fixture for limiting, supporting, and shaping the anchoring component semi-finished product 1 in Embodiment 1. The shaping fixture includes a first fixture 2 and a second fixture 3. The first fixture 2 and the anchoring component semi-finished product 1 are abutted together, with the anchoring component semi-finished product 1 sleeved outside the first fixture 2. The first fixture 2 is used to limit and shape the inner side of the anchoring component semi-finished product 1. The second fixture 3 is abutted together on the outer side of the anchoring component semi-finished product 1 to limit and shape the outer side of the anchoring component semi-finished product 1. The first fixture 2 and the second fixture 3 have a sliding state that allows relative movement under external force. The first fixture 2 is used to limit the shape of the inner side of the anchoring component semi-finished product 1, and the second fixture 3 is used to limit the shape of the outer side of the anchoring component semi-finished product 1.

[0062] The first tooling 2 and the second tooling 3 are connected by an external device to drive the relative sliding motion of the first tooling 2 and the second tooling 3. The external device can be a mechanically driven fixture or a robotic arm.

[0063] The anchoring component semi-finished product 1 is provided with a first connecting part 11 and a second connecting part 12 that are staggered and spaced apart; the first tooling 2 is provided with a first positioning part 21, which is installed on the outer wall surface of the first tooling 2 facing the anchoring component semi-finished product 1; the second tooling 3 is provided with a second positioning part 31, which is detachably connected to the first connecting part 11 and is located on the side of the second tooling 3 facing the anchoring component semi-finished product 1, and is movably connected to the second connecting part 12; in the sliding state, the first positioning part 21 abuts against the first connecting part 11, and the second positioning part 31 abuts against the second connecting part 12, so that the first connecting part 11 and the second connecting part 12 move away from each other, so that the anchoring component semi-finished product 1 is subjected to tension and limiting to form a three-dimensional anchoring component.

[0064] The first connecting part 11 is an arc-shaped structure provided on the anchoring part semi-finished product 1. In this embodiment, the first positioning part 21 is set as a connecting boss. The arc-shaped structure is limited by the connecting boss. There are two or more connecting bosses. The connecting bosses form a positioning space for the connecting part. The first connecting part 11 is locked and clamped at the first positioning part 21 by an external clamp.

[0065] In this embodiment, the anchoring component semi-finished product 1 is configured as a triangular structure, with three first connecting parts 11 and three second connecting parts 12. The second connecting parts 12 are located at the three corners of the triangular structure, and the first connecting parts 11 are located between two adjacent corners of the triangular structure.

[0066] The first tooling 2 is a cylindrical structure, comprising a first body 22 and a second body 23, with a first connecting part 11 disposed on the first body 22. The outer diameter of the first body 22 is larger than the outer diameter of the second body 23, causing the portion of the anchoring component semi-finished product 1 with the second connecting part 12 to deform towards the inner axis of the anchoring component semi-finished product 1. This results in the inner diameter of the anchoring component around the second connecting part 12 being smaller than the inner diameter around the first connecting part 11, meaning the inner diameter of the proximal end of the anchoring component during implantation is smaller than the inner diameter of the distal end, facilitating the implantation and release process. The proximal end of the anchoring component during implantation is the positioning sinus base. The inner diameter of the positioning sinus base of the anchoring component is smaller than the outer diameter of the externally mounted valve stent. After implantation and release, an interference fit occurs between the anchoring component and the valve stent, allowing the anchoring component to limit and tighten the valve stent, enabling the valve stent to provide greater clamping force and more firmly clamp the autologous valve leaflet. The valve as a whole exhibits the advantage of more secure and stable anchoring.

[0067] The second tooling 3 is configured as an arc-shaped plate structure, and is distributed in a ring around the outside of the anchoring component semi-finished product 1. In this embodiment, three second tooling 3s are provided. The second tooling 3 and the anchoring component semi-finished product 1 are slidably abutted together. The first connecting part 11 is stretched by the first positioning part 21, causing the first connecting part 11 to move away from the second connecting part 12; the second positioning part 31 is configured as a limiting arc surface, which limits and abuts against the outside of the anchoring component semi-finished product 1, so that the outer structure of the anchoring component semi-finished product 1 forms an arc surface that matches the limiting arc surface during the heat treatment process; one or more limiting arc surfaces can be configured to improve the limiting and shaping capability of the second tooling 3 on the outside of the anchoring component semi-finished product 1.

[0068] In some embodiments, the arc-shaped plate structure is designed to be conical, so that when the second tooling 3 limits the outer side of the anchoring part semi-finished product 1, part of its second connecting portion 12 deforms towards the inner axis direction of the anchoring part semi-finished product 1.

[0069] In some embodiments, the second tooling 3 may be configured with a limiting structure to connect the anchoring part 1 to the second body 23, thereby promoting the deformation of the part of the anchoring part 1 with the second connecting part 12 toward the inner axis of the anchoring part 1.

[0070] In this embodiment, the axial direction of the first tooling 2, the axial direction of the second tooling 3 distributed in a ring, and the axial direction of the anchoring component semi-finished product 1 are collinear.

[0071] The first connecting part 11 has one or more connecting holes for flexible connection with the valve stent. A flexible wire can be passed through the connecting hole to connect the anchor and the valve stent.

[0072] The inner diameter of the bottom end of the anchoring member at the second connection is set to 29±0.3mm, and the inner diameter of the end of the anchoring member at the first connection is set to 32±0.3mm.

[0073] Example 3

[0074] Based on the aortic valve shape required by the patient, a model of the planar unfolded state of the aortic valve anchor is established;

[0075] Select a substrate of suitable size;

[0076] The model is input into the cutting machine to cut the substrate to obtain the anchor semi-finished product 1 in the planar unfolded state;

[0077] The anchoring component semi-finished product 1 is heated to a temperature of 470 to 490°C and held for 8 to 12 minutes.

[0078] The anchoring component semi-finished product 1 undergoes a second heat treatment. Simultaneously, a shaping fixture is used to limit and stretch the anchoring component semi-finished product 1 during the second heat treatment to form a three-dimensional anchoring component. The shaping temperature of the heat treatment is set to 510 to 530℃, and the holding time is 13 to 17 minutes.

[0079] For example, taking the anchor with an inner diameter of 29mm, the three side lengths of the anchor semi-finished product 1 are set to 38mm.

[0080] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A method of making an aortic valve anchor, the method comprising: The method comprises the following steps: S1: cutting a substrate to form an anchor semi-finished product (1) in a planar unfolded state, comprising the following sub-steps; S11: establishing a model of the aortic valve anchor in a planar unfolded state; S12: selecting a substrate according to the model size; S13: inputting the model into a cutting machine to cut the substrate to obtain the anchor semi-finished product (1) in a planar unfolded state; S2: performing heat treatment and shaping operation on the anchor semi-finished product (1), comprising the following sub-steps: S21: performing first heating treatment on the anchor semi-finished product (1); S22: performing second heating treatment on the anchor semi-finished product (1), and simultaneously limiting and stretching the anchor semi-finished product (1) in the second heating treatment through a shaping tool to form an anchor in a three-dimensional state; Wherein, the shaping tool comprises a first tool (2) and a second tool (3), the first tool (2) and the anchor semi-finished product (1) are arranged in abutment, the anchor semi-finished product (1) is sleeved on the outside of the first tool (2), and the first tool (2) is used for limiting and shaping the inside of the anchor semi-finished product (1); the second tool (3) is arranged in abutment on the outside of the anchor semi-finished product (1), and the second tool (3) is used for limiting and shaping the outside of the anchor semi-finished product (1); The first tool (2) and the second tool (3) have a sliding state of relative motion under external force; The anchor semi-finished product (1) is provided with first connecting parts (11) and second connecting parts (12) arranged in alternation and at intervals; The first tool (2) is provided with a first positioning part (21) mounted on the outer wall surface of the first tool (2) facing the anchor semi-finished product (1), and the second tool (3) is provided with a second positioning part (31), the first positioning part (21) is detachably connected with the first connecting part (11), and the second positioning part (31) is arranged on one side of the second tool (3) facing the anchor semi-finished product (1), and the second positioning part (31) is movably connected with the second connecting part (12); In the sliding state, the first positioning part (21) abuts against the first connecting part (11), and the second positioning part (31) abuts against the second connecting part (12), so that the first connecting part (11) and the second connecting part (12) move away from each other, and the anchor semi-finished product (1) is stretched to form an anchor in a three-dimensional state; The first tool (2) is provided in a cylindrical structure, the first tool (2) comprises a first body (22) and a second body (23), the outer diameter of the first body (22) is greater than the outer diameter of the second body (23), and the first connecting part (11) is arranged on the first body (22); The second tool (3) is provided in an arc-shaped plate structure, and the second tool (3) is annularly distributed on the outside of the anchor semi-finished product (1).

2. The production method according to claim 1, wherein The anchor semi-finished product (1) is provided in a triangular structure, and the first connecting part (11) and the second connecting part (12) are respectively provided with three.

3. The method of making of claim 1, wherein, The axis direction of any tooling and the axis direction of the anchor semi-finished product are collinear.

4. The method of making of claim 1, wherein, The first connecting part (11) is provided with at least one connecting hole.

5. The method of making of claim 1, wherein, In step S21, the temperature of the first heating treatment is 470-490℃, and the holding time is 8-12 min.

6. The method of making of claim 1, wherein, In step S22, the temperature of the second heating treatment is 510-530℃, and the holding time is 13-17 min.

7. The method of making of claim 1, wherein, The substrate is a memory alloy piece.

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