An adjustable support force brace

Abstract

The application relates to the technical field of medical stents, in particular to a stent capable of adjusting support force. In the stent, outer layer frames and inner layer frames are arranged alternately along the axial direction, and the outer layer frames and the inner layer frames are connected to each other through multiple connecting rods. When the stent is unfolded, the inner layer frames are unfolded relative to the outer layer frames, at this time, the flat part of the stent is a single-layer structure, so that the support force of the flat part is small; when the stent is folded, the inner layer frames are folded in the inner circle of the outer layer frames, at this time, the folded part of the stent is a double-layer structure, so that the support force of the folded part is large; and by controlling the overlapping area of the outer layer frames and the inner layer frames in the folded part, the support force of the folded part is adjusted, so that the support force of different parts of the stent is adjusted, and the stent can adapt to the demand of different support forces of different stenosis degrees of blood vessels.

Description

Technical Field

[0001] This application relates to the field of medical stent technology, and in particular to a stent with adjustable support force. Background Technology

[0002] The incidence of vascular diseases is rising, with vascular stenosis accounting for a large proportion of cases. Stenosis can occur in the heart, coronary arteries, cerebral vessels, and peripheral vessels. Currently, treatment for vascular stenosis includes medication, surgery, or interventional procedures. In interventional procedures, stent implantation supports the narrowed portion of the blood vessel and effectively prevents in-stent restenosis. However, because blood vessels in the body experience varying pressure and the degree of stenosis differs, the required stent support varies depending on the location of the stenosis. Larger support is needed for narrowed areas, but the required support varies depending on the degree of stenosis, and it is difficult to determine the required support based on intraoperative angiography.

[0003] Current technology uses conventional stents, which provide the same radial support force in all locations. However, in order to ensure that the stent completely covers the stenotic segment and to allow the surgeon more room to maneuver during the procedure, a stent longer than the stenotic segment is chosen. This results in the stent's ends being longer than the stenotic segment, and even areas without stenosis will be supported by the stent. Excessive support force can damage healthy blood vessels and lead to complications.

[0004] Therefore, there is a need to provide an improved technical solution that addresses the shortcomings of the existing technology. Summary of the Invention

[0005] The purpose of this application is to provide an adjustable support bracket to solve or alleviate the problems existing in the prior art.

[0006] To achieve the above objectives, the adjustable support force bracket of the present invention provides the following technical solution: An adjustable support bracket, the bracket comprising a multi-ring outer frame and a multi-ring inner frame, the outer frame and the inner frame being alternately arranged; There are multiple connecting rods between adjacent outer and inner shelves; When the support is deployed, the inner frame unfolds relative to the outer frame to form the straight section of the support; When the support is folded, the inner frame folds into the inner ring of the outer frame. At this time, the inner frame and the outer frame have overlapping parts in the axial direction to form the folded part of the support. The straight section and the folded section of the bracket can be switched by pushing or pulling the bracket.

[0007] As described above, in a preferred embodiment of the adjustable support bracket, in one fold of the bracket, the axial length of an outer frame is A, the folding length between the outer frame and one side of the inner frame is A1, and the folding length between the outer frame and the other side of the inner frame is A2. Wherein, the outer frame provides support force Fr1, and the inner frame provides support force Fr2, then the support force of this folded part is: .

[0008] As described above, the adjustable support stent is preferably released through a delivery sheath. At the location of the most severe vascular stenosis, the delivery sheath releases the stent in a completely natural state, and the naturally released stent is in a folded state, at which point the inner and outer stents are folded to the maximum extent.

[0009] As described above, the adjustable support bracket is preferably released when the delivery sheath is pulled in a non-narrow area. At this time, the released bracket is in a straight position, thereby allowing the inner and outer frames of the bracket to fully unfold.

[0010] The adjustable support bracket described above is preferably manufactured by laser engraving.

[0011] The adjustable support bracket described above is preferably made by cutting or weaving.

[0012] The adjustable support bracket described above is preferably formed by subjecting the bracket to three heat treatments and acid pickling and polishing processes after it has been processed and shaped. The bracket heat treatment process uses a shaping mold for shaping, and the shaping mold includes a locking ring, an outer shaping ring, an inner shaping ring, and a locking bolt.

[0013] As described above, the adjustable support bracket preferably involves, during the first heat treatment of the bracket, after the bracket is fully unfolded, placing the bracket on a metal rod that matches the inner frame of the outer frame, and then performing the first heat treatment for shaping.

[0014] As described above, the adjustable support bracket preferably involves, during the second heat treatment of the bracket, after the bracket is fully unfolded, placing the bracket on the inner shaping ring, then pressing the inner frame onto the inner shaping ring, and then performing a second heat treatment for shaping.

[0015] As described above, the adjustable support bracket is preferably subjected to a third heat treatment after the bracket is fully folded. The folded bracket is then installed on a shaping mold for the third heat treatment shaping.

[0016] Compared with the closest prior art, the technical solution of this application has the following beneficial effects: In this stent, outer and inner layers are alternately arranged along the axial direction, and each outer and inner layer is interconnected by multiple links. When the stent is deployed, the inner layer unfolds relative to the outer layer, and the straight portion of the stent has a single-layer structure, resulting in lower support force in the straight portion. When the stent is folded, the inner layer folds inside the outer layer, and the folded portion of the stent has a double-layer structure, resulting in higher support force in the folded portion. By controlling the overlap area between the outer and inner layers in the folded portion, the support force of the folded portion can be adjusted, thereby allowing for adjustment of the support force in different parts of the stent. This enables the stent to adapt to the different support force requirements of different degrees of vascular stenosis. Attached Figure Description

[0017] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. Wherein: Figure 1 This is a schematic diagram of the straight portion and the folded portion of a bracket provided according to some embodiments of this application; Figure 2 A cross-sectional view of a bracket provided according to some embodiments of this application; Figure 3 This is a schematic diagram of a fully deployed support structure according to some embodiments of this application; Figure 4 This is a schematic diagram illustrating the principle of adjusting the support force of a bracket according to some embodiments of this application; Figure 5 This is a schematic diagram of a stent release process according to some embodiments of this application; Figure 6 This is a schematic diagram of the complete release of the stent according to some embodiments of this application; Figure 7 This is a schematic diagram of a molding die provided according to some embodiments of this application.

[0018] In the diagram: 1. Straight section; 2. Folded section; 3. Outer frame; 4. Inner frame; 5. Connecting rod; 201. Locking ring; 202. Outer shaping ring; 203. Inner shaping ring; 204. Locking bolt. Detailed Implementation

[0019] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0020] In the description of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," and "bottom," 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 do not require the invention to be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. The terms "connected" and "linked" used in this invention should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; they can refer to a direct connection or an indirect connection through intermediate components. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances. Furthermore, the term "proximal end" uniformly refers to the end closer to the operator, while "distal end" refers to the end farther from the operator.

[0021] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0022] The shapes and sizes of the components in the accompanying drawings do not reflect the actual proportions of the product; they are only intended to illustrate the content of the invention.

[0023] According to specific embodiments of this application, such as Figure 1-7 As shown, this application provides an adjustable support bracket, which includes a multi-ring outer frame and a multi-ring inner frame, with the outer and inner frames arranged alternately.

[0024] There are multiple connecting rods between adjacent outer and inner shelves.

[0025] When the support is deployed, the inner frame unfolds relative to the outer frame to form the flat section of the support.

[0026] When the support is folded, the inner frame folds over the inner ring of the outer frame. At this time, the inner and outer frames have overlapping parts in the axial direction to form the folded part of the support.

[0027] The straight section and the folded section of the bracket can be switched by pushing or pulling the bracket.

[0028] In this stent, outer and inner layers are alternately arranged along the axial direction, and each outer and inner layer is interconnected by multiple links. When the stent is deployed, the inner layer unfolds relative to the outer layer, and the straight portion of the stent has a single-layer structure, resulting in lower support force in the straight portion. When the stent is folded, the inner layer folds inside the outer layer, and the folded portion of the stent has a double-layer structure, resulting in higher support force in the folded portion. By controlling the overlap area between the outer and inner layers in the folded portion, the support force of the folded portion can be adjusted, thereby allowing for adjustment of the support force in different parts of the stent. This enables the stent to adapt to the different support force requirements of different degrees of vascular stenosis.

[0029] In a folded section of the support, the axial length of an outer frame is A, the folding length between the outer frame and one inner frame is A1, and the folding length between the outer frame and the other inner frame is A2. The supporting force provided by the outer frame is Fr1, and the supporting force provided by the inner frame is Fr2. Then the supporting force of this folded section is: F = Fr1 + Fr2(A1 + A2) / 2A.

[0030] In this embodiment, the outer frame is typically designed to be between 0.5mm and 2mm in length. The overlap lengths A1 and A2 are the lengths of the overlap between the inner and outer frames on both sides. When the support is fully extended, A1 + A2 = A. By pulling the support during the release process, the folding lengths of the outer frame and the inner frames on both sides can be adjusted to change the lengths of A1 and A2, thereby achieving the adjustment of the support force.

[0031] The stent is released through the delivery sheath. At the location of the most severe vascular stenosis, the delivery sheath releases the stent in a completely natural state. The naturally released stent is in the folded state, at which point the inner and outer stents are folded to the maximum extent.

[0032] In this embodiment, during use, the support force is adjusted during the release process of the bracket, such as... Figure 5 As shown, after the stent is anchored to the blood vessel at its distal end, the delivery sheath gradually changes from a stretched state to a natural state. At the location of the most severe stenosis, the delivery sheath releases the stent in a completely natural state. The naturally released stent is in a folded state, at which point the inner and outer stents are folded to the maximum extent, thereby maximizing the overlap of the stent at the location of the most severe stenosis and obtaining the greatest support force.

[0033] In areas without stenosis, the stent is released by pulling the delivery sheath. At this point, the released stent is in a straight position, allowing the inner and outer layers of the stent to fully unfold. In this embodiment, the support force in the straight section is minimized to accommodate areas without stenosis; the final released stent appears as follows: Figure 6 As shown.

[0034] The bracket is manufactured using laser engraving. In this embodiment, the bracket is made of nickel-titanium alloy tubing and is laser engraved.

[0035] The support is made by cutting or weaving. In other embodiments of this application, the support is a cut support or a woven support.

[0036] After the bracket is formed, it undergoes three heat treatments and acid pickling and polishing processes to form the final bracket. The bracket's heat treatment process uses a shaping mold for shaping, which includes a locking ring, an outer shaping ring, an inner shaping ring, and a locking bolt. In this embodiment, there are two locking rings, two outer shaping rings, and one inner shaping ring. The two outer shaping rings are located on either side of the inner shaping ring, and the two locking rings are located on either side of the two outer shaping rings. The locking bolt passes through one locking ring and is mounted on the other locking ring.

[0037] During the first heat treatment of the bracket, after the bracket is fully unfolded, it is fitted onto a metal rod that matches the inner frame of the outer frame, and then the first heat treatment is performed for shaping. In this embodiment, after the bracket is fully unfolded, it is fitted onto a metal rod that matches the inner frame of the outer frame, and then the bracket is placed in a 500-degree Celsius environment for 10 minutes for the first heat treatment for shaping.

[0038] During the second heat treatment of the bracket, after the bracket is fully unfolded, it is placed on the inner shaping ring, and then the inner frame is pressed onto the inner shaping ring before undergoing the second heat treatment for shaping. In this embodiment, during the second heat treatment, the inner frame is pressed onto the inner shaping ring, and then the bracket is placed in a 500-degree Celsius environment for 10 minutes for the second heat treatment for shaping.

[0039] During the third heat treatment of the bracket, after the bracket is fully folded, it is installed on a shaping mold for the third heat treatment shaping. In this embodiment, after the bracket is fully folded, an inner shaping ring is installed inside the bracket, and two outer shaping rings are installed at both ends of the bracket. Then, a locking bolt is passed through one locking ring and installed on the other locking ring. The bracket is then placed in a 500-degree Celsius environment for 20 minutes for the third heat treatment shaping.

[0040] 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. It is understood that the above description is merely exemplary, and the embodiments of this application do not limit the scope of the application.

[0041] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention are within the protection scope of the present invention.

Claims

1. A support bracket with adjustable support force, characterized in that, The support includes an outer ring with multiple rings and an inner ring with multiple rings, and the outer ring and inner ring are arranged alternately. There are multiple connecting rods between adjacent outer and inner shelves; When the support is deployed, the inner frame unfolds relative to the outer frame to form the straight section of the support; When the support is folded, the inner frame folds into the inner ring of the outer frame. At this time, the inner frame and the outer frame have overlapping parts in the axial direction to form the folded part of the support. The straight section and the folded section of the bracket can be switched by pushing or pulling the bracket.

2. The adjustable support bracket according to claim 1, characterized in that, In a folded section of the support, the axial length of an outer frame is A, the folding length between the outer frame and one side of the inner frame is A1, and the folding length between the outer frame and the other side of the inner frame is A2. Wherein, the outer frame provides support force Fr1, and the inner frame provides support force Fr2, then the support force of this folded part is: .

3. The adjustable support force bracket according to claim 2, characterized in that, The stent is released through a delivery sheath. At the location of the most severe vascular stenosis, the delivery sheath releases the stent in a completely natural state. The naturally released stent is in the folded state, at which point the inner and outer stents are folded to the maximum extent.

4. The adjustable support force bracket according to claim 3, characterized in that, In areas without narrow passages, the stent is released by pulling the delivery sheath. At this point, the released stent is in a straight position, allowing the inner and outer frames of the stent to fully unfold.

5. The adjustable support force bracket according to claim 4, characterized in that, The bracket is made by laser engraving.

6. The adjustable support force bracket according to claim 4, characterized in that, The support frame is made by cutting or weaving.

7. The adjustable support bracket according to claim 5 or 6, characterized in that, After the bracket is processed and shaped, it undergoes three heat treatments and acid pickling and polishing processes to form the final bracket; The bracket heat treatment process uses a shaping mold for shaping, and the shaping mold includes a locking ring, an outer shaping ring, an inner shaping ring, and a locking bolt.

8. The adjustable support force bracket according to claim 6, characterized in that, During the first heat treatment of the bracket, after the bracket is fully unfolded, it is placed on a metal rod that matches the inner frame of the outer frame, and then the first heat treatment is performed to fix the shape.

9. The adjustable support force bracket according to claim 8, characterized in that, During the second heat treatment of the bracket, after the bracket is fully unfolded, the bracket is placed on the inner shaping ring, and then the inner bracket is pressed on the inner shaping ring before the second heat treatment is performed to shape it.

10. The adjustable support force bracket according to claim 9, characterized in that, During the third heat treatment of the bracket, after the bracket is completely folded, the folded bracket is installed on the shaping mold for the third heat treatment to shape it.

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