WO2024129709A1

WO2024129709A1 - Stent

Info

Publication number: WO2024129709A1
Application number: PCT/US2023/083596
Authority: WO
Inventors: Samuel BREHM
Original assignee: Status Flow Llc
Priority date: 2022-12-12
Filing date: 2023-12-12
Publication date: 2024-06-20

Abstract

The stent described and provided herein may be received within a stent insertion device in order to be placed within an artery. When removed from the stent insertion device, the stent may expand into an expanded state and be positioned within the artery. The stent may be spiral shaped, such that, when placed in the artery, the stent may be configured to encourage or generate spiral laminar flow in the artery. The spiral shape of the stent may cause the blood to split into separate branches without pressing against the tip of the bifurcation and causing damage or further issues to an artery or already-developed aneurysm.

Description

STENT

Cross-Reference to Related Applications

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63/386,982, filed December 12, 2022, the entire contents of which are hereby incorporated by reference.

Field of Invention

[0002] The present invention relates generally to a stent. More specifically, the invention relates to a stent for placement in an artery.

Background of Invention

[0003] The predominant flow pattern inside arteries is spiral laminar flow. The presence of spiral laminar flow may cause reduced low-density lipoprotein transport, improved oxygen transport, flow stabilization at branches of the artery, and improved flow through stenosis. Loss of spiral laminar flow can lead to undesirable consequences. For example, fluid (e.g., blood) flowing via non-spiral laminar flow may flow in the middle of an artery, and the blood may reach the intima at the tip of the bifurcation, which may force the blood to split into separate branches of the artery. This may cause weakening and/or ballooning of the arterial wall at the bifurcation, which may cause an aneurysm.

[0004] In cerebral arteries, saccular (“berry”) aneurysms may occur at bifurcations of the arteries. Although treatment for cerebral aneurysms has, in recent years, shifted from open surgery to endovascular treatment, certain cerebral aneurysms may not be treated endovascularly. For example, endovascular treatment is not used for large aneurysms that occur at a wide-neck bifurcation of the middle cerebral artery, due to lack of adequate treatment and tools. As such, a need exists for an endovascular treatment that may be used for cerebral aneurysms, despite their locations or size.

Summary of Invention

[0005] The present invention overcomes many of the shortcomings and limitations of the prior art devices discussed above. The invention described herein includes several embodiments of a stent.

[0006] As stated above, endovascular treatments are not currently available for all types of aneurysms, including cerebral bifurcation aneurysms. Encouraging or generating spiral laminar flow in arteries may improve blood flow and aid in lessening the undesirable effects of standard blood flow in arteries (e.g., weakening and/or ballooning of an artery).

[0007] The stent described and provided herein may be spiral -shaped, such that when placed in an artery, the stent may be configured to encourage or generate spiral laminar flow in an artery. This may aid in preventing blood from being physically forced to split into separate branches after reaching and pressing against the tip of the bifurcation. This may assist in reducing wall shear of the artery, which may, in turn, reduce the effects of wall shear (e.g., aneurysms).

Brief Description of Drawings

[0008] Fig. 1 is a top view of a stent within a stent insertion device placed within an artery constructed according to the teachings of the present application;

[0009] Fig. 2 is a perspective view of the stent within the stent insertion device of Fig. 1;

[0010] Fig. 3 is a perspective view of the stent of Fig. 1 in a compressed state; [0011] Fig. 4 is a perspective view of the stent of Fig. 1 in an expanded state within the artery; and

[0012] Fig. 5 is a perspective view of the stent of Fig. 1 in the expanded state.

[0013] While the disclosure is susceptible to various modifications and alternative forms, a specific embodiment thereof is shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that the drawings and detailed description presented herein are not intended to limit the disclosure to the particular embodiment disclosed, but to the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

Detailed Description

[0014] The invention will now be described with reference to the drawing figures, in which like reference numerals refer to like parts throughout. For purposes of clarity in illustrating the characteristics of the present invention, proportional relationships of the elements have not necessarily been maintained in the drawing figures.

[0015] Turning first to Fig. 1, a stent 1 may be placed within a stent insertion device 5. The stent insertion device 5 may be configured to place the stent 1 within an artery 10. According to one embodiment, the stent 1 may be used when an aneurysm 15 develops along or within the artery 10. As illustrated in Fig. 2, the stent 1 may be received within an interior portion 20 of the stent insertion device 5. When received within the interior portion 20 of the stent insertion device 5, the stent 1 may be in a compressed state, as illustrated in Fig. 3. The stent insertion device 5 may cause the stent 1 to remain in a compressed state. According to one embodiment, the compressed state corresponds to the size of the stent insertion device 5, such that the stent 1 expands only to the maximum extent permitted by the size of the stent insertion device 5.

[0016] When released or separated from the stent insertion device 5, as illustrated in Fig. 4, the stent 1 may be in an expanded state. According to one embodiment, when the stent 1 is positioned in the correct place within the artery 10, a surgeon may release the stent 1 from the stent insertion device 5. In alternative embodiments, the stent 1 may be automatically released from the stent insertion device 5. When released, the stent 1 may expand within the artery 10. The stent 1 may be placed within the artery 10 to encourage or generate spiral laminar flow. The stent 1 may be spiral shaped. Such shape may encourage spiral laminar flow within the artery 10.

[0017] When blood flows through the artery 10 with a stent 1 placed, the blood may be encouraged to flow in a spiral manner. The stent 1 may be configured to cause the blood to spin in a spiral manner upstream of a bifurcation 25 and/or the aneurysm 15. The spiral shape of the stent 1 may cause blood to be pressed against walls 30 of the artery 10 due to centrifugal force. This may be valuable to treatment of the aneurysm 15, because the stent 1 may aid in reducing the impact of blood at the aneurysm 15. Such placement of the stent 1 may encourage the blood to be directed to branches 35a, 35b at the bifurcation 25 without affecting the aneurysm 15. Further, the stent 1 may be used to treat a wall aneurysm. Spinning the blood via the spiral shape of the stent 1 may assist in boundary layer separate inside of the artery with a wall aneurysm, which may assist in resolving the wall aneurysm. The arrows 40 illustrate how blood may flow through the artery 10 and into the branches 35a, 35b.

[0018] When manufactured, the stent 1 may be a flat component, as illustrated in Fig. 5, and the stent 1 may then be twisted to be formed into a spiral shape. The stent 1 may be designed to be compressed into a spiral shape in the short axis. The stent 1 may include side walls 45. According to one embodiment, and as illustrated, the stent 1 includes two side walls 45a, 45b.

[0019] At a first end 45, the side walls 45a, 45b may connect. According to various embodiments, the side walls 45a, 45b attach or are integrally formed with one another at the first end 50. The side walls 45a, 45b may form a first connection point 55 at the first end 50. The first connection point 55 may be formed such that the side walls 45a, 45b come to a singular point at the first end 50. Through a middle portion 60 of the stent 1, the side walls 45a, 45b may be connected via one or more connection mechanisms 65. According to various embodiments, the one or more connection mechanisms 65 may be wishbone shaped. The one or more connection mechanisms 65 may be any other suitable shape or size. The one or more connection mechanisms 65 may be spaced apart such that blood may flow through and around the stent 1. According to one embodiment, the side walls 45a, 45b may be connected via a single connection mechanism 65 which extends the lengths of the side walls 45a, 45b. In such a configuration, the blood may flow around the stent 1 but may not necessarily flow through the stent 1.

[0020] At a second end 70 of the stent 1, the side walls 45a, 45b may connect at a second connection point 75. According to various embodiments, the side walls 45a, 45b attach to or are integrally formed with one another at the second end 70. According to one embodiment, the second connection point 75 may be formed via a connection mechanism 65 attached to end points 80a, 80b of each of the side walls 45a, 45b, respectively. In such a configuration, the connection mechanism 65 may connect the side walls 45a, 45b to one another. The one or more connection mechanisms 65 described herein may be attached to or integrally formed with the side walls 45a, 45b. According to one embodiment, the first end 50 corresponds to an end of the stent 1 positioned further from the aneurysm 15, and the second end 70 corresponds to an end of the stent 1 positioned closer to the aneurysm. As illustrated, the side walls 45a, 45b may or may not be parallel. The side walls 45a, 45b may taper toward one another from the first end 50 to the second end 70. As such, the one or more connection mechanisms 65 may be different lengths depending on the positioning relative to the first end

50 and the second end 70.

[0021] The stent 1 may be made of any suitable material, including, but not limited to, thin nitinol, titanium, stainless steel, or wire. The metal frame of the stent 1 may be covered in a covering material, such as Dacron®. The stent 1 may include a removal component, which may be used to remove the stent 1 from the artery 10. The removal component may be attached at the first end 50 or the second end 70 of the stent. According to one embodiment, the removal component is threaded into the first connection point 55 of the first end 50. Although described above as having a particular shape or configuration, the stent 1 may be formed or configured in any suitable manner. Further, the attachments described herein may be achieved using any suitable manner now known or developed in the art.

[0022] As is evident from the foregoing description, certain aspects of the present invention are not limited by the particular details of the examples illustrated herein, and it is therefore contemplated that other modifications, applications, variations, or equivalents thereof, will occur to those skilled in the art. Many such changes, modifications, variations, and other uses and applications of the present constructions will, however, become apparent to those skilled in the art after considering the specification and the accompanying drawings. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. All such changes, modifications, variations, and other uses and applications which do not depart from the spirit and scope of the present inventions are deemed to be covered by the inventions which are limited only by the claims which follow.

Claims

1. A stent comprising: a spiral shaped component comprising: a plurality of side walls; and one or more connection mechanisms configured to connect the plurality of side walls; wherein the spiral shaped component is configured to be placed in an artery; and wherein the spiral shaped component is configured to generate spiral laminar flow of blood flowing in the artery.

2. The stent of claim 1, wherein each of the one or more connection mechanisms are spaced apart from the other one or more connection mechanisms to form a plurality of spaces.

3. The stent of claim 2, wherein blood flows through the plurality of spaces between the one or more connection mechanisms.

4. The stent of claim 1, wherein the spiral shaped component is made of at least one of thin nitinol, titanium, stainless steel, or wire.

5. The stent of claim 1, wherein the spiral shaped component comprises a coating material.

6. The stent of claim 1, wherein when the stent is in a first configuration, the stent is substantially flat, and wherein when the stent is in a second configuration, the stent is spiral shaped.

7. The stent of claim 1, wherein the spiral shaped component is configured to be placed in the artery ahead of a bifurcation, and wherein the spiral shaped component is configured to transport blood away from a tip of the bifurcation.

8. The stent of claim 1, wherein when received within a stent insertion device, the stent is in a compressed state, and wherein when removed from the stent insertion device and placed within the artery, the stent is in an expanded state.

9. A method for manufacturing a stent comprising: connecting a plurality of side walls via one or more connection mechanisms; developing a substantially flat component from the connected plurality of side walls and one or more connection mechanisms; twisting the substantially flat component into a spiral shape; and placing the stent in a stent insertion device for subsequent delivery into an artery.

10. The method of claim 9, wherein each of the one or more connection mechanisms are spaced apart from the other one or more connection mechanisms to form a plurality of spaces.

11. The method of claim 10, wherein blood flows through the plurality of spaces between the one or more connection mechanisms.

12. The method of claim 9, wherein the plurality of side walls and the one or more connection mechanisms are made of at least one of thin nitinol, titanium, stainless steel, or wire.

13. The method of claim 9, wherein each of the plurality of side walls and the one or more connection mechanisms comprise a coating material.

14. The method of claim 9, wherein when received within the stent insertion device, the stent is in a compressed state, and wherein when removed from the stent insertion device and placed within the artery, the stent is in an expanded state.

15. The method of claim 9, wherein the stent is configured to be placed in the artery ahead of a bifurcation.

16. The method of claim 15, wherein the stent is configured to generate spiral laminar flow of blood flowing in the artery.

17. A stent comprising: a spiral shaped component comprising: a plurality of side walls; and one or more connection mechanisms configured to connect the plurality of side walls; wherein the spiral shaped component is configured to be placed in an artery.

18. The stent of claim 17, wherein the spiral shaped component is configured to be placed in the artery ahead of a bifurcation.

19. The stent of claim 17, wherein the spiral shaped component is configured to generate spiral laminar flow of blood flowing in the artery.

20. The stent of claim 18, wherein the spiral shaped component is configured to transport blood away from a tip of the bifurcation.

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