CN-122003210-A - Stent and delivery system with anti-migration flange support

Abstract

The present disclosure relates to stents and/or implants that include a reinforcing member. An exemplary transluminal implant may include an elongate tubular body extending from a first end region to a second end region. The elongate tubular body may include a backbone forming a plurality of holes, a first flange adjacent the first end region, a second flange adjacent the second end region, and a saddle region extending between the first flange and the second flange. The saddle region may have an outer diameter, the addition being smaller than the outer diameters of the first and second flanges. A reinforcement member may be disposed within the lumen of the elongate tubular body and within the first flange.

Inventors

• Phion Stapleton
• John Thomas. Fafro
• Ryan Desmond Lynch
• COLLINS DAVID
• John O'Driscoll
• Darren Gerard Koren
• Alan Mofei

Assignees

• 波士顿科学国际有限公司

Dates

Publication Date

20260508

Application Date

20240809

Priority Date

20230814

Claims (15)

1. 1. A trans-luminal implant comprising: an elongate tubular body extending from a first end region to a second end region and comprising: a skeleton forming a plurality of holes; A first flange adjacent to the first end region; a second flange adjacent to the second end region, and A saddle region extending between the first flange and the second flange, the saddle region having an outer diameter that is smaller than the outer diameters of the first flange and the second flange, and A reinforcement member disposed within the lumen of the elongate tubular body and within the first flange, the reinforcement member comprising at least one bent wire.
2. 2. The transluminal implant of claim 1, wherein the reinforcement member is configured to apply a radially outward force on the elongate tubular body.
3. 3. The transluminal implant of any one of claims 1-2, wherein an outer diameter of the reinforcement member approximates an outer diameter of the first flange.
4. 4. The transluminal implant of any one of claims 1-2, wherein an outer diameter of the reinforcement member is greater than an outer diameter of the first flange.
5. 5. The transluminal implant of any one of claims 1-4, wherein the at least one curved wire comprises at least one coil extending around an inner surface of the first flange.
6. 6. The transluminal implant of any one of claims 1-4, wherein the at least one curved wire comprises at least two coils extending around an inner surface of the first flange.
7. 7. The transluminal implant of any one of claims 1 to 4, wherein the at least one curved wire comprises less than one turn of a coil.
8. 8. The transluminal implant of any one of claims 1-7, wherein the reinforcing member comprises two or more curved wires.
9. 9. The transluminal implant of any one of claims 1 to 8, wherein the at least one curved wire has a diameter of about 0.013 inches (0.330 millimeters).
10. 10. The transluminal implant of any one of claims 1-9, wherein a proximal end of the at least one curved wire is fixed to a distal end of the at least one curved wire.
11. 11. The transluminal implant of any one of claims 1-10, wherein the at least one curved wire comprises a shape memory material.
12. 12. The transluminal implant of any one of claims 1-11, further comprising a second reinforcement member disposed within the lumen of the elongate tubular body and within the second flange.
13. 13. The transluminal implant of any one of claims 1 to 12, wherein the elongate tubular body comprises a stent.
14. 14. The transluminal implant of any one of claims 1 to 12, wherein the elongate tubular body comprises a pyloric closure device.
15. 15. The transluminal implant of any one of claims 1 to 14, wherein the reinforcing member further comprises a stiffening material.

Description

Stent and delivery system with anti-migration flange support Cross Reference to Related Applications The application claims the benefit of U.S. provisional patent application Ser. No. 63/519,375, filed on 8/14 of 2023, the entire contents of which are incorporated herein by reference. Technical Field The present disclosure relates to medical devices, methods for manufacturing medical devices, and uses thereof. More particularly, the present disclosure relates to a stent for implantation in a body lumen or for transluminal implantation, and related methods. Background A wide variety of in vivo medical devices have been developed for medical use, for example, surgical and/or intravascular use. Obesity affects an increasingly large population and can cause additional diseases (such as type 2 diabetes) that greatly increase the health risk of the patient. Surgery such as weight-loss surgery (e.g., to restrict a portion of the stomach and/or the intestinal tract bypassing a portion) may be the only option for morbid obese patients. Furthermore, these types of procedures can have significant side effects, such as changes in gut hormones, and are relatively invasive surgical procedures with associated complications, tissue trauma, and/or infection, which in some cases can expose the patient to risk. In an alternative procedure, a stent may be used to create an opening between the stomach and jejunum to allow the flow of food particles and liquids from the stomach to the lower Gastrointestinal (GI) tract by bypassing the pylorus and duodenum. The stent may be used in conjunction with a device to occlude the pylorus. In known stents, endoluminal implants and/or transluminal implants, there is a continuing need to provide alternative configurations of stents, endoluminal implants and/or transluminal implants. Disclosure of Invention The present disclosure provides for the design, materials, methods of manufacture, and alternatives for use of medical devices. Example medical devices may include stents. In a first example, the transluminal implant may include an elongate tubular body extending from a first end region to a second end region. The elongate tubular body may include a backbone forming a plurality of holes, a first flange adjacent to the first end region, a second flange adjacent to the second end region, and a saddle region extending between the first flange and the second flange, the saddle region having an outer diameter less than the outer diameters of the first flange and the second flange. A reinforcement member may be disposed within the lumen of the elongate tubular body and within the first flange, the reinforcement member including at least one bent wire. Alternatively or additionally to any of the examples above, in another example, the reinforcement member may be configured to apply a radially outward force on the elongate tubular body. Alternatively or additionally to any of the examples above, in another example, the outer diameter of the reinforcement member may approximate the outer diameter of the first flange. Alternatively or additionally to any of the examples above, in another example, the outer diameter of the reinforcement member may be greater than the outer diameter of the first flange. Alternatively or additionally to any of the examples above, in another example, the at least one curved wire may include at least one coil extending around an inner surface of the first flange. Alternatively or additionally to any of the examples above, in another example, the at least one curved wire may include at least two coils extending around an inner surface of the first flange. Alternatively or additionally to any of the examples above, in another example, the at least one bent wire may include less than one turn of the coil. Alternatively or additionally to any of the examples above, in another example, the reinforcement member may include two or more curved wires. Alternatively or additionally to any of the examples above, in another example, the at least one curved wire may have a diameter of about 0.013 inches (0.330 millimeters). Alternatively or additionally to any of the examples above, in another example, the proximal end of the at least one curved wire may be fixed to the distal end of the at least one curved wire. Alternatively or additionally to any of the examples above, in another example, the at least one curved wire may comprise a shape memory material. Alternatively or additionally to any of the examples above, in another example, the transluminal implant may further comprise a second reinforcement member disposed within the lumen of the elongate tubular body and within the second flange. Alternatively or additionally to any of the examples above, in another example, the elongate tubular body may include a stent. Alternatively or additionally to any of the examples above, in another example, the elongate tubular body may include a pyloric closure device. Alternatively or additi