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EP-4739257-A1 - BILIARY STENT AND DELIVERY DEVICE

EP4739257A1EP 4739257 A1EP4739257 A1EP 4739257A1EP-4739257-A1

Abstract

Devices, systems, and methods for deploying a biliary stent. A biliary stent has lobes and creases to expand between contracted and expanded positions. The stent is delivered to a bile duct in a contracted position loaded on a shaft of a delivery device. When the shaft is retracted through the stent, wings on the shaft force the stent outward into the larger expanded position. In the expanded position, the creases form drainage channels to reduce blockage over the life of the stent.

Inventors

  • FOLAN, Martyn G.

Assignees

  • Boston Scientific Scimed, Inc.

Dates

Publication Date
20260513
Application Date
20240703

Claims (15)

  1. 1. A biliary stent comprising a plurality of lobes alternating radially with a plurality of creases; wherein each of the plurality of lobes has a first contracted position biased inwards from the creases such that the biliary stent has a first cross-sectional diameter; and wherein each of the plurality of lobes has a second expanded position biased outwards from the creases such that the biliary stent has a second cross-sectional diameter larger than the first cross-sectional diameter.
  2. 2. The biliary stent of claim 1, wherein the plurality of lobes are the same length such that the stent is symmetrical.
  3. 3. The biliary stent of claim 1 or 2, comprised of biocompatible plastic.
  4. 4. The biliary stent of any one of claim 1 to claim 3, wherein each of the lobes forms a convex curve with adjacent creases when in the second expanded position such that adjacent lobes form side walls of channels exterior to the stent upon expansion of the biliary stent.
  5. 5. The biliary stent of any one of claim 1 to claim 4, wherein the stent in the first contracted position has a cross-sectional diameter of between 1 mm and 5 mm.
  6. 6. The biliary stent of any one of claim 1 to claim 5, wherein the stent in the second expanded position has a cross-sectional diameter of between 2 mm and 10 mm.
  7. 7. The biliary stent of any one of claim 1 to claim 6, wherein the stent has an axial length of between 2 mm and 20 mm.
  8. 8. A biliary stent delivery device, comprising: a shaft sized for insertion into a bile duct of a patient; and one or more wings at the distal end of the shaft, wherein each wing shifts between a first proximal orientation pointed towards a proximal end of the shaft and a second distal orientation pointed towards the distal end of the shaft.
  9. 9. The device of claim 8, wherein the shaft is loaded with an expandable biliary stent for insertion into the bile duct, the expandable stent positioned proximally to the one or more wings such that, when the shaft is retracted through the loaded stent, the wings shift from the first proximal orientation to the second distal orientation to press outward on the stent, expanding the stent.
  10. 10. The device of claim 8 or 9, wherein the expandable biliary stent is a stent from any one of claim 1 to claim 7.
  11. 11. The device of any one of claim 8 to claim 10, wherein the wings have a cross- sectional diameter in the first proximal orientation of between 2.3 mm and 4.2 mm.
  12. 12. The device of any one of claim 8 to claim 11, wherein the wings have a cross- sectional diameter in the second distal orientation between 2.3 mm and 4.2 mm.
  13. 13. A method for deploying the biliary stent of any one of claim 1 to claim 7, comprising: loading the stent in the first position onto the shaft of the delivery device of any one of claim 8 to claim 12; inserting the distal end of the shaft into the bile duct of a patient; positioning the stent within the patient; expanding the stent into the second position; and retracting the shaft, leaving the expanded stent in the bile duct.
  14. 14. The method of claim 13, wherein the one or more wings at the distal end of the shaft are positioned in the first proximal orientation during insertion of the distal end of the shaft and positioning the stent; and wherein retracting the shaft comprises moving the distal end of the shaft through the stent such that the wings shift from the first proximal orientation to the second distal orientation; and wherein expanding the stent is a result of the wings pressing outward on the stent as the distal end of the shaft moves through the stent.
  15. 15. The method of claim 13 or 14, further comprising deploying a second stent loaded onto the device.

Description

BILIARY STENT AND DELIVERY DEVICE CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/512,554 filed on July 7, 2023, the disclosure of which is incorporated herein by reference. TECHNICAL FIELD [0002] This disclosure relates generally to medical devices and, more particularly, to expandable biliary stents. BACKGROUND [0003] A partial or total blockage of one or more bile ducts may be remedied by use of biliary stents. Conventional biliary stents are tubes made of plastic or metal, generally having a circular or ovular cross-section. With the advent of endoscopic surgery to install the stents, the maximum radius of each stent is limited by the maximum diameter in the endoscopic device channel used to deliver them. Expandable biliary stents are known, but the stent’s smooth cylindrical shape can result in the stent filling the bile duct and quickly becoming clogged. There is a need for a reliable method for delivering and deploying an expandable stent with easy, mechanical expansion and exterior channels for drainage. [0004] The present disclosure provides medical devices and methods of using the same that avoid the aforementioned shortcomings of existing devices. SUMMARY [0005] This disclosure provides design, material, manufacturing method, and use alternatives for medical devices and medical systems. In a first example, a biliary stent comprises a plurality of lobes alternating radially with a plurality of creases; wherein each of the plurality of lobes has a first contracted position biased inwards from the creases such that the biliary stent has a first cross-sectional diameter; and wherein each of the plurality of lobes has a second expanded position biased outwards from the creases such that the biliary stent has a second cross-sectional diameter larger than the first cross-sectional diameter. [0006] Alternatively or additionally to any of the examples above, the plurality of lobes are the same length such that the stent is symmetrical. [0007] Alternatively or additionally to any of the examples above, the stent is made of biocompatible plastic. [0008] Alternatively or additionally to any of the examples above, each of the lobes forms a convex curve with adjacent creases when in the second expanded position such that adjacent lobes form side walls of channels exterior to the stent upon expansion of the biliary stent. [0009] Alternatively or additionally to any of the examples above, the stent in the first contracted position has a cross-sectional diameter of between 1 mm and 5 mm. [0010] Alternatively or additionally to any of the examples above, the stent in the second expanded position has a cross-sectional diameter of between 2 mm and 10 mm. [0011] Alternatively or additionally to any of the examples above, the stent has an axial length of between 2 mm and 20 mm. [0012] In another example, a biliary stent delivery device comprises a shaft sized for insertion into a bile duct of a patient and one or more wings at the distal end of the shaft, wherein each wing shifts between a first proximal orientation pointed towards a proximal end of the shaft and a second distal orientation pointed towards the distal end of the shaft. [0013] Alternatively or additionally to any of the examples above, the shaft is loaded with an expandable biliary stent for insertion into the bile duct, the expandable stent positioned proximally to the one or more wings such that, when the shaft is retracted through the loaded stent, the wings shift from the first proximal orientation to the second distal orientation to press outward on the stent, expanding the stent. [0014] Alternatively or additionally to any of the examples above, the wings have a cross-sectional diameter in the first proximal orientation of between 2.3 mm and 4.2 mm. [0015] Alternatively or additionally to any of the examples above, the wings have a cross-sectional diameter in the second proximal orientation of between 2.3 mm and 4.2 mm. [0016] In another example, a method of deploying a biliary stent of any of the examples above can include the steps of loading the stent in the first position onto the shaft of the delivery device of any one of the examples above; inserting the distal end of the shaft into the bile duct of a patient; positioning the stent within the patient; expanding the stent into the second position; and retracting the shaft, leaving the expanded stent in the bile duct. [0017] Alternatively or additionally to any of the examples above, the one or more wings at the distal end of the shaft are positioned in the first proximal orientation during insertion of the distal end of the shaft and positioning the stent. Retracting the shaft includes moving the distal end of the shaft through the stent such that the wings shift from the first proximal orientation to the second distal orientation. Expanding the stent is a result of the wings pressing outward on the s