CN-121985924-A - Expandable stent with improved deliverability

CN121985924ACN 121985924 ACN121985924 ACN 121985924ACN-121985924-A

Abstract

A polymeric stent is disclosed that includes a polymeric tubular body extending from a distal region to a proximal region, the polymeric tubular body adapted to have a negative poisson's ratio. A distal engagement feature is formed in the distal region and a proximal engagement feature is formed in the proximal region. Also disclosed is a delivery device for a polymer scaffold comprising a tubular body having an outer surface adapted to receive the polymer scaffold thereon. The distal stent-engaging member is fixed relative to the tubular body and is adapted to releasably engage the distal engagement feature. The proximal stent-engaging member is fixed relative to the tubular body and is adapted to releasably engage the proximal engagement feature. The tubular body is adapted to cause a change in a distance between the distal stent-engaging member and the proximal stent-engaging member, thereby changing a length of the polymer stent.

Inventors

Martin G. Forrest

Assignees

波士顿科学国际有限公司

Dates

Publication Date: 20260505
Application Date: 20240823
Priority Date: 20230824

Claims (15)

1. A polymer scaffold adapted for placement within a biliary tract, the polymer scaffold comprising: a polymeric tubular body extending from a distal region to a proximal region; the polymeric tubular body has a delivery configuration having a first diameter and a first length; the polymeric tubular body has a deployed configuration having a second diameter greater than the first diameter and a second length greater than the first length; Wherein the polymeric tubular body is adapted to increase in diameter from the first diameter toward the second diameter in response to axial stretching of the polymeric tubular body from the first length toward the second length.
2. The polymeric stent of claim 1, wherein the polymeric tubular body comprises an auxetic structure.
3. The polymer scaffold of claim 2, wherein the auxetic structure comprises one of a rotating rectangular structure, a reentrant structure, or a chiral structure.
4. An assembly, comprising: A polymer scaffold, the polymer scaffold comprising: A polymeric tubular body extending from a distal region to a proximal region, the polymeric tubular body adapted to have a negative poisson's ratio; a distal engagement feature formed within the distal region, and A proximal engagement feature formed within the proximal region, and A delivery device adapted to deliver the polymeric scaffold, the delivery device comprising: A tubular body adapted to receive a polymer scaffold disposed on the tubular body; A distal stent-engaging member fixed relative to the tubular body, the distal stent-engaging member adapted to releasably engage the distal engagement feature; A proximal stent-engaging member fixed relative to the tubular body, the proximal stent-engaging member adapted to releasably engage the proximal engagement feature; wherein the tubular body is adapted to cause a change in a distance between the distal stent-engaging member and the proximal stent-engaging member, thereby changing a length of the polymer stent.
5. The assembly of claim 4, wherein increasing the length of the polymer scaffold increases the diameter of the polymer scaffold.
6. The assembly of claim 5, wherein subsequent to increasing the length of the polymer scaffold, subsequently decreasing the length of the polymer scaffold decreases the diameter of the polymer scaffold.
7. The assembly of any one of claims 4-6, wherein the distal stent engagement member and the proximal engagement member are each adapted to allow the polymer stent to disengage from the distal stent engagement member and the proximal engagement member once the proximal stent reaches a predetermined length.
8. The assembly of any one of claims 4 to 7, wherein: The distal stent-engaging member includes a distal protrusion extending above the outer surface of the tubular body, and The proximal stent-engaging member includes a proximal protrusion that extends above an outer surface of the tubular body.
9. The assembly of claim 8, wherein: The distal engagement feature includes a distal aperture formed in the distal region, the distal aperture adapted to releasably engage the distal stent-engaging member, and The proximal engagement feature includes a proximal aperture formed within the proximal region, the proximal aperture adapted to releasably engage the proximal bracket engagement member, or alternatively, wherein: the distal engagement feature includes a distal barb formed in the distal region, the distal barb adapted to releasably engage the distal stent barb member, and The proximal engagement feature includes a proximal aperture formed in the proximal region, the proximal barb being adapted to releasably engage the proximal bracket engagement member.
10. The assembly of any one of claims 4 to 9, wherein the tubular body comprises: an elongated outer member including an outer surface, and An elongated inner member including an outer surface; Wherein: The distal stent-engaging member is secured to an outer surface of the elongate outer member; The proximal stent-engaging member being secured to an outer surface of the elongate inner member, and Wherein the elongate inner member is adapted to translate within the elongate outer member, thereby changing the distance between the distal stent-engaging member and the proximal stent-engaging member.
11. The assembly of any one of claims 4 to 10, wherein the polymeric tubular body comprises one of a rotating rectangular structure, a reentrant structure, or a chiral structure.
12. A delivery device for delivering a polymer scaffold comprising a polymer tubular body adapted to grow radially in response to being axially stretched, the polymer scaffold comprising a first engagement feature and a second engagement feature, the delivery device comprising: A telescoping body comprising an elongated outer member and an elongated inner member adapted to translate within the elongated outer member; A first bracket engagement member fixed relative to the elongate outer member, the first bracket engagement member adapted to releasably engage the first engagement feature; A second bracket engagement member fixed relative to the elongate inner member, the second bracket engagement member adapted to releasably engage the second engagement feature; Wherein translating the elongate inner member relative to the elongate outer member in a first direction causes the distance between the first stent-engaging member and the second stent-engaging member to increase, thereby stretching the polymer stent and increasing the diameter of the polymer stent.
13. The delivery device of claim 12, wherein the distal stent-engaging member and the proximal engaging member are each adapted to allow the polymer stent to disengage from the distal stent-engaging member and the proximal engaging member once the proximal stent reaches a predetermined length.
14. The delivery device of claim 13, wherein: the distal stent-engaging member includes a distal projection extending radially away from the elongate outer member, and The proximal stent-engaging member includes a proximal protrusion extending radially away from the elongate inner member.
15. The delivery device of any one of claims 12 to 14, wherein the elongate inner member comprises a distal stop disposed at a distal end of the elongate inner member, the distal stop adapted to limit how far the elongate inner member can be withdrawn from the elongate outer member.

Description

Expandable stent with improved deliverability Cross Reference to Related Applications The present application claims the benefit and priority of U.S. provisional patent application Ser. No. 63/578,511 filed on 8/2023, 24, the disclosure of which is incorporated herein by reference. Technical Field The present disclosure relates generally to methods and apparatus for various digestive system diseases. More particularly, the present disclosure relates to different configurations of stents and methods of making and using the same. Background Implantable stents are devices that are placed in a body structure (such as a blood vessel, esophagus, trachea, biliary tract, colon, intestine, stomach, or body lumen) to provide support and hold the structure open. These devices are manufactured by any of a number of different manufacturing methods and may be used according to any of a number of methods. In known medical devices, delivery systems, and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and delivery devices, and alternative methods for making and using medical devices and delivery devices. Disclosure of Invention The present disclosure relates to several alternative designs, materials, and methods of manufacture of medical device structures and components, and uses thereof. One example may be embodied as a polymer scaffold adapted for placement within the biliary tract. The polymeric stent includes a polymeric tubular body extending from a distal region to a proximal region. The polymeric tubular body has a delivery configuration having a first diameter and a first length. The polymeric tubular body has a deployed configuration having a second diameter greater than the first diameter and a second length greater than the first length. The polymeric tubular body is adapted to increase in diameter from the first diameter toward the second diameter in response to axial stretching of the polymeric tubular body from the first length toward the second length. Alternatively or additionally, the polymeric tubular body may comprise an auxetic structure. Alternatively or additionally, the auxetic structure may comprise one of a rotating rectangular structure, a re-entrant structure (re-entrant structure) or a chiral structure. Another example may be embodied as a component. The assembly includes a polymeric stent and a delivery device adapted to deliver the polymeric stent. The polymeric stent includes a polymeric tubular body extending from a distal region to a proximal region, the polymeric tubular body adapted to have a negative poisson's ratio. A distal engagement feature is formed in the distal region and a proximal engagement feature is formed in the proximal region. The delivery device includes a tubular body adapted to receive a polymer scaffold disposed on the tubular body. A distal stent-engaging member is fixed relative to the tubular body, the distal stent-engaging member adapted to releasably engage the distal engagement feature. A proximal stent-engaging member is fixed relative to the tubular body, the proximal stent-engaging member adapted to releasably engage the proximal engagement feature. The tubular body is adapted to cause a change in a distance between the distal stent-engaging member and the proximal stent-engaging member, thereby changing a length of the polymer stent. Alternatively or additionally, increasing the length of the polymer scaffold may cause the diameter of the polymer scaffold to increase. Alternatively or additionally, subsequent to increasing the length of the polymer scaffold, decreasing the length of the polymer scaffold may cause the diameter of the polymer scaffold to decrease. Alternatively or additionally, the distal and proximal stent-engaging members may each be adapted to allow the polymeric stent to disengage from the distal and proximal stent-engaging members once the proximal stent reaches a predetermined length. Alternatively or additionally, the distal stent-engaging member may comprise a distal protrusion that extends above the outer surface of the tubular body and the proximal stent-engaging member may comprise a proximal protrusion that extends above the outer surface of the tubular body. Alternatively or additionally, the distal engagement feature may comprise a distal aperture formed in the distal region adapted to releasably engage the distal stent-engaging member, and the proximal engagement feature may comprise a proximal aperture formed in the proximal region adapted to releasably engage the proximal stent-engaging member. Or alternatively, the distal engagement feature may comprise a distal barb formed in the distal region that is adapted to releasably engage the distal stent-barb member, and the proximal engagement feature may comprise a proximal aperture formed in the proximal region that is adapted to releasably engage the proximal stent-engagement member. Alternatively or additio