Stent fixation with reduced plastic deformation

• US 9,254,209 B2
• Filed: 07/02/2012
• Issued: 02/09/2016
• Est. Priority Date: 07/07/2011
• Status: Active Grant

• Current Assignee: Japan Lifeline Co., Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US14/130,213
• Publication Number:
  US 20140172072A1
• Time in Patent Office: 1,317 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/945 hardenable, e.g. stents formed in situ
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

An endovascular stent system (10) includes first and second generally tubular stents members (20, 22), which are shaped so as to define first and second interface sections (40, 42), respectively, which are securely coupleable to each other. The first interface section (40) is shaped so as to define an opening (44). The second interface section (42) is shaped so as to define a neck portion (50). When the first and second stent members (20, 22) are coupled together, the neck portion (50) is at least in part defined by: (a) first ones (72) of structural elements (70), positioned at respective first circumferential locations, which are configured to apply, to the opening (44), distally- and radially-outwardly-directed forces, without applying any proximally-directed forces, and (b) separate from the first structural elements (72), second ones (74) of the structural elements (70), positioned at respective second circumferential locations different from the first circumferential locations, which are configured to apply, to the opening (44), a proximally- and radially-outwardly-directed forces, without applying any distally-directed forces.

Claims

1. Apparatus comprising a multi-component endovascular stent system, which comprises first and second generally tubular stents members, which (a) are configured to assume respective radially-compressed states for transluminal delivery, and respective radially-expanded states for intraluminal fixation, and (b) comprise structural elements, wherein the second stent member has proximal and distal ends,

wherein the first and the second stent members are shaped so as to define first and second interface sections, respectively, which are securely coupleable to each other when the first and the second stent members are in their respective radially-expanded states,

wherein the first interface section is shaped so as to define an opening having a structural circumference defined by one or more of the structural elements of the first stent member,

wherein the second interface section is shaped so as to define a neck portion longitudinally flanked by proximal and distal portions, which neck portion is generally radially narrower than the proximal and the distal portions,

wherein, when the first and the second stent members are coupled together in their respective radially-expanded states, the neck portion is at least in part defined by:

first ones of the structural elements of the second stent member, which are positioned at respective first circumferential locations, wherein each of at least a portion of the first structural elements longitudinally spans the structural circumference, and is configured to apply, to the structural circumference of the first interface section, a distally- and radially-outwardly-directed force, without applying any proximally-directed force, and

separate from the first structural elements, second ones of the structural elements of the second stent member, which are positioned at respective second circumferential locations different from the first circumferential locations, wherein each of at least a portion of the second structural elements longitudinally spans the structural circumference, and is configured to apply, to the structural circumference of the first interface section, a proximally- and radially-outwardly-directed force, without applying any distally-directed force, and wherein all of the first circumferential locations are circumferentially offset from all of the second circumferential locations.

2. The apparatus according to claim 1, wherein the first interface section is positioned at a longitudinal location other than at ends of the first stent member, such that the opening is defined by a lateral wall of the first stent member.

3. The apparatus according to claim 1, wherein the first interface section is positioned at a longitudinal end of the first stent member.

4. The apparatus according to claim 3, wherein the first interface section extends along a longitudinal portion of the first stent member longitudinally adjacent to the longitudinal end, which longitudinal portion radially narrows toward the longitudinal end.

5. The apparatus according to claim 1, wherein a length of the structural circumference of the first interface section is less than a perimeter of a narrowest portion of the neck portion of the second interface section, when the first and the second stent members are in their respective radially-expanded states, and not coupled to each other.

6. The apparatus according to claim 5, wherein the length of the structural circumference is at least 30% less than the perimeter of the narrowest portion of the neck portion.

9. The apparatus according to claim 1, wherein the stent system further comprises a first graft member, which is securely fixed to the first stent member, and a second graft member, which is securely fixed to the second stent member.

10. The apparatus according to claim 1, wherein the stent system further comprises a graft member, which is securely fixed to a stent member selected from the group consisting of:

the first stent member and the second stent member.

11. The apparatus according to claim 1, wherein each of all of the first structural elements is configured to apply, to the structural circumference of the first interface section, the distally- and radially-outwardly-directed force, without applying any proximally-directed force, and wherein each of all of the second structural elements is configured to apply, to the structural circumference of the first interface section, the proximally- and radially-outwardly-directed force, without applying any distally-directed force.

12. The apparatus according to claim 1, wherein, when the first and the second stent members are in their respective radially-expanded states, at least one of the first structural elements is shaped so as to define first proximal and first distal portions joined at a first apex, which first proximal portion is configured to apply, to the structural circumference, the distally- and radially-outwardly-directed force, and which first distal portion is configured not to apply any force to the structural circumference.

14. The apparatus according to claim 1, wherein a first combined total surface area of contact between the first structural elements and the structural circumference is at least 15% greater than a second combined total surface area of contact between the second structural elements and the structural circumference.

15. The apparatus according to claim 14, wherein the first combined total surface area of contact is at least 30% greater than the second combined total surface area of contact.

16. The apparatus according to claim 1, wherein a first combined total surface area of contact between the second structural elements and the structural circumference is at least 15% greater than a second combined total surface area of contact between the first structural elements and the structural circumference.

17. The apparatus according to claim 16, wherein the first combined total surface area of contact is at least 30% greater than the second combined total surface area of contact.

18. The apparatus according to claim 1, wherein the second interface section is shaped so as to gradually narrow from the proximal portion to the neck portion and from the distal portion to the neck portion.

19. The apparatus according to claim 1, wherein a first axial force applied between each of the first structural elements, taken separately, and the structural circumference is greater than a second axial force applied between each of the second structural elements, taken separately, and the structural circumference, when the first and the second stent members are coupled together in their respective radially-expanded states.

20. The apparatus according to claim 19, wherein the first axial force is at least 30% greater than the second axial force.

21. The apparatus according to claim 1, wherein a second axial force applied between each of the second structural elements, taken separately, and the structural circumference is greater than a first axial force applied between each of the first structural elements, taken separately, and the structural circumference, when the first and the second stent members are coupled together in their respective radially-expanded states.

22. The apparatus according to claim 21, wherein the second axial force is at least 30% greater than the first axial force.

26. The apparatus according to claim 1, wherein the first structural elements are arranged in first groups of one to ten circumferentially-adjacent first structural elements, wherein the second structural elements are arranged in second groups of one to ten circumferentially-adjacent second structural elements, and wherein the first and the second groups circumferentially alternate around the neck portion.

27. The apparatus according to claim 12, wherein, when the first and the second stent members are in their respective radially-expanded states, at least one of the second structural elements is shaped so as to define second proximal and second distal portions joined at a second apex, which second distal portion is configured to apply, to the structural circumference, the proximally- and radially-outwardly-directed force, and which second proximal portion is configured not to apply any force to the structural circumference.

7. Apparatus comprising a multi-component endovascular stent system, which comprises first and second generally tubular stents members, which (a) are configured to assume respective radially-compressed states for transluminal delivery, and respective radially-expanded states for intraluminal fixation, and (b) comprise structural elements, wherein the second stent member has proximal and distal ends,

wherein the first and the second stent members are shaped so as to define first and second interface sections, respectively, which are securely coupleable to each other when the first and the second stent members are in their respective radially-expanded states,

wherein the first interface section is shaped so as to define an opening having a structural circumference defined by one or more of the structural elements of the first stent member,

wherein the second interface section is shaped so as to define a neck portion longitudinally flanked by proximal and distal portions, which neck portion is generally radially narrower than the proximal and the distal portions,

wherein, when the first and the second stent members are coupled together in their respective radially-expanded states, the neck portion is at least in part defined by:

first ones of the structural elements of the second stent member, which are positioned at respective first circumferential locations, wherein each of at least a portion of the first structural elements is configured to apply, to the structural circumference of the first interface section, a distally- and radially-outwardly-directed force, without applying any proximally-directed force, and

separate from the first structural elements, second ones of the structural elements of the second stent member, which are positioned at respective second circumferential locations different from the first circumferential locations, wherein each of at least a portion of the second structural elements is configured to apply, to the structural circumference of the first interface section, a proximally- and radially-outwardly-directed force, without applying any distally-directed force, wherein all of the first circumferential location are circumferentially offset from all of the second circumferential locations, and

wherein the first structural elements are arranged in first groups of one to ten circumferentially-adjacent first structural elements, wherein the second structural elements are arranged in second groups of one to ten circumferentially-adjacent second structural elements, and wherein the first and the second groups circumferentially alternate around the neck portion.

8. The apparatus according to claim 7, wherein each of the first groups consists of exactly one of the first structural elements, and wherein each of the second groups consists of exactly one of the second structural elements.

13. Apparatus comprising a multi-component endovascular stent system, which comprises first and second generally tubular stents members, which (a) are configured to assume respective radially-compressed states for transluminal delivery, and respective radially-expanded states for intraluminal fixation, and (b) comprise structural elements, wherein the second stent member has proximal and distal ends,

wherein the first and the second stent members are shaped so as to define first and second interface sections, respectively, which are securely coupleable to each other when the first and the second stent members are in their respective radially-expanded states,

wherein the first interface section is shaped so as to define an opening having a structural circumference defined by one or more of the structural elements of the first stent member,

wherein the second interface section is shaped so as to define a neck portion longitudinally flanked by proximal and distal portions, which neck portion is generally radially narrower than the proximal and the distal portions,

wherein, when the first and the second stent members are coupled together in their respective radially-expanded states, the neck portion is at least in part defined by:

first ones of the structural elements of the second stent member, which are positioned at respective first circumferential locations, wherein each of at least a portion of the first structural elements is configured to apply, to the structural circumference of the first interface section, a distally- and radially-outwardly-directed force, without applying any proximally-directed force, and

separate from the first structural elements, second ones of the structural elements of the second stent member, which are positioned at respective second circumferential locations different from the first circumferential locations, wherein each of at least a portion of the second structural elements is configured to apply, to the structural circumference of the first interface section, a proximally- and radially-outwardly-directed force, without applying any distally-directed force, wherein all of the first circumferential locations are circumferentially offset from all of the second circumferential locations,

wherein, when the first and the second stent members are in their respective radially-expanded states, at least one of the first structural elements is shaped so as to define first proximal and first distal portions joined at a first apex, which first proximal portion is configured to apply, to the structural circumference, the distally- and radially-outwardly-directed force, and which first distal portion is configured not to apply any force to the structural circumference, and

wherein, when the first and the second stent members are in their respective radially-expanded states, at least one of the second structural elements is shaped so as to define second proximal and second distal portions joined at a second apex, which second distal portion is configured to apply, to the structural circumference, the proximally- and radially-outwardly-directed force, and which second proximal portion is configured not to apply any force to the structural circumference.

23. A method comprising:

providing a multi-component endovascular stent system, which includes first and second generally tubular stents members, which (a) are configured to assume respective radially-compressed states for transluminal delivery, and respective radially-expanded states for intraluminal fixation, and (b) comprise structural elements, wherein the second stent member has proximal and distal ends, wherein the first and the second stent members are shaped so as to define first and second interface sections, respectively, which are securely coupleable to each other when the first and the second stent members are in their respective radially-expanded states, wherein the first interface section is shaped so as to define an opening having a structural circumference defined by one or more of the structural elements of the first stent member, wherein the second interface section is shaped so as to define a neck portion longitudinally flanked by proximal and distal portions, which neck portion is generally radially narrower than the proximal and the distal portions, and wherein, when the first and the second stent members are coupled together in their respective radially-expanded states, the neck portion is at least in part defined by;

(a) first ones of the structural elements of the second stent member, which are positioned at respective first circumferential locations, wherein each of at least a portion of the first structural elements longitudinally spans the structural circumference, and is configured to apply, to the structural circumference of the first interface section, a distally- and radially-outwardly-directed force, without applying any proximally-directed force, and (b) separate from the first structural elements of the second stent member, second ones of the structural elements, which are positioned at respective second circumferential locations different from the first circumferential locations, wherein each of at least a portion of the second structural elements longitudinally spans the structural circumference, and is configured to apply, to the structural circumference of the first interface section, a proximally- and radially-outwardly-directed force, without applying any distally-directed force wherein all of the first circumferential locations are circumferentially offset from all of the second circumferential locations; and

deploying the first and the second stent members in a blood vessel of a patient such that the first and the second interface sections are coupled to each other.

24. Apparatus comprising a multi-component endovascular stent system, which comprises first and second generally tubular stents members, which (a) are configured to assume respective radially-compressed states for transluminal delivery, and respective radially-expanded states for intraluminal fixation, and (b) comprise structural elements, wherein the second stent member has proximal and distal ends,

wherein the first and the second stent members are shaped so as to define first and second interface sections, respectively, which are securely coupleable to each other when the first and the second stent members are in their respective radially-expanded states,

wherein the first interface section is shaped so as to define an opening having a structural circumference defined by one or more of the structural elements of the first stent member,

wherein the second interface section is shaped so as to define a neck portion longitudinally flanked by proximal and distal portions, which neck portion is generally radially narrower than the proximal and the distal portions, and

wherein, when the first and the second stent members are coupled together in their respective radially-expanded states, the neck portion is at least in part defined by:

first ones of the structural elements of the second stent member, which are positioned at respective first circumferential locations, wherein each of at least a portion of the first structural elements is configured to apply, to the structural circumference of the first interface section, a distally- and radially-outwardly-directed force, without applying any proximally-directed force, and wherein at least one of the first structural elements is shaped so as to define first proximal and first distal portions joined at a first apex, and

separate from the first structural elements, second ones of the structural elements of the second stent member, which are positioned at respective second circumferential locations different from the first circumferential locations, wherein each of at least a portion of the second structural elements is configured to apply, to the structural circumference of the first interface section, a proximally- and radially-outwardly-directed force, without applying any distally-directed force, wherein at least one of the second structural elements is shaped so as to define second proximal and second distal portions joined at a second apex, and wherein the first and the second apexes are disposed at longitudinally different positions, and wherein all of the first circumferential locations are circumferentially offset from all of the second circumferential locations.

25. The apparatus according to claim 24, wherein the first and the second apexes are disposed on longitudinally-opposite sides of the structural circumference, when the first and the second stent members are coupled together in their respective radially-expanded states.