Endoluminal device and method

• US 10,137,013 B2
• Filed: 12/11/2017
• Issued: 11/27/2018
• Est. Priority Date: 05/29/2010
• Status: Active Grant

• Current Assignee: Intact Vascular, Inc. (Koninklijke Philips N.V.)
• Original Assignee: Intact Vascular, Inc. (Koninklijke Philips N.V.)
• Inventors: Giasolli, Robert, Schneider, Peter
• Primary Examiner(s): Tyson, Melanie
• Application Number:
  US15/837,870
• Publication Number:
  US 20180110634A1
• Time in Patent Office: 351 Days
• Field of Search: 623 114, 623 115, 623 116
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/22081 Treatment of vulnerable plaque
• CPC Class Codes: A61B 2017/2937 with flexible part
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/8483 : Barbs
• CPC Class Codes: A61F 2002/8486 : provided on at least one of the ends
• CPC Class Codes: A61F 2002/91508 : the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/9583 : Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0062 : Kits of prosthetic parts to be assembled in various combinations for forming different prostheses

Abstract

An endoluminal device can be configured for precise positioning during deployment within a vessel. The endoluminal device can be a tack, stent, vascular implant or other type of implant. The endoluminal device can have circumferential member with an undulating configuration having multiple inward and outward apexes and struts extending therebetween. Two of the struts can be used to establish a foot for the precise positioning of the device during deployment. A method of placing the endoluminal device can include withdrawing an outer sheath such that a portion of the endoluminal device is expanded prior to the rest of the endoluminal device.

Claims

1. A self-expanding intravascular implant comprising:

a proximal sinusoidal ring forming a proximal end of the self-expanding intravascular implant, the proximal sinusoidal ring comprising;

a plurality of proximal ring struts, each proximal ring strut of the plurality of proximal ring struts having a proximal end and a distal end;

a plurality of proximal ring proximal apices, wherein each proximal ring proximal apex of the plurality of proximal ring proximal apices connects two proximal ends of two proximal ring struts of the plurality of proximal ring struts; and

a plurality of proximal ring distal apices, wherein each proximal ring distal apex of the plurality of proximal distal apices connects two distal ends of two proximal ring struts of the plurality of proximal ring struts;

a distal sinusoidal ring forming a distal end of the self-expanding intravascular implant, the distal sinusoidal ring comprising;

a plurality of distal ring struts, each distal ring strut of the plurality of distal ring struts having a proximal end and a distal end;

a plurality of distal ring distal apices, wherein each distal ring distal apex of the plurality of distal ring distal apices connects two distal ends of two distal ring struts of the plurality of distal ring struts; and

a plurality of proximal ring distal apices, wherein each distal ring proximal apex of the plurality of proximal ring distal apices connects two proximal ends of two distal ring struts of the plurality of distal ring struts;

a plurality of bridge members, each bridge member of the plurality of bridge members comprising a proximal end, a distal end, and a bridge midpoint, wherein the proximal end of each bridge member of the plurality of bridge members is connected to the proximal sinusoidal ring and the distal end of each bridge member of the plurality of bridge members is connected to the distal sinusoidal ring;

a plurality of anchors, the plurality of anchors being located on the plurality of bridge members;

wherein an outer surface of the proximal sinusoidal ring, an outer surface of the distal sinusoidal ring, an outer surface of each bridge member of the plurality of bridge members, and an outer surface of each anchor of the plurality of anchors forms a generally cylindrical shape when the self-expanding intravascular implant is in an unconstrained state, wherein the plurality of anchors remain in-plane when the self-expanding intravascular implant is in a generally cylindrical configuration, and wherein the plurality of anchors is configured to project out of plane when the self-expanding intravascular implant is forced into a non-round configuration.

2. The self-expanding intravascular implant of claim 1, wherein the plurality of anchors is configured such that only anchors of the plurality of anchors that are contained within a portion of the self-expanding intravascular implant that is forced into a non-round configuration project out of plane while all other anchors of the plurality of anchors remain in-plane.

3. The self-expanding intravascular implant of claim 1, wherein the plurality of anchors is configured to remain in-plane as the self-expanding intravascular implant cylindrically expands and cylindrically compresses between a cylindrical expanded configuration and a cylindrical compressed configuration.

4. The self-expanding intravascular implant of claim 1, wherein the plurality of anchors comprises two v-shaped points located on each bridge member of the plurality of bridge members, wherein the two v-shaped points extend from each bridge member of the plurality of bridge members in the same circumferential direction.

5. The self-expanding intravascular implant of claim 4, wherein the self-expanding intravascular implant further comprises at least one radiopaque marker located between the two v-shaped points located on each bridge member of the plurality of bridge members.

6. The self-expanding intravascular implant of claim 1, wherein the proximal end of each bridge member of the plurality of bridge members is connected to the one proximal ring distal apex of the plurality of proximal ring distal apices and the distal end of each bridge member of the plurality of bridge members is connected to one distal ring proximal apex of the plurality of distal ring proximal apices.

7. A self-expanding intravascular implant comprising:

a first cylindrical ring defining a first end of the self-expanding intravascular implant;

a second cylindrical ring defining a second end of the self-expanding intravascular implant;

a plurality of bridge members, wherein each bridge member of the plurality of bridge members has a first end and a second end, wherein the first end of each bridge member of the plurality of bridge members is attached to the first cylindrical ring and the second end of each bridge member of the plurality of bridge members is attached to the second cylindrical ring;

at least one anchor, wherein the at least one anchor is configured to remain within a cylinder defined by the first cylindrical ring, the second cylindrical ring and the plurality of bridge members when the self-expanding intravascular implant is in a generally cylindrical configuration, and wherein the at least one anchor is configured to extend outwards when the self-expanding implant is forced out of the generally cylindrical configuration.

8. The self-expanding intravascular implant of claim 7, wherein the first cylindrical ring comprises a first sinusoidal ring and the second cylindrical ring comprises a second sinusoidal ring.

9. The self-expanding intravascular implant of claim 7, wherein the at least one anchor is configured such that each anchor of the at least one anchor located in a portion of the self-expanding intravascular implant that is forced out of the generally cylindrical configuration extends outwards while every other anchor of the at least one anchor remains within the cylinder defined by the first cylindrical ring, the second cylindrical ring and the plurality of bridge members.

10. The self-expanding intravascular implant of claim 7, wherein the at least one anchor comprises at least one anchor disposed on at least one bridge member of the plurality of bridge members at a midpoint of the at least one bridge member of the plurality of bridge members.

11. The self-expanding intravascular implant of claim 7, wherein the at least one anchor comprises one or more anchors disposed on at least one bridge member of the plurality of bridge members adjacent a midpoint of the at least one bridge member of the plurality of bridge members.

12. The self-expanding intravascular implant of claim 11, wherein at least one bridge member of the plurality of bridge members comprises a radiopaque marker at the midpoint of the at least one bridge member of the plurality of bridge members and one or more anchors of the at least one anchors disposed on each side of the radiopaque marker.

13. The self-expanding intravascular implant of claim 12, wherein the radiopaque marker is held by an eyelet and the one or more anchors of the at least one anchors disposed on each side of the radiopaque marker extends from a single side of the bridge member parallel to each other anchor of the one or more anchors disposed on the at least one bridge member.

14. The self-expanding intravascular implant of claim 7, wherein the at least one anchor comprises one or more anchors disposed on at least one bridge member of the plurality of bridge members and extending from only a single side of the at least one bridge member of the plurality of bridge members.

15. The self-expanding intravascular implant of claim 7, wherein the at least one anchor comprises at least two anchors disposed on at least one bridge member of the plurality of bridge members, wherein at least one anchor of the at least two anchors extends from one side of the at least one bridge member of the plurality of bridge members and the other anchor of the at least two anchors ends from the other side of the at least one bridge member of the plurality of bridge members.

16. The self-expanding intravascular implant of claim 7, wherein the at least one anchor comprises a v-shaped point.

17. The self-expanding intravascular implant of claim 7, wherein the at least one anchor comprises a material thickness greater than a material thickness of the rest of the self-expanding intravascular implant.

18. The self-expanding intravascular implant of claim 7, wherein the at least one anchor comprises a radiopacity greater than a radiopacity of the rest of the self-expanding intravascular implant.

19. The self-expanding intravascular implant of claim 7, wherein the at least one anchor has an anchor length of about 0.01 mm to 5 mm.

20. The self-expanding intravascular implant of claim 19, wherein the at least one anchor has an anchor length of about 0.03 mm to 1 mm.

21. The self-expanding intravascular implant of claim 20, wherein the at least one anchor has an anchor length of about 0.05 mm to 0.5 mm.

22. A self-expanding intravascular implant comprising:

a proximal undulating ring having a generally cylindrical shape and defining a proximal end of the self-expanding intravascular implant;

a distal undulating ring having a generally cylindrical shape and defining a distal end of the self-expanding intravascular implant;

a plurality of bridge members, wherein each bridge member of the plurality of bridge members comprises a proximal end connected to the proximal undulating ring and a distal end connected to the distal undulating ring; and

a plurality of anchors;

wherein the plurality of bridge members and the plurality of anchors are curved with the proximal undulating ring and the distal undulating ring so that the plurality of anchors remain in-plane when the self-expanding intravascular implant is in a round configuration and so that the plurality of anchors project outward when the self-expanding intravascular implant is forced into a non-round configuration.

23. The self-expanding intravascular implant of claim 22, wherein the plurality of anchors are configured so that a first portion of the plurality of anchors project outward while a second portion of the plurality of anchors remain in-plane.

24. The self-expanding intravascular implant of claim 23, wherein the first portion of the plurality of anchors are contained within a region of the self-expanding intravascular implant that is forced out of round.

25. The self-expanding intravascular implant of claim 24, wherein the second portion of the plurality of anchors are contained within a region of the self-expanding intravascular implant that remains generally cylindrical.

26. The self-expanding intravascular implant of claim 24, wherein each anchor of the plurality of anchors is located on a bridge member of the plurality of bridge members.

27. A self-expanding intravascular implant comprising:

at least one first circumferential ring;

at least one second circumferential ring;

a plurality of bridge members extending between the at least one first circumferential ring and at least one second circumferential ring such that an outer surface of each of the at least one first circumferential ring, the at least one second circumferential ring lie in a generally cylindrical shape; and

a plurality of anchors extending along the generally cylindrical shape, wherein the plurality of anchors is configured to engage a volume outside the generally cylindrical shape when the self-expanding intravascular implant is forced out of round.

28. The self-expanding intravascular implant of claim 27, wherein the plurality of anchors are configured such that only those anchors of the plurality of anchors that are located within a portion of the self-expanding intravascular implant that is forced out of round engage the volume outside the generally cylindrical shape.

29. The self-expanding intravascular implant of claim 27, wherein the plurality of anchors is configured to remain in-plane as the self-expanding intravascular implant experiences generally cylindrical compression and generally cylindrical expansion.

30. The self-expanding intravascular implant of claim 27, wherein each anchor of the plurality of anchors is located on a bridge member of the plurality of bridge members.