Endoluminal device and method

• US 9,730,818 B2
• Filed: 01/24/2013
• Issued: 08/15/2017
• Est. Priority Date: 12/12/2007
• Status: Active Grant

• Current Assignee: Intact Vascular, Inc. (Koninklijke Philips N.V.)
• Original Assignee: Intact Vascular, Inc. (Koninklijke Philips N.V.)
• Inventors: Schneider, Peter, Giasolli, Robert M.
• Primary Examiner(s): Tyson, Melanie
• Application Number:
  US13/749,643
• Publication Number:
  US 20130144375A1
• Time in Patent Office: 1,664 Days
• Field of Search: 623 136, 623 115- 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 method of placing endoluminal devices, comprising:

advancing a distal portion of an elongate body of a catheter system through the vasculature of a patient, the catheter system including the elongate body having a plurality of identical endoluminal devices disposed thereon in a compressed state and an outer sheath positioned over the plurality of endoluminal devices, each of the endoluminal devices defining a longitudinal axis and comprising;

a first circumferential member disposed at a distal end of the first endoluminal device, the first circumferential member comprising a repeating pattern of a first outward apex connected to a first inward apex connected to a second outward apex connected to a second inward apex, the amplitude of the second outward apex being less than that of the first outward apex;

a second circumferential member disposed proximally from the first circumferential member along the longitudinal axis; and

a plurality of bridge members, each bridge member separately connecting the first circumferential member with the second circumferential member, every second inward apex being coupled with a first end of one of the bridge members of the plurality of bridge members;

retracting the outer sheath while maintaining the position of the elongated body to deploy a first endoluminal device of the plurality of endoluminal devices within a first blood vessel; and

retracting the outer sheath while maintaining the position of the elongated body to deploy a second endoluminal device of the plurality of endoluminal devices within a second blood vessel, the second endoluminal device being separate from and unconnected to the first endoluminal device when deployed, wherein when in the deployed state, the first and second endoluminal devices have a difference in outer diameter of at least 2.5 mm.

2. The method of claim 1, wherein when in the deployed state, the first and second endoluminal devices have a difference in outer diameter of at least 3.0 mm.

3. The method of claim 1, wherein each of the endoluminal devices of the plurality of endoluminal devices are expandable in outer diameter from 1.5 mm to 5.0 mm.

4. The method of claim 1, wherein each of the endoluminal devices of the plurality of endoluminal devices are expandable in outer diameter from 3 mm to 6 mm.

5. The method of claim 1, further comprising deploying one or more endoluminal devices of a second plurality of endoluminal devices in a blood vessel of the patient, each of the endoluminal devices of the second plurality being identical and being a different size than the endoluminal devices of the first plurality.

6. The method of claim 5, wherein only the two different sized pluralities of endoluminal devices are used to hold plaque against vessel walls in blood vessels throughout a leg of the patient from a hip to an ankle of the leg.

7. A method comprising performing an angioplasty with a drug coated balloon followed by the method of placing endoluminal devices of claim 1.

8. The method of claim 1, wherein the first circumferential member of each of the endoluminal devices of the plurality of endoluminal devices comprises a first sinusoidal ring and wherein the second circumferential member of each of the endoluminal devices of the plurality of endoluminal devices comprises a second sinusoidal ring, wherein the first sinusoidal ring and the second sinusoidal ring each have a dual amplitude.

9. The method of claim 1, wherein at least one bridge member of the plurality of bridge members of each of the endoluminal devices of the plurality of endoluminal devices comprises at least one anchor.

10. The method of claim 9, wherein at least one bridge member of the plurality of bridge members of each of the endoluminal devices of the plurality of endoluminal devices further comprises an eyelet configured to hold a radiopaque marker.

11. The method of claim 10, wherein the eyelet is positioned between a first anchor of the at least one anchor and a second anchor of the at least one anchor.

12. A method of placing endoluminal devices, comprising:

advancing a distal portion of an elongate body of a catheter system through the vasculature of a patient, the catheter system including the elongate body having a plurality of delivery platforms, and a plurality of identical endoluminal devices disposed thereon in a compressed state and an outer sheath positioned over the plurality of endoluminal devices and the plurality of delivery platforms, each of the endoluminal devices positioned in one of the plurality of delivery platforms, each of the endoluminal devices defining a longitudinal axis and having at least two circumferential members spaced apart along the longitudinal axis, each circumferential member comprising;

a repeating pattern of a first outward apex connected to a first inward apex connected to a second outward apex connected to a second inward apex, the amplitude of the second outward apex being less than that of the first outward apex;

retracting the outer sheath while maintaining the position of the elongated body to deploy a first endoluminal device of the plurality of endoluminal devices within a first blood vessel; and

retracting the outer sheath while maintaining the position of the elongated body to deploy a second endoluminal device of the plurality of endoluminal devices within a second blood vessel, wherein when in the deployed state, the first and second endoluminal devices have a difference in outer diameter of at least 2.5 mm.

13. The method of claim 12, wherein when in the deployed state, the first and second endoluminal devices have a difference in outer diameter of at least 3.0 mm.

14. The method of claim 12, wherein each of the endoluminal devices of the plurality of endoluminal devices are expandable in outer diameter from 1.5 mm to 5.0 mm.

15. The method of claim 12, wherein each of the endoluminal devices of the plurality of endoluminal devices are expandable in outer diameter from 3 mm to 6 mm.

16. The method of claim 12, further comprising deploying one or more endoluminal devices of a second plurality of endoluminal devices in a blood vessel of the patient, each of the endoluminal devices of the second plurality being identical and being a different size than the endoluminal devices of the first plurality.

17. The method of claim 16, wherein only the two different sized pluralities of endoluminal devices are used to hold plaque against vessel walls in blood vessels throughout a leg of the patient from a hip to an ankle of the leg.

18. A method comprising performing an angioplasty with a drug coated balloon followed by the method of placing endoluminal devices of claim 12.

19. The method of claim 12, wherein each circumferential member of the at least two circumferential members comprises a sinusoidal ring having a dual amplitude.

20. The method of claim 19, wherein each circumferential member of the at least two circumferential members is connected to another circumferential member of the at least two circumferential members by at least one bridge member.

21. The method of claim 20, wherein the at least one bridge member comprises at least one anchor.

22. The method of claim 21, wherein at least one bridge member comprises an eyelet configured to hold a radiopaque marker.

23. The method of claim 22, wherein the eyelet is positioned between a first anchor of the at least one anchor and a second anchor of the at least one anchor.

24. A method of placing endoluminal devices, comprising:

advancing a distal portion of an elongate body of a catheter system through the vasculature of a patient, the catheter system including the elongate body having a first plurality of endoluminal devices disposed thereon in a compressed state and an outer sheath positioned over the first plurality of endoluminal devices, each of the endoluminal devices of the first plurality of endoluminal devices being identical;

retracting the outer sheath while maintaining the position of the elongated body to deploy a first endoluminal device of the first plurality of endoluminal devices within a first blood vessel; and

retracting the outer sheath while maintaining the position of the elongated body to deploy a second endoluminal device of the first plurality of endoluminal devices within a second blood vessel, the second endoluminal device being separate from and unconnected to the first endoluminal device when deployed, wherein when in the deployed state, the first and second endoluminal devices of the first plurality of endoluminal devices have a difference in outer diameter of at least 2.5 mm.

25. The method of claim 24, further comprising deploying a first endoluminal device of a second plurality of endoluminal devices in a third blood vessel of the patient, each of the endoluminal devices of the second plurality being identical and being a different size than the endoluminal devices of the first plurality.

26. The method of claim 25, further comprising deploying a second endoluminal device of a second plurality of endoluminal devices in a fourth blood vessel of the patient, wherein when in the deployed state, the first and second endoluminal devices of the second plurality of endoluminal devices have a difference in outer diameter of at least 2.5 mm.

27. The method of claim 26, wherein only endoluminal devices of the first and second plurality of endoluminal devices are used to hold plaque against vessel walls in blood vessels throughout a leg of the patient from a hip to an ankle of the leg.

28. The method of claim 26, wherein each of the endoluminal devices of the first plurality of endoluminal devices are expandable in outer diameter from 1.5 mm to 5.0 mm.

29. The method of claim 24, wherein when in the deployed state, the first and second endoluminal devices of the first plurality of endoluminal devices have a difference in outer diameter of at least 3.0 mm.

30. The method of claim 29, wherein each of the endoluminal devices of the second plurality of endoluminal devices are expandable in outer diameter from 3 mm to 6 mm.

31. A method comprising performing an angioplasty with a drug coated balloon followed by the method of placing endoluminal devices of claim 24.

32. The method of claim 24, wherein retracting the outer sheath while maintaining the position of the elongated body to deploy a first endoluminal device of the first plurality of endoluminal devices within a first blood vessel further comprises expanding at least two circumferential members of the first endoluminal device, each circumferential member comprising a repeating pattern of a first outward apex connected to a first inward apex connected to a second outward apex connected to a second inward apex, the amplitude of the second outward apex being less than that of the first outward apex.

33. The method of claim 24, wherein each endoluminal device of the first plurality of endoluminal devices comprises at least one circumferential member.

34. The method of claim 33, wherein each circumferential member of the at least one circumferential member comprises a sinusoidal ring having a dual amplitude.

35. The method of claim 33, wherein the at least one circumferential member comprises a first circumferential member and a second circumferential member, wherein the first circumferential member is connected to the second circumferential member by at least one bridge member.

36. The method of claim 35, wherein the at least one bridge member comprises at least one anchor.

37. The method of claim 36, wherein at least one bridge member comprises an eyelet configured to hold a radiopaque marker.

38. The method of claim 37, wherein the eyelet is positioned between a first anchor of the at least one anchor and a second anchor of the at least one anchor.