Methods for placing a stent-graft to cover collateral vessels in lower extremity vasculature

• US 10,596,356 B2
• Filed: 05/30/2019
• Issued: 03/24/2020
• Est. Priority Date: 06/19/2014
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: LimFlow GmbH
• Inventors: Lenihan, Timothy, Rothman, Martin Terry, Ferraresi, Roberto, Kum, Steven
• Primary Examiner(s): David, Shaun L
• Assistant Examiner(s): Lauer, Christina C
• Application Number:
  US16/426,280
• Publication Number:
  US 20190321606A1
• Time in Patent Office: 299 Days
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3929 Active markers
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61M 2025/0092 Single injection needle protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A method of diverting fluid flow from a first vessel including an occlusion to a second vessel includes deploying a prosthesis at least partially in a fistula and making valves in the second vessel incompetent. Making the valves in the second vessel incompetent includes at least one of using a reverse valvulotome to cut the valves, inflating a balloon, expanding a stent, and lining the second vessel with a stent.

Claims

1. A method of modifying a vessel including covering collateral vessels of the vessel, the method comprising:

forming a fistula between a first vessel and the vessel, wherein the first vessel is an artery and the vessel is a vein, wherein forming the fistula comprises;

inserting a first catheter into the first vessel, the first catheter comprising a needle being configured to radially extend from the first catheter;

inserting a second catheter into the vessel, the second catheter comprising an expandable device; and

extending the needle from the first catheter, wherein extending the needle comprises;

exiting the first vessel,

traversing interstitial tissue between the first vessel and the vessel,

entering the vessel, and

puncturing the expandable device to confirm advancement of the needle into the vessel;

advancing a guidewire from the first vessel, through the needle, and into the vessel;

deploying a prosthesis at least partially in the fistula, wherein deploying the prosthesis comprises;

tracking the prosthesis over the guidewire, and

expanding the prosthesis with a balloon,

wherein after deploying the prosthesis, blood is diverted from the first vessel to the vessel through the prosthesis; and

making the valves in the vessel incompetent, wherein making the valves in the vessel incompetent comprises positioning a stent-graft in the vessel,

wherein positioning the stent-graft in the vessel comprises covering the collateral vessels of the vessel,

wherein the stent-graft is separate from the prosthesis, and

wherein a proximal segment of the stent-graft longitudinally overlaps a distal segment of the prosthesis.

2. The method of claim 1, wherein the proximal segment of the stent-graft is radially outward of the distal segment of the prosthesis after positioning the stent-graft and after deploying the prosthesis.

3. The method of claim 1, wherein making the valves incompetent comprises advancing a cutting balloon or valvulotome in the vessel.

4. The method of claim 1,

wherein making the valves incompetent comprises advancing a cutting balloon or valvulotome in the vessel,

wherein positioning the stent-graft in the vessel is before deploying the prosthesis, and

wherein the proximal segment of the stent-graft is radially outward of the distal segment of the prosthesis after positioning the stent-graft and after deploying the prosthesis.

5. A method of modifying a vessel including covering collateral vessels of the vessel, the method comprising:

forming a fistula between a first vessel and the vessel, wherein forming the fistula comprises;

inserting a catheter into the first vessel, the catheter comprising a needle configured to radially extend from the catheter, and

extending the needle from the catheter, wherein extending the needle comprises exiting the first vessel, traversing interstitial tissue between the first vessel and the vessel, and entering the vessel;

deploying a prosthesis at least partially in a fistula between the first vessel and the vessel, wherein after deploying the prosthesis, blood is diverted from the first vessel to the vessel through the prosthesis; and

placing a stent-graft in the vessel,

wherein placing the stent-graft in the vessel comprises;

expanding the stent-graft, and

covering the collateral vessels of the vessel including making the valves in the vessel incompetent,

wherein the stent-graft is separate from the prosthesis, and

wherein a proximal segment of the stent-graft longitudinally overlaps a distal segment of the prosthesis.

6. The method claim 5, wherein the prosthesis comprises a first portion configured to anchor in the first vessel, a second portion configured to anchor in and line a length of the vessel, and a third portion longitudinally between the first portion and the second portion.

7. The method claim 6, wherein the first portion and the third portion are separate from the second portion.

8. The method claim 7, wherein the third portion longitudinally overlaps the second portion.

9. The method claim 7, wherein the third portion is tapered after deploying the prosthesis.

10. The method of claim 5, further comprising advancing a cutting balloon or valvulotome in the vessel.

11. The method claim 5, further comprising advancing a cutting balloon in the vessel,

wherein the prosthesis comprises a first portion configured to anchor in the first vessel, a second portion configured to anchor in and line a length of the vessel, and a third portion longitudinally between the first portion and the second portion,

wherein the first portion and the third portion are separate from the second portion,

wherein the third portion longitudinally overlaps the second portion, and

wherein the third portion is tapered after deploying the prosthesis.

12. A method of modifying a vessel including covering collateral vessels of the vessel, the method comprising:

putting a first stent-graft in the vessel; and

deploying a prosthesis at least partially in a fistula between a first vessel and the vessel, wherein after deploying the prosthesis, blood is diverted from the first vessel to the vessel through the prosthesis,

wherein putting the first stent-graft in the vessel comprises covering the collateral vessels of the vessel including making the valves in the vessel incompetent,

wherein the first stent-graft is separate from the prosthesis, and

wherein a first segment of the first stent-graft longitudinally overlaps a second segment of the prosthesis.

13. The method of claim 12, wherein the vessel comprises a proximal tibial vein, and wherein putting the first stent-graft in the vessel comprises lining an entire length of the proximal tibial vein with the first stent-graft.

14. The method of claim 13, wherein the first stent-graft has a length between 2 cm and 30 cm.

15. The method of claim 12, further comprising advancing a cutting balloon or valvulotome in the vessel.

16. The method of claim 12, wherein the first segment of the first stent-graft is radially outward of the second segment of the prosthesis after putting the first stent-graft and after deploying the prosthesis.

17. The method of claim 12, further comprising putting a second stent-graft in the vessel, wherein a first segment of the second stent-graft longitudinally overlaps a second segment of the first stent-graft.

18. The method of claim 17, wherein the second stent-graft has a length between 2 cm and 30 cm.

19. The method of claim 17, wherein the first segment of the second stent-graft is radially outward of the second segment of the first stent-graft after putting the first stent-graft and after putting the second stent-graft.

20. The method of claim 12, further comprising:

putting a second stent-graft in the vessel, and

advancing a cutting balloon or valvulotome in the vessel,

wherein a first segment of the second stent-graft longitudinally overlaps a second segment of the first stent-graft,

wherein putting the second stent-graft in the vessel comprises covering the collateral vessels of the vessel,

wherein the second stent-graft is separate from the prosthesis, and

wherein the first segment of the second stent-graft is radially outward of the second segment of the first stent-graft after putting the first stent-graft and after putting the second stent-graft.