Methods for effecting retroperfusion in a body passage

• US 10,524,894 B1
• Filed: 08/27/2019
• Issued: 01/07/2020
• Est. Priority Date: 03/08/2013
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: LimFlow GmbH
• Inventors: Dickinson, Robert Julian, Ferraresi, Roberto, Kum, Steven, Lenihan, Timothy, Pacey, Andrew Robert, Rothman, Martin Terry
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US16/552,241
• Publication Number:
  US 20190380826A1
• Time in Patent Office: 133 Days
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• 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 2017/1103 Approximator
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 : Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/962 : having an outer sleeve
• CPC Class Codes: A61F 2002/068 : Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0017 : differing in yarn density
• CPC Class Codes: A61F 2250/0029 : differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0031 : made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• 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

Abstract

A device includes a first end portion, a second end portion, an intermediate portion, and a graft material. The first end portion has a first end diameter. The second end portion has a second end diameter smaller than the first end diameter. The first end portion comprises a first material. The second end portion comprises a second material different than the first material. The intermediate portion is between the first end portion and the second end portion. The intermediate portion tapers between the first end portion and the second end portion. The graft material is coupled to at least the intermediate portion.

Claims

1. A method of targeting a second passage from a first passage to effect retroperfusion in the second passage, the method comprising:

expanding an expandable device in the second passage, the expandable device comprising a balloon, wherein the expandable device comprises radiopaque material visible under fluoroscopy;

advancing a needle from a first catheter in the first passage out of the first passage and into the second passage to form a fistula between the first passage and the second passage,

wherein advancing the needle comprises;

targeting the expandable device under fluoroscopy;

puncturing the expandable device; and

monitoring the needle puncturing the balloon to confirm advancement of the needle into the second passage;

injecting contrast in the second passage; and

monitoring the contrast using fluoroscopy,

wherein disturbance of the contrast attributable to the needle puncturing the expandable device confirms advancement of the needle into the second passage.

2. The method of claim 1, further comprising making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve.

3. The method of claim 2, wherein making the valve in the second passage incompetent comprises using a cutting balloon or valvulotome.

4. The method of claim 1, further comprising deploying a prosthesis,

wherein deploying the prosthesis comprises balloon expanding a stent graft, and

wherein, after deploying the prosthesis, a first portion of the prosthesis is in the first passage, a second portion of the prosthesis is in the second passage, and a third portion of the prosthesis is in the fistula.

5. The method of claim 4, further comprising:

making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve, wherein making the valve in the second passage incompetent comprises using a cutting balloon or valvulotome,

balloon expanding a stent graft, wherein, after balloon expanding the stent graft, a first portion of the stent graft is in the first passage, a second portion of the stent graft is in the second passage, and a third portion of the stent graft is in the fistula,

wherein the first passage comprises an artery,

wherein the second passage comprises a vein, and

wherein advancing the needle comprises traversing the needle through interstitial tissue after advancing the needle out of the first passage and prior to advancing the needle into the second passage.

6. A method of targeting a second passage from a first passage to effect retroperfusion in the second passage, the method comprising:

expanding an expandable device in the second passage, the expandable device comprising a balloon;

advancing a needle from a first catheter in the first passage out of the first passage and into the second passage to form a fistula between the first passage and the second passage, wherein advancing the needle comprises puncturing the expandable device;

making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve; and

deploying a prosthesis,

wherein, after deploying the prosthesis, a first portion of the prosthesis is in the first passage, a second portion of the prosthesis is in the second passage, and a third portion of the prosthesis is in the fistula.

7. The method of claim 6, wherein advancing the needle comprises traversing the needle through interstitial tissue after advancing the needle out of the first passage and prior to advancing the needle into the second passage.

8. The method of claim 6, wherein deploying the prosthesis comprises balloon expanding a stent graft.

9. The method of claim 6, wherein making the valve in the second passage incompetent comprises using a cutting balloon or valvulotome.

10. The method of claim 6, further comprising:

injecting contrast in the second passage; and

monitoring the contrast using fluoroscopy,

wherein disturbance of the contrast attributable to the needle puncturing the expandable device confirms advancement of the needle into the second passage.

11. The method of claim 6, further comprising making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve,

wherein making the valve in the second passage incompetent comprises using a cutting balloon,

wherein the first passage comprises an artery,

wherein the second passage comprises a vein,

wherein deploying the prosthesis comprises balloon expanding the prosthesis, and

wherein advancing the needle comprises traversing the needle through interstitial tissue after advancing the needle out of the first passage and prior to advancing the needle into the second passage.

12. A method of targeting a second passage from a first passage to effect retroperfusion in the second passage, the method comprising:

expanding an expandable device in the second passage, the expandable device comprising a balloon;

advancing a needle from a first catheter in the first passage out of the first passage and into the second passage to form a fistula between the first passage and the second passage, wherein advancing the needle comprises targeting the expandable device under fluoroscopy, and wherein advancing the needle comprises puncturing the expandable device; and

monitoring the needle puncturing the balloon to confirm advancement of the needle into the second passage.

13. The method of claim 12, wherein the expandable device comprises radiopaque material visible under fluoroscopy.

14. The method of claim 12, further comprising:

injecting contrast in the second passage; and

monitoring the contrast using fluoroscopy,

wherein disturbance of the contrast is attributable to the needle puncturing the expandable device and confirms advancement of the needle into the second passage.

15. The method of claim 12, further comprising making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve.

16. The method of claim 15, wherein making the valve in the second passage incompetent comprises using a cutting balloon or valvulotome.

17. The method of claim 12, further comprising deploying a stent graft,

wherein deploying the stent graft comprises balloon expanding the stent graft, and

wherein, after deploying the stent graft, a first portion of the stent graft is in the first passage, a second portion of the stent graft is in the second passage, and a third portion of the stent graft is in the fistula.

18. The method of claim 12, further comprising:

making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve, wherein making the valve in the second passage incompetent comprises using a cutting balloon or valvulotome; and

balloon expanding a stent graft, wherein, after balloon expanding the stent graft, a first portion of the stent graft is in the first passage, a second portion of the stent graft is in the second passage, and a third portion of the stent graft is in the fistula,

wherein the first passage comprises an artery,

wherein the second passage comprises a vein,

wherein the expandable device comprises radiopaque material visible under fluoroscopy, and

wherein advancing the needle comprises traversing the needle through interstitial tissue after advancing the needle out of the first passage and prior to advancing the needle into the second passage.

19. A method of targeting a second passage from a first passage to effect retroperfusion in the second passage, the method comprising:

expanding an expandable device in the second passage, the expandable device comprising a balloon, wherein the expandable device comprises radiopaque material visible under fluoroscopy;

advancing a needle from a first catheter in the first passage out of the first passage and into the second passage to form a fistula between the first passage and the second passage,

wherein advancing the needle comprises;

targeting the expandable device under fluoroscopy;

puncturing the expandable device; and

monitoring the needle puncturing the balloon to confirm advancement of the needle into the second passage; and

making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve.

20. The method of claim 19, wherein making the valve in the second passage incompetent comprises using a cutting balloon.

21. The method of claim 19, wherein making the valve in the second passage incompetent comprises using a valvulotome.

22. The method of claim 19, further comprising deploying a prosthesis,

wherein deploying the prosthesis comprises balloon expanding a stent graft, and

wherein, after deploying the prosthesis, a first portion of the prosthesis is in the first passage, a second portion of the prosthesis is in the second passage, and a third portion of the prosthesis is in the fistula.

23. The method of claim 22, further comprising:

balloon expanding a stent graft, wherein, after balloon expanding the stent graft, a first portion of the stent graft is in the first passage, a second portion of the stent graft is in the second passage, and a third portion of the stent graft is in the fistula,

wherein advancing the needle comprises traversing the needle through interstitial tissue after advancing the needle out of the first passage and prior to advancing the needle into the second passage.

24. A method of targeting a second passage from a first passage to effect retroperfusion in the second passage, the method comprising:

expanding an expandable device in the second passage, the expandable device comprising a balloon, wherein the expandable device comprises radiopaque material visible under fluoroscopy;

advancing a needle from a first catheter in the first passage out of the first passage and into the second passage to form a fistula between the first passage and the second passage,

wherein advancing the needle comprises;

targeting the expandable device under fluoroscopy;

puncturing the expandable device; and

monitoring the needle puncturing the balloon to confirm advancement of the needle into the second passage;

deploying a prosthesis,

wherein deploying the prosthesis comprises balloon expanding a stent graft, and

wherein, after deploying the prosthesis, a first portion of the prosthesis is in the first passage, a second portion of the prosthesis is in the second passage, and a third portion of the prosthesis is in the fistula; and

making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve, wherein making the valve in the second passage incompetent comprises using a cutting balloon or valvulotome;

wherein the first passage comprises an artery,

wherein the second passage comprises a vein, and

wherein advancing the needle comprises traversing the needle through interstitial tissue after advancing the needle out of the first passage and prior to advancing the needle into the second passage.

25. The method of claim 24, wherein making the valve in the second passage incompetent comprises using a cutting balloon.

26. The method of claim 24, wherein making the valve in the second passage incompetent comprises using a valvulotome.

27. A method of targeting a second passage from a first passage to effect retroperfusion in the second passage, the method comprising:

expanding an expandable device in the second passage, the expandable device comprising a balloon;

advancing a needle from a first catheter in the first passage out of the first passage and into the second passage to form a fistula between the first passage and the second passage, wherein advancing the needle comprises puncturing the expandable device;

monitoring the needle puncturing the balloon to confirm advancement of the needle into the second passage;

injecting contrast in the second passage; and

monitoring the contrast using fluoroscopy,

wherein disturbance of the contrast is attributable to the needle puncturing the expandable device and confirms advancement of the needle into the second passage.

28. The method of claim 27, wherein the expandable device comprises radiopaque material visible under fluoroscopy.

29. The method of claim 27, further comprising making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve.

30. The method of claim 29, wherein making the valve in the second passage incompetent comprises using a cutting balloon or valvulotome.

31. The method of claim 27, further comprising deploying a stent graft,

wherein deploying the stent graft comprises balloon expanding the stent graft, and

wherein, after deploying the stent graft, a first portion of the stent graft is in the first passage, a second portion of the stent graft is in the second passage, and a third portion of the stent graft is in the fistula.

32. The method of claim 27, further comprising:

making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve, wherein making the valve in the second passage incompetent comprises using a cutting balloon or valvulotome; and

balloon expanding a stent graft, wherein, after balloon expanding the stent graft, a first portion of the stent graft is in the first passage, a second portion of the stent graft is in the second passage, and a third portion of the stent graft is in the fistula,

wherein the first passage comprises an artery,

wherein the second passage comprises a vein,

wherein the expandable device comprises radiopaque material visible under fluoroscopy, and

wherein advancing the needle comprises traversing the needle through interstitial tissue after advancing the needle out of the first passage and prior to advancing the needle into the second passage.

33. A method of targeting a second passage from a first passage to effect retroperfusion in the second passage, the method comprising:

expanding an expandable device in the second passage, the expandable device comprising a balloon;

advancing a needle from a first catheter in the first passage out of the first passage and into the second passage to form a fistula between the first passage and the second passage, wherein advancing the needle comprises puncturing the expandable device;

monitoring the needle puncturing the balloon to confirm advancement of the needle into the second passage; and

making a valve in the second passage incompetent to reduce inhibition of retroperfusion through the second passage by the valve.

34. The method of claim 33, wherein making the valve in the second passage incompetent comprises using a cutting balloon.

35. The method of claim 33, wherein making the valve in the second passage incompetent comprises using a valvulotome.

36. The method of claim 33, wherein the expandable device comprises radiopaque material visible under fluoroscopy.

37. The method of claim 33, further comprising deploying a stent graft,

wherein deploying the stent graft comprises balloon expanding the stent graft, and

wherein, after deploying the stent graft, a first portion of the stent graft is in the first passage, a second portion of the stent graft is in the second passage, and a third portion of the stent graft is in the fistula.

38. The method of claim 33, further comprising:

balloon expanding a stent graft, wherein, after balloon expanding the stent graft, a first portion of the stent graft is in the first passage, a second portion of the stent graft is in the second passage, and a third portion of the stent graft is in the fistula,

wherein the first passage comprises an artery,

wherein the second passage comprises a vein,

wherein the expandable device comprises radiopaque material visible under fluoroscopy, and

wherein advancing the needle comprises traversing the needle through interstitial tissue after advancing the needle out of the first passage and prior to advancing the needle into the second passage.