Methods for targeting body passages

• US 9,706,998 B2
• Filed: 03/30/2016
• Issued: 07/18/2017
• Est. Priority Date: 03/08/2013
• Status: Active Grant

• Current Assignee: Inari Medical, Inc.
• Original Assignee: LLimflow GmbH
• Inventors: Dickinson, Robert Julian, Ferraresi, Roberto, Kum, Steven, Lenihan, Timothy, Pacey, Andrew Robert, Rothman, Martin Terry
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US15/084,999
• Publication Number:
  US 20160206317A1
• Time in Patent Office: 475 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:

inserting a first catheter into the first passage, wherein the first passage comprises an artery, the first catheter comprising;

a needle, and

an ultrasound transmitting transducer;

inserting a second catheter into the second passage, wherein the second passage comprises a vein, the second catheter comprising;

a balloon, the balloon comprising a mesh configured to inhibit tearing of the balloon upon being punctured by the needle, wherein the mesh comprises radiopaque material visible under fluoroscopy, and

an ultrasound receiving transducer;

inflating the balloon, wherein inflating the balloon increases a diameter of the second passage;

aligning the ultrasound transmitting transducer and the ultrasound receiving transducer;

advancing the needle from the first catheter, 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 balloon,

wherein advancing the needle comprises targeting the mesh under fluoroscopy, and

wherein the mesh closes around the guidewire to grip the guidewire in the second passage;

monitoring at least one of;

reduction in pressure of the balloon and release of contrast from the balloon,

wherein at least one of;

the reduction in pressure of the balloon and the release of contrast from the balloon, attributable to the needle puncturing the balloon, confirms advancement of the needle into the second passage;

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

deploying a stent graft,

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,

wherein the stent graft comprises a longitudinal portion having a frustoconical shape, and

wherein the longitudinal portion comprises the third portion.

2. The method of claim 1, further comprising:

inflating a second balloon in the second passage;

forming a well between the inflated balloon and the inflated second balloon;

injecting contrast in the well; and

monitoring the contrast using fluoroscopy,

wherein release of the contrast from the well attributable to the needle puncturing the balloon confirms advancement of the needle into the second passage.

3. The method of claim 1, 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.

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

inserting a first catheter into the first passage, wherein the first passage comprises an artery, the first catheter comprising a needle;

inserting a second catheter into the second passage, wherein the second passage comprises a vein, the second catheter comprising an expandable device comprising a mesh, wherein the mesh comprises radiopaque material visible under fluoroscopy,

expanding the expandable device,

wherein expanding the expandable device comprises increasing a diameter of the second passage;

aligning the needle towards the expandable device,

wherein ultrasound guidance confirms alignment of the needle;

advancing the needle from the first catheter 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,

wherein puncturing the expandable device confirms advancement of the needle into the second passage,

wherein advancing the needle comprises targeting the mesh under fluoroscopy, and

wherein the mesh closes around a guidewire to grip the guidewire in the second passage; 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,

wherein the prosthesis comprises a longitudinal portion having a frustoconical shape, and

wherein the longitudinal portion comprises the third portion.

5. The method of claim 4, further comprising:

expanding a second expandable device in the second passage;

forming a well between the expanded expandable device and the expanded second expandable device;

injecting contrast in the well; 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.

6. The method of claim 4, wherein the first catheter comprises an ultrasound transmitting transducer and the second catheter comprises an ultrasound receiving transducer, and wherein advancing the needle comprises at least one of:

advancing the needle towards the ultrasound receiving transducer, and advancing the needle upon identification of alignment between the an ultrasound transmitting transducer and the ultrasound receiving transducer.

7. The method of claim 4, wherein expanding the expandable device comprises at least one of:

inflating the expandable device, allowing the expandable device to self-expand, and at least one of distally advancing a proximal portion of the expandable device and proximally retracting a distal portion of the expandable device.

8. The method of claim 4, wherein the expandable device comprises a balloon and the mesh is configured to inhibit tearing of the expandable device upon being punctured by the needle.

9. The method of claim 4, 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.

10. 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 mesh;

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; and

advancing a guidewire from the first passage, through the needle, and into the expandable device, wherein the mesh closes around the guidewire to grip the guidewire in the second passage,

wherein advancing the needle comprises;

puncturing the expandable device; and

monitoring at least one of;

reduction in pressure of the expandable device and release of contrast from the expandable device,

wherein at least one of;

the reduction in pressure of the expandable device and the release of contrast from the expandable device, attributable to the needle puncturing the expandable device, confirms advancement of the needle into the second passage.

11. The method of claim 10, wherein the mesh comprises radiopaque material visible under fluoroscopy, and wherein advancing the needle comprises targeting the mesh under fluoroscopy.

12. The method of claim 10, further comprising:

expanding a second expandable device in the second passage;

forming a well between the expanded expandable device and the expanded second expandable device;

injecting contrast in the well; and

monitoring the contrast using fluoroscopy,

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

13. The method of claim 10, wherein expanding the expandable device comprises at least one of:

inflating the expandable device, allowing the expandable device to self-expand, and at least one of distally advancing a proximal portion of the expandable device and proximally retracting a distal portion of the expandable device.

14. The method of claim 10, further comprising 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.

15. The method of claim 14, wherein the first passage comprises an artery, wherein the second passage comprises a vein, wherein the mesh comprises radiopaque material visible under fluoroscopy, wherein advancing the needle comprises targeting the mesh under fluoroscopy, wherein expanding the expandable device comprises increasing a diameter of the second passage, wherein the prosthesis comprises a longitudinal portion having a frustoconical shape, and wherein the longitudinal portion comprises the third portion.

16. The method of claim 10, 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.

17. 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 mesh, wherein the mesh comprises radiopaque material visible under fluoroscopy; and

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 at least one of;

reduction in pressure of the expandable device and release of contrast from the expandable device; and

targeting the mesh under fluoroscopy,

wherein at least one of;

the reduction in pressure of the expandable device and the release of contrast from the expandable device, attributable to the needle puncturing the expandable device, confirms advancement of the needle into the second passage.

18. The method of claim 17, further comprising:

expanding a second expandable device in the second passage;

forming a well between the expanded expandable device and the expanded second expandable device;

injecting contrast in the well; and

monitoring the contrast using fluoroscopy,

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

19. The method of claim 17, wherein expanding the expandable device comprises at least one of:

inflating the expandable device, allowing the expandable device to self-expand, and at least one of distally advancing a proximal portion of the expandable device and proximally retracting a distal portion of the expandable device.

20. The method of claim 17, further comprising 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.

21. The method of claim 20, wherein the first passage comprises an artery, wherein the second passage comprises a vein, wherein expanding the expandable device comprises increasing a diameter of the second passage, wherein the prosthesis comprises a longitudinal portion having a frustoconical shape, and wherein the longitudinal portion comprises the third portion.

22. The method of claim 17, 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.

23. 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, wherein the first passage comprises an artery, wherein the second passage comprises a vein, wherein expanding the expandable device comprises increasing a diameter of the second passage, the expandable device comprising a mesh, wherein the mesh comprises radiopaque material visible under fluoroscopy; and

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 at least one of;

reduction in pressure of the expandable device and release of contrast from the expandable device; and

targeting the mesh under fluoroscopy,

wherein at least one of;

the reduction in pressure of the expandable device and the release of contrast from the expandable device, attributable to the needle puncturing the expandable device, confirms advancement of the needle into the second passage; 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, wherein the prosthesis comprises a longitudinal portion having a frustoconical shape, and wherein the longitudinal portion comprises the third portion.

24. The method of claim 23, further comprising:

expanding a second expandable device in the second passage;

forming a well between the expanded expandable device and the expanded second expandable device;

injecting contrast in the well; and

monitoring the contrast using fluoroscopy,

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

25. The method of claim 23, wherein expanding the expandable device comprises at least one of:

inflating the expandable device, allowing the expandable device to self-expand, and at least one of distally advancing a proximal portion of the expandable device and proximally retracting a distal portion of the expandable device.

26. The method of claim 23, 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.