Fistula flow disruptor methods

• US 8,790,365 B1
• Filed: 03/25/2014
• Issued: 07/29/2014
• Est. Priority Date: 07/29/2013
• Status: Active Grant

• Current Assignee: Insera Therapeutics, Inc.
• Original Assignee: Insera Therapeutics, Inc.
• Inventors: Janardhan, Vallabh, Janardhan, Vikram
• Primary Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US14/224,817
• Time in Patent Office: 126 Days
• Field of Search: 623/1.13, 623/1.14, 623/1.15, 623/1.16, 623/1.17, 623/1.18, 623/1.19, 623/1.2, 623/1.21, 623/1.3, 623/1.31, 623/1.34, 623/1.51, 623/1.53, 623/13.19, 606/159, 606/191, 606/194, 606/198, 606/200, 606/213, 606/214, 606/215, 606/216, 606/228, 606/229, 606/230, 606/231, 604/523, 604/524, 604/525, 600/139, 600/140, 600/141, 600/142, 600/146, 600/587, 128/831, 128/843
• US Class Current: 606/213
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/22067 : Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/011 : Instruments for their placement or removal
• CPC Class Codes: A61F 2002/018 : made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61M 1/74 : Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/84 : Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2025/0042 : Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2202/06 : Solids
• CPC Class Codes: A61M 2207/10 : Device therefor
• CPC Class Codes: A61M 2210/12 : Blood circulatory system
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: B23K 26/083 : Devices involving movement of the workpiece in at least one axial direction
• CPC Class Codes: B23K 26/14 : using a fluid stream, e.g. a jet of gas, in conjunction with the laser beam; Nozzles therefor B23K26/12 takes precedence
• CPC Class Codes: B23K 26/142 : for the removal of by-products
• CPC Class Codes: B23K 26/1435 : involving specially adapted flow control means
• CPC Class Codes: B23K 26/146 : the fluid stream containing a liquid
• CPC Class Codes: B23K 26/20 : Bonding soldering by means of radiant energy B23K1/005; joining of preformed plastics parts by heating using laser beam B29C65/16
• CPC Class Codes: B23K 26/38 : by boring or cutting
• CPC Class Codes: B26F 3/004 : by means of a fluid jet methods for use of abrasive blasting for cutting B24C1/045; guns for abrasive fluid jets B24C5/02; perforating by non-mechanical means, e.g. by fluid jet B26F1/26
• CPC Class Codes: D04C 1/06 : Braid or lace serving particular purposes
• CPC Class Codes: D04C 1/12 : Cords, lines, or tows
• CPC Class Codes: D04C 3/48 : Auxiliary devices
• CPC Class Codes: D10B 2403/0333 : with tubular portions of variable diameter or distinct axial orientation
• CPC Class Codes: D10B 2509/06 : Vascular grafts; stents
• CPC Class Codes: Y10T 137/8376 : Combined
• CPC Class Codes: Y10T 137/85954 : Closed circulating system
• CPC Class Codes: Y10T 156/10 : Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 29/49913 : by constricting outer annulus
• CPC Class Codes: Y10T 29/49995 : Shaping one-piece blank by removing material
• CPC Class Codes: Y10T 82/2521 : Bar feeder

Abstract

A method of disrupting flow through a fistula may include deploying a flow disruptor across the fistula through a microcatheter at a point in vasculature proximate to the fistula. Deploying the flow disruptor may include expanding a first bulb on a first side of the fistula and expanding a second bulb on a second side of the fistula, the flow disruptor including a neck between the first bulb and the second bulb and traversing the fistula. The first bulb may have a first braid angle, the second bulb may have a second braid angle, and the neck may have a third braid angle less than the first braid angle and the second braid angle.

Claims

1. A method of disrupting flow through a fistula, the method comprising:

advancing a microcatheter through a guide catheter, the guide catheter having a distal end at a first point in vasculature, the microcatheter having a distal end;

advancing a steerable microwire through the guide catheter, the steerable microwire extending distal to the distal end of the microcatheter;

after advancing the steerable microwire through the guide catheter, further advancing and steering the steerable microwire to a second point in the vasculature, the fistula being proximate to the second point in the vasculature;

after further advancing and steering the steerable microwire, advancing the microcatheter over the steerable microwire to the second point in the vasculature;

after further advancing the microcatheter over the steerable microwire to the second point in the vasculature, removing the steerable microwire;

advancing a flow disruptor through the microcatheter to the second point in the vasculature, the flow disruptor comprising, in an expanded state;

a first bulb having a first braid angle,

a second bulb,

a first neck between the first bulb and the second bulb,

a third bulb,

a second neck between the second bulb and the third bulb,

a fourth bulb having a second braid angle, the second neck having a third braid angle less than the first braid angle and the second braid angle, and

a third neck between the third bulb and the fourth bulb;

expanding the first bulb and the second bulb on a first side of the fistula;

extending the second neck through the fistula; and

expanding the third bulb and the fourth bulb on a second side of the fistula.

2. The method of claim 1, wherein the first point in the vasculature is an internal jugular vein at a base of a skull.

3. The method of claim 1, wherein expanding the first bulb and the second bulb on the first side of the fistula comprises expanding the first bulb and the second bulb in a left cavernous sinus, and wherein expanding the third bulb and the fourth bulb on the second side of the fistula comprises expanding the third bulb and the fourth bulb in a right cavernous sinus.

4. The method of claim 1, wherein the fistula is one of a carotid-cavernous fistula, a coronary fistula, an atrial septal defect, and a ventricular septal defect.

5. The method of claim 1, wherein the second bulb has a fourth braid angle and the third bulb has a fifth braid angle, the third braid angle less than the fourth braid angle and the fifth braid angle.

6. The method of claim 1, wherein the second neck has an outer diameter oversized between 10% and 25% to a width of the fistula and wherein the second neck has a length oversized between 10% and 25% to a length of the fistula.

7. The method of claim 1, further comprising:

inserting the guide catheter and a dilator into an entry point in the vasculature, the dilator having a distal end;

inserting a steerable guidewire into the guide catheter and the dilator, the steerable guidewire extending distal to the distal end of the dilator;

advancing and steering the steerable guidewire;

after advancing and steering the steerable guidewire, advancing the guide catheter and dilator over the steerable guidewire;

after advancing the guide catheter and dilator over the steerable guidewire, removing the dilator;

after removing the dilator, further advancing and steering the steerable guidewire to the first point in the vasculature;

after further advancing and steering the steerable guidewire, advancing the guide catheter over the steerable guidewire to the first point in the vasculature; and

after advancing the guide catheter over the steerable guidewire to the first point in the vasculature, removing the steerable guidewire.

8. A method of disrupting flow through a fistula, the method comprising:

deploying a flow disruptor across the fistula through a microcatheter at a point in vasculature proximate to the fistula, wherein deploying the flow disruptor comprises;

expanding a first plurality of bulbs on a first side of the fistula,

expanding a second plurality of bulbs on a second side of the fistula, the second side of the fistula longitudinally opposite the first side of the fistula, and

extending a neck through the fistula, the neck between the first plurality of bulbs and the second plurality of bulbs.

9. The method of claim 8, wherein the first plurality of bulbs comprises a first bulb having a first braid angle, the second plurality of bulbs comprises a second bulb having a second braid angle, and the neck has a third braid angle less than the first braid angle and the second braid angle.

10. The method of claim 9, wherein the first plurality of bulbs comprises a third bulb having a fourth braid angle, the second plurality of bulbs comprises a fourth bulb having a fifth braid angle, and wherein the third braid angle is less than the fourth braid angle and the fifth braid angle.

11. The method of claim 8,

wherein the first plurality of bulbs comprises:

a proximal-most bulb having a first diameter, and

a third bulb having a second diameter less than the first diameter, and

wherein the second plurality of bulbs comprises;

a distal-most bulb having a third diameter, and

a fourth bulb having a fourth diameter less than the third diameter.

12. The method of claim 8, wherein the flow disruptor has a longitudinal axis, wherein the flow disruptor comprises a second neck proximal to the first plurality of bulbs, wherein the flow disruptor comprises a third neck distal to the second plurality of bulbs, and wherein the second neck and the third neck are radially offset from the longitudinal axis.

13. The method of claim 12, wherein the second neck and the third neck are differently radially offset from the longitudinal axis.

14. The method of claim 8, wherein the neck has an outer diameter oversized between 10% and 25% to a width of the fistula and wherein the neck has a length oversized between 10% and 25% to a length of the fistula.

15. The method of claim 8, wherein the point in the vasculature is a cavernous sinus.

16. A method of disrupting flow through a fistula, the method comprising:

deploying a flow disruptor across the fistula through a microcatheter at a point in vasculature proximate to the fistula, wherein deploying the flow disruptor comprises;

expanding a first bulb on a first side of the fistula, the first bulb having a first braid angle, and

expanding a second bulb on a second side of the fistula, the second bulb having a second braid angle,

the flow disruptor comprising a neck between the first bulb and the second bulb, the neck traversing the fistula, the neck having a third braid angle less than the first braid angle and the second braid angle.

17. The method of claim 16, wherein deploying the flow disruptor further comprises:

expanding a third bulb on the first side of the fistula; and

expanding a fourth bulb on the second side of the fistula,

wherein the first bulb has a first diameter, the second bulb has a second diameter, the third bulb has a third diameter less than the first diameter, and the fourth bulb has a fourth diameter less than the third diameter.

18. The method of claim 16, wherein the flow disruptor has a longitudinal axis, wherein the flow disruptor comprises a second neck proximal to the first bulb, wherein the flow disruptor comprises a third neck distal to the second bulb, and wherein the second neck and the third neck are radially offset from the longitudinal axis.

19. The method of claim 18, wherein the second neck and the third neck are differently radially offset from the longitudinal axis.

20. The method of claim 16, wherein the second neck has an outer diameter oversized between 10% and 25% to a width of the fistula and wherein the second neck has a length oversized between 10% and 25% to a length of the fistula.