Fistula flow disruptors

• US 8,795,330 B1
• Filed: 03/25/2014
• Issued: 08/05/2014
• 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:
  US14/224,787
• Time in Patent Office: 133 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 device for disrupting flow through a fistula may include a woven textile having a compressed state and an expanded state. The woven textile may include, in the expanded state, a neck, a first bulb coupled to a proximal side of the neck, and a second bulb coupled to a distal side of the neck. The neck has a first braid angle. The first bulb may have a second braid angle greater than the first braid angle. The second bulb may have a third braid angle greater than the first braid angle.

Claims

1. A device for disrupting flow through a fistula, the device comprising:

a woven textile having a compressed state and an expanded state, the woven textile comprising, in the expanded state;

a first bulb having a first braid angle and a first diameter,

a second bulb having a second diameter larger than the first diameter,

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

a third bulb having a third diameter,

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

a fourth bulb having a second braid angle and a fourth diameter smaller than the third diameter, 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,

the second neck configured to extend through a fistula, the first bulb and the second bulb configured to be on a first side of the fistula, the third bulb and the fourth bulb configured to be on a second side of the fistula.

2. The device of claim 1, where 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.

3. The device of claim 1, wherein each of the second bulb and the third bulb comprises an oblate spheroid having a diameter of a polar axis that is shorter than a diameter of an equatorial axis.

4. The device of claim 3, wherein the second bulb and the third bulb are connected along the polar axes of the second bulb and the third bulb.

5. The device of claim 4, wherein each of the first bulb and the fourth bulb comprises an oblate spheroid having a diameter of a polar axis that is shorter than a diameter of an equatorial axis, wherein the first bulb and the second bulb are connected along the polar axes of the first bulb and the second bulb, and wherein the third bulb and the fourth bulb are connected along the polar axes of the third bulb and the fourth bulb.

6. The device of claim 1, wherein at least one of the first bulb, the second bulb, the third bulb, and the fourth bulb is longitudinally offset from another of the first bulb, the second bulb, the third bulb, and the fourth bulb.

7. A device for disrupting flow through a fistula, the device comprising:

a woven textile having a longitudinal axis, a compressed state, and an expanded state, the woven textile comprising, in the expanded state;

a first bulb,

a first neck proximal to the first bulb,

a second bulb, wherein each of the first bulb and the second bulb comprises an oblate spheroid having a diameter of a polar axis that is shorter than a diameter of an equatorial axis,

a second neck distal to the second bulb, each of the first neck and the second neck radially offset from the longitudinal axis, and

a third neck between the first bulb and the second bulb, the third neck configured to extend through a fistula.

8. The device of claim 7, wherein each of the first neck and the second neck is differently radially offset from the longitudinal axis.

9. The device of claim 7, wherein the first bulb has a first braid angle, the second bulb has a second braid angle, and the third neck has a third braid angle less than the first braid angle and the second braid angle.

10. The device of claim 7, wherein the woven textile structure further comprises, in the expanded state:

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

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

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

11. The device of claim 10, wherein each of the third bulb and the fourth bulb comprises an oblate spheroid having a diameter of a polar axis that is shorter than a diameter of an equatorial axis.

12. The device of claim 7, wherein the third neck has a diameter between 2 mm and 16 mm and a length between 2 mm and 26 mm.

13. A device for disrupting flow through a fistula, the device comprising:

a woven textile having a longitudinal axis, a compressed state, and an expanded state, the woven textile comprising, in the expanded state;

a first neck;

a first plurality of bulbs coupled to a proximal side of the first neck;

a second neck proximal to the first plurality of bulbs;

a second plurality of bulbs coupled to a distal side of the first neck; and

a third neck distal to the second plurality of bulbs, each of the second neck and the third neck radially offset from the longitudinal axis,

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.

14. The device of claim 13, wherein each of the first plurality of bulbs comprises an oblate spheroid having a diameter of a polar axis that is shorter than a diameter of an equatorial axis, and wherein each of the second plurality of bulbs comprises an oblate spheroid having a diameter of a polar axis that is shorter than a diameter of an equatorial axis.

15. The device of claim 14, wherein the first plurality of bulbs are connected along the polar axes and wherein the second plurality of bulbs are connected along the polar axes.

16. The device of claim 15, wherein the first plurality of bulbs are connected to the second plurality of bulbs along the polar axes of a distal-most bulb of the first plurality of bulbs and a proximal-most bulb of the second plurality of bulbs.

17. The device of claim 13, wherein the first neck has a diameter between 2 mm and 16 mm and a length between 2 mm and 26 mm.

18. The device of claim 13, wherein the first neck has a first braid angle, wherein at least a first bulb of the first plurality of bulbs has a second braid angle greater than the first braid angle, and wherein at least a second bulb of the second plurality of bulbs has a third braid angle greater than the first braid angle.

19. The device of claim 18, wherein the third bulb has a fourth braid angle and the fourth bulb has a fifth braid angle, and wherein the first braid angle is less than the fourth braid angle and the fifth braid angle.