Methods of embolic filtering

• US 8,882,797 B2
• Filed: 04/22/2014
• Issued: 11/11/2014
• Est. Priority Date: 03/15/2013
• 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:
  US14/258,504
• Publication Number:
  US 20140277098A1
• Time in Patent Office: 203 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, 606/198, 606/200, 606/228, 606/229, 606/230, 606/231, 600/139, 600/140, 600/141, 600/142, 600/146, 600/587, 604/264, 604/523, 604/524, 604/525
• US Class Current: 606/200
• 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

Methods of providing embolic protection during treatment of a vessel include advancing a microcatheter in the vessel, inserting a textile structure in a collapsed state into the microcatheter, and advancing the textile structure through the microcatheter. The methods may include, after advancing the textile structure and retracting the microcatheter to unsheathe a self-expanding bulb of the textile structure from the microcatheter, thereby allowing the self-expanding bulb to self-expand from the collapsed state to an expanded state. The methods may include performing a vascular procedure. In the expanded state, the self-expanding bulb may filter emboli released during performing the vascular procedure.

Claims

1. A method of providing embolic protection during treatment of a vessel, the method comprising:

advancing a microcatheter in the vessel, wherein advancing the microcatheter includes crossing a thrombus with a distal end of the microcatheter;

inserting a textile structure in a collapsed state into the microcatheter, the textile structure comprising a plurality of self-expanding bulbs and a plurality of necks,

wherein the plurality of self-expanding bulbs comprises five to twenty self-expanding bulbs, each of the plurality of self expanding bulbs having a spherical shape or an oblong shape,

wherein pairs of the self-expanding bulbs are spaced by a neck of the plurality of necks;

advancing the textile structure through the microcatheter proximate to the distal end of the microcatheter, wherein advancing the textile structure includes crossing the thrombus with a distal-most bulb of the plurality of self-expanding bulbs;

after advancing the textile structure, retracting the microcatheter to unsheathe a length of the textile structure, wherein retracting the microcatheter to unsheathe the length of the textile structure comprises;

unsheathing at least the distal-most bulb of the plurality of self-expanding bulbs from the microcatheter, and

self-expanding at least the distal-most bulb of the plurality of self-expanding bulbs from the collapsed state to an expanded state; and

removing the thrombus from the vessel,

wherein, in the expanded state, the distal-most bulb;

apposes sidewalls of the vessel, and

filters emboli released during the removing the thrombus from the vessel.

2. The method of claim 1, wherein removing the thrombus comprises further retracting the microcatheter to unsheathe another length of the textile structure comprising other bulbs of the plurality of self-expanding bulbs, wherein, upon being unsheathed from the microcatheter, the other bulbs self-expand from the collapsed state to an expanded state, the other bulbs entrapping the thrombus.

3. The method of claim 2, further comprising torsionally rasping the textile structure, the distal-most bulb of the plurality of self-expanding bulbs providing a distal anchor for the torsionally rasping.

4. The method of claim 1, wherein removing the thrombus comprises deploying a thrombectomy device proximal to the distal-most bulb of the plurality of self-expanding bulbs, the thrombectomy device different than the textile structure.

5. The method of claim 4, wherein deploying the thrombectomy device includes crossing the thrombus with a distal section of the thrombectomy device.

6. The method of claim 4, further comprising, at least one of after and during removing the thrombus from the vessel, further retracting the microcatheter, wherein further retracting the microcatheter comprises unsheathing other bulbs of the plurality of self-expanding bulbs and self-expanding the other bulbs of the plurality of self-expanding bulbs from the collapsed state to an expanded state, the other bulbs of the plurality of self-expanding bulbs in the expanded state entrapping residual thrombus.

7. The method of claim 1, wherein retracting the microcatheter to unsheathe the length of the textile structure comprises expanding the vessel.

8. A method of providing embolic protection during treatment of a vessel, the method comprising:

advancing a microcatheter in the vessel;

inserting a textile structure in a collapsed state into the microcatheter, the textile structure comprising a plurality of self-expanding bulbs and a plurality of necks, pairs of the self-expanding bulbs spaced by a neck of the plurality of necks;

advancing the textile structure through the microcatheter proximate to a distal end of the microcatheter;

after advancing the textile structure, retracting the microcatheter to unsheathe a length of the textile structure, wherein retracting the microcatheter to unsheathe the length of the textile structure comprises;

unsheathing at least a distal-most bulb of the plurality of self-expanding bulbs from the microcatheter, and

self-expanding at least the distal-most bulb of the plurality of self-expanding bulbs from the collapsed state to an expanded state; and

performing a vascular procedure, wherein performing the vascular procedure comprises using a vascular device different than the textile structure,

wherein, in the expanded state, the distal-most bulb of the plurality of self-expanding bulbs filters emboli released during performing the vascular procedure,

torsionally rasping the textile structure, the distal-most bulb of the plurality of self-expanding bulbs providing a distal anchor for the torsionally rasping.

9. The method of claim 8, further comprising, at least one of after and during performing the vascular procedure, further retracting the microcatheter, wherein further retracting the microcatheter comprises unsheathing other bulbs of the plurality of self-expanding bulbs and self-expanding the other bulbs of the plurality of self-expanding bulbs from the collapsed state to an expanded state, the other bulbs of the plurality of self-expanding bulbs in the expanded state entrapping residual emboli.

10. The method of claim 8, wherein the distal-most bulb of the plurality of self-expanding bulbs in the expanded state comprises a spherical shape or an oblong shape.

11. The method of claim 8, wherein the vascular procedure comprises thrombectomy.

12. The method of claim 8, wherein the vascular procedure comprises at least one of angioplasty, atherectomy, aspiration, stenting, embolic coil insertion, intra-arterial thrombolysis, and bypass.

13. The method of claim 8, wherein retracting the microcatheter to unsheathe the length of the textile structure comprises expanding the vessel.

16. The method of claim 13, wherein the vascular procedure comprises thrombectomy.

14. A method of providing embolic protection during treatment of a vessel, the method comprising:

advancing a microcatheter in the vessel;

inserting a woven textile structure in a collapsed state into the microcatheter;

advancing the textile structure through the microcatheter proximate to a distal end of the microcatheter;

after advancing the textile structure, retracting the microcatheter to unsheathe a self-expanding bulb from the microcatheter, thereby allowing the self-expanding bulb to self-expand from the collapsed state to an expanded state; and

performing a vascular procedure, wherein, in the expanded state, the self-expanding bulb filters emboli released during performing the vascular procedure,

at least one of after and during performing the vascular procedure, further retracting the microcatheter, wherein further retracting the microcatheter comprises unsheathing other self-expanding bulbs and self-expanding the other self-expanding bulbs from the collapsed state to an expanded state, the other self-expanding bulbs in the expanded state entrapping residual emboli.

15. The method of claim 14, further comprising torsionally rasping the textile structure, the self-expanding bulb providing an anchor for the torsionally rasping.

17. The method of claim 14, wherein the vascular procedure comprises at least one of angioplasty, atherectomy, aspiration, stenting, embolic coil insertion, intra-arterial thrombolysis, and bypass.

18. The method of claim 14, wherein retracting the microcatheter to unsheathe the self-expanding bulb comprises expanding the vessel.