Methods of aspirating thrombi

• US 8,932,320 B1
• Filed: 04/16/2014
• Issued: 01/13/2015
• 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): Nguyen, Tuan V
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US14/254,271
• Publication Number:
  US 20150032122A1
• Time in Patent Office: 272 Days
• Field of Search: 606/200, 606/110, 606/114, 606/115, 606/159
• 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 suction may include providing suction patterns having varying intensity levels, such as a “crescendo suction” pattern. Cycles of crescendo suction patterns may comprise variable intensities of negative suction in a crescendo pattern (such as a small intensity negative suction pressure, a medium intensity negative suction pressure, and a large intensity negative suction pressure). The suction patterns may include pauses or temporary stops to the negative suction pressure.

Claims

1. A method of aspirating thrombi using a varying suction pattern, comprising:

inserting a distal end of a microcatheter within vasculature and advancing the distal end of the microcatheter to a location proximal to a thrombus;

inserting a thrombectomy device to at least partially span the thrombus,

applying suction to a proximal end of the microcatheter to aspirate the thrombus,

wherein the suction applied comprises a repetitive pattern of varying suction intensity levels each applied for a particular time duration, wherein the repetitive pattern comprises three different suction intensity levels and at least one pause for a pause time duration,

wherein applying suction to the proximal end of the microcatheter comprises causing an automated control unit to apply negative suction having the repetitive pattern, and

wherein the at least one pause is at the end of the repetitive pattern such that there is a pause between each repetition of the repetitive pattern.

2. The method of claim 1, wherein the three different suction intensity levels each have a time duration between 1 and 30 seconds.

3. The method of claim 1, wherein the pause time duration is between 1 and 15 seconds.

4. The method of claim 1, wherein the time duration of a first suction intensity level of the repetitive pattern is longer than the time duration of a second suction intensity level of the repetitive pattern.

5. The method of claim 1, wherein the repetitive pattern comprises a first suction intensity level for a first time duration, a second suction intensity level for a second time duration, and a third suction intensity level for a third time duration, wherein the first suction intensity level is lower than the second suction intensity level and wherein the second suction intensity level is lower than the third suction intensity level and greater than the first suction intensity level.

6. The method of claim 5, wherein the at least one pause is between the third time duration and the first time duration.

7. The method of claim 5, wherein the repetitive pattern comprises a pause for the pause time duration between each of the time durations of the suction intensity levels.

8. The method of claim 5, wherein the first time duration, the second time duration and the third time duration are uniform.

9. The method of claim 5, wherein the first suction intensity level is within a range between −

100 and −

350 mm Hg, wherein the second suction intensity level is within a range between −

351 and −

550 mm Hg, and wherein the third suction intensity level is within a range between −

551 and −

769 mm Hg.

10. A method of aspirating thrombi using a varying suction pattern, comprising:

inserting a distal end of a catheter within vasculature to a location proximate a thrombus;

causing negative suction to be applied to the location through the catheter, using an automated control unit, wherein the negative suction applied has a repetitive suction pattern and a pause between each repetition of the repetitive suction pattern,

wherein the repetitive suction pattern comprises a first intensity level for a first time duration, a second intensity level for a second time duration, and a pause time duration wherein suction is paused, and

wherein the second intensity level is greater than the first intensity level.

11. The method of claim 10, wherein the first time duration, the second time duration and the pause time duration are uniform.

12. The method of claim 10, wherein the repetitive suction pattern comprises a pause having the pause time duration between each of the first and second time durations.

13. The method of claim 10, wherein the repetitive suction pattern comprises, in order, the first intensity level for the first time duration, a first pause for the pause time duration, the second intensity level for the second time duration, a second pause for the pause time duration, a third intensity level for a third time duration, and a third pause for the pause time duration.

14. The method of claim 10, wherein the repetitive suction pattern comprises, in order, the first intensity level for the first time duration, the second intensity level for the second time duration, a third intensity level for a third time duration, and a pause for the pause time duration.

15. The method of claim 10, wherein at least one of the time durations is different from at least one of the other time durations.

16. A method of aspirating thrombi using a varying suction pattern, comprising:

providing an aspiration system comprising a catheter, suction tubing and an automated suction control unit, the aspiration system configured for;

causing suction to be applied by the suction control unit to a location proximate to a thrombus through the suction tubing coupled to a proximal end of the catheter upon user selection of one of a plurality of preconfigured repetitive suction patterns,

wherein each of the preconfigured repetitive suction patterns comprises a first intensity level having a first time duration, a second intensity level having a second time duration, and a pause time duration wherein suction is paused, and

wherein the second intensity level is greater than the first intensity level, and

wherein the applied suction comprises a pause between each repetition of the repetitive suction pattern.

17. The method of claim 16, wherein the catheter is selected from the group consisting of:

a microcatheter, a distal access microcatheter, a guide catheter and a balloon catheter.

18. The method of claim 16, wherein the catheter is a microcatheter.

19. The method of claim 16, wherein at least one of the three time durations is different from at least one of the other three time durations.