Thrombus aspiration using an operator-selectable suction pattern

• US 10,251,739 B2
• Filed: 09/10/2018
• Issued: 04/09/2019
• 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): Louis, Richard G
• Application Number:
  US16/126,651
• Publication Number:
  US 20190008627A1
• Time in Patent Office: 211 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/12163 having a string of elements connected to each other
• 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 2017/00137 Details of operation mode
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2017/00181 Means for setting or varying the pulse energy
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• 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 2017/22001 : 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 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/012 : Multiple filtering units
• CPC Class Codes: A61F 2/013 : Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/07 : Stent-grafts
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/016 : made from wire-like elements
• CPC Class Codes: A61F 2002/018 : made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/061 : provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/823 : Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0023 : differing in porosity
• CPC Class Codes: A61M 1/74 : Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/75 : Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• 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 1/87 : Details of the aspiration tip, not otherwise provided for
• CPC Class Codes: A61M 2025/0042 : Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• 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 1/02 : made from particular materials
• CPC Class Codes: D04C 1/06 : Braid or lace serving particular purposes
• CPC Class Codes: D04C 3/40 : for making tubular braids by circulating strand supplies around braiding centre at equal distances
• CPC Class Codes: D04C 3/48 : Auxiliary devices
• CPC Class Codes: D10B 2401/046 : Shape recovering or form memory
• 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

Vascular treatment devices and methods include a woven structure including a plurality of bulbs that may be self-expanding, a hypotube, for example including interspersed patterns of longitudinally spaced rows of kerfs, and a bonding zone between the woven structure and the hypotube. The woven structure may include patterns of radiopaque filaments measureable under x-ray. Structures may be heat treated to include various shapes at different temperatures. The woven structure may be deployable to implant in a vessel. A catheter may include a hypotube including interspersed patterns of longitudinally spaced rows of kerfs and optionally a balloon. Laser cutting systems may include fluid flow systems.

Claims

1. A system for facilitating aspiration of a thrombus in a vessel using an operator-selectable suction pattern, the system comprising:

an automated motor pump configured to facilitate aspiration of the thrombus, the automated motor pump comprising an external control panel configured to receive input from an operator; and

power electronics configured to power and control the automated motor pump to generate a plurality of variable suction patterns having a plurality of intensity levels,

wherein the plurality of intensity levels comprises;

a first intensity level having a first negative pressure; and

a second intensity level having a second negative pressure,

wherein the first negative pressure is between 551 and 769 mm Hg, and

wherein the first negative pressure is more negative than the second negative pressure;

wherein a first variable suction pattern of the plurality of variable suction patterns comprises a repetitive cycle comprising the first intensity level for a first duration and the second intensity level for a second duration after the first duration,

wherein the first duration and the second duration are each between 1 and 30 seconds, and

wherein a total duration of the repetitive cycle of the first variable suction pattern is between 1 minute and 15 minutes.

2. The system of claim 1,

wherein the first variable suction pattern is selectable by the operator from the plurality of variable suction patterns using the external control panel, and

wherein the second negative pressure is between 351 and 550 mm Hg.

3. The system of claim 1,

wherein the first variable suction pattern is selectable by the operator from the plurality of variable suction patterns using the external control panel, and

wherein the second negative pressure is between 100 and 350 mm Hg.

4. The system of claim 1, wherein the plurality of intensity levels comprises a third intensity level having a third negative pressure, wherein the third negative pressure is more negative than the second negative pressure, and wherein the first negative pressure is more negative than the third negative pressure.

5. The system of claim 1, wherein the first variable suction pattern is selectable by the operator from the plurality of variable suction patterns using the external control panel.

6. The system of claim 1, wherein the repetitive cycle includes a pause duration during which suction is paused.

7. A system for facilitating aspiration of a thrombus in a vessel using an operator-selectable suction pattern, the system comprising:

a pump configured to facilitate aspiration of the thrombus; and

power electronics configured to power and control the pump to generate a plurality of variable suction patterns having at least two different intensity levels,

wherein a first variable suction pattern of the plurality of variable suction patterns comprises a repetitive cycle comprising a first intensity level for a first duration and a second intensity level for a second duration after the first duration,

wherein the first intensity level has a first pressure,

wherein the second intensity level has a second pressure, and

wherein the first pressure is more negative than the second pressure.

8. The system of claim 7:

wherein the first duration and the second duration are each between 1 and 30 seconds; and

wherein a total duration of the repetitive cycle of the first variable suction pattern is between 1 minute and 15 minutes, and

wherein the first variable suction pattern is selectable by an operator from the plurality of variable suction patterns using an external control panel communicatively coupled to the power electronics.

9. The system of claim 7, wherein the first pressure is between −

551 and −

769 mm Hg and wherein the second pressure is between −

100 and −

350 mm Hg.

10. The system of claim 7, wherein the first pressure is between −

551 and −

769 mm Hg and wherein the second pressure is between −

351 and −

550 mm Hg.

11. The system of claim 7, wherein the first variable suction pattern is selectable by an operator from the plurality of variable suction patterns using an external control panel communicatively coupled to the power electronics.

12. A system for facilitating aspiration of a thrombus in a vessel using an operator-selectable suction pattern, the system comprising:

a pump configured to facilitate aspiration of the thrombus, the pump configured to generate a plurality of suction patterns, wherein each of the plurality of suction patterns comprises a plurality of different intensity levels,

wherein a first suction pattern of the plurality of suction patterns is selectable from the plurality of suction patterns by an operator using an external control panel, and wherein the first suction pattern comprises a first intensity level for a first duration and a second intensity level for a second duration, and

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

13. The system of claim 12, wherein the plurality of suction patterns comprises at least one of:

a plurality of crescendo suction patterns, a plurality of diminuendo suction patterns, or a combination of both crescendo and diminuendo suction patterns.

14. The system of claim 12, wherein the first duration and the second duration are uniform.

15. The system of claim 12, wherein the first duration and the second time duration are variable.

16. The system of claim 12, wherein the suction of the first intensity level is between −

551 and −

769 mm Hg and wherein the suction of the second intensity level is between −

100 and −

350 mm Hg.

17. The system of claim 12, wherein the suction of the first intensity level is between −

551 and −

769 mm Hg and wherein the suction of the second intensity level is between −

351 and −

550 mm Hg.

18. The system of claim 12, wherein the first suction pattern comprises a repetitive cycle.

19. The system of claim 12, wherein the first suction pattern comprises a third intensity level for a third duration, wherein suction of the third intensity level is different than the suction of the first intensity level and the suction of the second intensity level.

20. The system of claim 12, wherein the first suction pattern comprises a pause duration during which suction is paused.