Aspiration systems

• US 8,932,321 B1
• Filed: 04/24/2014
• 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:
  US14/260,655
• Publication Number:
  US 20150032120A1
• Time in Patent Office: 264 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

Thrombus aspiration may be performed using manual negative intermittent suction (e.g., provided by a syringe) or using an automated negative suction device (e.g., provided by a vacuum pump). The suction device may be connected through suction tubing to a hub of a catheter. The automated negative suction device may include an external control panel for the operator configured to allow the operator to choose from any of a plurality of suction patterns during an aspiration procedure.

Claims

1. A system for aspirating thrombi using an operator-selectable suction pattern, comprising:

a catheter, wherein the catheter is configured to be advanced to a location within a blood vessel proximal to a thrombus;

an external control panel for allowing an operator to choose from any of a plurality of variable suction patterns during a thrombus aspiration procedure,

wherein each of the plurality of variable suction patterns comprises a repetitive preconfigured cycle pattern having at least two different suction intensity levels and at least one pause duration at the end of each preconfigured cycle pattern,

wherein the different suction intensity levels and the at least one pause duration of the plurality of preconfigured cycle pattern are configured for facilitating increased aspiration or agitation of thrombi;

a peristaltic motor pump, the peristaltic motor pump comprising power electronics configured to generate the plurality of variable suction patterns,

a disposable canister; and

suction tubing coupled to the disposable canister and to the peristaltic motor pump, a portion of the suction tubing configured to extend from the disposable canister to a hub at a proximal end of the catheter.

2. The system of claim 1, wherein the power electronics comprise a customized integrated circuit board or an integrated chip.

3. The system of claim 1, wherein at least one of the variable suction patterns comprises a repetitive preconfigured cycle pattern having three different suction intensity levels.

4. The system of claim 1, wherein at least one of the variable suction patterns comprises a repetitive preconfigured cycle pattern having at least one pause duration between each change in suction intensity level.

5. The system of claim 1, wherein at least one of the variable suction patterns comprises a repetitive preconfigured cycle pattern having the following order:

a first intensity level for a first time duration, a second intensity level for a second time duration, a third intensity level for a third time duration, wherein the second intensity level is greater than the first intensity level, and wherein the third intensity level is greater than the second intensity level.

6. The system of claim 5, wherein the first intensity level is within a range between −

100 and −

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

351 and −

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

551 and −

769 mm Hg.

7. The system of claim 1, wherein time durations of the different suction intensity levels are between 1 and 30 seconds.

8. The system of claim 1, wherein time durations of the different suction intensity levels are uniform.

9. The system of claim 1, wherein a first one of the plurality of variable suction patterns is configured for aspiration of soft clots and wherein a second one of the plurality of variable suction patterns is configured for aspiration of hard clots.

10. The system of claim 1, wherein the different suction intensity levels of the repetitive preconfigured cycle pattern increase in intensity over the repetitive preconfigured cycle pattern.

11. A system for aspirating thrombi using an operator-selectable suction pattern, comprising:

an external control panel for allowing an operator to select from any of a plurality of preconfigured suction patterns during a thrombus aspiration procedure,

wherein each of the plurality of preconfigured suction patterns comprises a repetitive cycle pattern having at least two different suction intensity levels and at least one pause duration at the end of each repetitive cycle pattern,

wherein the different suction intensity levels and the at least one pause duration of the plurality of preconfigured suction patterns are configured for facilitating increased aspiration or agitation of different types of thrombi;

a vacuum pump configured to generate the plurality of preconfigured suction patterns, and

suction tubing coupled to the vacuum pump, a portion of the suction tubing configured to extend from the vacuum pump to a hub at a proximal end of a catheter.

12. The system of claim 11, wherein time durations of the different suction intensity levels are between 1 and 30 seconds.

13. The system of claim 11, wherein time durations of the different suction intensity levels are uniform.

14. The system of claim 11, wherein a first one of the plurality of preconfigured suction patterns is configured for aspiration of soft clots and wherein a second one of the plurality of preconfigured patterns is configured for thrombus aspiration of hard clots.

15. The system of claim 11, wherein the vacuum pump comprises a peristaltic pump.

16. The system of claim 11, wherein at least one of the preconfigured suction patterns comprises a repetitive cycle pattern having three different suction intensity levels.

17. A system for aspirating thrombi using an operator-selectable suction pattern, comprising:

an external control panel for allowing an operator to select from any of a plurality of variable suction patterns,

wherein each of the plurality of variable suction patterns comprises a repetitive preconfigured cycle pattern having at least two different suction intensity levels and at least one pause duration at the end of each repetitive preconfigured cycle pattern,

wherein the different suction intensity levels are configured for addressing different clinical scenarios;

an automated negative suction device configured to generate the plurality of variable suction patterns, and

suction tubing coupled to the automated negative suction device, a portion of the suction tubing configured to extend from the automated negative suction device to a hub at a proximal end of a catheter.

18. The system of claim 17, wherein a first one of the plurality of variable suction patterns is configured for aspiration of soft clots and wherein a second one of the plurality of variable suction patterns is configured for aspiration of hard clots.

19. The system of claim 17, further comprising the catheter, wherein the catheter comprises a laser-cut hypotube.

20. The system of claim 17, wherein the different suction intensity levels of the repetitive preconfigured cycle pattern increase in intensity over the repetitive preconfigured cycle pattern.