Aspiration devices and methods

• US 10,390,926 B2
• Filed: 08/14/2018
• Issued: 08/27/2019
• 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): Mensh, Andrew J
• Application Number:
  US16/103,410
• Publication Number:
  US 20180368965A1
• Time in Patent Office: 378 Days
• Field of Search: 604540
• 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 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• 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 2017/00154 pulsed
• CPC Class Codes: A61B 2017/00159 Pulse shapes
• CPC Class Codes: A61B 2017/00185 Means for setting or varying the pulse height
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• 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 2017/00867 : shape memory effect
• CPC Class Codes: A61B 2017/1205 : Introduction devices
• CPC Class Codes: A61B 2017/12054 : Details concerning the detachment of the occluding device from the introduction device
• 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 2017/22079 : with suction of debris
• 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 2/013 : 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 2/82 : Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/856 : Single tubular stent with a side portal passage
• 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 2002/068 : Modifying the blood flow model, e.g. by diffuser or deflector
• 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 2230/001 : Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0017 : differing in yarn density
• CPC Class Codes: A61F 2250/0023 : differing in porosity
• CPC Class Codes: A61F 2250/0032 : differing in radiographic density
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0097 : Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 1/74 : Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/742 : by changing the size of a vent A61M1/7411 takes precedence
• CPC Class Codes: A61M 1/75 : Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 1/76 : Handpieces specially for suction-irrigation A61M1/774, aspiration tips A61M1/84
• CPC Class Codes: A61M 1/81 : Piston pumps, e.g. syringes
• CPC Class Codes: A61M 1/82 : Membrane pumps, e.g. bulbs
• 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 2205/3561 : local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• 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 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

An aspiration system includes a pump and a control system in communication with the pump. The control system includes a microcontroller, an antenna configured to receive a signal, and a pump control board in communication with the microcontroller. The antenna is in communication with the microcontroller. Upon receiving the signal, the pump control board operates the pump to create negative pressure according to the signal.

Claims

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

an external control panel that allows an operator to choose from any of a plurality of stored crescendo suction patterns during a thrombus aspiration procedure,

wherein each of the plurality of stored crescendo suction patterns comprises a repetitive cycle pattern having at least two different suction intensity levels,

wherein the at least two different suction intensity levels are selected from one of three suction intensity levels,

wherein a first suction intensity level is within a range between −

100 and −

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

351 and −

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

551 and −

769 mm Hg,

wherein a first suction pattern of the plurality of stored crescendo suction patterns is configured for aspiration of soft clots,

wherein a second suction pattern of the plurality of stored crescendo suction patterns is configured for aspiration of hard clots; and

a vacuum pump comprising power electronics that generate the plurality of stored crescendo suction patterns.

2. The system of claim 1, wherein the repetitive cycle pattern of at least one of the plurality of stored crescendo suction patterns comprises a repetitive cycle pattern having the following order:

the first suction intensity level for a first time duration, the second suction intensity level for a second time duration, and the third suction intensity level for a third time duration, wherein the first duration, the second duration and the third duration are each between 1 and 30 seconds.

3. The system of claim 2, wherein the first duration, the second duration, and the third duration are uniform.

4. The system of claim 2, wherein at least one of the first duration, the second duration, and the third duration is different.

5. The system of claim 1, further comprising a catheter comprising a lumen;

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

6. The system of claim 5, wherein the catheter is selected from the group consisting of:

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

7. The system of claim 5, wherein the portion of the suction tubing is flexible.

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

an external control panel that allows an operator to select from any of a plurality of stored suction patterns during a thrombus aspiration procedure,

wherein a first suction pattern of the plurality of stored suction patterns is configured for aspiration of soft clots,

wherein a second suction pattern of the plurality of stored suction patterns is configured for aspiration of hard clots,

wherein each of the plurality of stored suction patterns comprises a repetitive cycle pattern having at least two different suction intensity levels,

wherein the at least two different suction intensity levels comprises;

a first suction intensity level having a first negative pressure; and

a second suction intensity level having a second negative pressure,

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

a vacuum pump comprising power electronics that generate the plurality of stored suction patterns.

9. The system of claim 8, wherein the repetitive cycle pattern of at least one of the plurality of stored suction patterns comprises a repetitive cycle pattern having three different suction intensity levels.

10. The system of claim 8, wherein the repetitive cycle pattern of at least one of the plurality of stored suction patterns comprises a repetitive cycle pattern having at least one pause duration between each change in suction intensity level.

11. The system of claim 8, wherein the repetitive cycle pattern of at least one of the plurality of stored suction patterns comprises a repetitive 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.

12. The system of claim 11, 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.

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

an automated negative suction device that facilitates aspiration of a thrombus;

power electronics that control the automated negative suction device by generating a plurality of different stored suction patterns during a thrombus aspiration procedure;

an external control panel that allows a user to choose between the plurality of different stored suction patterns; and

wherein a first suction pattern of the plurality of different stored suction patterns is configured for aspiration of soft clots,

wherein a second suction pattern of the plurality of different stored suction patterns is configured for aspiration of hard clots,

wherein at least one of the different stored suction patterns comprises a plurality of suction intensity levels, and

wherein the plurality of suction intensity levels comprises;

a first suction intensity level; and

a second suction intensity level having a larger magnitude than the first.

14. The system of claim 13, wherein the at least one of the different stored suction patterns comprises a third suction intensity level having a larger magnitude than the second suction intensity level.

15. The system of claim 13, wherein the automated negative suction device comprises a pump, and further comprising:

a catheter comprising a lumen;

a suction tubing, a portion of the suction tubing configured to extend from the pump to a hub at a proximal end of the catheter; and

a control system in communication with the pump.

16. The system of claim 15, wherein the catheter is selected from the group consisting of:

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