Systems and Methods for Removing Undesirable Material Within a Circulatory System

• US 20110213290A1
• Filed: 04/06/2011
• Published: 09/01/2011
• Est. Priority Date: 12/20/2007
• Status: Abandoned Application

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Vortex Medical Inc. (AngioDynamics, Inc.)
• Inventors: Chin, Albert K., Glennon, Michael, deGuzman, Brian, Aklog, Lishan, Kramer, Thomas A.
• Application Number:
  US13/081,184
• Publication Number:
  US 20110213290A1
• Time in Patent Office: Days
• US Class Current: 604/6.09
• 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 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/79 Filters for solid matter specially adapted for dental use A61C17/065
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2205/7545 for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• 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

Abstract

A system for removing undesirable material from vessels and from chambers within the heart is provided. The system includes a suction cannula for removing the undesirable material from a site of interest within a patient. A filter device may be provided for capturing the undesirable material and removing it from the fluid flow. The system also includes pump for generating the necessary suction force through the suction cannula to dislodge the undesirable material from the site of interest and for generating a sufficient driving force to direct the fluid flow downstream within the system. The system further includes a reinfusion cannula for introducing fluid removed from the site of interest back into a patient. A method for removing undesirable material from vessels and from heart chambers is also provided.

Claims

1. A system for removing an undesirable material from within a vessel, the system comprising:

a first cannula having a distal end and an opposing proximal end, the first cannula designed for maneuvering within a vessel to a site of interest, such that the undesirable material can be directed substantially en bloc through the distal end and removed along the first cannula away from the site of interest;

a funnel designed to be situated at and in fluid communication with the distal end of the first cannula, the funnel having a mechanism designed to apply a distal force to the undesirable material that may be attached to a wall of the vessel, so as to dislodge the undesirable material therefrom; and

a pump, in fluid communication with the proximal end of the first cannula, to provide a sufficient suction force for pulling the undesirable material from the site of interest into the first cannula.

2. A system as set forth in claim 1, wherein the first cannula includes one or more side port to permit introduction of a balloon dilator, an angiography catheter, a balloon embolectomy catheter, and/or other instruments or devices into the first cannula.

3. A system as set forth in claim 1, wherein the first cannula includes multiple lumens.

4. A system as set forth in claim 1, wherein the funnel is in fluid communication with the distal end of the first cannula via a fluid channel.

5. A system as set forth in claim 1, wherein the funnel is deployable between a collapsed closed position and an open position.

6. A system as set forth in claim 5, wherein the funnel is deployable by a balloon dilator to expand from the collapsed closed position to the open position.

7. A system as set forth in claim 1, wherein the funnel includes two walls and a plurality of microspheres provided between the two walls, the plurality of microspheres designed to engage one another to form a substantially continuous, rigid structure, so as to provide the funnel with sufficient rigidity.

8. A system as set forth in claim 1, wherein the funnel includes a plurality of veins and a plurality of microspheres provided within the veins, the plurality of microspheres designed to engage one another to form a substantially continuous, rigid structure, so as to provide the funnel with sufficient rigidity.

9. A system as set forth in claim 1, wherein the mechanism includes an atraumatic tip of the funnel, an extension from the funnel, or a ring situated above or about the funnel, the mechanism being designed to be made sufficiently rigid so as to dislodge the undesirable material.

10. A system as set forth in claim 7, wherein the pump can generate a negative pressure to create a suction force necessary to pull the plurality of microspheres to form the substantially continuous, rigid structure.

11. A system as set forth in claim 1, further including a second cannula in fluid communication with the pump and being designed to have its distal end situated in spaced relation to the distal end of the first cannula, such that fluid removed from the site of interest by the first cannula can be directed along the second cannula and reinfused through the distal end of the second cannula.

12. A system as set forth in claim 11, wherein the fluid removed from the site of interest by the first cannula can be simultaneously reinfused through the distal end of the second cannula.

13. A method for removing an undesirable material from within a vessel, the method comprising:

maneuvering a first cannula having a distal end and an opposing proximal end to a site of interest within a vessel in a patient, such that the distal end of the first cannula is positioned adjacent an undesirable material;

deploying a funnel situated at and in fluid communication with the distal end of the first cannula from a collapsed closed position to an open position, such that in the open position the funnel can be used to engage and capture the undesirable material;

providing a suction force, through the distal end of the first cannula, to the undesirable material; and

applying, via a substantially rigid mechanism at the distal end of the first cannula, a distal force to the undesirable material that may be attached to a wall of the vessel so as to dislodge the undesirable material therefrom, such that the undesirable material is removed substantially en bloc away from the site of interest through the distal end of the first cannula.

14. A method as set forth in claim 13, wherein the step of maneuvering includes introducing via one or more side port into the first cannula a balloon dilator, an angiography catheter, a balloon embolectomy catheter, and/or other instruments or devices.

15. A method as set forth in claim 13, wherein the step of deploying includes expanding, at the site of interest, the funnel using a balloon dilator.

16. A method as set forth in claim 13, wherein the step of providing includes applying the suction force to the funnel, via a fluid channel in fluid communication with the funnel and the distal end of the first cannula, to make the funnel sufficiently rigid.

17. A method as set forth in claim 16, wherein the step of applying includes applying the suction force via the fluid channel to a plurality of microspheres provided within the funnel, to pull the plurality of microspheres to form a substantially continuous, rigid structure, so as to provide the funnel with sufficient rigidity.

18. A method as set forth in claim 13, further including:

positioning a second cannula, in fluid communication with the first cannula, such that its distal end is situated in spaced relation to the distal end of the first cannula; and

reinfusing, through the distal end of the second cannula, any fluid removed along with the undesirable material to a location in spaced relation from the distal end of the first cannula.

19. A method as set forth in claim 18, wherein the step of providing includes entrapping, downstream of the proximal end of the first cannula and towards a source for the suction force, the undesirable material so as to remove it from the fluid before the step of reinfusing.

20. A method as set forth in claim 19, wherein the step of entrapping includes permitting the fluid to continuously flow into the second cannula, while impeding movement of the undesirable material toward the second cannula.

21. A method as set forth in claim 18, wherein the step of reinfusing includes continuously collecting fluid directed from the proximal end of the first cannula and using the collected fluid as a source of fluid for reinfusion.

22. A method as set forth in claim 18, wherein the step of reinfusing includes collecting fluid directed from the proximal end of the first cannula and simultaneously using the collected fluid as a source of fluid for reinfusion.

23. A method as set forth in claim 22, wherein at least 10 cm³ of the undesirable material is removed from the site of interest without substantial fragmentation.

24. An apparatus for removing an undesirable material from within a vessel, the apparatus comprising:

an elongated tube having a distal end through which an undesirable material can be captured, a pathway extending along the tube to provide a passage for transporting the undesirable material from the distal end, and a proximal end in opposing relations to the distal end through which the undesirable material can exit;

a funnel designed to be situated at and in fluid communication with the distal end of the tube, the funnel designed for deployment between a collapsed closed position and an open position, the funnel having a mechanism designed to apply a distal force to the undesirable material that may be attached to a wall of the vessel, so as to dislodge the undesirable material therefrom; and

a fluid channel extending between the distal end of the tube and the funnel, to provide fluid communication between the distal end of the tube and the funnel.

25. An apparatus as set forth in claim 24, wherein the tube includes one or more side port to permit introduction of a balloon dilator, an angiography catheter, a balloon embolectomy catheter, and/or other instruments or devices into the tube.

26. An apparatus as set forth in claim 24, wherein the tube includes multiple lumens.

27. An apparatus as set forth in claim 24, wherein the funnel is deployable by a balloon dilator to expand from the collapsed closed position to the open position.

28. An apparatus as set forth in claim 24, wherein the funnel includes two walls and a plurality of microspheres provided between the two walls, or the funnel includes a plurality of veins and a plurality of microspheres provided within the veins, the plurality of microspheres designed to engage one another to form a substantially continuous, rigid structure, so as to provide the funnel with sufficient rigidity.

29. An apparatus as set forth in claim 24, wherein the mechanism includes an atraumatic tip of the funnel, an extension from the funnel, or a ring situated above or about the funnel, the mechanism being designed to be made sufficiently rigid so as to dislodge the undesirable material.

30. An apparatus as set forth in claim 28, wherein the fluid channel is designed to communicate a suction force to the funnel to pull the plurality of microspheres to form the substantially continuous, rigid structure.

31. An apparatus as set forth in claim 24, wherein the apparatus further includes a sheath designed to slide toward and away from the distal end of the tube, so as to expose or cover up the funnel to permit the funnel to be deployed into the open position or the collapsed closed position, respectively.