Systems and Methods for Removing Undesirable Material Within a Circulatory System Utilizing a Balloon Catheter

• US 20110213393A1
• Filed: 04/12/2011
• Published: 09/01/2011
• Est. Priority Date: 12/20/2007
• Status: Active Grant

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: Vortex Medical Inc. (AngioDynamics, Inc.)
• Inventors: Glennon, Michael, Aklog, Lishan
• Granted Patent: US 8,506,512 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• 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 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 2205/7545 for solid matter, e.g. microaggregates

Abstract

A system for removing an undesirable material from within a vessel is provided. The system includes a cannula designed for maneuvering within a blood vessel to a site of interest and applying a suction force, such that the undesirable material can be captured and removed along the cannula away from the site. The system also may include a catheter having a balloon at its distal end. The balloon may be designed to be positioned adjacent to the undesirable material such that the undesirable material is situated between the balloon and the cannula. The catheter may also be designed to subsequently impart a force onto the undesirable material for removal of the undesirable material. A method for removing an undesirable material from within a vessel 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 and for applying a suction force, such that the undesirable material can be captured substantially en bloc through the distal end and removed along the first cannula away from the site;

a catheter having a distal end designed to be positioned adjacent to the undesirable material such that the undesirable material is situated between the distal end of the catheter and the distal end of the cannula;

a balloon bonded to the distal end of the catheter, the bond sufficient to withstand a force imparted onto the undesirable material by the balloon without the balloon becoming dislodged from the catheter.

2. A system as set forth in claim 1 wherein the first cannula includes a lumen.

3. A system as set forth in claim 2 wherein the catheter is further designed to be extended from the lumen in order to position the balloon within the vessel and adjacent to the undesirable material.

4. A system as set forth in claim 1 wherein the balloon is designed occlude a flow of blood in the vessel when the balloon is inflated and allow the flow of blood in the vessel to pass when the balloon is deflated.

5. A system as set forth in claim 1 wherein the distal end of the catheter is designed to be extended past the undesirable material while the balloon is in a deflated mode.

6. A system as set forth in claim 1 wherein the distal end of the catheter is designed to be extended through the undesirable material while the balloon is in a deflated mode.

7. A system as set forth in claim 1 wherein the balloon, once inflated, is designed to impart the force on the undesirable material by pulling against the undesirable material.

8. A system as set forth in claim 1 wherein the balloon is designed to exert the force on the undesirable material by inflating and deflating within the vessel, thereby increasing and decreasing a fluid pressure and creating a flushing action within the vessel for dislodging the undesirable material.

9. A system as set forth in claim 1 further comprising a pump, in fluid communication with a proximal end of the first cannula, designed to provide a suction force for capture of the undesirable material from the vessel.

10. A system as set forth in claim 1 further comprising 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.

11. A system as set forth in claim 10 wherein the second cannula includes a lumen.

12. A system as set forth in claim 11 wherein the catheter is further designed to be extended from the lumen in order to position the balloon within the vessel and adjacent to the undesirable material

13. A system as set forth in claim 1 wherein the first cannula and the catheter are designed to remove the undesirable material from a medium size blood vessel or a large size blood vessel.

14. A system as set forth in claim 1 wherein the first cannula and the catheter are designed to remove the undesirable material without substantial fragmentation.

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

maneuvering, to a site of interest, a first cannula having a distal end and an opposing proximal end, such that the distal end of the first cannula is positioned at the site of interest to capture an undesirable material;

directing a balloon catheter having a balloon at its distal end toward the undesirable material such that the undesirable material is situated between the balloon and the distal end of the first cannula;

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

manipulating the balloon so as to impart a force onto the undesirable material in order to dislodge the undesirable material from the vessel for subsequent capture through the distal end of the first cannula.

16. A method as set forth in claim 15 wherein the step of maneuvering includes positioning the first cannula in a medium size blood vessel or a large size blood vessel.

17. A method as set forth in claim 15 wherein the step of directing includes extending the catheter into the vessel from the distal end of the first cannula.

18. A method as set forth in claim 15 wherein the step of directing includes moving the balloon to a position within the vessel adjacent to the undesirable material.

19. A method as set forth in claim 15 wherein the step of directing includes extending the catheter past the undesirable material while the balloon is in a deflated mode.

20. A method as set forth in claim 15 wherein the step of directing includes extending the catheter through the undesirable material while the balloon is in a deflated mode.

21. A method as set forth in claim 15 wherein the step of providing includes capturing the undesirable material without substantial fragmentation.

22. A method as set forth in claim 15 wherein the step of manipulating includes inflating the balloon and subsequently moving the catheter within the vessel so that the balloon imparts pulling force onto the undesirable material in order to dislodge the undesirable material from the vessel.

23. A method as set forth in claim 15 wherein the step of manipulating includes inflating the balloon to occlude a flow of fluid in the vessel and deflating the balloon to allow a flow of fluid in the vessel in order to create a flushing action within the vessel.

24. A method as set forth in claim 15 further comprising positioning a second cannula, in fluid communication with the first cannula, such that a distal end of the second cannula is situated in spaced relation to the distal end of the first cannula.

25. A method as set forth in claim 24 further comprising reinfusing, through the distal end of the second cannula, fluid removed from the patient by the suction force, to a location in spaced relation from the distal end of the first cannula