TREA

Vessel cleaner and barrier

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Information

  • Patent Grant
  • 6818002
  • Patent Number
    6,818,002
  • Date Filed
    Monday, September 23, 2002
    22 years ago
  • Date Issued
    Tuesday, November 16, 2004
    20 years ago
  • Inventors
  • Examiners
    • Truong; Kevin T.
    Agents
    • Shiber; Samuel
Information
Abstract
A rotary flexible agitator system for removing an obstruction from within a patient's vessel that a motor-driven rotary flexible agitator-shaft disposed in the tubular housing, the agitator-shaft having an offset distal-agitator attached to its distal end that extends out of the open distal end, the effective diameter of the offset distal-agitator being substantially larger than its cross-sectional diameter, wherein rotating the offset distal-agitator breaks the obstruction in the vessel to pieces and the relative motion between the rotary flexible agitator-shaft and the flexible tube reduces the longitudinal friction that may resist the movement of the pieces through the flexible tube; and a catheter in which the flexible tube is disposed and guided into the vessel having a barrier at its distal end section for temporarily blocking flow through the vessel and reducing the likelihood of distal embolization.
Description




BACKGROUND AND SUMMARY OF THE INVENTION




The rotary flexible-agitator system is designed for removing an obstruction from within a patient's vessel through a tube of small diameter and particularly for opening vessels, such as blood vessels, that tend to become obstructed by a thrombi.




Current treatments such as pharmacological, surgical or trans-catheter procedures can be time-consuming, traumatic and expensive. Thus, objects of the present invention are to simplify, improve and shorten the process by enabling the physician to navigate and thread the system through obstructions, curved vessels and bifurcations and then break the obstruction to small pieces that are simultaneously removed through the tube by a combination of suction and mechanical means. To further reduce the likelihood of pieces of the obstruction being carried down stream into the vasculature the system can be delivered through a guiding catheter with a distal barrier that temporarily occludes flow through the vessel during the procedure. These and other objects of the invention will become apparent from the following discussion and the accompanying drawings.











BRIEF DESCRIPTION OF THE FIGURES




In the following FIGS. the midsection of the embodiments is represented by an intermittent line to enable to fit the FIGS. on the drawing sheet and the embodiments' distal section is enlarged to show certain details.





FIG. 1

shows a cross section view of a first embodiment having a flexible tube and a offset distal agitator extending out of the open distal end of the flexible tube, inserted into a curved vessel through a catheter with a distal barrier.





FIG. 2

shows an enlarged cross section of the system as viewed on a cross-sectional plane


2


—


2


(note FIG.


1


).





FIG. 3

shows a further enlarged sectional view of a portion of the expandable balloon.





FIG. 4

shows the first embodiment with the offset distal-agitator being pulled into the flexible tube causing its effective diameter to decrease.





FIG. 5

shows a cross-sectional view of modified first embodiment that is equipped with ferrules to limit the extension of the agitator-shaft from over-extending out of the flexible tube.




FIG.


6


. shows an enlarged cross-section of a portion of the embodiment of

FIG. 5

that is marked by an oblong circle and contains the ferrules.





FIG. 7

shows a second embodiment of the invention, where the system is deliverable into the vessel over a guidewire





FIG. 8

shows a cross section of the agitator-shaft as viewed on a cross-sectional plane


8


—


8


as marked on FIG.


7


.




FIG.


9


. shows an enlarged cross-section of a portion of the embodiment of

FIG. 7

that is marked by a circle and contains the ferrules.











DETAILED DESCRIPTION





FIGS. 1

,


2


and


3


shows a rotary flexible agitator system and barrier


10


for removing an obstruction


19


(e.g., thrombus) from within a patient's vessel


11


(same items will be marked with same numbers throughout the FIGS.). It comprises a tubular housing


12


having a flexible tube


13


with an open distal end


14


and a proximal end section


15


with a suction port


16


. A rotary flexible agitator-shaft


17


, coupled to and driven by an electric motor


29


, is disposed in the tubular housing. The agitator-shaft has an offset distal-agitator


18


attached to its distal end that extends out of the open distal end. The effective diameter of the offset distal-agitator is substantially larger than the diameter of its cross section. Rotating the offset distal-agitator breaks the obstruction in the vessel to pieces and the relative motion between the rotary flexible agitator-shaft and the flexible tube reduces the longitudinal friction that may resist the movement of the pieces through the flexible tube as further explained in my U.S. Pat. No. 6,143,009.




The flexible agitator-shaft is moveable relative to the flexible tube to thereby pull or push the offset distal agitator in or out of the flexible tube as shown in FIG.


4


and as further explained in my co-pending parent application Ser. No. 09/867,307 (note

FIG. 3

in the parent case).




The flexible tube


13


is disposed in a catheter


20


having an expandable distal barrier


21


for temporarily occluding the vessel. The barrier preferably comprises a selectively inflatable balloon


22


with a toroidal (donut-like) shape that is attached to the distal end section of the catheter. A passage


23


, defined in the wall of the catheter


24


, connects the balloon to a port


25


to which an inflation device such as a syringe (not shown) can be connected to effect inflation or deflation of the balloon. The catheter has an additional port


26


that communicates with the vessel through a main lumen


27


of the catheter. The agitator-shaft preferably comprises a spiral wire


28


. The agitator-shaft and offset distal-agitator can be made of one continuous wire (see FIG.


5


). The agitator-shaft and the offset distal-agitator are made from one continuous flattened wire wound on its edge and the distal-agitator is made from the flattened wire wound on its side, as shown in FIG.


5


.




The cross-section of the agitator shaft is larger than the cross-section of the offset distal-agitator as also shown in FIG.


5


.




A first ferrule


31


having a first internal diameter


32


and a first bearing surface


33


is fitted inside and attached to the flexible tube. A second ferrule


34


having a second bearing surface


35


and a second external diameter


36


is fitted over and attached to the spiral wire. The second external diameter is larger than the internal diameter. The first bearing surface is located at a first distance


37


from the open distal end and the second bearing surface is located at a second distance


38


from the open distal end, whereas the second distance is not smaller than the first distance. As the bearing surfaces come in contact the extension of the agitator-shaft out of the flexible tube is limited. Absent the ferrules an agitator-shaft, especially in long version of the system, may become extended in the process of conveying debris or due to external forces.





FIGS. 7

,


8


and


9


shows a second embodiment


50


that can be delivered into the vessel over a guidewire


44


or a similarly elongated flexible component. In order to provide a distal opening for the guidewire a spiral wire


51


is transitioned to an offset distal-agitator


52


that is shifted sideways as shown in FIG.


8


. The shift is achieved by slightly elongating the transitional section


55


(as compared to the transitional section


38


in the parent case Ser. No. 09/867,307). The proximal end of the second embodiment


56


is similar to the proximal end of the shown in the parent case (less the illumination means


77


) to which reference is made for further construction details.




Another aspect of the invention is a method of removing an obstruction from a vessel comprises the following steps: inserting into the vessel a distal end of a catheter having an expandable distal barrier, inserting into the vessel a rotary flexible-agitator system comprising a tubular housing having a flexible tube with an open distal end and a proximal end section with a suction port, a motor driven rotary flexible agitator-shaft disposed in the tubular housing, the agitator having an offset distal-agitator attached to its distal end, temporarily occluding the vessel by expanding the distal barrier, rotating the offset distal-agitator that extends out of the open distal end, and has an effective diameter substantially larger than its cross section, to break the obstruction in the vessel to pieces, the relative motion between the rotary flexible agitator and the flexible tube reducing the longitudinal friction that may resist the movement of the pieces through the flexible tube




The catheter is preferably inserted into the vessel through a standard introducer


42


, which can have a port


43


through which fluid is introduced into or withdrawn from the vessel.




While the present invention has been illustrated by a limited number of embodiments, it should be understood that modifications and substitutions may be made within the spirit of the invention and the scope of the claims.



Claims
  • 1. A process of removing an obstruction from a vessel comprising the following steps:inserting into the vessel a distal end of a catheter having an expandable distal barrier; inserting into the vessel a rotary flexible agitator system comprising a tubular housing having a flexible tube with an open distal end and a proximal end section with a suction port, a motor-driven rotary flexible agitator-shaft disposed in the tubular housing, the agitator-shaft having an offset distal-agitator attached to its distal end; temporarily occluding the vessel by expanding the distal barrier; rotating the offset distal-agitator that extends out of the open distal end, and has an effective diameter substantially larger than its cross section, to break the obstruction in the vessel to pieces, the relative motion between the rotary flexible-agitator and the flexible tube reducing the longitudinal friction that may resist the movement of the pieces through the flexible tube.
  • 2. As in claim 1 wherein the catheter is inserted into the vessel through an introducer.
  • 3. As in claim 2 wherein the introducer has a side arm through which fluid is introduced into or withdrawn from the vessel.
CROSS REFERENCE TO OTHER APPLICATIONS

This application is a continuation in part (CIP) of my application Ser. No. 09/867,307 filed on May 29, 2001 now U.S. Pat. No. 6,758,851 (my doc. Th5) that is a CIP of my earlier application Ser. No. 09/654,934 filed on Sep. 1, 2000 now U.S. Pat. No. 6,482,215 (my doc. Th4) that is a CIP of my earlier application Ser. No. 09/389,712 filed on Sep. 3, 1999 (my doc. Th3; now U.S. Pat. No. 6,143,009) that is a CIP 09/241,802 filed on Feb. 2, 1999 (my doc. Th2; now abandoned). This application also relies for priority on my international patent application PCT/US00/01797 filed on Jan. 25, 2000 that relies for priority on the above mentioned patent applications Ser. No. 09/389,712 and Ser. No. 09/241,802 and on a provisional application Ser. No. 60/118,611 filed on Feb. 4, 1999. Additionally this application is a CIP of my earlier application Ser. No. 10/086465 (my doc. Cth1), filed on Mar. 1, 2002 now U.S. Pat. No. 6,767,353. All the above prior applications are being incorporated herein by reference.

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Continuation in Parts (5)
Number Date Country
Parent 10/086465 Mar 2002 US
Child 10/252290 US
Parent 09/867307 May 2001 US
Child 10/086465 US
Parent 09/654934 Sep 2000 US
Child 09/867307 US
Parent 09/389712 Sep 1999 US
Child 09/654934 US
Parent 09/241802 Feb 1999 US
Child 09/389712 US