Side branch occlusion catheter device having integrated endoscope for performing endoscopically visualized occlusion of the side branches of an anatomical passageway

• US 5,707,389 A
• Filed: 06/07/1995
• Issued: 01/13/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Rosenthal, David, Louw, Frank, Sosnowski, Stephen A.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): RASCHE, PATRICK WILLIAM
• Application Number:
  US08/486,038
• Time in Patent Office: 951 Days
• Field of Search: 606/191, 606/194, 606/198, 606/200, 600/104, 600/105, 600/106, 600/107, 600/123, 600/153, 600/170
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter

Abstract

The device for blocking (e.g., embolizing) the side branches of an anatomical passageway under endoscopic guidance. The device comprises an elongate catheter body having a side branch blocking apparatus, such as an embolization catheter, disposed therein and further incorporating an endoscope (e.g., an angioscope). The incorporated endoscope is useable to A) visually locate side branches which emanate from the anatomical passageway and b) visually observe the operation of the side branch blocking apparatus. Also disclosed are methods for utilizing a device of the forgoing character, including methods for performing in situ embolization of the side branches of a vein, under angioscopic visualization. The endoscopic component of the device may also be utilized to visually observe the use and/or effect of one or more separate device, such as valvulotome(s) used for cutting venous valves located within the lumen of a vein.

Claims

1. A device for endoluminal embolization of the side branches of an anatomical passageway under endoscopic visualization, said device comprising:

an elongate flexible catheter body having a longitudinal axis, a proximal end, a distal end, and at least first and second lumens extending longitudinally therethrough;

an embolization device disposed within said second lumen of said catheter body;

a side opening formed in said catheter body near the distal end thereof, said side opening being communicative with said second lumen and defining an exit port through which said embolization device exits said catheter body;

an endoscope disposed within the first lumen of said catheter body, said endoscope having a distal end and at least one image receiving port, said endoscope being alternately moveable back and forth, relative to said catheter body, between;

i. a distally advanced position whereat the image receiving port of said endoscope is positioned distal of the exit port and to provide viewing of an area ahead of the distal end of said catheter body; and

,

ii. a proximally retracted position whereat the image receiving port of said endoscope is positioned to provide viewing of said side opening without obstructing passage of said embolization device out of said side opening.

2. The device of claim 1 wherein:

a deflection surface is formed within said catheter body, between the distal end of said second lumen and said side opening formed in said catheter body; and

,

wherein said embolization device comprises an elongate embolization catheter having a distal end, and a deflectable distal tube portion formed on the distal end thereof;

said elongate embolization catheter being disposed within the second lumen of said catheter body, and moveable back and forth therein;

said deflection surface being configured and positioned such that, when said embolization catheter is moved in the distal direction, the distal tube member of said embolization catheter will contact, and be deflected by, said deflection surface, such that said distal tube member will protrude out of the side opening of said catheter body.

3. The device of claim 2 wherein said deflection surface is of curved configuration, so as to form a curvate transitional surface between said second lumen and said side opening of said device.

4. The device of claim 3 wherein said embolization member comprises a resilient embolization coil disposed, in an outstretched elongate configuration, within said embolization catheter, and which is resiliently biased to a coiled configuration such that, when expelled out of the distal end of said distal tube member, said embolization coil will assume a coiled configuration.

5. The device of claim 2 wherein said deflection surface is in the form of an angular bend, thereby forming an angular transition surface between said second lumen and said side opening of said device.

6. The device of claim 5 wherein said embolization catheter further comprises a push member disposed within said embolization catheter, proximal to said embolization coil, said push wire being operative to push said embolization coil through said catheter and out of the distal end of said distal tube portion thereof, while said distal tube portion protrudes out of the side opening of said catheter body.

7. The device of claim 2 wherein said curved deflection surface is configured such that, when said distal tube portion of said embolization catheter is thereby deflected out of the side opening of said catheter body, said distal tube member will protrude from said catheter body in a direction which is substantially perpendicular to the longitudinal axis of said catheter body.

8. The device of claim 1 wherein said endoscope comprises:

an elongate, pliable, scope body having a longitudinal axis, a proximal end and a distal end;

an image receiving port formed in said scope body;

an illumination outlet port formed in said scope body;

at least one image receiving optical fiber extending longitudinally through said scope body and communicative with said image receiving port;

at least one illumination transmitting fiber extending longitudinally through said scope body and communicative with said illumination outlet port.

9. The device of claim 8 wherein the endoscope, when in its distally advanced position, is located, such that the illumination outlet port and image receiving port of said endoscope are positioned to cast illuminating light ahead of the distal end of said catheter body;

and to receive an optical image from a visual field located ahead of the distal end of said catheter body, and when said endoscope is in said proximally retracted position, the distal end of said endoscope is located proximal to the side opening of said catheter body such that the illumination port of said endoscope is position to cast illuminating light within the side opening of said catheter body, and the image receiving port of said endoscope is positioned to receive a visual image from a visual field which includes an area within the side opening of said catheter body.

10. The device of claim 9 wherein a shoulder is formed in the distal end of said catheter body such that the distal end of said endoscope will rest upon said shoulder when said endoscope is in said distally advanced position.

11. The device of claim 10 wherein said shoulder comprises a generally U-shaped notch having a chamfered distal edge.

12. The device of claim 1, further comprising a fine adjustment mechanism for adjusting the longitudinal positioning of the endoscope.

16. A method of blocking side branches which emanate from an anatomical passageway, said method comprising the steps of:

a) providing a device in accordance with claim 6;

b) inserting said device into said anatomical passageway;

c) positioning said endoscope in its distally advanced position;

d) advancing said device, distal end first, through said anatomical passageway until the distal end of said device is positioned adjacent a side branch which emanates from said anatomical passageway;

e) retracting said endoscope to its proximally retracted position;

f) adjusting, as necessary, the position of said device such that said side opening is positioned next to the side branch which emanates from said anatomical passageway;

g) advancing said embolization catheter through said second lumen such that the distal tube member of said embolization catheter is deflected by said curved deflection surface, out of the side opening of said catheter body and into the side branch which is positioned next to the side opening of said catheter body;

h) causing said embolization coil to pass through said catheter body and out of the distal end of the distal tube member thereof, such that said embolization coil will assume its coiled configuration within said side branch; and

,

i) retracting said embolization catheter into the second lumen of said catheter body.

17. The method of claim 16 further comprising the steps of:

j) returning said endoscope to its distally advanced position; and

k) further advancing said device, distal end first, through said anatomical passageway until the distal end of said device becomes positioned adjacent another side branch which emanates from said anatomical passageway.

18. The method of claim 16 wherein said anatomical passageway is a vein having at least one side branch emanating therefrom and at least one venous valve located therein, and wherein the endoscope of the device provided in step A of the method is further utilized to endoscopically view the positioning and use of a valvulotome device to cut said venous valve.

13. A method of blocking side branches which emanate from an anatomical passageway, said method comprising the steps of:

a) providing a device comprising;

an elongate flexible catheter body having a longitudinal axis, a proximal end, a distal end, and at least first and second lumens extending longitudinally therethrough;

an embolization device disposed within said second lumen of said catheter body;

a side opening formed in said catheter body near the distal end thereof, said side opening being communicative with said second lumen and defining an exit port through which said embolization device exits said catheter body;

an endoscope disposed within the first lumen of said catheter body, said endoscope having a distal end and at least one image receiving port, said endoscope being alternately moveable back and forth, relative to said catheter body, between;

i. a distally advanced position whereat the image receiving port of said endoscope is positioned distal of the exit port and to provide viewing of an area ahead of the distal end of said catheter body; and

,

ii. a proximally retracted position whereat the image receiving port of said endoscope is positioned to provide viewing of said side opening without obstructing passage of said embolization device out of said side opening;

b) inserting said device into said anatomical passageway;

c) positioning the endoscope of said device in its distally advanced position;

d) advancing said device, distal end first, through said anatomical passageway while observing the visual image provided by said endoscope;

e) stopping the advancement of said device when the visual image of said endoscope indicates that the distal end of said endoscope is adjacent a side branch emanating from said anatomical passageway;

f) retracting said endoscope to its proximally retracted position;

g) adjusting the positioning of said device, as necessary, to locate said side opening of said catheter body immediately adjacent the side branch emanating from said anatomical passageway; and

h) utilizing said embolization device to pass at least one embolization member out of said side opening and into said side branch.

14. The method of claim 13 further comprising the step of:

i) returning said endoscope to its distally advanced position; and

,

j) further advancing said device, distal end first, while monitoring the visual image provided by said endoscope to determine when the distal end of said device has become positioned adjacent another side branch emanating from said anatomical passageway.

15. The method of claim 13 wherein said anatomical passageway is a vein having at least one side branch emanating therefrom and at least one venous valve located therein, and wherein the endoscope of the device provided in step A of the method is further utilized to endoscopically view the positioning and use of a valvulotome device to cut said venous valve.