Irregular surface balloon catheters for body passageways and methods of use

• US 5,423,745 A
• Filed: 07/06/1994
• Issued: 06/13/1995
• Est. Priority Date: 04/28/1988
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Research Medical, Inc. (Baxter International Inc.)
• Inventors: Todd, Robert J., Crocker, Gary L.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): MULCARE, NANCY C
• Application Number:
  US08/271,261
• Time in Patent Office: 342 Days
• Field of Search: 604/53, 604/96, 604/102-103, 604/280-281, 606/192, 606/194
• US Class Current: 604/500
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon

Abstract

This invention relates to balloon catheters for use in infusing a solution into a body passageway, and their methods of use and manufacture. Each catheter contains at least one lumen through which a solution flows into the body. The balloons of each catheter are secured to the proximal end of the catheter, and each have a plurality of protuberances projecting outwardly from the outer surface of the balloons for the purpose of firmly gripping the walls of the body passageway so as to secure placement of the catheter within the passageway. A malleable wire assists in retaining the catheter in position within the body passageway. A double balloon catheter allows sealing of the body passageway to be accomplished separately from securely gripping the walls.

Claims

1. A balloon catheter for use in transporting a fluid between an external location and a body passageway comprising:

a. a flexible cannula having at least one lumen, the flexible cannula having a distal end being of a size capable of insertion into a body passageway, and a proximal end capable of connection to an outside location, said cannula being adapted to transport fluids between the outside location and the body passageway when inserted therein;

b. a balloon, having a distal end and a proximal end, attached to the cannula periphery near the distal end of said cannula, thereby forming a chamber within the balloon and outside of the cannula;

c. expansion means in communication with the balloon for admitting fluid into and thereby inflating said balloon; and

d. knob means for securely gripping the walls of the body passageway when the balloon is inflated in order to secure the catheter in place during use and forming a seal within the body passageway, said knob means comprising a plurality of knobs projecting outwardly from the outer surface of said balloon, and wherein the plurality of knobs are formed from a material and are of a size and shape that they will securely grip the walls of a body passageway and form a seal within the body passageway when the balloon is inflated.

2. A balloon catheter as defined in claim 1, wherein the expansion means comprises an inflation lumen in communication with the balloon, for use in inflating the balloon.

3. A balloon catheter as defined in claim 1, wherein the expansion means comprises at least one aperture in the at least one lumen of the flexible cannula, such that fluid flowing through the lumen will flow through the at least one aperture into the interior of the balloon, thereby inflating the balloon.

4. A balloon catheter as defined in claim 3, further comprising an internal plug positioned within a lumen, thereby blocking passage through said lumen.

5. A balloon catheter as defined in claim 4, wherein the at least one aperture comprises a distal balloon aperture located on the lumen distal to the internal plug and a proximal balloon aperture located on the lumen proximal to the internal plug, such that fluid flowing through the lumen will exit the lumen at the distal balloon aperture and enter the balloon chamber, thereby filling the balloon, and will exit the chamber and re-enter the lumen through the proximal balloon aperture.

6. A balloon catheter as defined in claim 1, wherein the plurality of knobs each has generally a cylindrical base formed in the outer surface of the balloon, a body which projects outwardly substantially perpendicularly from the outer surface of the balloon, and a rounded terminus capable of gripping the inner wall of the body passageway.

7. A balloon catheter as defined in claim 1, further comprising a malleable wire located within a portion of the cannula, the malleable wire being constructed of a malleable material such that the malleable wire can be used to assist in maintaining the shape of the flexible cannula in the body passageway, wherein the malleable wire extends within the cannula from the proximal end of the cannula to substantially near but not past the distal end of the balloon.

8. A balloon catheter as defined in claim 1, wherein the catheter further comprises a malleable wire lumen in which is positioned a malleable wire, the malleable wire being used to maintain the shape of the flexible cannula in the body passageway.

9. A balloon catheter as defined in claim 1, wherein said balloon is substantially cylindrical when inflated.

10. A balloon catheter as defined in claim 9, wherein the distal end of said balloon is tapered.

11. A balloon catheter as defined in claim 10, wherein the tapered distal end of the balloon is free of knobs.

12. A method for transporting a solution between an external location and a body passageway comprising the steps of:

a. inserting a balloon catheter through a small incision or opening in the body into a body passageway, the catheter comprising;

(1) a cannula having at least one lumen, the cannula having a distal end being of a size capable of insertion into a body passageway, and a proximal end capable of connection to an outside location;

(2) a balloon attached to the cannula periphery near the distal end of the cannula, thereby forming a chamber within the balloon and outside of the cannula;

(3) expansion means in communication with the balloon for admitting fluid into and thereby inflating said balloon; and

(4) knob means for securely gripping the walls of the body passageway when the balloon is inflated so as to secure the cannula in place during use and forming a seal within the body passageway, the knob means comprising a plurality of knobs projecting outwardly from the outer surface of the balloon, and wherein the plurality of knobs are formed from a material and are of a size and shape that they will securely grip the walls of a body passageway and form a seal within the body passageway when the balloon is inflated;

b. introducing fluid through the expansion means so as to inflate the balloon, thereby allowing the knob means to securely engage the walls of the body passageway and form a seal therewith; and

c. allowing solution to flow through the secured catheter.

13. A method as defined in claim 12, wherein the expansion means comprises an inflation lumen in communication with the balloon, for use in inflating the balloon.

14. A method as defined in claim 12, wherein the expansion means comprises at least one aperture in an area of the cannula within the chamber.

15. A method as defined in claim 12, wherein the catheter further comprises a malleable wire extending within the cannula from the proximal end to substantially near but not past the distal end of the balloon, the malleable wire being constructed of a malleable material such that the malleable wire can be used to assist in maintaining the shape of the flexible cannula in the body passageway.

16. A method as defined in claim 12, wherein the balloon is substantially cylindrical when inflated.

17. A method as defined in claim 16, wherein the distal end of said balloon is tapered.

18. A method as defined in claim 17, wherein the tapered distal end of the balloon is free of knobs.

19. A balloon catheter for use in transporting a fluid between an external location and a body passageway comprising:

a. a flexible cannula having at least one lumen, the flexible cannula having a distal end being of a size capable of insertion into a body passageway, and a proximal end capable of connection to an outside location, said cannula being adapted to transport fluids between the outside location and the body passageway when inserted therein;

b. a balloon, having a distal end and a proximal end, attached to the cannula periphery near the distal end of said cannula, thereby forming a chamber within the balloon and outside of the cannula;

c. expansion means in communication with the balloon for admitting fluid into and thereby inflating said balloon; and

d. a malleable wire located within a portion of the cannula, the malleable wire being constructed of a malleable material such that the malleable wire can be used to assist in maintaining the shape of the flexible cannula in the body passageway, wherein the malleable wire extends within the cannula from the proximal end of the cannula to substantially near but not past the distal end of the balloon.

20. A method for transporting a solution between an external location and a body passageway comprising the steps of:

a. inserting a balloon catheter through a small incision or opening in the body into a body passageway, the catheter comprising;

(1) a cannula having at least one lumen, the cannula having a distal end being of a size capable of insertion into a body passageway, and a proximal end capable of connection to an outside location;

(2) a balloon attached to the cannula periphery near the distal end of the cannula, thereby forming a chamber within the balloon and outside of the cannula;

(3) expansion means in communication with the balloon for admitting fluid into and thereby inflating said balloon; and

(4) a malleable wire extending within the cannula from the proximal end to substantially near but not past the distal end of the balloon, the malleable wire being constructed of a malleable material such that the malleable wire can be used to assist in maintaining the shape of the flexible cannula in the body passageway;

b. introducing fluid through the expansion means so as to inflate the balloon; and

c. allowing solution to flow through the secured catheter.