Tubular medical device and method of making and using the same

• US 4,863,424 A
• Filed: 11/18/1983
• Issued: 09/05/1989
• Est. Priority Date: 11/18/1983
• Status: Expired due to Fees

• Current Assignee: Jack W. Kaufman, Joseph W. Blake III
• Original Assignee: Jack W. Kaufman, Joseph W. Blake III
• Inventors: Kaufman, Jack W., Blake, Joseph W. III
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US06/553,200
• Time in Patent Office: 2,118 Days
• Field of Search: 604/236, 604/246, 604/169, 604/213, 604/247, 604/256, 604/103, 604/270, 604/271, 604/266, 604/267, 604/282, 604/96, 604/49, 604/54
• US Class Current: 604/524
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/1027 Making of balloon catheters

Abstract

This invention relates generally to a tubular medical device, and more particularly to a tubular medical device for fluid feeding to or fluid drainage from a body cavity. The invention describes both a device and a method of making a device that comprises an elongated flexible primary tube forming a lumen having an open end, a secondary tube concentrically surrounding and spaced from the primary tube and extending between the open end and a position spaced from the open end. The primary and secondary tubes have an integral joining portion at the open end. The primary and secondary tubes form a chamber that is sealably closed and filled with a heavy metal so that a weighted tip element, or bolus is formed. Alternatively, the chamber may be pressurized and expanded to form a balloon element by way of a side tube affixed to the primary tube and connected at one end to a source of pressurized air and at the other end to a position within the chamber.

Claims

1. A tubular medical device for fluid feeding into or fluid drainage from a body cavity of a patient, comprising, in combination an elongated flexible primary tube having an open end,

a secondary tube concentrically surrounding and spaced from said primary tube and extending between said open end and a position spaced from said open end, said secondary tube having a joining portion integral with said primary tube at said open end and sealably connected to said primary tube around said position,

said secondary tube and said primary tube forming a sealed chamber, and

a heavy substance means in said chamber for positioning said chamber and said open end in the body cavity of the patient.

2. A tubular medical device according to claim 1, wherein said secondary tube has an outer surface having a hydrophilic coating.

3. A tubular medical device according to claim 2, wherein said heavy substance means is a heavy metal.

4. A tubular device according to claim 3, wherein said heavy metal is mercury.

5. A tubular device according to claim 3, wherein said heavy metal is tungsten.

6. A tubular medical device according to claim 3, wherein said primary and secondary tubing are made of a radio opaque material.

7. A tubular medical device according to claim 6, wherein said radio opaque material is a urethane composition.

8. A tubular medical device according to claim 1, including one-way valve means for precluding back flow of gastric juices.

9. A tubular medical device according to claim 8, wherein said one-way valve means is a ring with a check valve disposed in said primary tube.

10. A tubular medical device according to claim 9, wherein said check valve and ring are integrally made of plastic and is secured to the bottom end of said primary tube.

11. A tubular medical device according to claim 1, including at least one side hole in said primary tube.

12. A tubular medical device according to claim 11, wherein said at least one side hole is provided in connector means between said primary tube and said sealed chamber.

15. A method of making a tubular medical device according to claim 11, wherein said substance is mercury.

16. A method of making a tubular medical device according to claim 15, wherein said substance is tungsten.

17. A method of making a tubular medical device according to claim 11, wherein said primary tube and said secondary tube are radio opaque.

18. A method of making a tubular medical device according to claim 17, wherein said radio opaque material is a urethane composition.

13. A method of making a tubular medical device for fluid feeding into or fluid drainage from a body cavity of a patient, which comprises:

(a) treating the inner surface of the front end portion of an elongated, flexible primary tube with a hydrophilic coating, said front end portion being heat expandable;

(b) expanding said treated front portion by heating and pressing said front end portion into a secondary tube having a diameter greater than the diameter of the primary tube;

(c) everting said secondary tube concentrically around and spaced from said primary tube, wherein said hydrophilic coating is carried over to the outer surface of said secondary tube, said primary tube and said secondary tube forming a chamber having an opening at the rear end of said secondary tube;

(d) placing a heavy substance into said chamber for positioning the front end of the device in the body cavity of the patient; and

(e) sealing the chamber at the opening by sealably joining the rear end of the secondary tube with the outer surface of the primary tube, wherein a tip element is formed.

14. A method of making a tubular medical device according to claim 13, wherein said heavy substance placed in said chamber is a heavy metal.

19. A method of making and positioning a tubular medical device for fluid feeding into or fluid drainage from a body cavity of a patient, which comprises:

(a) treating the inner surface of at least the front end portion of an elongated, flexible primary tube with a hydrophilic coating, the front end portion being heat expandable;

(b) affixing an elongated flexible side tube having opposed inlet and outlet ends to the outer surfaces of the primary tube wherein the outlet end is spaced form the front end portion,

(c) expanding the treated front end portion by heating and forming the front end portion into a secondary tube having a diameter greater than the diameter of the primary tube;

(d) everting the secondary tube concentrically around and spaced from the primary tube, wherein the hydrophilic coating is carried over to the outer surface of the secondary tube, the primary tube and the secondary tube forming a chamber having an opening at the rear end of the secondary tube;

(e) inserting a support ring into the front end of the primary tube and affixing said support ring with the inner surface of the primary tube, the support ring having an inner diameter approximately equal to the inner diameter of the primary tube,

(f) sealing the chamber at the opening by sealably joining the rear end of said secondary tube with the outer surface of the primary tube, wherein a tip element is formed, ambient air being sealed in the chamber;

(g) sealably joining the secondary tube with the side tube;

(h) inserting the sealed chamber of the device via a body canal into a body cavity of a patient;

(i) connecting the inlet end of the side tube to a source of pressurized air;

(j) expanding the chamber to form a balloon tip of the device that positions the device in the body cavity and prevents the device from sliding from the body cavity into the body canal.

20. The method of claim 19, wherein the primary and secondary tubes are radio opaque.

21. The method of claim 20, further including the step of forming at least one side hole in the primary tube near the outlet end.

22. The method of claim 19, further including the step of positioning a one-way check valve with the support ring after step (e).

23. A tubular medical device for fluid feeding into or fluid drainage from a body cavity of a patient, comprising, in combination,

an elongated flexible primary tube having an open end,

a secondary tube concentrically surrounding and spaced from said primary tube and extending between said open end and a position spaced from said open end, said secondary tube having a joining portion integral with said primary tube at said open end and sealably connected to said primary tube around said position,

said secondary tube and said primary tube forming a sealed chamber,

said secondary tube being made of a flexible material,

a side tube affixed to the outer surface of said primary tube, said side tube having inlet and outlet ends affixed to said primary tube, said outlet end being positioned in said chamber,

a source of pressurized air connected to said inlet end, said secondary tube being expanded under pressure from said pressurized air wherein said chamber forms a balloon, and

one-way valve means positioned at said open end of said primary tube for precluding back flow of liquid, said one-way valve means being a stiffening ring and a check valve positioned at said open end,

said primary tube forming at least one side hole.

24. The device according to claim 23, wherein said secondary tube has an outer surface having a hydrophilic coating.

25. The device according to claim 24, wherein said primary tube forms at least one hole near said secondary tube.