Catheter

• US 4,619,643 A
• Filed: 06/18/1984
• Issued: 10/28/1986
• Est. Priority Date: 07/25/1983
• Status: Expired due to Fees

• Current Assignee: Chao-Liang Bai
• Original Assignee: Chao-Liang Bai
• Inventors: Bai, Chao-Liang
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US06/621,482
• Time in Patent Office: 862 Days
• Field of Search: 604/27, 604/39, 604/43, 604/144, 604/45, 604/93, 604/164, 604/280, 604/4
• US Class Current: 604/43
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 5/1582 Double lumen needles

Abstract

A double lumen catheter made up of an elongated integral flexible plastic thin-walled tubular body extending from a proximal end part, through an intermediate part, to a distal end part, terminating in a tip. The intermediate part has an outer wall and an internal septum wall containing juxtaposed arterial and venous lumens. The terminal end of each lumen in the proximal part is adapted for connection to an access tube to hemodialysis apparatus. At the junction of the intermediate part and the distal part, the arterial lumen is terminated and the venous lumen continued at least part way to the tip of the distal part. The outside surface of the outer walls are continuous and smooth to offer minimum resistance to insertion into the body of a patient. The walls are also relatively thin to provide for lumens of relatively large cross-section compared to the total cross-section of the catheter body. Removable obturators are inserted in the lumens to prevent the catheter from buckling. The inner surface of the outer walls and the surfaces of the septum wall are continuous and smooth and any change of direction in the lumen wall is in a gradual curve to accommodate negotiation by a flexible obturator. Alternatively, the catheter may be made from tubing sufficiently resistant in itself to buckling for the catheter to be inserted without the use of obturators. One such form of tubing is made of alternating hard and soft plastic rings welded together. Another form employs wire reinforcing within the walls. Welding and molding methods for making the catheters are disclosed.

Claims

1. A double lumen catheter for gaining vascular access to the circulatory system of a living being, comprising,

an elongated integral plastic thin walled tubular body requiring support against buckling and kinking and having a proximal end part, a distal end part and an intermediate part,

the intermediate part having an outer wall and a septum wall providing juxtaposed arterial and venous lumens,

the proximal end part being a continuation of the intermediate part and diverging into, integrally connected branches each containing the continuation of a lumen for connection to access tubing leading to a hemodialysis apparatus,

the distal end part comprising a continuation of the outer wall tapering to a slender tip merging gradually and smoothly from said body and having an internal guidewire passage leading from the venous lumen and closure means terminating the arterial lumen, short of the tip, including a part of the outer wall tapering inwards to merge with the septum wall,

the outside surface of the outer wall being smooth and continuous to offer minimum frictional resistance to insertion into the body of a patient,

the inside walls of both lumens being smooth and continuous and the transition of the lumens between the said respective parts being smooth and uninterrupted to facilitate the insertion and removal of obturators into and from the respective lumens to extend from their proximal ends to their distal ends, and

the outer wall being provided with at least one blood access orifice in the distal end part of the arterial lumen and at least one blood access orifice in the distal end part of the venous lumen.

2. A double lumen catheter for gaining vascular access to the circulatory system of a patient, as defined in claim 1, having an elongated integral plastic tubular body which has an outer wall and a septum wall providing two juxtaposed lumens in which the cross-section of the outer wall is non-circular and the cross-section has a long axis and a short axis, the septum wall being parallel to the short axis.

3. A catheter, as defined in claim 2, in which said intermediate part is symmetrical and each lumen is of the same cross-sectional shape, and the septum wall is on the short axis of the cross-section.

4. A catheter, as defined in claim 2, in which the intermediate part of the tubing body is non-symmetrical and each lumen has the same area but a different cross-sectional shape.

5. A catheter, as defined in claim 1, in which a branched adapter is connected to and contains the proximal end of the body and part of the branches.

6. A catheter, as defined in claim 1, in which the end of each branch is provided with a connector in the form of a hard plastic tube, a triangular tubular adapter surrounds the proximal end of the body and part of the connector of each branch, and a spacing block is located between respective connectors thereby to establish a fixed spacing between them, said block being fastened to said triangular adapter.

7. A double lumen catheter, as defined in claim 1, in which the thickness of the wall is within the range from 0.009 inches to 0.011 inches.

8. A double lumen catheter, as defined in claim 1, in which the catheter tube is circular and has a cross-sectional diameter within the range from 9 to 11 French.

9. A double lumen catheter, as defined in claim 1, in which the cross-section of the tube is ovoid and the diameter across the narrow axis of the cross-section is from 8 to 10 French and across the long axis is from 10 to 12 French.

10. A double lumen catheter, as defined in claim 1, in which the catheter tube is circular and has a cross-sectional diameter within the range from 9 to 11 French and the catheter wall has a thickness within the range from 0.009 inches to 0.011 inches.

11. A double lumen catheter, as defined in claim 1, in which the cross-section of the tube is ovoid and the width across the narrow axis of the cross-section is from 8 to 10 French and across the long axis is from 10 to 12 French and the outer wall has a thickness within the range from 0.009 to 0.011 inches.

12. A double lumen catheter, as defined in claim 1, in which the tip is integral with the body.

13. A double lumen catheter for gaining vascular access to the circulatory system of a living being, comprising,

an elongated integral plastic thin walled tubular body requiring support against buckling and kinking and having a proximal end part, a distal end part and an intermediate part,

the intermediate part having an outer wall and a septum wall providing juxtaposed arterial and venous lumens,

the proximal end part being a continuation of the intermediate part and the end of each lumen therein being adapted for connection to access tubing leading to a hemodialysis apparatus,

the distal end part comprising a continuation of the outer wall tapering to a slender tip merging gradually and smoothly from said body and having an internal guidewire passage leading from the venous lumen and closure means terminating the arterial lumen, short of the tip, including a part of the outer wall tapering inwards to merge with the septum wall,

the outside surface of the outer wall being smooth and continuous to offer minimum frictional resistance to insertion into the body of a patient,

the inside walls of both lumens being smooth and continuous and the transition of the lumens between the said respective parts being smooth and uninterrupted to facilitate the insertion and removal of obturators into and from the respective lumens to extend from their proximal ends to their distal ends,

the outer wall being provided with at least one blood access orifice in the distal end part of the arterial lumen and at least one blood access orifice in the distal end part of the venous lumen, and

an obturator extending within each lumen throughout its length to prevent the tubular body from kinking when the catheter is inserted in the body of a living being and removable after insertion whereby the catheter remains in the body unkinked, the obturator in the venous lumen having a central passage for a guidewire extending lengthwise through it.

14. A catheter, as defined in claim 13, in which a single integral venous lumen extends from the body at the distal end to a tip, and the arterial lumen terminates at a predetermined point spaced from the tip, and a hollow obturator protrudes from the end of the venous lumen, and the surface of the tip of the distal end of the venous lumen merges smoothly to the surface of the obturator.

15. A catheter, as defined in claim 13, in which there is an obturator in each lumen made of flexible plastic and of substantially the same cross-sectional shape and size to fit in the lumen in the intermediate part, the obturator in the arterial lumen being solid and the obturator in the venous lumen having a passage extending longitudinally therethrough to receive a metallic guidewire extending through it.

16. A catheter, as defined in claim 13, in which there are obturators having different cross-sections from their respective lumens, whereby after the obturators are assembled in both lumens there is a slight spacing in the vicinity of the junction of the septum wall and the wall of the tubing between the obturator and the tubing wall.

17. A catheter, as defined in claim 13, in which the obturators are plastic rods provided with longitudinal slits to make them more flexible.

18. A catheter, as defined in claim 13, in which the end of each obturator is connected to a male luer lock and the male luer lock is, in turn, connected to a female luer lock connected to an elastic tubing fitting the end of an adapter connected to the end of each lumen, the male luer lock being screwed tightly on the female luer lock so that the obturators bear against the ends of the respective lumens and put the body of the catheter under prestressed tension.