Catheter with novel lumens shapes

• US 5,160,325 A
• Filed: 01/22/1991
• Issued: 11/03/1992
• Est. Priority Date: 10/06/1986
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Nordgren, Gregory N., Nichols, Colin J., Moorehead, Harvey R.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/644,970
• Time in Patent Office: 651 Days
• Field of Search: 128/658, 604/9, 604/43-45, 604/164, 604/168, 604/170, 604/247, 604/280-284, 137/493, 137/847-849
• US Class Current: 604/247
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• 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 25/0075 Valve means
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod

Abstract

Catheter tubes of elastomeric material having novel lumen shapes which prevent occlusion and accommodate continued liquid flow even when kinked. Also, catheter tube slit valves are disclosed, the walls of which are not chemically weakened. Symmetrical and asymmetrical versions of said slit valves are disclosed. Combinations of highly reliable slit valves and catheter tubes are disclosed. Independently operable multi-lumen catheter assemblies of synthetic material, such as silicone rubber are disclosed, wherein the distal end of each lumen is normally closed by a three-position slit valve formed in a catheter tube covering. Multi-lumen catheters, and related methods, are also disclosed wherein the lumens are internal at the proximal and distal ends of the catheter tube but comprise separate tubes in between whereby, following placement of the distal end of the catheter tube in the body cavity of a patient, the unified proximal end of the tube is manipulated, sometimes subcutaneously, with the ultimately exposed tubes being thereafter severed and each equipped with a hub at a convenient exposed body site for selective independent passage of influent and effluent liquid along each lumen.

Claims

1. An indwelling catheter tube comprising:

(a) an elongated body of elastomeric material having an outside surface;

(b) a lumen longitudinally formed through said body of elastomeric material and comprising a plurality of longitudinally extending inner wall surfaces, one of said inner wall surfaces in a cross section of said body of elastomeric material taken normal to the longitudinal axis thereof comprising a straight segment, the end points of said straight segment being disposed closer to said outside surface of said body of elastomeric material than the portions of said straight segment therebetween, thereby to define, between said straight segment and said outside surface of said body of elastomeric material radially outwardly from said straight segment, a solid outer wall portion of said catheter tube integrally formed of said elastomeric material.

2. A catheter tube as recited in claim 1, further comprising a longitudinally extending juncture between said straight segment and the one of said inner wall surfaces adjacent thereto, said juncture in a cross section of said body of elastomeric material taken normal to the longitudinal axis thereof being disposed closer to said outside surface of said body of elastomeric material than portions of said straight segment and said one of said inner wall surfaces proximate to said juncture.

3. A catheter tube as recited in claim 2, wherein in said cross section of said body of elastomeric material said juncture comprises an arcuate fillet tangentially connecting said adjacent pair of said inner wall surfaces.

4. A catheter tube as recited in claim 2, wherein in said cross section of said body of elastomeric material said juncture comprises an arcuate fillet nontangentially interconnecting an end point of each of said adjacent pair of said inner wall surfaces.

5. A catheter tube as recited in claim 2, wherein in said lateral cross section of said body of elastomeric material said juncture comprises a linear inner wall segment disposed at an oblique angle to each of said adjacent pair of said inner wall surfaces.

6. A catheter tube as recited in claim 2, wherein in said cross section of said body of elastomeric material the portions of each of said adjacent pair of said inner wall surfaces proximate to said juncture are substantially linear.

7. A catheter tube as recited in claim 1, wherein in a cross section of said body of elastomeric material taken normal to the longitudinal axis thereof one of said inner wall surfaces of said adjacent pair of said inner wall surfaces comprises an arc, the end points of said arc being disposed closer to said outside surface of said body of elastomeric material than the portions of said arc therebetween, thereby to define between said arc and said outside surface of said body of elastomeric material a solid outer wall portion of said catheter tube.

8. A catheter tube as recited in claim 7, wherein the radius of curvature of said arc is greater than the radius of curvature of the portion of said outside surface of said body of elastomeric material opposite thereto.

9. An indwelling catheter tube comprising:

(a) an elongated body of elastomeric material having an outside surface;

(b) a lumen longitudinally formed through said body of elastomeric material and comprising a plurality of longitudinally extending inner wall surfaces; and

(c) prevention means associated with a first of said inner wall surfaces and said outside surface of said elongated body of elastomeric material for preventing occlusion of said lumen and for accommodating fluid flow in said lumen when negative pressure is applied to said lumen relative to said outside surface of said body of elastomeric material, said prevention means comprising a solid outer wall portion of said catheter tube integrally formed of said elastomeric material between said first of said inner wall surfaces and said outside surface of said elongated body of elastomeric material radially outwardly from said first inner wall surface, the distance in a cross section of said body of elastomeric material taken normal the longitudinal axis thereof measured normal to said outside surface between said first of said inner wall surfaces and said outside surface radially outwardly from said first inner wall surface defining the thickness of said solid outer wall portion, said thickness thereof varying from a maximum at the center thereof to a minimum at the ends thereof.

10. An indwelling catheter tube as recited in claim 9, wherein in said cross section of said body of elastomeric material said first of said inner wall surfaces comprises an arc.

11. An indwelling catheter tube as recited in claim 9, wherein in said cross-section of said body of elastomeric material said first of said inner wall surfaces comprises an straight segment.

12. An indwelling catheter tube, comprising:

(a) an elongated body of elastomeric material having an outside surface; and

(b) a lumen longitudinally formed through said body of elastomeric material said lumen assuming a D-shape in a cross section of said body of elastomeric material taken normal to the longitudinal axis thereof, said D-shape assumed by said lumen in said cross section of said body of elastomeric material comprising;

(i) an arcuate inner wall surface; and

(ii) a generally linear inner wall surface opposite said arcuate inner wall surface, the ends of said linear inner wall surface in said cross section of said body of elastomeric material being disposed closer to said outside surface of said body of elastomeric material than any other portions of said generally linear inner wall surface, thereby to define, between said linear inner wall surface of said lumen and said outside surface of said body of elastomeric material radially outwardly from said first inner wall surface, a solid outer wall portion of said catheter tube integrally formed of said elastomeric material.

13. A catheter tube as recited in claim 12, wherein in said cross section of said body of elastomeric material said juncture comprises an arcuate fillet tangentially connected to said adjacent pair of said inner wall surfaces.

14. A catheter tube as recited in claim 12, wherein in said cross section of said body of elastomeric material said juncture comprises an arcuate fillet nontangentially interconnecting an end point of each of said adjacent pair of said inner wall surfaces.

15. A catheter tube as recited in claim 12, wherein in said cross section of said body of elastomeric material said juncture comprises a linear inner wall surface disposed at an oblique angle to each of said adjacent pair of said inner wall surfaces.

16. A catheter tube as recited in claim 12, wherein in a cross section of said body of elastomeric material taken normal to the longitudinal axis thereof said lumen generally assumes a quadrilateral shape.

17. A catheter tube as recited in claim 12, wherein in a cross section of said body of elastomeric material taken normal to the longitudinal axis thereof one of said inner wall surfaces of said lumen is disposed opposite the outside surface of said body of elastomeric material, thereby to define between said one of said inner wall surface of said lumen and said outside surface of said body of elastomeric material a solid outer wall portion of said catheter tube, the distance in said cross section of said body of elastomeric material between said one of said inner wall surfaces and said outside surface measured normal to said outside surface defining the thickness of said solid outer wall portion, said thickness thereof varying from a maximum at the center thereof to a minimum at the ends thereof.

18. A catheter tube as recited in claim 12, wherein in a lateral cross section of said body of elastomeric material taken normal to the longitudinal axis thereof said lumen generally assumes a polygonal shape.

19. A catheter tube as recited in claim 18, wherein in said cross section of said body of elastomeric material two adjacent sides of said polygonal shape are tangentially joined by an arcuate corner segment.

20. A catheter tube as recited in claim 12, wherein in said cross section of body of elastomeric material said lumen comprises a longitudinally extending juncture between said adjacent pair of said inner wall surfaces, said juncture in said lateral cross section of said body of elastomeric material taken normal to the longitudinal axis thereof being disposed closer to said outside surface of said body of elastomeric material than portions of said pair of said adjacent pair of said inner wall surfaces proximate to said juncture.

21. An indwelling catheter tube, comprising:

(a) an elongated body of elastomeric material having a cylindrical outside surface; and

(b) a lumen longitudinally formed through said body of elastomeric material, said lumen assuming a radially asymmetric shape in a cross section of said body of elastomeric material taken normal to the longitudinal axis thereof, said lumen comprising;

(i) a plurality of longitudinally extending inner wall surfaces; and

(ii) a longitudinally extending juncture between each end of a first of said inner wall surfaces and the one of said inner wall surfaces adjacent thereto, each of said junctures in said cross section of said body of elastomeric material being disposed closer to said outside surface of said body of elastomeric material than portions of said first inner wall surface between said junctures, thereby to define, between said first inner wall surface of said lumen and said outside surface of said body of elastomeric material radially outwardly from said first inner wall surface, a solid outer wall portion of said catheter tube integrally formed of said elastomeric material, the distance in said cross section of said body of elastomeric material measured normal to said outside surface between said first inner wall surface and said outside surface radially outwardly from said first inner wall surface defining the thickness of said solid outer wall portion, said thickness thereof varying from a maximum at the center thereof to a minimum at the ends thereof.

22. A catheter tube as recited in claim 21, wherein in said cross section of said body of elastomeric material each of said junctures comprises an arcuate fillet tangentially connected between said first of said inner wall surfaces and said one of said inner wall surfaces adjacent thereto.

23. A catheter tube as recited in claim 21, wherein in said cross section of said body of elastomeric material each of said junctures comprises an arcuate fillet nontangentially interconnecting an end point of said first of said inner wall surfaces and an end point of said one of said inner wall surfaces adjacent thereto.

24. A catheter tube as recited in claim 21, wherein in said lateral cross section of said body of elastomeric material each of said junctures comprises a linear inner wall segment disposed at an oblique angle to said first of said inner wall surfaces and said one of said inner wall surfaces adjacent thereto.

25. An indwelling catheter tube, comprising:

(a) an elongated body of elastomeric material having an outside surface; and

(b) a plurality of lumens longitudinally formed through said body of elastomeric material, first and second lumens of said plurality of lumens assuming a radially asymmetric shape in a cross section of said body of elastomeric material taken normal the longitudinal axis thereof, said first and second lumens each comprising;

(i) a plurality of longitudinally extending inner wall surfaces; and

(ii) a longitudinally extending juncture between an adjacent pair of said inner wall surfaces, said juncture in said cross section of said body of elastomeric material being disposed closer to said outside surface of said body of elastomeric material than portions of said adjacent pair of said inner wall surfaces proximate to said juncture.

26. A catheter tube as recited in claim 25, wherein in said cross section of said body of elastomeric material each of said first and second lumens assumes a D-shape, and wherein said first and second lumens are so disposed within said body of elastomeric material that in said cross section of said body of elastomeric material the curved portions of said D-shapes are oriented toward the center of said cross section.

27. A catheter tube as recited in claim 25, wherein in said cross section of said body of elastomeric material, one of said lumens assumes a polygonal shape and a vertex of said polygonal shape is disposed closer to the other of said lumens than any other portions of said polygonal shape.

28. An indwelling catheter tube, comprising:

(a) an elongated body of elastomeric material having an outside surface; and

(b) a lumen longitudinally formed through said body of elastomeric material said lumen assuming a D-shape in a cross section of said body of elastomeric material taken normal to the longitudinal axis thereof, said D-shape comprising;

(i) an arcuate inner wall surface;

(ii) a straight inner wall surface opposite said accurate inner wall surface; and

(iii) a longitudinally extending juncture between one end of said straight inner wall surface and an adjacent inner wall surface, said juncture in said cross section of said body of elastomeric material being disposed closer to said outside surface of said body of elastomeric material than portions of said straight inner wall surface and said adjacent inner wall surface proximate to said juncture.

29. An indwelling catheter tube as recited in claim 28, wherein said adjacent inner wall surface comprises one end of said arcuate inner wall surface.

30. An indwelling catheter tube as recited in claim 28, wherein said adjacent inner wall surface comprises a linear inner wall surface tangentially connected to one end of said arcuate inner wall surface.

31. An indwelling catheter tube, comprising:

(a) an elongated body of elastomeric material having an outside surface; and

(b) first and second lumens longitudinally formed through said body of elastomeric material, each of said first and second lumens in a cross section of said body of elastomeric material taken normal the longitudinal axis thereof assuming a D-shape, said first and second lumens being so disposed within said body of elastomeric material that in said cross section of said body of elastomeric material the curved portions of said D-shapes are oriented toward the center of said cross section, thereby to strengthen the structure of said body of elastomeric material to prevent occlusion of said first and second lumens due to negative pressure applied thereto.

32. An indwelling catheter tube, comprising:

(a) an elongated body of elastomeric material having a cylindrical outside surface;

(b) first and second lumens longitudinally formed through said body of elastomeric material, each of said first and second lumens assuming a noncircular shape in a cross section of said body of elastomeric material taken normal to the longitudinal axis thereof, and each of said first and second lumens comprising;

(i) first and second adjacent longitudinally extending inner wall surfaces; and

(ii) a longitudinally extending juncture between said first and second inner wall surfaces, said juncture in said cross section of said body of elastomeric material being disposed closer to said outside surface thereof than portions of said first and second inner wall surfaces proximate to said juncture in said cross-section of said elastomeric body, said first inner wall surfaces of said first and second lumens being disposed adjacent to each other between said second inner wall surfaces; and

(c) safety means associated with said first inner wall surfaces of said first and second lumens for preventing occlusion of said first and second lumens to accommodate fluid flow therein when said body of elastomeric material tends to be kinked or laterally compressed by externally imposed stresses.

33. A catheter tube as recited in claim 32, wherein said safety means comprises a solid internal portion of said body of elastomeric material bounded in said cross section thereof by said cylindrical outside surface and said first inner wall surfaces of said first and second lumens, the distance in said cross section of said body of elastomeric material measured concentric with said cylindrical outer surface between said first inner wall surfaces of said first and second lumens defining the thickness of said solid internal portion of said body of elastomeric material, said thickness thereof varying from a maximum at said junctures to a minimum radially centrally thereof in said cross section of said body of elastomeric material.