The invention provides a co-axial dual lumen catheter having a main section, a tip section, and a U-shaped proximal portion extending from the main section, and ending at a junction where intake and outlet tubes are connected to the proximal portion. An inner tube extends from the junction to the tip of the catheter to define a return lumen, and combines with outer tubes in the main section and the proximal portion to define an intake lumen. The inner tube is thin walled relative to the wall thickness of a first outer tube used in the main section, and a second outer tube used in the proximal portion has a greater cross-sectional area than the first outer tube. A proximal end structure is also described in which the intake and outlet tubes extend generally parallel with the main body and to one side of the main body.
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0. 38. A dual lumen catheter comprising:
a main section having a proximal end and a distal end;
a generally U-shaped proximal portion attached to said proximal end of said main section;
an inner tube extending through said main section and said proximal portion said inner tube defining a return lumen therewithin, and said inner tube combining with said main section and said proximal portion to define an intake lumen between said inner tube and said main section and said proximal portion;
a tip section at said distal end of said main section attached to a first end of said inner tube, the outer surface of said tip section tapering radially inwardly in a distal direction to an end opening through which said return lumen communicates with the exterior of said catheter; and
wherein the outer cross section of said proximal portion differs from the outer cross section of the main section.
0. 37. A dual coaxial lumen hemodialysis catheter, the catheter comprising:
a main section for insertion into the body of a patient, said main section having a proximal end and a distal end, said main section comprising a first outer tube;
a tip section attached to said distal end of said main section, said tip section having a smaller outer cross section than the outer cross section of said first outer tube;
a generally U-shaped proximal portion extending from said proximal end of said main section, said proximal portion comprising a second outer tube; and
an inner tube extending from said tip section through said first outer tube and said second outer tube and enclosing a return lumen that communicates with the exterior of said catheter through said tip section, the space between said inner tube and said first outer tube and said second outer tube defining an intake lumen; and
wherein the outer cross section of said proximal portion is greater than the outer cross section of said first outer tube.
0. 21. A dual lumen catheter comprising:
a main section having a proximal end and a distal end and comprising a first outer tube;
a tip section at said distal end of said main section;
a generally U-shaped proximal portion having a distal end and a proximal end, said distal end of said proximal portion being attached to said proximal end of the main section, and said proximal portion comprising a second outer tube;
a junction attached to said proximal end of said proximal portion;
an inner tube extending inside said first outer tube and said second outer tube and enclosing a return lumen, a first end of said inner tube being anchored at said tip section and a second end of said inner tube being anchored at said junction, said inner tube combining with said first outer tube and said second outer tube to define an annular intake lumen between said inner tube and said first and second outer tubes, each of said return lumen and said intake lumen communicating at the respective distal ends thereof with the exterior of said catheter.
13. A co-axial dual lumen catheter for use in dialysis, the catheter comprising:
a main section for insertion and having a selected cross-section;
a tip section of smaller cross-section than the selected cross-section and attached to a distal end of the main section;
a U-shaped proximal section extending from a proximal end of the main section and having a cross-section greater than said selected cross-section;
the main section having a first outer tube of a selected wall thickness and having said selected cross-section and the proximal section having a second outer tube having a wall thickness greater than said selected wall thickness;
an inner tube extending from the tip section through the first and second outer tubes and having a wall thickness less than said selected wall thickness whereby an intake lumen is defined in the space between the inner tube and the first and second outer tubes, and a return lumen is defined by the inner tube and the tip section; and
a junction coupled to the inner tube and the second outer tube to facilitate connecting the catheter to dialysis equipment.
1. A co-axial dual lumen catheter comprising:
a main section having proximal and distal ends and including a first outer tube;
a tip section at said distal end;
an attachment at said proximal end for anchoring the catheter to a patient immediately adjacent an incision where the catheter entry is effected;
a U-shaped proximal portion having a distal end attached to the main section at said proximal end of the main section and having a proximal end, the proximal portion including a second outer tube;
a junction attached to the proximal end of the proximal portion;
an inner tube extending loosely inside the first and second outer tubes and anchored at the tip and the junction to define a return lumen and combining with the first and second outer tubes to define an annular intake lumen;
intake and outlet tubes attached to the junction, the tubes extending generally in parallel with the main section and to one side of the main section and being coupled to the respective intake and return lumens; and
the inner tube being thin walled relative to the wall thickness of the first outer tube, and the second outer tube having a greater cross-sectional area than the first outer tube.
10. A co-axial dual lumen catheter comprising:
a main section having proximal and distal ends and including a first outer tube, the first outer tube extending along a longitudinal axis and defining intake openings;
a U-shaped proximal section including a proximal and a distal end, said distal end of said U-shaped proximal section being attached to the proximal end of the main section, the proximal section including a second outer tubes ;
an inner tube extending through the first and second outer tubes; the inner tube defining a return lumen and combining with the first and second outer tubes to define an annular intake lumen;
intake and outlet tubes;
a junction coupling the intake and outlet tubes to the proximal section with the intake tube coupled for receiving blood from the intake lumen and the outlet tube coupled for delivering treated blood to the return lumen; and
the intake and outlet tubes leaving the junction generally parallel with the main section and to one side of the main section and with an angle of divergence between the intake and the outlet tubes of less than about 30 degrees and spaced substantially equally to either side of an extension of said the longitudinal axis of said U-shaped proximal section at said proximal end thereof.
0. 42. A cardiovascular access catheter comprising:
an outer conduit having a distal end and a proximal end, a portion of said outer conduit adjacent said proximal end thereof being configured into a generally U-shaped proximal portion;
a central conduit extending through said outer conduit from said proximal end to said distal end thereof and projecting distally beyond said distal end of said outer conduit,
the portion of said central conduit projecting distally beyond said distal end of said outer conduit defining a tip section projecting from said distal end of said outer conduit and having a smaller outer cross section than the outer cross section of said outer conduit at said distal end thereof,
said central conduit defining therewithin a return lumen, and
said central conduit and said outer conduit defining an intake lumen between the exterior of said central conduit and the interior of said outer conduit;
a distal transition portion at said distal end of said outer conduit terminating the distal extent of said intake lumen and smoothly and continuously interconnecting the outer surface of said outer conduit at said distal end thereof with the outer surface of said tip section; and
means for affording fluid access individually to the proximal end of said return lumen and to the proximal end of said intake lumen.
0. 41. A catheter comprising:
a main section having a proximal end and a distal end;
a generally U-shaped proximal portion attached to said proximal end of said main section;
a central conduit extending through said proximal portion and said main section and projecting distally beyond said distal end of said main section,
the portion of said central conduit projecting distally beyond said distal end of said main section defining a tip section projecting from said distal end of said main section and having a smaller outer cross section than the outer cross section of said main section at said distal end thereof,
said central conduit defining therewithin a return lumen, and
said central conduit in combination with said proximal portion and said main section defining an intake lumen between the exterior of said central conduit and the interiors of said proximal portion and said main section;
a distal transition portion at said distal end of said main section terminating the distal extent of said intake lumen and smoothly and continuously interconnecting the outer surface of said main section with the outer surface of said tip section;
attachment means on the distal end of said proximal portion for anchoring said catheter to the skin of a patient, when said main section and said tip section are implanted in the body of the patient;
a junction at the end of said proximal portion opposite from said main section; said junction being attached to the proximal end of said central conduit;
an inlet tube attached to said junction and coupled therethrough to said intake lumen; and
an outlet tube attached to said junction and coupled therethrough to said return lumen, said inlet tube and said outlet tube being positioned on a single side of said main section.
4. A catheter as claimed in
5. A catheter as claimed in
6. A catheter as claimed in
7. A catheter as claimed in
8. A catheter as claimed in
9. A catheter as claimed in
12. A catheter as claimed in
14. A catheter as claimed in
15. A co-axial catheter as claimed in
16. A catheter as claimed in
17. A catheter as claimed in
18. A catheter as claimed in
19. A catheter as claimed in
20. A dual lumen catheter as claimed in
0. 22. A dual lumen catheter as recited in
0. 23. A dual lumen catheter as recited in
0. 24. A dual lumen catheter as recited in
0. 25. A dual lumen catheter as recited in
an inlet tube attached to said junction and coupled therethrough with said intake lumen at said proximal end of said proximal portion; and
an outlet tube attached to said junction and coupled therethrough with said return lumen at said proximal end of said proximal portion.
0. 26. A dual lumen catheter as recited in
0. 27. A dual lumen catheter as recited in
0. 28. A dual lumen catheter as recited in
0. 29. A dual lumen catheter as recited in
0. 30. A dual lumen catheter as recited in
0. 31. A dual lumen catheter as recited in
0. 32. A dual lumen catheter as recited in
0. 33. A dual lumen catheter as recited in
0. 34. A dual lumen catheter as recited in
0. 35. A dual lumen catheter as recited in
0. 36. A dual lumen catheter as recited in
0. 39. A dual lumen catheter as recited in
0. 40. A dual lumen catheter as recited in
0. 43. A cardiovascular access catheter as recited in
a junction interconnecting said proximal end of said outer conduit with said proximal end of said central conduit;
an inlet tube attached to said junction and coupled therethrough to said intake lumen; and
an outlet tube attached to said junction and coupled therethrough to said return lumen, said inlet tube and said outlet tube being generally parallel with the portion of said outer conduit distal of said U-shaped proximal portion, being disposed on a common side thereof, and being spaced substantially symmetrically to either side of the longitudinal axis of said proximal section at said proximal end thereof.
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The First tube 26 and second tubes 28 meet at a junction 32 at the proximal end of a U-shaped proximal portion 34 which of catheter 20. Proximal portion 34 terminates at its the distal end thereof in a proximal transition portion 36 leading to of catheter that is 20 located at the proximal end of a main section 37 and hence to of catheter 20. Main section 37 terminates at the distal end thereof at a tip section 38 which meets the main body at of catheter 20 and a distal transition portion 39 of catheter 20 that is located between tip section 38 and main section 37. Blood is withdrawn through withdrawal side openings 40 and at the distal end of main section 37. Blood returns through further return side openings 42 and end opening 44 at the distal end of tip section 38.
As a result of this arrangement the first and second access tubes 26, 28 extend generally in parallel with the main section 37 of catheter 20 and lie to one together on the same side of the main section 37.
As seen in
The Inner tube 48 thus freely and loosely extends through outer tube 46 and outer tube 60. Withdrawal openings 40, shown in
The junction 32 at the proximal end of the U-shaped proximal portion 34 connects tubes 48, 60 to the first tube 26 and second tubes 26, 28 (as will be explained) and the catheter to respective of the lumens in catheter 20. First tube 26 communicates through junction 32 with intake lumen 50 in inner tube 48. Thus, first tube 26 will on occasion hereinafter in the alternative be referred to as intake tube 26. Second tube 28 communicates through junction 32 with the part of return lumen 52 formed between inner tube 48 and outer tube 60 in proximal portion 34 of catheter 20. Second tube 28 will on occasion hereinafter in the alternative be referred to as outlet tube 28.
Catheter 20 is completed by the provision of an attachment in the form of a wing structure 54 that can be used to hold the catheter 20 in place in a patient in conventional fashion. It is preferable that the wing structure 54 be rotatable on the catheter 20, and provision is made for this with the longitudinal location provided by positioning of wing structure 54 along catheter 20 between a tapered sleeve 56 and a the distal end of the proximal portion 34. These parts are elements of the transition portion 36 of catheter 20 as will be explained with reference to FIG. 3.
The Withdrawal side openings 40 and return side openings 42 are typical of openings that can be provided around the periphery of the catheter 20 to ensure flow into and out of the catheter 20 from anywhere about the catheter 20. Consequently, if the catheter 20 should be positioned so that some of the side openings are occluded by engagement with the wall of a vein, other of the side openings will provide the essential flow.
Reference is next made to
As a preliminary, the outer tube 46 is placed in a suitable conventional injection moulding machine and positioned suitably to mold the sleeve 56 about the tube. The materials are compatible thermoplastics so that the sleeve becomes an integral part of the tube 46. Next, the outer tube is used in an assembly shown in FIG. 4. In this step the inner tube 48 has a leading part indicated by numeral 68 within a corresponding part 70 of the tip section 38. These parts can of course be deformed to fit together in this way, but as shown, round tubing is selected for these parts so that they fit within one another quite readily but at the same time quite closely. If preferred, the parts can be attached to one another using a suitable adhesive. Typically the inner tube is #6 French and the tip section #8 French. After this step has been completed, the outer tube 46 is placed about the inner tube 48 and a leading part 72 of the outer tube overlaps part 70 of the tip section. Consequently the parts 68, 70 and 72 are located about one another. Again an adhesive can be used to fix the assembly.
A tubular cylindrical mandrel 74 is proportioned to fit inside the outer tube 46 and about the inner tube 48. Typically the outer tube is #12 French and the materials of all of the inner and outer tubes and the tip section are polyurethane with the selection of the materials being chosen to give the physical characteristics desired. For instance if a soft tip is required, then a material of a suitable Durometer is provided for the tip section 38 and of course sufficient rigidity must be provided in the outer tube 48 to ensure that the catheter is stable during insertion and when in place. It should be noted that the inner tube is protected to some extent against collapse by the outer tube so that the inner tube can be of a relatively soft thin walled polyurethane. As will be described, this assists in forming the U-shaped proximal portion 34 as well as maximizing the space available for flow in the catheter.
A solid second mandrel 76 is provided to support the inner tube so that this tube extends between the mandrels 74 and 76. Mandrel 74 has a rounded end and stops against the part 70 of the tip section 38 whereas the inner mandrel 66 projects into the tip section 38. This provides support along the space occupied by two halves of a mold 78 which are operable to move into contact with the assembly.
The mold 78 is used to form the transition portion 39 by moving the mold halves into contact with the assembly shown in
As seen in
The return lumen 52 formerly described with reference to the inner tube 48, now continues distally through the distal transition portion, 39 and through the tip section 38. The Distal transition portion 39 ends the intake lumen 50 and blends smoothly from the outer surface of the tip section 38 to the outer surface of the main section 37, and in particular to the outer surface of the outer tube 46.
It should be noted in
After the assembly has been molded as demonstrated in
Next the proximal transition portion 36 is completed. Referring to
The assembly is now complete from the proximal transition portion 36 to the distal end of the catheter. The outer tube 60 of the portion 34 contains part of the inner tube 48 which, as was described, ends at and is anchored in, the distal transition portion 39. The next step is to give the proximal portion 34 its U-shape. To do this, a flexible tubular mandrel indicated as 86 in
As seen in
After cooling in the die, the proximal portion 34 has a U-shaped configuration as seen in
The last step is to form the proximal end structure or junction 32 reference is now made of FIG. 7. After trimming the inner and outer tubes 48, 60 as required, the assembly is prepared by first positioning a proximal end of the proximal portion 34 in a mold (not shown) which is to create the junction 32 by injection molding using conventional techniques. The portion 34 is positioned using first and second mandrels 94, 96. The mandrel 96 has a cylindrical portion 98 blending into a converging generally conical portion 100, which in turn blends into a cylindrical end part 102 angled with respect to the portion 100. The part 102 fits closely inside a proximal end of the inner tube 48 and this tube is maintained in a position in engagement with the outer tube 60 by the mandrels 94, 96.
The mandrel 94 has an outer cylindrical portion 104 which blends into a converging and generally conical portion 106 ending at a projection 108. This projection has a generally U-shaped cross-section (as will be explained) and is angled with respect to the conical portion 106.
The projection 108 on the end of the mandrel 94 is shaped to fit the space provided between outer tube 60 and inner tube 48, when the inner tube 48 is held by mandrel 96 against the inner surface of the outer tube 60. As a result it projection 108 has a generally U-shaped configuration. The angular offsets of the projection 108 of mandrel 94 and the the angular offset of end part 102 of lumen mandrel 96 result in the projection 108 and end part 102 extending in parallel axially with respect to axis L of the end of proximal portion 34 at junction 32. The cylindrical Cylindrical portions 98 of mandrel 96 and cylindrical portion 104 of mandrel 94 can thus be assembled as shown in
Once the assembly shown in
The mandrels are removed, and because there is some flexibility in the material, the mandrels can be pulled out without causing any damage.
The structure shown in
The angle shown as “A” in
The catheter is now complete but for the final shaping of the proximal portion 34. Up to this point this portion has remained straight and consists of the outer tube 60 and part of the inner tube 48 which starts at the junction 32 (
Reference is now made to
The catheter shown as a preferred embodiment is typical of catheters that could be made in accordance with the invention. As mentioned earlier it is possible to proportion the tip and/or provide soft material for the tip to ensure that after insertion the tip will flex and will not damage veins. At the same time, there is sufficient rigidity in the transition portion to maintain the relationship between the tip and the inner and outer tubes so that the intake lumen 50 remains patent while the insertion takes place and during use.
It will be apparent that the structure can be varied within the scope of the invention. In particular, the tip section need not be tapered and in some cases (depending upon requirements) the distal end of the catheter could be closed. Also, the proximal transition portion could be arranged with a cuff instead of the wing structure 20. Either of these attachments can be used advantageously.
The proportions of the parts can be varied and it would be possible to do some preforming before assembly.
In a typical embodiment of catheter 20 the various tubes used in the structure are polyurethane. The outer Outer tube 46 is a firm polyurethane having a 65D Durometer. It is , a 3.175 mm inside diameter, and a 3.734 mm outside diameter. The tip Tip section 38 is also 65D Durometer, but with an inside diameter of 1.727 mm and an outside diameter of 2.667 mm. The inner Inner tube 48 is of a soft, thin-walled polyurethane dimensioned to fit into extend through the assembly shown in FIG. 3, and the with sufficient clearance between the exterior of inner tube 48 and the interior of that assembly to result in the creation of intake lumen 50 therebetween. Inner tube 48 has a wall thickness that is less than the wall thickness of outer tube 46. Outer tube 60 is proportioned to fit over the about outer tube 46 in the manner illustrated in
It is important to note that this catheter 20 overcomes disadvantages in the art.
Firstly, the structure of catheter 20 is such that the inner tube 48 can be thin walled because it is protected by the stiffer outer tube 46 in the main section 37 and by the outer tube 60 in the curved proximal portion 34. The Thus, thin-walled, soft inner tube 48 takes up minimal cross-sectional space, thereby permitting the portion of the co-axial catheter 20 which is to be inserted into the body of a patent to have a smaller cross-section.
Another feature of catheter 20 is the fact that there is a minimum of upwardly extending structure beyond the attachment proximal transition portion 36, when the catheter 20 is placed in a jugular vein. This is very important to the comfort of the patient. Also, because attachment takes place where the catheter 20 exits the incision, manipulation of the intake tube 26 and outlet tubes 28 to make connections etc. will have less likelihood of dislodging or moving the catheter 20.
The invention incorporates all variations within the scope of the claims and is not restricted to the embodiments disclosed.
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