CATHETER FOR VASCULAR ACCESS AND METHOD FOR MANUFACTURING THE SAME

• US 20090069792A1
• Filed: 11/05/2004
• Published: 03/12/2009
• Est. Priority Date: 11/05/2004
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Frey, Helmut, Dieringer, Ingolf, Ruhl, Uwe
• Granted Patent: US 8,398,612 B2
• Time in Patent Office: Days
• US Class Current: 604/535
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014

Abstract

Catheter (1) for vascular access comprising a cannula (2) having at least one first lumen (21), at least one first connection tube (3), and a connection molded simultaneously on an end of the cannula (2) and on at least one part of the first connection tube (3) and manufacturing process comprising the following stages: taking a cannula (2) having at least one first lumen (21), taking one first connection tube (3), placing in a mould one end of the cannula (2) and one end of the first connection tube (3), injecting into the mould a molding material to obtain the connection (4) between the end of the first connection tube (3) and the end of the cannula placing the first lumen (21) and at least the first tube (3) in fluid communication and device for implementing the manufacturing process.

Claims

1. Catheter (1) for vascular access comprising:

a cannula (2) having at least one first lumen (21),

at least one first connection tube (3),

connection means (4) for placing at least the first lumen (21) of the cannula in fluid communication with at least the first connection tube (3),

wherein the connection means (4) is molded on an end of the cannula (2) and on at least one part of the first connection tube (3).

2. Catheter according to claim 1, wherein the connection means (4) comprises:

a first connection portion molded on an end of the cannula (2) and defining a hub (41) forming at least one first passage (411) communicating with the first lumen (21) of the cannula and with a tube end (511) of the first connection tube (3);

a second connection portion (42), molded on at least one part of the hub (41) and on at least one part of the first connection tube (3), connecting first tube end (511) and hub (41).

3. Catheter according to claim 2, wherein the first and the second connection portions (41, 42) have mechanical connection means cooperating with one another.

4. Catheter according to the preceding claim, wherein the mechanical connection means comprises:

at least one cavity (412) on the first connection portion (41),

at least one protuberance (421) the shape of which complements that of said cavity (412), said protuberance being integral to the second connection portion (42).

5. Catheter according to the preceding claim, wherein the cavity (412) has the shape of an incision on at least one part surrounding the first passage (411) of the first connection portion (41).

6. Catheter according to the preceding claim, wherein the incision surrounds at least the first passage.

7. Catheter according to claim 5, wherein the incision has the shape of a groove in the first connection portion (41).

8. Catheter according to the preceding claim, wherein the cavity (412) comprises in longitudinal section a first part with a first depth and a second part with a different second depth.

9. Catheter according to claim 2, wherein the first portion (41) defines a collar of limited axial length extending around first tube end.

10. Catheter according to claim 3, wherein the mechanical connection means comprises:

at least one cavity (413) on the first connection portion (41) traversing at least partially the first connection portion (41) according to an axis transverse to the longitudinal axis of the first lumen (21) of the cannula,

at least one protuberance (422) integral to the second connection portion (42) and complementary shaped to the cavity (413), said protuberance traversing at least partially the cavity.

11. Catheter according to claim 3, wherein the mechanical connection means comprises:

at least one cavity (413) on the first connection portion (41) traversing at least partially the first connection portion (41) according to an axis transverse to the longitudinal axis of the first lumen of the cannula,

at least one auxiliary cavity (412) on the first connection portion (41),

at least one protuberance (422) integral to the second connection portion (42) and shaped complementary to the cavity (413), said protuberance traversing at least partially the cavity,

at least one auxiliary protuberance (421) integral to the second connection portion (42) and having shape which corresponds to that of the auxiliary cavity (412).

12. Catheter according to the preceding claim, wherein the auxiliary cavity (412) has the shape of a incision on at least one part surrounding the first passage (411) of the first connection portion (41).

13. Catheter according to the preceding claim, wherein the incision surrounds at least the first passage.

14. Catheter according to claim 12, wherein the incision has the shape of a groove obtained in the first connection portion (41).

15. Catheter according to the preceding claim, wherein the auxiliary cavity (412) comprises in longitudinal section a first part with a first depth and a second part with a different second depth.

16. Catheter according to claim 1 comprising:

at least one second lumen (22) in the cannula (2);

at least one second connection tube (3′

), wherein the connection means places the second lumen of the cannula (22) in fluid communication with the second connection tube (3′

) and is molded on a part of the second connection tube (3′

).

17. Catheter according to claim 16, wherein the connection means (4) comprises:

a first connection portion molded on an end of the cannula (2) and defining a hub (41) forming at least one first passage (411) communicating with the first lumen (21) of the cannula and with a tube end (511) of the first connection tube (3);

a second connection portion (42) molded on at least one part of the hub (41) and on at least one part of the first connection tube (3) and connecting first tube end (511) and hub (41),

and wherein the hub (41) forms at least one second passage (411′

) communicating with the second lumen (22) of the cannula and with a tube end (511′

) of the second connection tube (3′

).

18. Catheter according to the preceding claim, wherein the second connection portion (42) is molded on at least a part of the first and second connection tubes (3, 3′

) and connects first and second tube ends (511, 511′

) with hub first and second passage.

19. Catheter according to claim 18, wherein the first and the second connection portions (41, 42) have mechanical connection means cooperating with one another comprising:

at least one cavity (412) on the first connection portion (41),

at least one protuberance (421) the shape of which complements that of said cavity (412), said protuberance being integral to the second connection portion (42).

20. Catheter according to claim 16, wherein the second portion (42) defines a collar of limited axial length extending around first and second tube end, said collar comprising axial tubular elements each housing a respective tube end and an intermediate joining portion transversely connecting the tubular elements.

21. Catheter according to claim 19, wherein the cavity (412) of the first connection portion (41) surrounds the first passage (411) and the second passage (411′

).

22. Catheter according to claim 19, wherein the cavity (413) traverses at least partially the first connection portion (41) in correspondence an area of the hub placed between the first passage (411) and the second passage (411′

), said cavity extending according to an axis transverse to the longitudinal axis of the first lumen (22).

23. Catheter according to claim 22, further comprising an auxiliary cavity (412) in the first connection portion (41) surrounding the first and the second passage (411, 411′

) and at least one auxiliary protuberance (421) integral to the second connection portion (42) and having shape which corresponds to that of the auxiliary cavity (412).

24. Catheter according to claim 16, wherein the second connection tube (3′

) is in the axis of the cannula and the first connection tube (3) is at an angle to the axis of the cannula comprised between 10 and 30 degrees.

25. Manufacturing process of a catheter for vascular access comprising the following stages:

taking a cannula (2) having at least one first lumen (21),

taking at least one first connection tube (3),

placing in a mould at least one end of the cannula (2) and at least one end of the first connection tube (3),

injecting into the mould a molding material to obtain connection means (4) between the end of the first connection tube (3) and the end of the cannula and placing the first lumen (21) and at least the first tube (3) in fluid communication.

26. Process according to the preceding claim, wherein the placing and injecting comprise the following sub-steps:

placing in a first mould at least the end of the cannula (2) and a core inserted into at least the first lumen (21) of the cannula (2);

injecting into the first mould a molding material to obtain a first connection portion (41) defining at least one first passage (411) communicating the first lumen (21) of the cannula with connection tube (3);

withdrawing the core from the cannula;

placing an auxiliary core in at least the first connection tube (3) and in at least one part of the first passage (411) of the first connection portion;

placing at least one part of the assembly constituted by the first connection portion (41) and by at least an end of first connection tube (3) in a second mould,

injecting into the second mould a molding material to obtain a second connection portion (42) molded to connect at least one part of the first connection portion (42) and at least one part of the first connection tube (3).

27. Process according to the preceding claim comprising molding at least one cavity (412) in the first connection portion (41) and at least one protuberance (421) the shape of which complements that of said cavity (412), said protuberance being integral to the second connection portion.

28. Process according to claim 25, wherein the catheter comprises at least a second lumen (22) in the cannula (2) and at least one second connection tube (3′

), wherein the placing in the mould comprises also the placing in the mould of at least one end of the second connection tube (3′

), and wherein injecting into the mould obtains connection means (4) for putting into fluid communication the second lumen (22) of the cannula with the second connection tube (3′

).

29. Process according to claim 25, wherein the catheter comprises at least one second lumen (22) in the cannula (2) and at least one second connection tube (3′

), and wherein the placing and injecting steps comprise the following sub-steps;

placing in a first mould at least the end of the cannula (2) and a core inserted into each lumen (21, 22) of the cannula (2),

injecting into the first mould a molding material to obtain a first connection portion (41) defining at least one first and second passage (411, 411′

) each communicating respectively with the first and the second lumen (21, 22) of the cannula (2);

withdrawing the two cores from the cannula;

placing a first auxiliary core in at least the first connection tube (3) and at least one part of the first passage (411) and a second auxiliary core in the second connection tube (3′

) and at least one part of the second passage (411′

),

placing at least one part of the assembly constituted by the first connection portion (41) and by at least the first and second connection tubes (3, 3′

) and by the two auxiliary cores in a second mould,

injecting into the second mould a molding material to obtain a second connection portion (42) connecting at least one part of the first connection portion (41) to at least one part of the first and of the second connection tubes (3, 3′

).

31. Device comprising a first mould, a second mould, at least one first core and at least one additional first core for implementing the manufacturing process according to claim 25.

32. Device comprising a first mould, a second mould, at least one first core, at least one additional first core, at least one second core and at least one additional second core for implementing the process according to claim 29.

30. Process according to preceding claim wherein injecting into the first mould causes molding a cavity (412) on the first connection portion (41) and injecting into the second mould causes molding a protuberance (421) the shape of which complements that of said cavity (412).