Catheter with changeable number of lumens

• US 5,156,596 A
• Filed: 02/04/1991
• Issued: 10/20/1992
• Est. Priority Date: 02/04/1991
• Status: Expired due to Term

• Current Assignee: Menlo Care, Inc. (Johnson & Johnson)
• Original Assignee: Menlo Care, Inc. (Johnson & Johnson)
• Inventors: Balbierz, Daniel J., Thomas, Joseph R.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): LAVIOLA JR, FRANK
• Application Number:
  US07/650,439
• Time in Patent Office: 624 Days
• Field of Search: 604/93, 604/158, 604/164, 604/167, 604/244, 604/245, 604/246, 604/264, 604/280, 604/283, 604/284, 604/905
• US Class Current: 604/164.11
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/0693 including means for seal penetration

Abstract

A catheter assembly is provided. An attachment structure has a proximal end portion of an outer cannula attached to it. A needle is insertable through the outer cannula and the attachment structure. An inner cannula is attached to an inner cannula attachment region of the attachment structure. The inner cannula is insertable axially through the attachment structure. The attachment structure can comprise two hubs, one for the outer cannula and the other for the inner cannula, the two hubs being attachable to one another to form the overall attachment structure. A valve structure is associated with the attachment structure, suitably with the outer cannula hub. The valve structure normally closes communication between an access passage in the attachment structure, e.g., in the outer cannula hub, and the outer cannula lumen. The valve structure opens sufficiently for the inner cannula to pass through it and to open communication between the access passage and the outer cannula lumen when the inner cannula is inserted through another passage in the attachment structure and through the outer cannula lumen. The assembly allows the removal of the inner cannula and the insertion of a replacement inner cannula, if desired, without removing the outer cannula from the blood vessel. Use of a relatively small diameter needle for a desired diameter outer cannula can also be provided if the material of the outer cannula is such that it will swell in place.

Claims

1. An over-the-needle insertable multi-lumen catheter assembly, comprising:

an attachment structure have proximal and distal end regions, first and second internal passages which join one another at a junction region to form a distal exit passage, an outer cannula attachment region of a size and construction sufficient to allow a needle to be inserted therethrough, an inner cannula attachment region, a first proximal access region providing access to the first passage, a second proximal access region providing access to the second passage and an exit passage access region providing access to the distal exit passage;

an outer cannula having proximal and distal end portions and an outer cannula lumen, the proximal end portion of the outer cannula being attached to the outer cannula attachment region, the outer cannula lumen being of a size sufficient to allow the needle to be inserted therethrough;

an inner cannula having proximal and distal end portions and an inner cannula lumen, the proximal end portion of the inner cannula being attached to the inner cannula attachment region in such a manner that fluid flow communication is blocked between the first proximal access region and the outer cannula lumen, the inner cannula being insertable axially through the first passage and the outer cannula lumen, the inner cannula being of a construction such that when inserted in to the outer cannula lumen it does not prevent flow therethrough; and

valve means associated with the attachment structure for closing communication between the second passage and the outer cannula lumen, the valve means being openable sufficiently for the inner cannula to pass therethrough and to open up communication between the second passage and the outer cannula lumen.

2. An assembly as set forth in claim 1, wherein the outer cannula softens by at least a ratio of 2:

1 on being inserted in a blood vessel.

3. An assembly as set for in claim 2, wherein the valve means comprises a septum having a self-sealing opening therethrough.

4. An assembly as set forth in claim 3, wherein the valve means further includes:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough leaving a surrounding annular space through which a fluid can flow; and

means for positioning the sleeve through the self-sealing opening.

5. An assembly as set forth in claim 2, wherein the outer cannula lumen swells by at least 1.3:

1 on the outer cannula being inserted in a blood vessel.

6. An assembly as set forth in claim 5, wherein the valve means comprises a septum having a self-sealing opening therethrough.

7. An assembly as set forth in claim 6, wherein the valve means further includes:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough leasing a surrounding annular space through which a fluid can flow; and

means for positioning the sleeve through the self-sealing opening.

8. An assembly as set forth in claim 1, wherein the outer cannula lumen swells by at least 1.3:

1 on the outer cannula being inserted in a blood vessel.

9. An assembly as set forth in claim 1, wherein the valve means comprises a septum having a self-sealing opening therethrough.

10. An assembly as set forth in claim 9, wherein the valve means further includes:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough leaving a surrounding annular space through which a fluid can flow; and

means for positioning the sleeve through the self-sealing opening.

11. An assembly as set forth in claim 10, wherein the valve means comprises a septum having a self-sealing opening therethrough.

12. An assembly as set forth in claim 11, wherein the attachment structure further includes a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough and means for positioning the sleeve through the self-sealing opening.

13. An assembly as set forth in claim 1, wherein the attachment structure includes:

an outer cannula hub having a proximal end portion and the attachment structure distal end portion and including the outer cannula attachment region and a distal portion of the exit passage access region; and

an inner cannula hub having a distal end portion, the attachment structure proximal end portion, the first and second internal passages, the junction region, the distal exit passage, the inner cannula attachment region, the first proximal access region, the second proximal access region and a proximal portion of the exit passage access region;

the distal end portion of the inner cannula hub being releasably couplable to the proximal end portion of the outer cannula hub with the distal and proximal portions of the exit passage access region in flow communication.

14. An assembly as set forth in claim 13, further including:

a further inner cannula hub having further inner cannula hub distal and proximal end portions, first and second further inner cannula hub internal passages, a junction region defined by the joining of the first and second internal passages, a distal exit passage, a further inner cannula attachment region, a first proximal further access region, a second proximal further access region and an exit passage access region, the distal end portion of the further inner cannula hub being releasably couplable to the proximal end portion of the inner cannula hub with the exit passage access regions of the inner cannula hub and of the further inner cannula hub in flow communication;

a further inner cannula having proximal and distal end portions and a further inner cannula lumen, the proximal end portion of the further inner cannula being attached to the further inner cannula attachment region in such a manner that fluid flow communication is blocked between the first proximal further access region and the inner cannula lumen, the further inner cannula being insertable axially through the first passage of the further inner cannula hub and the inner cannula lumen, the further inner cannula being of a construction such that when inserted into the inner cannula lumen it does not prevent flow therethrough; and

further valve means associated with the inner cannula hub for closing communication between the further inner cannula second passage and the inner cannula lumen, the further valve means being openable sufficiently for the further inner cannula to pass therethrough and to open up communication between the further inner cannula second passage and the inner cannula lumen.

15. An assembly as set forth in claim 14, wherein the first mentioned valve means comprises a septum having a self-sealing opening therethrough.

16. An assembly as set forth in claim 15, wherein the first mentioned valve means further includes:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough leaving a surrounding annular space through which a fluid can flow; and

means for positioning the sleeve through the self-sealing opening.

17. An assembly as set forth in claim 1, wherein said inner cannula is internally divided into a plurality of internal lumens, and wherein said assembly further includes:

a plurality of inner lumen access passages each of which provides access to a respective one of said plurality of internal lumens.

18. An assembly as set for in claim 17, wherein the valve means comprises a septum having a self-sealing opening therethrough.

19. An assembly as set forth in claim 18, wherein the valve means further includes:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough leaving a surrounding annular space through which a fluid can flow; and

means for positioning the sleeve through the self-sealing opening.

20. A catheter structure with which the number of available lumens can be changed without removal from a patient'"'"'s body, comprising:

an outer cannula hub having proximal and distal end portions, a passageway therethrough from the distal to the proximal end portion thereof and an outer cannula attachment region;

an inner cannula hub having proximal and distal end portions, a first internal passage therethrough from the distal to the proximal end portion thereof and a second internal passage which joins the first internal passage at a junction region, an inner cannula attachment region, the distal end portion of the inner cannula hub being releasably couplable to the proximal end portion of the outer cannula hub with the first internal passage in the inner cannula hub in communication with the passageway through the outer cannula hub;

an outer cannula having proximal and distal end portions and an outer cannula lumen, the proximal end portion fo the outer cannula being attached to the outer cannula attachment region so that the outer cannula extends distally from the outer cannula hub;

an inner cannula attached to the inner cannula attachment region in such a manner as to block fluid flow communication between the proximal and distal end portions of the first passage, the inner cannula having proximal and distal end portions, the distal end portion thereof being insertable through the passageway in the outer cannula hub from the proximal end portion thereof and out of the distal end portion thereof; and

an elastomeric septum having a self-sealing opening therethrough associated with the outer cannula hub for closing communication between the second passage and the outer cannula lumen, the distal end portion of the inner cannula being insertable through the opening through the septum; and

inner cannula sheathing means for preventing the septum from exerting inward radial pressure on the inner cannula when the inner cannula distal end portion is inserted through the opening in the septum and for providing fluid flow communication of the second passage with the outer cannula lumen.

21. A catheter structure as set forth in claim 20, wherein the outer cannula softens by at least a ratio of 2:

1 on being inserted in a blood vessel.

22. A catheter structure as set forth in claim 21, wherein the inner cannula softens by at least a ratio of 2:

1 on being inserted in a blood vessel.

23. A catheter structure as set forth in claim 22, wherein the inner cannula sheathing means comprises:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough and sufficient to allow fluid to flow between the inner cannula and the sleeve; and

means for positioning the sleeve through the self-sealing opening.

24. A catheter structure as set forth in claim 22, wherein the outer cannula lumen swells by at least 1.3:

1 on the outer cannula being inserted in a blood vessel.

25. A catheter structure as set forth in claim 21, wherein the inner cannula sheathing means comprises:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough and sufficient to allow fluid to flow between the inner cannula and the sleeve; and

means for positioning the sleeve through the self-sealing opening.

26. A catheter structure as set forth in claim 21, wherein the outer cannula lumen swells by at least 1.3:

1 on the outer cannula being inserted in a blood vessel.

27. A catheter structure as set forth in claim 21, wherein the inner cannula softens by at least a ratio of 2:

1 on being inserted in a blood vessel.

28. A catheter structure as set forth in claim 27, wherein the inner cannula sheathing means comprises:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough and sufficient to allow fluid to flow between the inner cannula and the sleeve; and

means for positioning the sleeve through the self-sealing opening.

29. A catheter structure as set forth in claim 28, wherein the outer cannula lumen swells by at least 1.3:

1 on the outer cannula being inserted in a blood vessel.

30. A catheter structure as set forth in claim 21, wherein the inner cannula, when softening on being inserted in a blood vessel, exhibits a 2.5% Secant Modulus of no more than 7,000 N/cm².

31. A catheter structure as set forth in claim 21, wherein the inner cannula exhibits a 2.5% Secant Modulus of no more than 7,000 N/cm².

32. A catheter structure as set forth in claim 31, wherein the inner cannula sheathing means comprises:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough and sufficient to allow fluid to flow between the inner cannula and the sleeve; and

means for positioning the sleeve through the self-sealing opening.

33. A catheter structure, comprising:

an attachment structure having proximal and distal end regions, first and second internal passages which join one another at a junction region to form a distal exit passage, an outer cannula attachment region, an inner cannula attachment region, a first proximal access region providing access to the first passage, a second proximal access region providing access to the second passage and an exit passage access region providing access to the distal exit passage;

an outer cannula having proximal and distal end portions and an outer cannula lumen and being formulated of a material that softens with a softening ratio of greater than 2;

1, the proximal end portion of the outer cannula being attached to the outer cannula attachment region;

an inner cannula having proximal and distal end portions and an inner cannula lumen, the proximal end portion of the inner cannula being attached to the inner cannula attachment region in such a manner as to block fluid flow communication between the proximal and distal end portions of the first passage, the inner cannula being insertable axially through the first proximal access region and the first passage; and

valve means associated with the attachment structure for closing communication between the second passage and the outer cannula lumen, the valve means being openable sufficiently for the distal end portion of the inner cannula to pass therethrough and to open communication between the second passage and the outer cannula lumen.

34. A catheter structure as set forth in claim 33, further including:

inner cannula sheathing means for preventing the valve means from exerting inward radial pressure on the inner cannula when the inner cannula is inserted through the valve means.

35. A catheter structure as set forth in claim 34, wherein the valve means comprises a septum having a self-sealing opening therethrough.

36. A catheter structure as set forth in claim 35, wherein the inner cannula sheathing means comprises:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough; and

further including;

means for positioning the sleeve through the self-sealing opening.

37. A catheter structure as set forth in claim 34, wherein the outer cannula lumen swells by at least 1.3:

1 on the outer cannula being inserted in a blood vessel.

38. A catheter structure as set forth in claim 37, wherein the inner cannula sheathing means comprises:

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough; and

further including;

means for positioning the sleeve through the valve means.

39. A catheter assembly as set forth in claim 33, wherein said inner cannula is formulated of a material that softens with a softening ratio of greater than 2:

1.

40. A catheter assembly, comprising:

an outer cannula hub having proximal and distal end portions and defining a central longitudinal passageway therethrough having proximal and distal end portions, the passageway extending from the outer cannula hub proximal end portion to the outer cannula hub distal end portion;

an outer cannula having proximal and distal end portions and defining an outer cannula lumen extending from the outer cannula proximal end portion to the outer cannula distal end portion, the outer cannula proximal end portion being attached to the outer cannula hub with the outer cannula lumen in flow communication with the outer cannula hub passageway;

an inner cannula hub having proximal and distal end portions and defining first and second passageways therethrough;

an inner cannula having proximal and distal end portions and defining an inner cannula lumen extending from the inner cannula proximal end portion to the inner cannula distal end portion, the inner cannula proximal end portion being attached to the inner cannula hub with the inner cannula lumen in flow communication with the inner cannula hub first passageway and such that fluid flow from the inner cannula hub first passageway can only proceed through the inner cannula lumen;

attaching means for detachably attaching the inner cannula hub to the outer cannula hub with the inner cannula positioned within and extending longitudinally along the outer cannula lumen; and

valve means associated with the outer cannula hub for blocking communication between the proximal end portion of the outer cannula hub passageway and the outer cannula lumen, the valve means being openable in response to the inner cannula hub being attached to the outer cannula hub, the valve means, when open, providing flow therethrough from the inner cannula hub second passageway to the outer cannula lumen.

41. A catheter assembly as set forth in claim 40, further including:

an outer cannula lumen access member having proximal and distal end portions and an access member passageway therethrough, the access member being detachably attachable to the outer cannula hub by the attaching means if the inner cannula hub is not so attached, the valve means opening in response to attachment of the access member to the outer cannula hub, the valve means, when open, providing flow therethrough from the access member passageway to the outer cannula lumen.

42. A catheter structure as set forth in claim 41, wherein the valve means comprises a septum having a self-sealing opening therethrough;

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough with sufficient clearance to allow fluid flow from the inner cannula second passageway to the outer cannula lumen; and

means for positioning the sleeve through the self-sealing opening.

43. A catheter structure as set forth in claim 40, wherein the valve means comprises a septum having a self-sealing opening therethrough;

a rigid sleeve having an internal diameter sufficient to allow the inner cannula to pass therethrough with sufficient clearance to allow fluid flow form the inner cannula second passageway to the outer cannula lumen; and

means for positioning the sleeve through the seal-sealing opening.

44. A catheter structure with which the number of available lumens can be changed without removal from a patient'"'"'s body, comprising:

an outer cannula hub having proximal and distal end portions, a passageway therethrough from the distal to the proximal end portion thereof and an outer cannula attachment region;

an inner cannula hub having proximal and distal end portion, a first internal passage therethrough from the distal to the proximal end portion thereof and a second internal passage which joins the first internal passage at a junction region, an inner cannula attachment region, the distal end portion of the inner cannula hub being releasably couplable to the proximal end portion of the outer cannula hub with the first internal passage in the inner cannula hub in communication with the passageway through the outer cannula hub;

an outer cannula having proximal and distal end portions and an outer cannula lumen, the proximal end portion of the outer cannula being attached to the outer cannula attachment region so that the outer cannula extends distally from the outer cannula hub;

an inner cannula attached to the inner cannula attachment region in such a manner as to block off fluid flow communication between the proximal and distal end portions of the first passage, the inner cannula having proximal and distal end portions, the distal end portion thereof being insertable through the passageway in the outer cannula hub from the proximal end portion thereof and out of the distal end portion thereof; and

an elastomeric septum having a self-sealing opening therethrough associated with the outer cannula hub for closing communication between the second passage and the outer cannula lumen, the distal end portion of the inner cannula being insertable through the opening through the septum;

an opening member adapted to open the opening in the septum when positioned therein; and

moving means for moving the opening member into the opening in the septum to thereby provide fluid flow communication between the second passage and the outer cannula lumen.