Methods and apparatus for inserting multi-lumen split-tip catheters into a blood vessel

• US 8,597,275 B2
• Filed: 04/12/2012
• Issued: 12/03/2013
• Est. Priority Date: 05/27/2003
• Status: Active Grant

• Current Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Original Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Inventors: Nimkar, Shekhar D., Albrecht, Stephen E., Anand, Paramjith, Tobin, Eric
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US13/445,713
• Publication Number:
  US 20120203206A1
• Time in Patent Office: 600 Days
• Field of Search: 604/264, 604/284, 604/523, 604/524, 604/528, 604/533
• US Class Current: 604/510
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61M 1/16 with membranes
• 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 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

Methods and apparatus are disclosed for inserting flexible, multi-lumen catheters into blood vessels, and in particular, for inserting flexible, split-tip catheters into blood vessels. The invention accomplishes these objects by temporarily stiffening each catheter lumen and tip independently through use of intra-catheter stiffener elements disposed within the catheter lumens. This provides means for advancing the catheter/stiffeners assembly through a subcutaneous tunnel, and over a plurality of guidewires until a distal tip of the catheter is at a desired position within the vessel. The intra-catheter stiffener elements are sufficiently stiffening to allow advancing the catheter over guidewires, but sufficiently flexible to allow bending and looping of the catheter for proper placement within the vessel.

Claims

1. A method of treating a patient, comprising:

providing a catheter including a first lumen in fluid communication with a first distal opening and a second lumen in fluid communication with a second distal opening;

advancing a distal end of a first intra-catheter stiffener element through the first lumen and out of the first distal opening;

coupling the first intra-catheter stiffener element to the catheter;

advancing a distal end of a second intra-catheter stiffener element through the second lumen and out of the second distal opening;

coupling the second intra-catheter stiffener element to the catheter;

advancing the catheter into a blood vessel;

uncoupling the first intra-catheter stiffener element from the catheter and removing the first intra-catheter stiffener element from the first lumen; and

uncoupling the second intra-catheter stiffener element from the catheter and removing the second intra-catheter stiffener element from the second lumen.

2. The method according to claim 1, wherein following the advancing of the distal ends of the first and second intra-catheter stiffener elements out of the first and second distal openings and coupling the first and second intra-catheter stiffener elements to the catheter, the distal end of the first intra-catheter stiffener element is distal of the distal end of the second intra-catheter stiffener element.

3. The method according to claim 1, wherein the distal ends of the first and second intra-catheter stiffener elements are tapered to facilitate the advancing the catheter into the blood vessel.

4. The method according to claim 1, wherein the advancing the catheter into a blood vessel further comprises:

positioning a guidewire at a desired position in a blood vessel;

threading a proximal end of the guidewire through the second intra-catheter stiffener element; and

advancing the catheter over the guidewire into the blood vessel.

5. The method according to claim 4, further comprising removing the guidewire from the second intra-catheter stiffener element prior to uncoupling the first and second intra-catheter stiffener elements from the catheter.

6. The method according to claim 1, further comprising forming a subcutaneous tunnel between a first location and a second location.

7. The method according to claim 6, further comprising:

removably attaching a distal end of the catheter to a tunneling member;

moving the tunneling member and catheter through the subcutaneous tunnel until the catheter distal end exits the tunnel; and

removing the catheter from the tunneling member.

8. The method according to claim 1, wherein the coupling the first intra-catheter stiffener element to the catheter comprises coupling a first coupler at a proximal end of the first intra-catheter stiffener element to a first mating coupler at a first proximal opening of the catheter.

9. The method according to claim 8, wherein the coupling the second intra-catheter stiffener element to the catheter comprises coupling a second coupler at a proximal end of the second intra-catheter stiffener element to a second mating coupler at a second proximal opening of the catheter.

10. A method of preparing a catheter for use, the catheter including a first lumen in fluid communication with a first distal opening and a second lumen in fluid communication with a second distal opening, comprising:

advancing a distal end of a first intra-catheter stiffener element through the first lumen and out of the first distal opening;

coupling the first intra-catheter stiffener element to the catheter;

advancing a distal end of a second intra-catheter stiffener element through the second lumen and out of the second distal opening; and

coupling the second intra-catheter stiffener element to the catheter.

11. The method according to claim 10, wherein following the advancing of the distal ends of the first and second intra-catheter stiffener elements out of the first and second distal openings and coupling the first and second intra-catheter stiffener elements to the catheter, the distal end of the first intra-catheter stiffener element is distal of the distal end of the second intra-catheter stiffener element.

12. The method according to claim 10, wherein the distal ends of the first and second intra-catheter stiffener elements are tapered to facilitate the advancing the catheter into a blood vessel.

13. The method according to claim 10, wherein the coupling the first intra-catheter stiffener element to the catheter comprises coupling a first coupler at a proximal end of the first intra-catheter stiffener element to a first mating coupler at a first proximal opening of the catheter.

14. The method according to claim 13, wherein the coupling the second intra-catheter stiffener element to the catheter comprises coupling a second coupler at a proximal end of the second intra-catheter stiffener element to a second mating coupler at a second proximal opening of the catheter.