Dialysis catheter and methods of insertion

• US 7,390,322 B2
• Filed: 09/10/2004
• Issued: 06/24/2008
• Est. Priority Date: 01/09/2001
• Status: Expired due to Term

• Current Assignee: Argon Medical Devices
• Original Assignee: REX Medical LP
• Inventors: Tashjian, Paul, McGuckin, James F. Jr., Hinchliffe, Peter W. J., Paris, Michael W.
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): Mehta; Bhisma
• Application Number:
  US10/939,102
• Publication Number:
  US 20050090776A1
• Time in Patent Office: 1,383 Days
• Field of Search: 604/43, 604/500, 604/507, 604/508, 604/514, 604/523, 604/524, 604/29, 604/264, 604/104, 604/105, 604/107, 604/510
• US Class Current: 604/500
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 25/0028 characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves catheter hubs A61M25/0097
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• 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 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• 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 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

A method of inserting a dialysis catheter into a patient comprising the steps of inserting a guidewire into the jugular vein of the patient through the superior vena cava and into the inferior vena cava, providing a trocar having a lumen and a dissecting tip, inserting the trocar to enter an incision in the patient and to create a subcutaneous tissue tunnel, threading the guidewire through the lumen of the trocar so the guidewire extends through the incision, providing a dialysis catheter having first and second lumens, removing the trocar, and inserting the dialysis catheter over the guidewire through the incision and through the jugular vein and superior vena cava into the right atrium.

Claims

1. A method of inserting a dialysis catheter into a right atrium of a patient comprising:

providing a dialysis catheter having a first lumen for blood flow and a second lumen for blood flow, a terminal end of the first and second lumens being axially spaced;

providing a first guidewire having a proximal end portion and a distal tip;

inserting the first guidewire into the inferior vena cava of the patient so the distal tip remains in the vena cava and a proximal end portion extends out of the patient;

passing the guidewire through a subcutaneous tissue tunnel by passing an exposed proximal end portion of the guidewire through the tunnel in a proximal direction;

inserting a stiffening member through the first lumen in the catheter to advance the catheter over the guidewire;

advancing the dialysis catheter and stiffening member over the guidewire into the vein and into the right atrium of the patient; and

removing the guidewire leaving the dialysis catheter in place for a period of time.

2. The method of claim 1, wherein the step of inserting the stiffening member comprises the step of inserting the stiffening member such that a dilating distal tip of the stiffening member extends distally of the catheter.

3. The method of claim 2, further comprising the step of advancing the dialysis catheter subcutaneously over the guidewire through a tissue tunnel prior to the step of advancing the dialysis catheter into the vein.

4. The method of claim 1, wherein the guidewire is initially inserted through a needle.

5. A method of inserting a catheter into a patient comprising:

creating a subcutaneous tissue tunnel;

providing a guide member having a proximal end portion and a distal tip;

inserting a guide member so the distal tip extends into and is positioned unexposed in the vein of the patient and an exposed proximal end portion extends outside of the patient;

providing a catheter having a first lumen for blood delivery and a second lumen for blood withdrawal;

after the step of inserting the guide member, passing the guide member in a proximal direction so the proximal end portion extends through the subcutaneous tissue tunnel; and

inserting the catheter into the vein of the patient over the guide member in a direction toward the distal tip of the guide member with the distal tip remaining unexposed in the vein during insertion.

6. The method of claim 5, further comprising the step of inserting into the catheter a stiffening member having a lumen so the stiffening member is inserted into the vein of the patient over the guide member.

7. The method of claim 6, further comprising the steps of removing the guide member and leaving the catheter in position extending through the subcutaneous tissue tunnel and vein to enable blood delivery to the patient through the first lumen and blood withdrawal from the patient through the second lumen to treat the patient'"'"'s blood, the step of leaving the catheter in place further comprises the step of enabling blood withdrawal through at least one withdrawal opening in the catheter and enabling blood delivery through at least one opening in a distal portion of the catheter axially spaced from the withdrawal opening.

8. The method of claim 6, wherein the step of inserting the stiffening member includes the steps of securing the stiffening member to a proximal portion of the catheter.

9. The method of claim 6, wherein the step of inserting the stiffening member includes the step of inserting the stiffening member through the blood delivery lumen of the catheter.

10. The method of claim 6, wherein the step of inserting the stiffening member comprises the step of inserting the stiffening member such that a dilating distal tip of the stiffening member extends distally of the catheter.

11. The method of claim 5 wherein the step of inserting the catheter over the guide member includes the guide member extending through one of the lumens in the catheter.

12. The method of claim 5, further comprising the step of forming a loop in the catheter prior to full insertion of the catheter into the vein of the patient.

13. The method of claim 5, wherein the guide member is initially inserted through a needle.

14. A method of inserting a catheter into a patient without the use of a tear away sheath comprising:

providing a catheter;

inserting a guide member through the incision into the vein of a patient so a distal tip of the guide member extends into and is positioned unexposed in the vein of the patient and an exposed proximal end portion extends outside of the patient;

creating a subcutaneous tissue tunnel;

providing an insert member;

inserting the insert member into the catheter;

passing an exposed portion of the guide member through the subcutaneous tissue tunnel;

inserting, without the use of a tear away sheath, the insert member and catheter into the vein of the patient over the guide member in a direction toward the distal tip of the guide member as the guide member extends through an opening in the insert member and the distal tip remains unexposed in the vein during insertion; and

securing the catheter to the patient.

15. The method of claim 14, further comprising the step of securing the insert member to the catheter.

16. The method of claim 14, wherein the step of passing the guide member through the subcutaneous tissue tunnel comprises the step of providing a trocar and inserting the guide member through an opening in the trocar.

17. A method of inserting a catheter into a vein of a patient comprising:

inserting a guidewire into the vein of a patient, the guidewire extending out of and incision to form a loop outside the patient;

creating a subcutaneous tissue tunnel;

inserting a catheter through a first end of the subcutaneous tissue tunnel to exit a second end of the tunnel;

inserting the catheter over the loop in the guidewire and into the vein of the patient, the step of inserting including the step of providing a stiffening member within the catheter having an opening to pass over the guidewire as it is advanced into the vein with the catheter; and

securing the catheter to the patient.

18. The method of claim 17, further comprising the step of securing the stiffening member to the catheter.

19. The method of claim 17, wherein the step of providing a stiffening member within the catheter includes the step of placing the stiffening member within a lumen of the catheter.

20. The method of claim 17, further comprising the step of inserting the catheter into the patient is performed without inserting the catheter through a tear away sheath.

21. The method of claim 17, wherein the guidewire is initially inserted through a needle.