Dialysis catheter

• US 7,799,014 B2
• Filed: 08/23/2004
• Issued: 09/21/2010
• Est. Priority Date: 01/09/2001
• Status: Expired due to Term

• Current Assignee: Argon Medical Devices
• Original Assignee: REX Medical LP
• Inventors: Hinchliffe, Peter W. J., Tashjian, Paul, McGuckin, James F. Jr., Paris, Michael W.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): MOULTON, ELIZABETH ROSE
• Application Number:
  US10/924,076
• Publication Number:
  US 20050131341A1
• Time in Patent Office: 2,220 Days
• Field of Search: 604/524, 604/29, 604/43, 604/6.16
• US Class Current: 604/524
• 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 dialysis catheter comprising a catheter body having a proximal portion, a distal portion, a first longitudinally extending central lumen configured to deliver blood, and at least three longitudinally extending lumens positioned radially of the central lumen and configured to withdraw blood from a patient. At least one blood delivery opening is formed in the distal portion of the catheter body and in fluid communication with the first lumen and configured for passage of blood therethrough. At least three blood withdrawal openings are formed in the outer wall of the catheter body, wherein each of the openings is in fluid communication with one of the at least three lumens and is configured for passage of blood from a patient.

Claims

1. A system for placement of a catheter comprising:

a) a guidewire having a length with a proximal end and a distal end adapted and configured for positioning in a right atrium and having an outer diameter and configured for receipt within a catheter for passage of the catheter thereover;

b) a unitary trocar having an elongated tubular portion, a handle portion, and a lumen extending longitudinally through the tubular portion and handle portion, and a first opening at a proximal portion of the trocar and a second opening at a distal portion of the trocar, the second opening spaced proximally from a distalmost tip of the trocar, the first and second openings communicating with the lumen, the tubular portion terminating in a blunt dilating tip configured to dilate tissue and create a subcutaneous tissue tunnel extending for a distance under the skin from a first entry point to a second exit point, the lumen of the trocar having a first internal diameter smaller than an outer diameter of the catheter, the guidewire proximal end insertable through the lumen of the trocar and through the tissue tunnel in a proximal direction, the diameter of the lumen being greater than an outer diameter of the guidewire and the proximal end of the guidewire received first into the second opening at the distal portion of the trocar and exiting at the first opening at the proximal portion of the trocar to enable proximal movement of the guidewire, the trocar withdrawable from over the guidewire for subsequent insertion of the catheter;

c) the catheter having a first lumen configured for blood delivery to a patient and a second independent lumen configured for blood withdrawal from the patient, at least a portion of the catheter having an outer diameter configured for insertion through a subcutaneous tissue tunnel without the use of the trocar, the catheter configured to receive a guidewire which passes through the subcutaneous tissue tunnel, and

d) a tubular stiffening member having a proximal portion extending proximally from the catheter, a distal portion and a longitudinally extending lumen extending from the proximal portion to the distal portion, the tubular stiffening member received in the catheter such that the catheter with the stiffening member positioned therein is inserted into the patient, at least a portion of the stiffening member configured and dimensioned to receive a guidewire within the lumen and pass through the subcutaneous tissue tunnel and dimensioned to pass over the guidewire after the trocar has been removed from a position over the guidewire, the guidewire extending proximally of the stiffening member.

2. The system of claim 1, wherein the stiffening member is removably secured to the catheter.

3. The system of claim 1, wherein the stiffening member is received in one of the lumens of the catheter.

4. The system of claim 2, wherein the stiffening member includes threads at a proximal portion for securement to the catheter.

5. The system of claim 1, wherein the second lumen of the catheter terminates proximally of the first lumen.

6. The system of claim 5, wherein the distal portion of the catheter includes a reduced diameter region.

7. The system of claim 1, wherein the stiffening member is positioned in the first lumen of the catheter.

8. The system of claim 1, wherein at least a portion of the first lumen is circular in cross-section and at least a portion of the second lumen is non-circular in cross-section.

9. The system of claim 8, wherein the second lumen terminates in an opening proximal of a distal opening of the first lumen.

10. The system of claim 8, wherein the stiffener is removably positioned in the first lumen of the catheter.

11. The system of claim 1, wherein the catheter includes a spacer rib.

12. The system of claim 11, wherein the second lumen communicates with the patient proximal of the spacer rib.

13. The system of claim 8, further comprising side holes communicating with the first lumen.

14. The system of claim 1, wherein the distal end of the catheter has an elongated reduced diameter region, the first lumen extending through the reduced diameter region.

15. The system of claim 14, wherein the first lumen terminates in a distal opening in the reduced diameter region and the second lumen terminates in an opening proximal of the distal opening.

16. The system of claim 15, wherein at least a portion of the first lumen is circular in cross-section and at least a portion of the second lumen is non-circular in cross-section.

17. A system for placement of a catheter comprising:

a) a catheter configured for fluid transport to and from a patient and having a distal end, a proximal end and a central longitudinal axis, a first central lumen concentric with the central longitudinal axis and a second independent lumen, at least a portion of the catheter having an outer diameter configured for insertion through a subcutaneous tissue tunnel extending for a distance under the skin from a first entry point to a second exit point, the catheter configured to receive a guidewire therein for passage thereover, the guidewire having a length with a distal end adapted and configured to extend into a right atrium and a proximal end which passes through the subcutaneous tissue tunnel,

b) a single tubular stiffening member for insertion of the catheter, the stiffening member having a proximal end opening adjacent a region of attachment of the stiffener to the catheter and a distal end opening and a lumen extending from the proximal end opening to the distal end opening, the stiffening member received in the central lumen of the catheter and attached to the catheter at the attachment region such that the catheter with the stiffening member positioned therein is inserted into the patient while the other lumen remains free of stiffeners positioned therein during insertion of the catheter, at least a portion of the stiffening member configured to pass through the subcutaneous tissue tunnel to extend for the distance under the skin, and a lumen extending along a length of the stiffener from the proximal end opening to the distal end opening and dimensioned to receive a guidewire therein a distal tip of the stiffening member terminating proximal of a distal tip of the catheter; and

c) a trocar having a distal tip and connecting structure at a proximal end, the connecting structure removably connectable to the distal end of the catheter.

18. The system of claim 17, wherein the trocar distal tip has a blunt dilating tip configured to dilate tissue and create a subcutaneous tissue tunnel, and the connecting structure includes a barbed end.

19. The system of claim 17, further comprising a first opening communicating with the first lumen and a second opening communicating with the second lumen, and a spacer positioned between the first and second openings and forming a raised surface between the first and second openings and extending from an outer surface of the catheter to contact a wall of a vessel lumen, wherein a transverse dimension of the catheter at the region of the spacer exceeds a transverse dimension of the catheter at the region at the first opening and at the region of the second opening.