Catheter

• US 5,853,394 A
• Filed: 12/31/1996
• Issued: 12/29/1998
• Est. Priority Date: 05/09/1994
• Status: Expired due to Term

• Current Assignee: ACT Medical, Inc.
• Original Assignee: Fernando Alvarez De Toledo, Marc Joshua Tolkoff
• Inventors: de Toledo, Fernando Alvarez, Tolkoff, Marc Joshua
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/775,176
• Time in Patent Office: 728 Days
• Field of Search: 604/165, 604/264, 604/280-282, 604/265-270
• US Class Current: 604/288.01
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

The present invention relates to catheters for use with subcutaneous access ports for continuous or intermittent infusion therapy. These catheters utilize a pretensioned, helical coil which is incorporated into a flexible cannulated portion. This feature allows the flexible cannula to be bent without kinking under normal use. This flexibility provides a great deal of comfort to the patent. These catheters also incorporate a puncture needle which is positioned axially down the length of the catheter such that the sharp point at the distal end of the needle extends beyond the distal end of the catheter. This combination of a pretensioned, flexible catheter and a puncture needle achieves a stiffness sufficient to penetrate the tough, self-sealing septum used in subcutaneous access ports, yet, once the puncture needle is removed the patient is left with a comfortable alternative to commonly used hypodermic needles. The present invention also relates to improved transcutaneous infusion systems which utilize these catheters.

Claims

1. A subcutaneous access port catheter assembly comprising:

a flexible catheter, said catheter having distal and proximal ends and having an inner wall portion defined by a pretensioned, continuous helical coil and an outer sheathing formed from a tube of smooth, inert flexible plastic material, wherein said sheath is in intimate contact with the outer spiral of said coil; and

an elongated puncture needle having a sharp point at the distal end and a knob member at the proximal end, said puncture needle being inserted coaxially down the length of said catheter such that the sharp point at the distal end of the elongated puncture needle extends beyond the distal end of said catheter,

wherein the assembly has sufficient rigidity to penetrate a septum which has a Shore A durometer of at least 25 and wherein said elongated puncture needle can be removed from said catheter.

2. A subcutaneous access port catheter assembly according to claim 1 wherein the resistive force necessary to deflect the tip of a 1.4 inch length of catheter increases by at least about 5% as the compressive force on the catheter is increased from 0 lb. to 3 lb.

3. A subcutaneous access port catheter assembly according to claim 2 wherein the resistive force necessary to deflect the tip of a 1.4 inch length of catheter increases by at least about 25% as the compressive force on the catheter is increased from 0 lb. to 3 lb.

4. A subcutaneous access port catheter assembly according to claim 3 wherein the resistive force necessary to deflect the tip of a 1.4 inch length of catheter increases by at least about 50% as the compressive force on the catheter is increased from 0 lb. to 3 lb.

5. A subcutaneous access port catheter assembly according to claim 2 wherein said coil is produced by wire-wrapping at a negative lead angle.

6. A subcutaneous access port catheter assembly according to claim 5 wherein said coil is produced by wire-wrapping at a negative lead angle of from 0°

to 4°

.

7. A subcutaneous access port catheter assembly according to claim 6 wherein said coil is produced by wire-wrapping at a negative lead angle of from 2°

to 3°

.