Catheter introducer with flexible tip

• US 4,950,257 A
• Filed: 09/15/1988
• Issued: 08/21/1990
• Est. Priority Date: 09/15/1988
• Status: Expired due to Fees

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Mallinckrodt Incorporated (Mallinckrodt plc)
• Inventors: Liebmann, Vern, Spinks, Dennis, Hibbs, Lee, Jang, Yue-teh
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/244,290
• Time in Patent Office: 705 Days
• Field of Search: 604/93, 604/158-170, 604/264, 604/265, 604/280-283, 128/348.1, 128/658
• US Class Current: 604/265
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/0646 Duckbill-valve
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A catheter introducer has a tubular sheath with a relatively rigid tubular body and a soft flexible tubular tip for reducing sheath buckling tendencies.

Claims

1. A catheter introducer comprising

a body portion formed from a thin-walled flexible tube for extending into a body cavity or blood vessel, the body portion being sized to receive a catheter therein and permit the catheter to pass therethrough so as to guide the catheter during insertion and placement of the catheter in the cavity or vessel,

a valve housing at a proximal end of the body portion having a seal therein through which a catheter is inserted into the introducer so as to maintain a fluid-tight relationship with the body cavity or blood vessel to prevent leakage therefrom,

a tip portion formed from a thin-walled flexible tube attached to the distal end of the body portion, said tip portion being sized to receive the catheter and permit the catheter to pass therethrough,

said tube forming the body portion having sufficient rigidity and columnar strength to withstand forces applied by a physician to drive the tip portion through tissue stretched by a dilator around an opening through which a guide wire extends, and

said tube forming the tip portion including a polymer material rendering the tip portion substantially more flexible than the tube forming the body portion.

2. A catheter introducer as claimed in claim 1 wherein the tube forming the tip portion has a Shore hardness which is from 25 to 75 percent of a Shore hardness of the tube forming the body portion.

3. A catheter introducer as claimed in claim 1 wherein the flexible tube forming the body portion includes a nylon and from 0% to 50% ester linked polyether-polyamide copolymer, and the flexible tube forming the tip portion includes a nylon and from 50% to 100% ester linked polyether-polyamide copolymer wherein the percentage of copolymer in the tip portion is substantially greater than the percentage of copolymer in the body portion so as to render the tip portion softer and more flexible than the body portion.

4. A catheter introducer as claimed in claim 1 wherein the tube forming the tip portion is from 1.2 cm to 2.5 cm in length.

5. A catheter introducer as claimed in claim 1 wherein the flexible tubes forming the tip and body portions have a coating of lubricious hydrogel on the interior surfaces of the tubes to promote ease of catheter insertion.

6. A catheter introducer as claimed in claim 1 wherein the flexible tube forming the tip portion has a coating of lubricious hydrogel on the exterior surface to render insertion through tissue easier.

7. A catheter introducer as claimed in claim 6 wherein the hydrogel is a copolymer of polyurethane and polyvinylpyrrolidone having from 1 to 3 parts by weight polyvinylpyrrolidone to 1 part polyurethane.

8. A catheter introducer as in claim 1 wherein all internal surfaces are coated with a hydrogel to reduce thrombogenicity.

9. A catheter introducer as claimed in claim 8 wherein the coating on the internal surfaces is a lubricious copolymer of polyurethane and polyvinylpyrrolidone having from 1 to 3 parts by weight polyvinylpyrrolidone to 1 part polyurethane.

10. A catheter introducer comprising

a body portion formed from a thin-walled flexible tube for extending into a body cavity or blood vessel to guide a catheter during insertion and placement of the catheter in the cavity or vessel,

a tip portion formed from a thin-walled flexible tube attached to the distal end of the body portion,

said tube forming the body portion having sufficient rigidity and columnar strength to withstand forces applied by a physician to drive the tip portion through tissue stretched by a dilator around an opening through which a guide wire extends,

said tube forming the tip portion including a polymer material rendering the tip portion substantially more flexible than the tube forming the body portion,

wherein the flexible tube forming the body portion includes nylon-11 and an ester linked polyether-polyamide copolymer, and the flexible tube forming the tip portion includes nylon-11 and an ester linked polyether-polyamide copolymer, said copolymer in the tip portion having a hardness which is substantially less than the hardness of the copolymer in the body portion so as to render the tip portion softer and more flexible than the body portion, and

wherein the copolymer in the body portion has a Shore hardness in the range from 40D to 70D and the copolymer in the tip portion has a Shore hardness in the range from 25D to 50D.

11. A catheter introducer comprising

a body portion formed from a thin-walled flexible tube for extending into a body cavity or blood vessel to guide a catheter during insertion and placement of the catheter in the cavity or vessel,

a tip portion formed from a thin-walled flexible tube attached to the distal end of the body portion,

said tube forming the body portion having sufficient rigidity and columnar strength to withstand forces applied by a physician to drive the tip portion through tissue stretched by a dilator around an opening through which a guide wire extends,

said tube forming the tip portion including a polymer material rendering the tip portion substantially more flexible than the tube forming the body portion,

wherein the flexible tube forming the body portion includes nylon-11 and an ester linked polyether-polyamide copolymer, and the flexible tube forming the tip portion includes nylon-11 and an ester linked polyether-polyamide copolymer, said copolymer in the tip portion having a hardness which is substantially less than the hardness of the copolymer in the body portion so as to render the tip portion softer and more flexible than the body portion, and

wherein the weight percentage of copolymer in the flexible tube forming the body portion is substantially greater than the weight percentage of the copolymer in the flexible tube forming the tip portion.

12. A catheter introducer as claimed in claim 11 wherein the tube forming the tip portion is from 1.2 cm to 2.5 cm in length.

13. A catheter introducer as claimed in claim 11 wherein all internal surfaces of the introducer have a coating of lubricious hydrogel to promote ease of catheter insertion.

14. A catheter introducer as claimed in claim 11 wherein the flexible tube forming the tip portion has a coating of lubricious hydrogel on the exterior surface to render insertion through tissue easier.

15. A catheter introducer as claimed in claim 14 wherein all internal surfaces of the introducer have a coating of lubricious hydrogel to promote ease of catheter insertion.

16. A catheter introducer as claimed in claim 15 wherein the hydrogel is a copolymer of polyurethane and polyvinylpyrrolidone having from 1 to 3 parts by weight polyvinylpyrrolidone to 1 part polyurethane.

17. A catheter introducer comprising

a body portion formed from a thin-walled flexible tube for extending into a body cavity or blood vessel to guide a catheter during insertion and placement of the catheter in the cavity or vessel,

valve and seal means attached to a proximal end of the body portion for closing the proximal end of the body portion when the catheter is withdrawn and for forming a seal at the proximal end during insertion and placement of the catheter to prevent leakage, and

a tip portion formed from a thin-walled flexible tube attached to the distal end of the body portion,

said tube forming the tip portion including a polymer material rendering the tip portion substantially more flexible than the tube forming the body portion.

18. A catheter introducer as claimed in claim 17 wherein the valve and seal means includes an integral valve and seal structure having a rear disc-like portion with an opening for receiving and sealing a catheter, and a forward conical portion terminating in a disc with a valve slot.

19. A catheter introducer as claimed in claim 17 wherein the valve and seal means includes an integral valve and seal structure having a rear disc-like portion with an opening for receiving and sealing a catheter, and a forward tubular portion with a forward end wall having a valve slot.

20. A catheter introducer as claimed in claim 19 wherein the tubular portion of the integral valve and seal structure has an intermediate portion with an internal diameter which is necked down to form a second seal.

21. A catheter introducer as claimed in claim 17 wherein the tube forming the tip portion has a Shore hardness which is from 25 to 75 percent of a Shore hardness of the tube forming the body portion.

22. A catheter introducer as claimed in claim 17 wherein the flexible tube forming the body portion includes a nylon and from 0% to 50% ester linked polyether-polyamide copolymer, and the flexible tube forming the tip portion includes a nylon and from 50% to 100% ester linked polyether-polyamide copolymer wherein the percentage of copolymer in the tip portion is substantially greater than the percentage of copolymer in the body portion so as to render the tip portion softer and more flexible than the body portion.

23. A catheter introducer as claimed in claim 17 wherein the tube forming the tip portion is from 1.2 cm to 2.5 cm in length.

24. A catheter introducer as claimed in claim 17 wherein the flexible tubes forming the tip and body portions have a coating of lubricious hydrogel on the interior surfaces of the tubes to promote ease of catheter insertion.

25. A catheter introducer as claimed in claim 17 wherein the flexible tube forming the tip portion has a coating of lubricious hydrogel on the exterior surface to render insertion through tissue easier.

26. A catheter introducer as claimed in claim 25 wherein the hydrogel is a copolymer of polyurethane and polyvinylpyrrolidone having from 1 to 3 parts by weight polyvinylpyrrolidone to 1 part polyurethane.

27. A catheter introducer as claimed in claim 17 wherein all internal surfaces are coated to reduce thrombogenicity.

28. A catheter introducer as claimed in claim 27 wherein the coating on the internal surfaces is a lubricious copolymer of polyurethane and polyvinylpyrrolidone having from 1 to 3 parts by weight polyvinylpyrrolidone to 1 part polyurethane.

29. A catheter introducer as claimed in claim 17 wherein the flexible tube forming the body portion includes nylon-11 and an ester linked polyether-polyamide copolymer, and the flexible tube forming the tip portion includes nylon-11 and an ester linked polyether-polyamide copolymer, said copolymer in the tip portion having a hardness which is substantially less than the hardness of the copolymer in the body portion so as to render the tip portion softer and more flexible than the body portion.

30. A catheter introducer as claimed in claim 29 wherein the copolymer in the body portion has a Shore hardness in the range from 40D to 70D and the copolymer in the tip portion has a Shore hardness in the range from 25D to 50D.

31. A catheter introducer as claimed in claim 29 wherein the weight percentage of copolymer in the flexible tube forming the body portion is substantially greater than the weight percentage of the copolymer in the flexible tube forming the tip portion.

32. A catheter introducer as claimed in claim 31 wherein the tube forming the tip portion is from 1.2 cm to 2.5 cm in length.

33. A catheter introducer as claimed in claim 31 wherein all internal surfaces of the introducer have a coating of lubricious hydrogel to promote ease of catheter insertion.

34. A catheter introducer as claimed in claim 31 wherein the flexible tube forming the tip portion has a coating of lubricious hydrogel on the exterior surface to render insertion through tissue easier.

35. A catheter introducer as claimed in claim 34 wherein all internal surfaces of the introducer have a coating of lubricious hydrogel to promote ease of catheter insertion.

36. A catheter introducer as claimed in claim 35 wherein the hydrogel is a copolymer of polyurethane and polyvinylpyrrolidone having from 1 to 3 parts by weight polyvinylpyrrolidone to 1 part polyurethane.