Catheter introducer system

• US 20040147877A1
• Filed: 01/27/2003
• Published: 07/29/2004
• Est. Priority Date: 01/27/2003
• Status: Active Grant

• Current Assignee: Arizona Medical Systems, LLC
• Original Assignee: Richard R. Heuser
• Inventors: Heuser, Richard R.
• Granted Patent: US 7,166,088 B2
• Time in Patent Office: Days
• US Class Current: 604/165.02
• 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: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/3441 with distal sealing means
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• 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 25/0662 Guide tubes
• 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
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A catheter introducer system is provided with a catheter sheath having a valve providing for a friction fit around a catheter. The friction fit is selectively adjustable to vary between a first configuration for longitudinal movement of the catheter through the valve and a second configuration for holding the catheter longitudinally in place. The valve may includes a chuck to grip the catheter radially. The chuck may include an annular base and an opposed annular clamp, and a washer disposed between the base and the clamp. At least one of the base and the clamp may include a beveled surface that forces the washer radially inwardly as the base and the clamp are drawn together. The system also includes one or more dilators layered within the sheath. The layered dilators and sheaths are typically softer and more hydrophilic proceeding from the innermost dilator out to the sheath. The dilator may be reinforced by a wire embedded in the body of the dilator. The distal tip of the sheath may be stiffened by a ring affixed adjacent the distal end. The sheath may include in the innermost dilator a trocar formed of a flexible, hollow outer wire and an inner stiff needle, which can extend beyond the wire for piercing and be withdrawn to relax the wire for advancement of the dilator.

Claims

1. A catheter introducer system comprising a catheter sheath including a generally elongate body and a housing coupled to the body, the body and housing including a lumen and distal and proximal openings communicating with the lumen and configured for insertion and longitudinal movement of a catheter therethrough, the sheath including a valve with an opening configured to receive the catheter therethrough, the valve providing for a friction fit around the catheter, the friction fit being selectively adjustable to vary between a first configuration for longitudinal movement of the catheter through the valve and a second configuration for holding the catheter longitudinally in place.

2. The catheter introducer system of claim 1 further comprising a first dilator defining a generally elongate body having a distal end and a proximal end, wherein the first dilator is disposed substantially within the lumen of the sheath, with the distal end of the first dilator extending through the distal opening of the sheath, the first dilator removable from the sheath for insertion of the catheter.

3. The catheter introducer system of claim 1, further including a first dilator defining a generally elongate body having a distal end and a proximal end, and further including a second dilator defining a generally elongate body having a distal end and a proximal end, an opening adjacent each end, and an open lumen communicating with the openings, wherein the first dilator is disposed substantially within the lumen of the second dilator with the distal end of the first dilator extending through the distal opening of the second dilator, and wherein the second dilator is disposed substantially within the lumen of the sheath with the distal end of the second dilator extending through the distal opening of the sheath, and further wherein the first and second dilators are removable from the sheath for insertion of the catheter.

4. The catheter introducer system of claim 1 wherein the valve includes a chuck to grip the catheter radially.

5. The catheter introducer system of claim 4 wherein the chuck includes an annular base and an opposed annular clamp, and a washer disposed between the base and the clamp.

6. The catheter introducer system of claim 5 wherein at least one of the base and the clamp include a beveled surface that forces the washer radially inwardly as the base and the clamp are drawn together.

7. The catheter introducer system of claim 5 wherein the washer includes a beveled surface that interfaces with one of the base or the clamp to force the washer radially inwardly as the base and the clamp are drawn together.

8. A catheter introducer system comprising:

a first dilator defining a generally elongate body having a distal end and a proximal end;

a second dilator defining a generally elongate body having a distal end and a proximal end, an opening adjacent each end, and an open lumen communicating with the openings, wherein the first dilator is disposed substantially within the lumen of the second dilator with the distal end of the first dilator extending through the distal opening of the second dilator;

a sheath defining a generally elongate body having a distal end and a proximal end, an opening adjacent each end, and an open lumen communicating with the openings, wherein the second dilator is disposed substantially within the lumen of the sheath with the distal end of the second dilator extending through the distal opening of the sheath.

9. The catheter introducer system of claim 8 wherein the first dilator is constructed to be stiffer than the second dilator.

10. The catheter introducer system of claim 8 wherein the second dilator is constructed to be stiffer than the sheath.

11. The catheter introducer system of claim 10 wherein the first dilator is constructed to be stiffer than the second dilator.

12. The catheter introducer system of claim 8 wherein the first dilator includes an opening adjacent each end, and an open lumen communicating with the openings, and further comprising a trocar inserted through the lumen of the first dilator.

13. The catheter introducer system of claim 8 further including a third dilator defining a generally elongate body having a distal end and a proximal end, an opening adjacent each end, and an open lumen communicating with the openings, wherein the third dilator is disposed substantially within the sheath, with the distal end of the third dilator extending through the distal opening of the sheath.

14. The catheter introducer system of claim 13 wherein the sheath defines an inner diameter of at least about 10 french in size.

15. The catheter introducer system of claim 13 wherein the sheath defines an inner diameter of at least about 18 french in size.

16. The catheter introducer system of claim 15 wherein the first dilator defines an inner diameter of no more than about 3 french in size.

17. The catheter introducer system of claim 8 wherein the body of the first dilator is reinforced.

18. The catheter introducer system of claim 8 wherein the distal end of the sheath is reinforced.

19. The catheter introducer system of claim 8 wherein the first dilator includes a hemostasis valve defining an opening configured to receive therethrough a catheter, the valve being selectively adjustable to vary between a first configuration providing for longitudinal movement of the catheter, and a second configuration for preventing blood loss between the valve and the catheter.

20. The catheter introducer system of claim 8 wherein the sheath defines an inner diameter at least about 16 french in size.

21. The catheter introducer system of claim 8 wherein the first dilator defines an inner diameter no more than about 3 french in size.

22. A sheath and dilator system comprising:

a sheath defining a generally elongate body, distal and proximal ends, openings adjacent each end, and a lumen communicating between the openings, the sheath configured for insertion into a bodily fluid vessel and for receiving a catheter through the lumen and the openings; and

a dilator defining a generally elongate body having distal and proximal ends, the dilator removably inserted through the lumen of the sheath, the dilator body being comprised of a flexible material suitable for insertion into a human blood vessel, and the dilator body further including a reinforcement.

23. The sheath and dilator system of claim 22 wherein the reinforcement of the dilator includes a stiffener extending along at least a portion of the body of the dilator.

24. The sheath and dilator system of claim 23 wherein the stiffener is a wire web embedded in the body of the dilator.

25. The sheath and dilator system of claim 22 wherein the sheath includes a ring affixed adjacent the distal end.

26. The sheath and dilator system of claim 25 wherein the ring is comprised substantially of metal.

27. A system of layered dilators and a sheath for percutaneous insertion of a catheter, the system comprising:

at least two dilators and a sheath, each defining distal and proximal ends, openings adjacent each ends, and a lumen communicating between the openings, the dilators and sheath arranged with one of the dilators disposed substantially within at least one other of the dilators, which in turn is disposed substantially within the sheath, the dilators and sheath ranging in size of an inner diameter from no more than about 3 french to at least about 5 french in size.

28. The system of claim 27 wherein the innermost dilator is more stiff than the sheath.

29. The system of claim 28 wherein the sheath is at least about 9 french in size.

30. The system of claim 27 wherein the sheath is at least about 18 french in size.

31. The system of claim 27 wherein the sheath is at least about 24 french in size.

32. The system of claim 27 further comprising a third dilator.

33. The system of claim 27 wherein at least one of the dilators is tapered substantially along its entire length.

34. A catheter introducer system comprising:

a catheter sheath defining a generally elongate body with a lumen and distal and proximal openings communicating with the lumen and configured for insertion and longitudinal movement of a catheter therethrough;

a first dilator defining a generally elongate body having a distal end and a proximal end, wherein the first dilator is disposed substantially within the lumen of the sheath, with the distal end of the first dilator extending through the distal opening of the sheath, the first dilator removable from the sheath for insertion of the catheter; and

a trocar inserted through the lumen of the first dilator, the trocar including a flexible, hollow outer wire, and a stiff, inner needle with a distal end extending beyond a distal end of the wire, the needle configured for piercing through a patient'"'"'s derma and entering a blood vessel.

35. The catheter introducer system of claim 34 wherein the needle of the trocar is hollow, and includes distal and proximal openings configured to allow blood to flow from the distal opening through to the proximal opening.

36. The catheter introducer system of claim 35 wherein the needle is beveled at the distal end to provide a derma-piercing point.

37. The catheter introducer system of claim 34 wherein the needle includes a proximal end extending out of a proximal end of the outer wire of the trocar, the proximal end configured to be grasped by a physician to withdraw the distal end of the needle.

38. The catheter introducer system of claim 37 wherein withdrawing the needle prevents further blood flow through the trocar.

39. The catheter introducer system of claim 37 wherein withdrawing the needle allows the outer wire to flex.