DRAINAGE CATHETER AND GUIDE WIRE INTRODUCER KIT

• US 20200129065A1
• Filed: 10/28/2019
• Published: 04/30/2020
• Est. Priority Date: 10/30/2018
• Status: Active Application

• Current Assignee: John S. Demeritt, Patrick J. Toth
• Original Assignee: RLS Interventional, Inc.
• Inventors: DEMERITT, JOHN S., TOTH, PATRICK J.
• Application Number:
  US16/665,397
• Publication Number:
  US 20200129065A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 1/00119 Tubes or pipes in or with an endoscope
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• 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: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2205/0222 Materials for reducing friction
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• 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 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract
• 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 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The present disclosure includes a guide wire insertion kit and drainage catheter assembly. The guide wire insertion kit can include a guide wire, an introduction needle, a hollow dilator or sheath dilator. Optionally, the guide wire insertion kit can include the drainage catheter assembly. The drainage catheter assembly can include a catheter, a hollow rod, and at least one fluid port.

Claims

1. A drainage catheter assembly comprising:

a catheter comprising a flexible, hollow body terminating in a distal end comprising a tapered tip, and the hollow body defining a catheter lumen with a tip outlet in the tapered tip;

a hollow stiffening rod slidably received within the catheter lumen and defining a stiffening rod lumen marginally greater than 0.455 millimeters (0.018 inches);

the catheter lumen having a first portion sized to slidably receive the stiffening rod and a second portion, at least including the tip outlet, and marginally greater than 0.455 millimeters (0.018 inches); and

at least one fluid port located in the hollow body at the distal end.

2. The drainage catheter assembly of claim 1 wherein the at least the distal end comprises a curled portion.

3. The drainage catheter assembly of claim 2 wherein the curled portion is straightened when the stiffening rod is received within the catheter lumen.

4. The drainage catheter assembly of claim 3 wherein the at least one fluid port is located in the curled portion.

5. The drainage catheter assembly of claim 4 wherein the at least one fluid port comprises multiple fluid ports.

6. The drainage catheter assembly of claim 4 where in the first portion extends into the tapered tip.

7. The drainage catheter assembly of claim 5 wherein the at least one fluid port directly fluidly couples to the first portion of the catheter lumen.

8. The drainage catheter assembly of claim 7 wherein the first portion has a larger inner diameter than the second portion.

9. The drainage catheter assembly of claim 1 where in the first portion extends into the tapered tip.

10. The drainage catheter assembly of claim 1 wherein the at least one fluid port directly fluidly couples to the first portion of the catheter lumen.

11. The drainage catheter assembly of claim 1 wherein the first portion has a larger inner diameter than the second portion.

12. The drainage catheter assembly of claim 1 wherein at least the tapered tip comprises a lubricious coating.

13. The drainage catheter assembly of claim 1 wherein the tapered tip tapers continuously.

14. The drainage catheter assembly of claim 1 further comprising a 0.018 inch (0.46 millimeters) diameter guide wire that can be slidably received through the first and second portion.

15. The drainage catheter assembly of claim 14 wherein the guide wire comprises a guide wire distal end.

16. The drainage catheter assembly of claim 15 wherein the guide wire distal end is curled, soft, shapeable, or flexible.

17. The drainage catheter assembly of claim 16 wherein the wire or curled portion is flexible and made from a shape-memory material.

18. The drainage catheter assembly of claim 1 further comprising an imaging structure provided on at least one of the catheter or stiffening rod, with the imaging structure having at least one imaging modality.

19. The drainage catheter assembly of claim 18 wherein the at least one imaging modality is:

computed tomography, fluoroscopy, magnetic resonance imaging, mammography, x-ray, positron emission tomography, or ultrasound.

20. The drainage catheter assembly of claim 18 wherein the imaging structure comprises a series of gradations.

21. The drainage catheter assembly of claim 20 wherein the series of gradations comprises a distance scale.

22. A guide wire insertion kit comprising:

a guide wire having a diameter of 0.018 inch (0.46 millimeters) or smaller;

an introduction needle having an insertion tip and defining a needle lumen greater than the diameter of the guide wire; and

a hollow dilator of 4 to 10.5 French terminating in a tapered tip and defining a dilator lumen defining an outlet at the tapered tip, with at least the outlet of the lumen having being marginally larger than the diameter of the guide wire to provide a sliding fit clearance for the guide wire.

23. The kit of claim 22 wherein the dilator is a sheath dilator.

24. The kit of claim 23 wherein the sheath dilator is of 4 to 10.5 French.

25. The kit of claim 22 wherein the dilator can include a dilator stiffening rod slidably received within the dilator lumen and defining a dilator stiffening rod lumen marginally greater than 0.455 millimeters (0.018 inches).

26. The kit of claim 22 wherein the guide wire comprises a guide wire distal end.

27. The kit of claim 26 wherein the guide wire distal end comprises a curled portion.

28. The kit of claim 27 wherein the curled portion is flexible and made from a shape-memory material.

29. The kit of claim 25 further comprising an imaging structure provided on at least one of the dilator or the dilator stiffening rod, with the imaging structure having at least one imaging modality.

30. The kit of claim 29 wherein the at least one imaging modality is:

computed tomography, fluoroscopy, magnetic resonance imaging, mammography, x-ray, positron emission tomography, or ultrasound.

31. The kit of claim 29 wherein the imaging structure comprises a series of gradations.

32. The kit of claim 31 wherein the series of gradations comprises a distance scale.

33. The kit of claim 22 wherein the insertion tip comprises a sharpened tip.

34. The kit of claim 33 wherein the insertion tip comprises a beveled tip to form the sharpened tip.

35. The kit of claim 22 wherein the needle lumen is marginally larger than the diameter of the guide wire to provide a sliding fit clearance between the guide wire and the introduction needle.

36. The kit of claim 22 further comprising a drainage catheter assembly defining a catheter lumen greater than the diameter of the guide wire.

37. The kit of claim 36 wherein the catheter comprises a flexible, hollow body terminating in a distal end comprising a tapered tip, and the hollow body defining the catheter lumen with a tip outlet in the tapered tip.

38. The kit of claim 37 wherein the catheter lumen has a portion at the tip outlet marginally larger than the diameter of the guide wire to provide a sliding fit clearance for the guide wire.

39. The kit of claim 38 further comprising a hollow stiffening rod slidably received within at least a portion of the catheter lumen and defining a stiffening rod lumen greater than the diameter of the guide wire.

40. The kit of claim 39 wherein the catheter comprises at least one fluid port located in a hollow body at the distal end.

41. The kit of claim 40 wherein the distal end of the catheter comprises a curled portion.

42. The kit of claim 41 wherein the curled portion is straightened when the stiffening rod is received within the catheter lumen.

43. The kit of claim 42 wherein the at least one fluid port is located in the curled portion.

44. The kit of claim 43 wherein at least the tapered tip of the catheter comprises a lubricious coating.

45. A method of draining a site in a tissue mass, the method comprising:

imaging the tissue mass to locate the site;

while imaging the site in the tissue mass, non-intravenously introducing a guide wire to the site, where the guide wire diameter is 0.018 inch (0.46 millimeters) or smaller;

dilating the tissue mass by sliding a dilator of 4 to 10.5 French, with a dilator lumen of marginally larger than the diameter of the guide wire, over the guide wire; and

placing a drainage catheter assembly of 4 to 10.5 French at the site, with a catheter lumen marginally larger than the diameter of the guide wire, by sliding the drainage catheter assembly over the guide wire and to the site.

46. The method of claim 45 wherein the dilator is removed from the tissue mass prior to the sliding of the drainage catheter assembly over the guide wire.

47. The method of claim 45 wherein the dilator is a sheath dilator comprising a dilator and a surrounding sheath and the dilating the tissue mass comprises removing the dilator while leaving the sheath and the placing the drainage catheter assembly comprises sliding the drainage catheter assembly into the sheath.

48. The method of claim 47 comprising removing the sheath after the placing of the drainage catheter assembly.

49. The method of claim 45 wherein the sliding the drainage catheter assembly is done during imaging of the tissue mass.

50. The method of claim 49 wherein the sliding the drainage catheter assembly is done while imaging the tissue mass.

51. The method of claim 50 wherein the sliding the drainage catheter assembly while imaging comprises sliding the drainage catheter assembly until an imaging structure on a catheter is at a desired location relative to the site based on the imaging.

52. The method of claim 45 further comprising removing a hollow stiffening rod from the drainage catheter assembly after the placing of the drainage catheter assembly.